,,ii #aai? ,,congress #a/ ,session ,s4 #achg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #i1 #bjbe,mr4 ,"y 7= himself & ,mr4 ,padilla7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to au?orize ! ,national ,biote*nology ,initiative1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,national ,biote*nology ,initiative ,act ( #bjbe4 #b4 ,def9itions ,9 ?is ,act3 7#a7 ,biolit]acy ,! t]m biolit]acy ref]s to ! concept ( imbu+ p1 p]sonnel1 or teams ) an und]/&+ ( & ability to engage ) biology & biote*nology4 7#b7 ,biological data ,! t]m biological data means ! in=mation1 includ+ associat$ descriptors1 d]iv$ f ! /ructure1 function1 or process ( a biological sy/em7s7 t is ei!r measur$1 collect$1 or aggregat$ = analysis4 7#c7 ,biomanufactur+ ,! t]m biomanufactur+ means ! application ( biote*nology to manufactur+4 7#d7 ,biote*nology ,! t]m biote*nology means ! application ( sci5ce & eng9e]+ 9 ! direct or indirect use ( liv+ organisms1 or p>ts or products ( liv+ organisms1 includ+ modifi$ =ms4 7#e7 ,director ( ! ,national ,biote*nology ,coord9ation ,(fice ,! t]m ,director ( ! ,national ,biote*nology ,coord9ation ,(fice means ! individual appo9t$ pursuant to section #d7;b77#b77;,a74 7#f7 ,initiative ,! t]m ,initiative means ! ,national ,biote*nology ,initiative e/abli%$ "u section #c4 7#g7 ,int]ag5cy ,committee ,! t]m ,int]ag5cy ,committee means ! int]ag5cy committee designat$ pursuant to section #ajdjc7;a77#a74 7#h7 ,(fice ,! t]m ,(fice means ! ,national ,biote*nology ,coord9ation ,(fice e/abli%$ "u section #d7;b74 7#i7 ,p>ticipat+ ag5cy ,! t]m p>ticipat+ ag5cy means a dep>tm5t1 (fice1 or ag5cy set =? "u section #c7;b74 #c4 ,au?orization ( ! ,national ,biote*nology ,initiative 7a7 ,initiative requir$ 7#a7 ,9 g5]al ,! ,presid5t1 act+ ?r\gh ! ,executive ,(fice ( ! ,presid5t1 %all implem5t an initiative to advance national security1 economic productivity1 & competitiv5ess ?r\gh advancem5t & coord9ation ( ,f$]al activities relat+ to biote*nology4 7#b7 ,designation ,! initiative implem5t$ pursuant to p>agraph 7#a7 %all be kn[n z ! ,national ,biote*nology ,initiative4 7b7 ,p>ticipat+ ag5cies ,! foll[+ %all be p>ticipants 9 ! ,initiative3 7#a7 ,! ,dep>tm5t ( ,agriculture4 7#b7 ,! ,dep>tm5t ( ,comm]ce4 7#c7 ,! ,dep>tm5t ( ,def5se4 7#d7 ,! ,dep>tm5t ( ,en]gy4 7#e7 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#f7 ,! ,dep>tm5t ( ,homel& ,security4 7#g7 ,! ,dep>tm5t ( ! ,int]ior4 7#h7 ,! ,dep>tm5t ( ,/ate4 7#i7 ,! ,environm5tal ,protection ,ag5cy4 7#aj7 ,! ,national ,a]onautics & ,space ,adm9i/ration4 7#aa7 ,! ,national ,sci5ce ,f\ndation4 7#ab7 ,! ,(fice ( ! ,director ( ,national ,intellig5ce4 7#ac7 ,! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 7#ad7 ,su* o!r ,f$]al dep>tm5ts & ag5cies z ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice consid]s appropriate4 7c7 ,activities ,ea* head ( a p>ticipat+ ag5cy %all c>ry out ! ,initiative1 includ+ by c>ry+ out ! activities requir$ by section #f & by address+ & coord9at+ ! foll[+3 7#a7 ,f$]al activities relat+ to biote*nology1 includ+ to create & ma9ta9 a national /rategy on biote*nology4 7#b7 ,national security implications ( em]g+ biote*nology4 7#c7 ,su/a9$ support = rese>* & developm5t t accel]ates sci5tific und]/&+ & te*nological innovation 9 biote*nology4 7#d7 ,su/a9$ support = biological data1 databases1 & relat$ tools z a /rategic national res\rce4 7#e7 ,private sector translation & comm]cialization ( products t are produc$ ) biote*nology4 7#f7 ,regulatory /reaml9+ = products t are produc$ ) biote*nology4 7#g7 ,biosafety & biosecurity issues associat$ ) em]g+ biote*nology4 7#h7 ,developm5t ( a dome/ic work=ce1 includ+ ! ,f$]al work=ce1 to advance biote*nology across ! ,unit$ ,/ates4 7#i7 ,biolit]acy activities t provide cle>1 easy-to-f9d in=mation = policymak]s1 innovators1 & ! public4 7#aj7 ,int]national p>tn]%ips1 includ+ regulatory & comm]cial diplomacy4 7#aa7 ,su* o!r activities relat+ to biote*nology z ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice & ! ,int]ag5cy ,committee jo9tly det]m9e are ne$$ to advance national security1 economic productivity1 & competitiv5ess relat+ to biote*nology4 #d4 ,initiative coord9ation 7a7 ,int]ag5cy committee 7#a7 ,designation ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t %all1 act+ ?r\gh ! ,executive ,(fice ( ! ,presid5t1 designate an int]ag5cy committee to coord9ate activities ( ! ,initiative4 7#b7 ,duties ,ea* memb] ( ! ,int]ag5cy ,committee %all-- 7,a7 "w ) ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice to ov]see ! plann+1 managem5t1 & coord9ation ( ! ,initiative2 7,b7 ensure ! dep>tm5t or ag5cy ( ! memb] supports ! ,initiative ?r\gh relevant activities set =? "u section #f2 7,c7 keep ! o!r memb]s ( ! ,int]ag5cy ,committee appris$ ( ! activities describ$ 9 subp>agraph 7,b72 & 7,d7 communicate activities ( ! ,int]ag5cy ,committee ) relevant compon5ts ( ! ,dep>tm5t or ag5cy ( ! memb]4 7#c7 ,memb]%ip ,! ,int]ag5cy ,committee %all include #a memb] at ! ,assi/ant ,secret>y level f ea* p>ticipat+ ag5cy select$ by ! head ( ! p>ticipat+ ag5cy4 7#d7 ,co-*airp]sons 7,a7 ,9 g5]al ,! ,int]ag5cy ,committee %all h #c co-*airp]sons1 ( :om-- 7i7 "o co-*airp]son %all be ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice2 & 7ii7 two co-*airp]sons %all be select$ by ! memb]s ( ! ,int]ag5cy ,committee f among ! memb]s ( ! ,int]ag5cy ,committee4 7,b7 ,t]ms ,ea* co-*airp]son select$ pursuant to subp>agraph 7,a77ii7 %all s]ve a t]m ( #b ye>s1 except = ! fir/ t]m ! ,int]ag5cy ,committee %all select "o co-*airp]son to s]ve a t]m ( #c ye>s1 su* t subsequ5t t]ms are /agg]$4 7,c7 ,vacancies 7i7 ,9 g5]al ,a vacancy "u ?is p>agraph %all be fill$ 9 ! mann] 9 :i* ! orig9al appo9tm5t 0 made & %all be subject to any conditions t appli$ ) respect to ! orig9al appo9tm5t4 7ii7 ,fill+ unexpir$ t]m ,an individual *os5 to fill a vacancy %all be appo9t$ = ! unexpir$ t]m ( ! co-*airp]son replac$4 7,d7 ,quorum ,a majority ( ! memb]s ( ! ,int]ag5cy ,committee %all con/itute a quorum = ! purposes ( vot+ = co-*airp]sons "u clauses 7i77,,ii7 & 7ii77,,ii7 ( subp>agraph 7,a71 ) co-*airp]sons select$ by ! memb] :o receives ! highe/ plurality ( votes4 7,e7 ,limitation ,a memb] ( ! ,int]ag5cy ,committee f a p>ticul> ,f$]al dep>tm5t or ag5cy may n s]ve consecutive t]ms z co-*airp]son ( ! ,int]ag5cy ,committee4 7b7 ,national ,biote*nology ,coord9ation ,(fice 7#a7 ,e/abli%m5t ( ,national ,biote*nology ,coord9ation ,(fice 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t %all e/abli% an (fice 9 ! ,executive ,(fice ( ! ,presid5t to support ! ,initiative4 7,b7 ,designation ,! (fice e/abli%$ pursuant to subp>agraph 7,a7 %all be kn[n z ! ,national ,biote*nology ,coord9ation ,(fice4 7#b7 ,director ( ,national ,biote*nology ,coord9ation ,(fice 7,a7 ,appo9tm5t ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t %all appo9t an individual to s]ve z ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice4 7,b7 ,duties ,! duties ( ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice are z foll[s3 7i7 ,to s]ve z ! pr9cipal advisor to ! ,presid5t = biote*nology4 7ii7 ,to adm9i/] ! functions ( ! ,(fice set =? "u p>agraph 7#c74 7,c7 ,au?orities ,9 support ( ! ,initiative1 ! ,director may-- 7i7 advise ! ,director ( ! ,(fice ( ,managem5t & ,budget = ! purposes ( track+ & adju/+ ag5cy sp5d+ relat+ to biote*nology1 includ+ to ensure t ,f$]al ef=ts are complem5t>y & n duplicative2 7ii7 conv5e memb]s ( ! ,int]ag5cy ,committee 9 ord] to advance & coord9ate ,f$]al activities relat+ to biote*nology2 7iii7 coord9ate ,f$]al regulation ( products t are produc$ ) biote*nology2 7iv7 select1 appo9t1 employ1 & fix ! comp5sation ( su* (fic]s & employees z are necess>y & prescribe _! duties2 7v7 ent] into & p]=m su* contracts1 leases1 coop]ative agreem5ts1 or o!r transactions1 z appropriate1 to ! conduct ( ! "w ( ! ,(fice2 7vi7 utilize1 ) _! cons5t1 ! s]vices1 p]sonnel1 & facilities ( o!r ,f$]al ag5cies2 & 7vii7 accept volunt>y & uncomp5sat$ s]vices1 not)/&+ ! provisions ( section #acdb ( title #ca1 ,unit$ ,/ates ,code4 7#c7 ,functions ( ! ,(fice ,! functions ( ! ,(fice %all be1 9 support ( ! ,initiative1 ! foll[+3 7,a7 ,plann+ & coord9ation ,functions relat+ to plann+ & coord9ation z foll[s3 7i7 ,work+ ) ! ,int]ag5cy ,committee to ov]see ! plann+1 managem5t1 & coord9ation ( ,f$]al activities relat+ to biote*nology4 7ii7 ,provid+ te*nical & adm9i/rative support to ! ,int]ag5cy ,committee4 7iii7 ,assess+ ! l&scape & gaps associat$ ) ! diff]5t compon5ts ( ! ,initiative4 7iv7 ,coord9at+ a fell[%ip program 9 :i* ,f$]al employees are detail$ to #a or m ,f$]al ag5cies to ga9 great] und]/&+ ( biote*nology activities outside ( _! home ag5cy4 7v7 ,build+ & ma9ta9+ a coord9at$ website = ,f$]al activities relat+ to biote*nology pursuant to subsection 7c74 7vi7 ,coord9at+ developm5t ( an annual report "u subsection 7d7 & a national /rategy z requir$ by subsection 7e74 7vii7 ,conduct+ su* o!r activities to support ! ,initiative z ! ,director consid]s appropriate4 7,b7 ,national security ,functions relat+ to national security z foll[s3 7i7 ,assess+ & address+ ! national security & economic security implications ( em]g+ biote*nology4 7ii7 ,id5tify+ & rem$y+ any major ne$s or in=mation gaps 9 curr5t national security assessm5ts & activities1 includ+ to conduct c\nt]9tellig5ce ef=ts to fill gaps relat+ to biote*nology4 7iii7 ,provid+ coord9ation 9 address+ =eign inve/m5ts & acquisition f adv]s>ial c\ntries4 7,c7 ,rese>* & developm5t ,functions relat+ to rese>* & developm5t z foll[s3 7i7 ,coord9at+ su/a9$ support = rese>* & developm5t t accel]ates sci5tific und]/&+ & te*nological innovation 9 biote*nology4 7ii7 ,facilitat+ jo9t ag5cy solicitations = fund+ = individual grants1 collaborative grants1 & int]discipl9>y rese>* c5t]s4 7iii7 ,develop+ & propos+ focus areas or *all5ges = rese>* fund+ meant to advance biote*nology1 p>ticul>ly relat+ to conv]g5ce ) o!r te*nologies su* z artificial intellig5ce4 7iv7 ,develop+1 /&>diz+1 & deploy+ robu/ me*anisms = docum5t+ & quantify+ ! outputs & economic b5efits ( biote*nology4 7,d7 ,data & databases ,functions relat+ to data & databases z foll[s3 7i7 ,coord9at+ su/a9$ support = biological data1 databases1 & relat$ tools z a /rategic national res\rce to advance human heal? & ! und]/&+ ( animals1 plants1 microbes1 & o!r organisms4 7ii7 ,recomm5d+ actions to integrate security into biological data access & int]national reciprocity agreem5ts4 7iii7 ,coord9at+ frameworks = biological data /&>dization to create datasets t are int]op]able & usable by advanc$ computation me?ods su* z artificial intellig5ce4 7,e7 ,product comm]cialization ,functions relat+ to product comm]cialization z foll[s3 7i7 ,/rategiz+ & coord9at+ on private sector translation & comm]cialization ( products t are produc$ ) biote*nology4 7ii7 ,assi/+ 9 coord9at+ a national network ( te/b$s to enable scale-up ( biote*nology rese>*4 7,f7 ,regulatory /reaml9+ ,functions relat+ to regulatory /reaml9+ z foll[s3 7i7 ,coord9at+ ! eas+ ( regulatory burd5 = types ( biote*nology products t h become well-und]/ood by regulators1 includ+ products t c\ld h occurr$ naturally or be5 develop$ ) conv5tional means4 7ii7 ,negotiat+ int]ag5cy agreem5ts t describe cle> regulatory pa?ways = ea* type ( biote*nology product1 ) in=mation ab\t timel9es1 decision po9ts1 expect$ data requirem5ts1 cle> h&-(fs betwe5 ag5cies1 & o!r in=mation deem$ necess>y by ! ,(fice to resolve regulatory gaps1 ov]laps1 & ambiguities = biote*nology products4 7iii7 ,provid+ regul> /atus updates to ! ,(fice ( ,managem5t & ,budget z to ! developm5t ( cle> regulatory pa?ways1 & 9 ! ev5t t ! ,(fice & ! ,int]ag5cy ,committee _c rea* timely agreem5t on a cle> regulatory pa?way = any product type1 assi/+ ! ,director ( ! ,(fice ( ,managem5t & ,budget 9 c>ry+ out p>agraph 7#e74 7iv7 ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 jo9tly ) ! ,int]ag5cy ,committee develop+ & mak+ available to ! public a plan = regulatory /reaml9+4 7,g7 ,biosafety & biosecurity ,functions relat+ to biosafety & biosecurity z foll[s3 7i7 ,develop+ /rategies & coord9at+ to address biosafety & biosecurity issues associat$ ) em]g+ biote*nology4 7ii7 ,coord9at+ on assessm5t & mitigation ( pot5tial biosafety & biosecurity ?reats relat+ to biote*nology rese>*1 includ+ ?r\gh collaboration ) regulatory ag5cies & indu/ry4 7,h7 ,work=ce developm5t ,functions relat+ to work=ce developm5t z foll[s3 7i7 ,coord9at+ & develop+ /rategies to develop a dome/ic work=ce = biote*nology4 7ii7 ,coord9at+ ) appropriate ag5cies to e/abli% a national biote*nology work=ce framework to def9e biote*nology jobs & skills 9 public & private sectors4 7iii7 ,coord9at+ ) appropriate ag5cies to conduct an int]ag5cy assessm5t ( biote*nology work=ce ne$s1 & subsequ5tly develop+ & provid+ tra9+ programs4 7,i7 ,biolit]acy ,functions relat+ to biolit]acy z foll[s3 7i7 ,coord9at+ developm5t ( pla9-language mat]ials ab\t biote*nology4 7ii7 ,provid+ c5tral locations1 includ+ ! website requir$ by subsection 7c71 = cle>1 easy-to-f9d in=mation ab\t biote*nology = policymak]s1 innovators1 & ! public4 7,j7 ,int]national p>tn]%ips ,functions relat+ to int]national p>tn]%ips z foll[s3 7i7 ,coord9at+ ,f$]al regulatory & comm]cial diplomacy activities4 7ii7 ,assess+ ! curr5t regulatory & comm]cial diplomacy activities c>ri$ out across ! ,f$]al ,gov]nm5t1 id5tify+ gaps1 & develop+ an outrea* /rategy to improve ! regulatory l&scape & m>ket access = products ( ! ,unit$ ,/ates4 7iii7 ,id5tify+ non-regulatory solutions = trade & m>ket access conc]ns 7su* z ! use ( id5tity pres]vation = c]ta9 agricultural biote*nology products7 & work+ ) relevant gov]nm5t ag5cies & /akehold]s to implem5t solutions4 7,k7 ,o!r ,su* o!r activities z ! ,director consid]s necess>y to advance national security1 economic productivity1 & competitiv5ess relat$ to biote*nology4 7#d7 ,adm9i/rative support & au?orization ( appropriations 7,a7 ,adm9i/rative support ,! ,director ( ! ,national ,sci5ce ,f\ndation %all provide support = ! adm9i/ration & implem5tation ( ! ,initiative1 includ+-- 7i7 appo9t+ & provid+ comp5sation = employees ( ! ,(fice1 )\t reg>d to any provision relat+ to appo9tm5t or comp5sation "u title #e1 ,unit$ ,/ates ,code1 includ+-- 7,i7 deputy directors z ne$$ to address ! responsibilities 9 p>agraph 7#c71 z det]m9$ necess>y by ! ,director ( ! ,(fice2 & 7,,ii7 o!r appropriate employees1 includ+ exp]ts 9 ! sci5ce ( biote*nology1 biote*nology policy1 regulatory policy1 & sci5ce communication1 legal c\nsel1 & s(tw>e design]s & develop]s1 z det]m9$ necess>y by ! ,director ( ! ,(fice2 7ii7 fix+ ! comp5sation ( employees ( ! ,(fice 9 an am\nt t does n exce$ ! am\nt ( annual comp5sation 7exclud+ exp5ses7 specifi$ 9 section #ajb ( title #c1 ,unit$ ,/ates ,code2 7iii7 detail+ employees ( ! ,national ,sci5ce ,f\ndation to ! ,(fice & receiv+ ! detail ( employees f o!r ag5cies to ! ,(fice2 & 7iv7 assi/ance ) o!r co/s associat$ ) runn+ ! ,initiative1 includ+ physical space1 o!r /aff1 & ov]head support4 7,b7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to ! ,director ( ! ,national ,sci5ce ,f\ndation to c>ry out subp>agraph 7,a7-- 7i7 #bb1jjj1jjj = fiscal ye> #bjbf2 7ii7 #ce1jjj1jjj = fiscal ye> #bjbg2 7iii7 #be1jjj1jjj = fiscal ye> #bjbh2 7iv7 #be1jjj1jjj = fiscal ye> #bjbi2 & 7v7 #be1jjj1jjj = fiscal ye> #bjcj4 7#e7 ,regulatory /reaml9+ by ,(fice ( ,managem5t & ,budget ,9 ! ev5t t ! ,(fice & ! ,int]ag5cy ,committee _c rea* timely agreem5t on a cle> regulatory pa?way = a product type1 z describ$ 9 p>agraph 7#c77;,f77iii71 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all-- 7,a7 id5tify ov]laps1 gaps1 or ambiguities 9 ! regulation = su* product type2 7,b7 negotiate an int]ag5cy agreem5t t describes a cle> regulatory pa?way = su* product type1 ) in=mation ab\t timel9es1 decision po9ts1 expect$ data requirem5ts1 cle> h&-(fs betwe5 ag5cies1 & o!r in=mation deem$ necess>y by ! ,(fice ( ,managem5t & ,budget to resolve regulatory gaps1 ov]laps1 & ambiguities2 & 7,c7 recomm5d & ov]see rulemak+ or *anges to guidance z ne$$ to implem5t cle> regulatory pa?ways4 7#f7 ,w9d-d[n 7,a7 ,9 g5]al ,! ,(fice %all w9d-d[n its activities on ! date t is #bj ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & transition to s]v+ z an executive secret>iat = ! ,initiative4 7,b7 ,w9d-d[n activities ,! activities specifi$ 9 ?is clause are z foll[s3 7i7 ,! transf] ( au?orities1 requirem5ts1 res\rces1 p]sonnel1 & obligations ( ! ,(fice to ! fulle/ ext5t possible to ! ,int]ag5cy ,committee & su* elem5ts ( ! ,f$]al ,gov]nm5t z ! ,director & ! ,int]ag5cy ,committee consid] appropriate4 7ii7 ,! ,(fice %all ma9ta9 au?orities1 requirem5ts1 res\rces1 p]sonnel1 & obligations necess>y to s]ve z ! executive secret>iat = ! ,initiative1 includ+ to cont9ue ! coord9ation 9 subsection 7b77#c77;,a71 ! website 9 subsection 7c71 & any o!r activities t ! ,director & ! ,int]ag5cy ,committee consid] appropriate4 7,c7 ,treatm5t ( transf]r$ functions ,comm5c+ on ! date on :i* ! ,(fice is t]m9at$ "u subp>agraph 7,a71 any ref]5ce to a requirem5t or an au?ority ( ! ,(fice t has be5 transf]r$ to ! ,int]ag5cy ,committee or an elem5t ( ! ,f$]al ,gov]nm5t %all be treat$ z a ref]5ce to ! ,int]ag5cy ,committee or ! elem5t ( ! ,f$]al ,gov]nm5t to :i* su* requirem5t or au?ority 0 transf]r$ pursuant to subp>agraph 7,b74 7c7 ,website 7#a7 ,9 g5]al ,n lat] ?an #edj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice & ! ,int]ag5cy ,committee %all jo9tly develop & publi% = ! public a s+le1 coord9at$ ,f$]al website = biote*nology t adh]es to be/ practices = website design1 developm5t1 & ma9t5ance4 7#b7 ,cont5ts ,! website develop$ & publi%$ pursuant to p>agraph 7#a7 %all include ! foll[+3 7,a7 ,a da%bo>d ( ,f$]al ,gov]nm5t activities relat+ to biote*nology1 includ+ in=mation ab\t op5 fund+ opportunities4 7,b7 ,pla9-language in=mation ab\t biote*nology1 includ+ in=mation = policymak]s1 innovators1 trad+ p>tn]s1 & ! public4 7,c7 ,a me*anism = /akehold]s to ask a "q & receive a s+le1 coord9at$ response4 7,d7 ,me*anisms1 :i* may be populat$ ov] "t1 to provide consolidat$ in=mation ab\t biote*nology product regulation1 focus+ on products t are regulat$ by m ?an #a ,f$]al ag5cy1 ) cont5t t includes ! foll[+3 7i7 ,a repository ( int]ag5cy agreem5ts t describe cle> regulatory pa?ways1 ) l9ks to relevant regulations & guidance docum5ts = ea* type ( biote*nology product4 7ii7 ,a repository ( regulatory decision docum5ts = biote*nology products4 7iii7 ,a digital portal t all[s submission ( a s+le application & in=mation %>+ betwe5 ,f$]al ag5cies4 7#c7 ,updates ,! ,director & ! ,int]ag5cy ,committee %all jo9tly update ! website requir$ by p>agraph 7#a7 p]iodically4 7d7 ,annual reports 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & n less frequ5tly ?an once ea* ye> !reaft]1 except 9 ye>s 9 :i* a national /rategy = biote*nology is requir$ "u subsection 7e71 ! ,director ( ,national ,biote*nology ,coord9ation ,(fice & ! ,int]ag5cy ,committee %all jo9tly submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,sci5ce1 ,space1 & ,te*nology ( ! ,h\se ( ,repres5tatives an annual report on ! ,initiative4 7#b7 ,cont5ts ,ea* annual report submitt$ pursuant to p>agraph 7#a7 %all include1 = ! p]iod cov]$ by ! report1 ! foll[+3 7,a7 ,an inv5tory & acc\nt+ ( ,f$]al ,gov]nm5t activities & sp5d+ 9 support ( ! ,initiative4 7,b7 ,actions t ! ,director & ! ,int]ag5cy ,committee plan to take 9 support ( ! ,initiative 9 ! next fiscal ye>4 7e7 ,national /rategy 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & n less frequ5tly ?an once e #e ye>s !reaft]1 ! ,director ( ,national ,biote*nology ,coord9ation ,(fice & ! ,int]ag5cy ,committee %all jo9tly make available to ! public & submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,sci5ce1 ,space1 & ,te*nology ( ! ,h\se ( ,repres5tatives a compreh5sive national /rategy = biote*nology4 7#b7 ,elem5ts ,ea* national /rategy made available & submitt$ pursuant to p>agraph 7#a7 %all cov] ! foll[+3 7,a7 ,actions1 goals1 & priorities to advance ! ,initiative1 includ+ h[ ea* ,f$]al dep>tm5t & ag5cy w address ! requirem5ts ( section #f & h[ ea* ,f$]al dep>tm5t & ag5cy w integrate biote*nology into _! own /rategies4 7,b7 ,activities t are an urg5t priority to advance biote*nology 9 ! ,unit$ ,/ates b n curr5tly be+ conduct$ by ,f$]al ag5cies1 ) an e/imat$ #e-ye> budget = ^? activities4 7,c7 ,recomm5dations = legislative or adm9i/rative action to advance biote*nology 9 ! ,unit$ ,/ates4 7,d7 ,an inv5tory ( all ,f$]al ,gov]nm5t databases ) biological data ) an assessm5t t id5tifies opportunities-- 7i7 to improve ! utility ( su* databases1 9 a mann] t does n compromise national security or ! privacy & security ( in=mation )9 su* databases2 & 7ii7 to in=m inve/m5t 9 su* databases z critical infra/ructure = ! biote*nology rese>* ent]prise4 7,e7 ,an assessm5t ( ,unit$ ,/ates competitiv5ess 9 biote*nology relative to pe] c\ntries1 includ+-- 7i7 contributions ( biote*nology to ,unit$ ,/ates economic gr[? & o!r societal indicators2 7ii7 contributions ( biote*nology to economic gr[? 9 o!r c\ntries1 especially pe]-competitors2 & 7iii7 curr5t b>ri]s to comm]cialization ( biote*nology products1 processes1 & tools 9 ! ,unit$ ,/ates4 7,f7 ,a national biological data /rategy to ensure biote*nology rese>* fully lev]ages plant1 animal1 & microbe biodiv]sity1 z appropriate & 9 a mann] t does n compromise economic competitiv5ess1 national security1 or ! privacy or security ( human g5etic in=mation4 7,g7 ,! in=mation t is requir$ z a "p ( ! annual report requir$ by subsection 7d74 7f7 ,comptroll] ,g5]al review ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 beg9 a review to assess ! efficacy ( int]ag5cy coord9ation & fulfillm5t ( ! activities conduct$ by ! ,(fice & ! ,int]ag5cy ,committee "u ! ,initiative2 7#b7 n lat] ?an #c4e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 provide ,congress a brief+ on ! initial f9d+s ( ! ,comptroll] ,g5]al ) respect to ! activities describ$ 9 p>agraph 7#a72 7#c7 n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is ,act1 submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,sci5ce1 ,space1 & ,te*nology ( ! ,h\se ( ,repres5tatives a report ) recomm5dations to improve ! ,initiative2 & 7#d7 repeat ! process outl9$ 9 p>agraphs 7#a71 7#b71 & 7#c7 e #e ye>s !reaft] until ! date t is #bj ye>s aft] ! date ( ! enactm5t ( ?is ,act4 #e4 ,conv5+ ( exp]ts on biote*nology rese>* & developm5t 7a7 ,9 g5]al ,! ,director ( ! ,national ,biote*nology ,coord9ation ,(fice may1 9 consultation ) ! ,int]ag5cy ,committee1 conv5e exp]ts to assess & in=m ! activities ( ! ,initiative 9 a "t & mann] z deem$ appropriate & necess>y by ! ,director4 7b7 ,application ( ,f$]al ,advisory ,committee ,act ,section #ajac ( title #e1 ,unit$ ,/ates ,code1 %all n apply to ! conv5+ ( exp]ts "u ?is section4 #f4 ,ag5cy activities ,ea* head ( a p>ticipat+ ag5cy %all1 9 support ( ! ,initiative & 9 coord9ation ) ! ,(fice1 conduct or support1 9 a mann] consi/5t ) ! duties & mission ( ! respective dep>tm5t or ag5cy1 ! foll[+ activities to advance biote*nology across def5se1 human heal?1 food & agriculture1 en]gy1 space1 m9+1 environm5tal /ew>d%ip1 & o!r sectors3 7#a7 ,plann+ & coord9ation ,activities relat+ to plann+ & coord9ation z foll[s3 7,a7 ,designat+ an individual )9 ! respective dep>tm5t or ag5cy at ! level ( ,assi/ant ,secret>y to lead ! biote*nology activities = ! dep>tm5t or ag5cy1 if su* p]son is n already designat$1 & to s]ve z ! dep>tm5t or ag5cy liaison to ! ,initiative & memb] ( ! ,int]ag5cy ,committee4 7,b7 ,designat+ individuals )9 ! respective dep>tm5t or ag5cy to s]ve z memb]s ( subcommittees t may be e/abli%$ by ! ,int]ag5cy ,committee4 7,c7 ,coord9at+ activities ( ! p>ticipat+ ag5cy t relate to biote*nology ) ! ,(fice4 7,d7 ,implem5t+ applicable portions ( ! national /rategy requir$ by section #d7;e7 9 ways t improve gov]nm5t effici5cy & r$uce r$undancy4 7,e7 ,provid+ insight & in=mation ab\t biote*nology to ! heads ( o!r ,f$]al dep>tm5ts & ag5cies & to ,congress4 7,f7 ,lev]ag+ horizon scann+ & te*nology =esight to ensure ,unit$ ,/ates lead]%ip 9 future biote*nology advancem5ts4 7#b7 ,national security ,activities relat+ to national security z foll[s3 7,a7 ,analyz+ ongo+ & em]g+ ?reats f =eign adv]s>y developm5t & application ( biote*nology1 includ+ =eign inve/m5ts & acquisition ( ,unit$ ,/ates capabilities1 te*nologies1 & biological data4 7,b7 ,provid+ exp]tise to address =eign inve/m5ts & acquisition f adv]s>ial c\ntries4 7,c7 ,analyz+ & id5tify+ actions to mitigate supply *a9 risks pos$ by =eign adv]s>y involvem5t 9 su* supply *a9s4 7,d7 ,coord9at+ & ensur+ in=mation %>+ ) =eign s]vice (fic]s reg>d+ ?reats to & opportunities = biote*nology4 7,e7 ,coord9at+ ) indu/ry on ?reat in=mation %>+1 vuln]ability disclosure1 & risk mitigation = cyb]security & infra/ructure risks1 includ+ risks to biological data & relat$ physical & digital infra/ructure & devices4 7,f7 ,improv+ cyb]security & /ress-te/+ relat$ to s5sitive biological data & to biote*nology infra/ructure1 tools1 & in/rum5tation4 7#c7 ,rese>* & developm5t ,activities relat+ to rese>* & developm5t z foll[s3 7,a7 ,provid+ su/a9$ support = rese>* & developm5t t accel]ates sci5tific und]/&+ & te*nological innovation 9 biote*nology4 7,b7 ,conduct+ jo9t ag5cy solicitation & selection ( applications = fund+ ( individual grants1 collaborative grants1 & int]discipl9>y rese>* c5t]s4 7,c7 ,develop+ in/rum5tation1 equipm5t1 & infra/ructure = biote*nology1 includ+ to optimize1 /&>dize1 scale1 & deliv] new products & solutions4 7,d7 ,develop+ /&>d ref]5ce mat]ials & measurem5ts to promote int]op]ability betwe5 new compon5t te*nologies & processes = biote*nology discov]y1 innovation1 & production processes4 7,e7 ,increas+ und]/&+ ( ! risks & b5efits ( biote*nology1 includ+ h[ products develop$ ) biote*nology c affect or protect ! environm5t4 7,f7 ,increas+ und]/&+ ( ! e?ical1 legal1 & social implications ( biote*nology1 includ+ rese>* t contributes to public und]/&+ ( biote*nology4 7#d7 ,data & databases ,activities relat+ to data & databases z foll[s3 7,a7 ,provid+ su/a9$ support = biological data1 databases1 & relat$ tools to advance human heal? & ! und]/&+ ( animals1 plants1 microbes1 & o!r organisms4 7,b7 ,e/abli%+1 curat+1 & ma9ta9+ g5omics1 epig5omics1 & o!r relevant omics & biological data & databases1 su* z ?r\gh a c5traliz$ biological data access hub ) appropriate protections = ! privacy or security ( in=mation )9 su* databases4 7,c7 ,develop+ /&>ds = biological data & databases1 includ+ = curation1 int]op]ability1 & protection ( privacy & security4 7,d7 ,develop+ computational tools1 includ+ artificial intellig5ce tools1 to accel]ate rese>* & innovation us+ biological data & databases4 7,e7 ,develop+ tools t use omics & associat$ bio9=matic sci5ces to improve monitor+1 managem5t1 assessm5ts1 & =eca/s4 7#e7 ,product comm]cialization ,activities relat+ to product comm]cialization z foll[s3 7,a7 ,provid+ su/a9$ support = private sector translation & comm]cialization ( products t are produc$ ) biote*nology1 includ+ biomanufactur+4 7,b7 ,utiliz+ exi/+ ,f$]al programs1 su* z ! ,small ,bus9ess ,innovation ,rese>* ,program & ! ,small ,bus9ess ,te*nology ,transf] ,program 7z describ$ 9 section #i ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #fch771 9 support ( biote*nology1 includ+ to support pro( ( concept activities1 & ! =mation ( />tup companies4 7,c7 ,accel]at+ ! translation1 scale-up1 & comm]cialization ( new products1 processes1 & te*nologies 9 ord] to transf] fundam5tal rese>* results to indu/ry & accel]ate comm]cial applications4 7,d7 ,facilitat+ public-private p>tn]%ips 9 biote*nology rese>* & developm5t t address & r$uce b>ri]s to scal+ up biote*nology innovations4 7,e7 ,support+ a national network ( te/b$s bas$ on op5 /&>ds1 int]faces1 & processes1 includ+ by repurpos+ exi/+ facilities1 to enable scale-up ( biote*nology rese>*4 7,f7 ,provid+ inc5tives = retool+ ( indu/rial sites across ! ,unit$ ,/ates to fo/] a pivot to biote*nology4 7,g7 ,provid+ access to us] facilities ) advanc$ or unique equipm5t1 s]vices1 mat]ials1 & o!r res\rces1 includ+ secure access to high-p]=mance comput+1 z appropriate1 to indu/ry1 in/itutions ( high] education1 nonpr(it organizations1 & gov]nm5t ag5cies to p]=m rese>* & te/+4 7#f7 ,regulatory /reaml9+ ,activities relat+ to regulatory /reaml9+ z foll[s3 7,a7 ,conduct+ & coord9at+ regulatory /reaml9+ = products t are produc$ ) biote*nology4 7,b7 ,eas+ regulatory burd5 = types ( biote*nology products t h become well-und]/ood by regulators1 includ+ products t c\ld h occurr$ naturally or be5 develop$ ) conv5tional means4 7,c7 ,e/abli%+ cle> regulatory pa?ways = biote*nology products1 includ+ ?r\gh %ort-t]m regulatory trials to e/abli% new or update exi/+ regulatory pa?ways4 7,d7 ,ensur+ consi/5t1 risk-proportionate regulation ( biote*nology rese>* & developm5t activities1 includ+ = release ( products or organisms into ! environm5t4 7,e7 ,conduct+ horizon scann+ to id5tify novel biote*nology products & develop cle> regulatory pa?ways = su* products4 7#g7 ,biosafety & biosecurity ,activities relat+ to biosafety & biosecurity z foll[s3 7,a7 ,address+ biosafety1 biosecurity1 & responsible biology issues associat$ ) em]g+ biote*nology4 7,b7 ,develop+ an appli$ managem5t plan to address biological risks ( biote*nology rese>*4 7,c7 ,creat+ an adaptable1 evid5ce-bas$ framework to respond to em]g+ biosecurity *all5ges t consid]s & in=ms updates ( exi/+ biosecurity gov]nance policies1 guidance1 & directives & id5tifies necess>y safegu>ds = new products1 processes1 & sy/ems ( biote*nology4 7,d7 ,conduct+ outrea* to indu/ry1 in/itutions ( high] education1 nonpr(it organizations1 & gov]nm5t ag5cies to increase aw>5ess ( biosafety & biosecurity implications ( biote*nology rese>*4 7#h7 ,work=ce developm5t ,activities relat+ to work=ce developm5t z foll[s3 7,a7 ,provid+ su/a9$ support = developm5t ( a dome/ic biote*nology work=ce4 7,b7 ,ensur+ t ,congress & ,f$]al dep>tm5ts & ag5cies h access to necess>y exp]tise across national security & em]g+ biote*nology issues4 7,c7 ,support+ ,f$]al biote*nology education & work=ce tra9+ programs & initiatives = /ud5ts & work]s4 7,d7 ,support+ education & tra9+ ( und]graduate & graduate /ud5ts 9 biote*nology1 includ+ biomanufactur+1 bioprocess eng9e]+1 & computational sci5ce appli$ to biote*nology4 7,e7 ,connect+ rese>*]s1 graduate /ud5ts1 & po/doctoral fell[s ) entrepr5eur%ip education & tra9+ opportunities1 includ+ to aw>d grants1 on a competitive basis1 t enable in/itutions to support graduate /ud5ts1 & po/doctoral fell[s :o p]=m "s ( _! biote*nology rese>* 9 an indu/ry sett+4 7,f7 ,support+ pr(essional developm5t1 cont9u+ education1 & skills developm5t 7su* z re-skill+ & upskill+7 = vet]ans1 indu/ry work]s1 & te*nology pr(essionals4 7,g7 ,support+ curriculum developm5t & rese>* exp]i5ces = second>y1 und]graduate1 & graduate /ud5ts 9 biote*nology1 includ+ ?r\gh support = graduate fell[%ips & tra9ee%ips 9 biote*nology to ensure t /ud5ts are receiv+ up-to-date tra9+ t keeps pace ) biote*nologies z !y evolve & meets indu/ry work=ce ne$s s /ud5ts are qualifi$ = employm5t4 7,h7 ,support+ curriculum developm5t & rese>* exp]i5ces 9 biote*nology & associat$ data & in=mation sci5ces across ! ,f$]al work=ce1 includ+ = ! milit>y education sy/em4 7#i7 ,biolit]acy ,activities relat+ to biolit]acy z foll[s3 7,a7 ,provid+ cle>1 easy-to-f9d in=mation ab\t biote*nology = policymak]s1 innovators1 & ! public4 7,b7 ,support+ great] evid5ce-bas$ public disc\rse ab\t ! b5efits & risks ( biote*nology4 7,c7 ,ensur+ t public input & outrea* are integrat$ into ,f$]al biote*nology activities ?r\gh regul> & ongo+ public discussions su* z work%ops1 cons5sus conf]5ces1 & educational ev5ts1 z may be appropriate4 7#aj7 ,int]national p>tn]%ips ,activities relat+ to int]national p>tn]%ips z foll[s3 7,a7 ,develop+ an int]nal int]national engagem5t /rategy = ! respective dep>tm5t or ag5cy1 9 coop]ation ) relevant int]ag5cy p>tn]s4 7,b7 ,/r5g!n+ & develop+ bilat]al & multilat]al relation%ips to advance ,unit$ ,/ates priorities 9 biote*nology abroad4 7,c7 ,provid+ su/a9$ support & coord9at+ int]ag5cy activities 9 int]national biote*nology outrea* & engagem5t ) allies & p>tn]s4 7,d7 ,engag+ 9 coord9at$ regulatory & comm]cial diplomacy to bett] align biote*nology regulations & exp& m>ket access = biote*nology products4 7,e7 ,support+ ! developm5t ( int]national /&>ds & norms = biote*nology1 includ+ to def9e %>$ values & int]e/s4 7,f7 ,support+ biological data-%>+ agreem5ts ) p>tn] c\ntries4 7,g7 ,support+ biote*nology tal5t ex*anges ) p>tn] c\ntries1 includ+ ?r\gh fell[%ips1 "w au?orization programs1 & o!r me*anisms4 7,h7 ,support+ h>monization ( multilat]al export controls to protect aga9/ misuse ( biote*nology4 7#aa7 ,o!r ,su* o!r activities z ! head ( ! p>ticipat+ ag5cy det]m9es may be ne$$ to advance national security1 economic productivity1 & competitiv5ess relat+ to biote*nology4