,,ii #aah? ,,congress #a/ ,session ,s4 #cdaa ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #e1 #bjbc,mr4 ,pet]s introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ,a ,,bill ,to prohibit contract+ ) c]ta9 biote*nology provid]s4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safegu>d+ ,am]ican ,g5etic ,data ,act ( #bjbc4 #b4 ,prohibition on contract+ ) c]ta9 biote*nology provid]s 7a7 ,designation ( ,f$]al entity ,n lat] ?an #cj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t %all designate a ,f$]al entity 79 ?is section ref]r$ to z ! ,f$]al entity7 to e/abli% guidance to ensure t ,executive ag5cies d n directly procure or obta9 any cov]$ biote*nology equipm5t or s]vice4 ,! ,f$]al entity1 ! head ( :i* %all be ! ,director ( ! ,(fice ( ,managem5t & ,budget1 %all include ! ,secret>y ( ,def5se1 ! ,attorney ,g5]al1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,comm]ce1 ! ,director ( ,national ,intellig5ce1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,/ate1 & ! heads ( o!r appropriate ,f$]al ag5cies z id5tifi$ by ! ,presid5t4 7b7 ,policy1 guidance1 & regulations 7#a7 ,recomm5dations ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,f$]al entity1 9 coord9ation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil & o!r heads ( ,executive ag5cies z det]m9$ appropriate by ! ,presid5t1 %all issue guidance & recomm5d ! e/abli%m5t ( policy & regulations1 z necess>y1 to implem5t ! requirem5ts ( ?is section4 7#b7 ,,omb policy ,n lat] ?an #ahj days aft] ! date ( issuance ( recomm5dations "u p>agraph 7#a71 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all issue any policy necess>y to effectuate ! recomm5dations4 7#c7 ,f$]al acquisition regulation ,n lat] ?an "o ye> aft] ! date ( issuance ( recomm5dations "u p>agraph 7#a71 ! ,f$]al ,acquisition ,regulatory ,c\ncil %all revise ! ,f$]al ,acquisition ,regulation z necess>y to implem5t ! requirem5ts ( ?is section4 7#d7 ,effective date ,any prohibition includ$ 9 ! guidance e/abli%$ by ! ,f$]al entity 9 accordance ) p>agraph 7#a7 %all take effect n lat] ?an "o ye> aft] ! e/abli%m5t ( su* guidance4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to require any cov]$ biote*nology equipm5t or s]vice 9 use or resid5t 9 equipm5t1 sy/ems1 or s]vices z ( ! day be=e ! applicable effective date specifi$ 9 subsection 7b77#d7 to be remov$ or replac$2 or 7#b7 to prohibit or limit ! utilization ( su* cov]$ biote*nology equipm5t or s]vice ?r\gh\t ! lifecycle ( su* exi/+ equipm5t4 7d7 ,exceptions ,any prohibition includ$ 9 ! guidance e/abli%$ by ! ,f$]al entity "u subsection 7b7 %all n apply to-- 7#a7 any activity subject to ! report+ requirem5ts "u title ,v ( ! ,national ,security ,act ( #aidg 7#ej ,u4,s4,c4 #cjia et seq47 or any au?oriz$ def5se or intellig5ce activities ( ! ,unit$ ,/ates ,gov]nm5t2 7#b7 heal? c>e s]vices & relat$ equipm5t & supplies =-- 7,a7 employees ( ! ,unit$ ,/ates ,gov]nm5t1 includ+ memb]s ( ! uni=m$ s]vices 7z t t]m is def9$ 9 section #aja7;a7 ( title #aj1 ,unit$ ,/ates ,code71 ^: (ficial duty /ations are locat$ ov]seas or are on p]missive tempor>y duty travel outside ( ! cont95tal ,unit$ ,/ates2 or 7,b7 employees ( contractors or subcontractors ( ! ,unit$ ,/ates-- 7i7 :o are p]=m+ "u a contract t directly supports ! missions or activities ( individuals describ$ 9 subp>agraph 7,a72 & 7ii7 ^: (ficial duty /ations are locat$ ov]seas or are on p]missive tempor>y duty travel outside ( ! cont95tal ,unit$ ,/ates4 7#c7 ! acquisition1 use1 or di/ribution ( multiomic data1 h[ev] compil$1 t is comm]cially or publicly available4 7e7 ,waiv] au?orities 7#a7 ,9 g5]al ,! policy1 guidance1 & regulations e/abli%$ "u subsection 7b7 %all all[ ! head ( an ,executive ag5cy to waive any prohibition implem5t$ 9 connection ) su* guidance on a case-by-case basis aft] consultation ) ! ,f$]al entity4 7#b7 ,duration 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 a waiv] grant$ "u p>agraph 7#a7 %all la/ = a p]iod ( n m ?an "o ye>4 7,b7 ,ext5sion ,! head ( an ,executive ag5cy may ext5d a waiv] grant$ to an ,executive ag5cy "u p>agraph 7#a7 "o "t1 = a p]iod up to #ahj days aft] ! date on :i* ! waiv] w\ld o!rwise expire1 if su* an ext5sion is 9 ! national security int]e/s ( ! ,unit$ ,/ates & ! ,executive ag5cy submits to ! appropriate congressional committees a notification ( su* waiv] n lat] ?an #cj days aft] grant+ ! waiv]4 7f7 ,det]m9ation ( c]ta9 biote*nology entities 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,f$]al entity %all develop a li/ ( entities det]m9$ to be a biote*nology company ( conc]n4 ,! ,f$]al entity %all def9e a biote*nology company ( conc]n z any entity t-- 7,a7 is subject to ! jurisdiction1 direction1 control1 or op]ates on behalf ( ! gov]nm5t ( a =eign adv]s>y2 7,b7 is to any ext5t involv$ 9 ! manufactur+1 di/ribution1 provision1 or procurem5t ( biote*nology equipm5t or s]vices2 & 7,c7 poses a risk to ! national security ( ! ,unit$ ,/ates bas$ on-- 7i7 engag+ 9 jo9t rese>* )1 be+ support$ by1 or be+ affiliat$ ) a =eign adv]s>y's milit>y1 int]nal security =ces1 or intellig5ce ag5cies2 7ii7 provid+ multiomic data obta9$ via biote*nology equipm5t or s]vices to ! gov]nm5t ( a =eign adv]s>y2 or 7iii7 obta9+ human multiomic data via biote*nology equipm5t or s]vices )\t express$ & in=m$ cons5t4 7#b7 ,updates ,! ,f$]al entity %all p]iodically1 b n less ?an annually1 review &1 z appropriate1 modify ! li/ ( biote*nology companies ( conc]n4 7g7 ,evaluation ( c]ta9 biote*nology entities ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,f$]al entity %all det]m9e :e!r ,,bgi1 ,,mgi1 ,complete ,g5omics1 & any subsidi>y1 affiliate1 or successor ( su* entities1 are biote*nology companies ( conc]n4 ,if any su* entities1 subsidi>ies1 affiliates1 or successors are id5tifi$ z biote*nology companies ( conc]n1 no ,executive ag5cy %all directly procure or obta9 any biote*nology equipm5t or s]vices f su* entities1 subsidi>ies1 affiliates1 or successors4 ,! ,director ( ! ,(fice ( ,managem5t & ,budget %all issue su* policy1 & ! ,f$]al ,acquisition ,regulatory ,c\ncil %all promulgate su* regulations1 z may be necess>y to effectuate ?is prohibition4 7h7 ,analysis1 assessm5t1 & /rategy ,n lat] ?an #ahj days aft] develop+ ! li/ ( entities "u subsection 7f77#a7 & ! det]m9ation ( entities "u subsection 7g71 ! ,f$]al entity1 to ! greate/ ext5t practicable1 lev]ag+ relevant previ\s analyses & assessm5ts1 %all-- 7#a7 conduct an analysis ( ! li/ ( entities id5tifi$ "u subsections 7f77#a7 & 7g71 includ+-- 7,a7 active ,f$]al grants to or contracts ) private companies1 academic in/itutions1 & public sector entities1 includ+-- 7i7 ! numb] & type ( cov]$ biote*nology equipm5t or s]vices already or expect$ to be procur$2 7ii7 ! anticipat$ lifespan ( cov]$ biote*nology equipm5t or s]vices already or expect$ to be procur$2 7iii7 ! e/imat$ co/s & timel9e to replace cov]$ biote*nology equipm5t or s]vices already procur$2 & 7,b7 ! dome/ic & int]national m>ket %>e2 7#b7 assess risks to national security pos$ by ! entities id5tifi$ "u subsections 7f77#a7 & 7g71 obta9+ active & future ,f$]al grants to or contracts ) private companies1 academic in/itutions1 & public sector entities2 7#c7 develop a /rategy to-- 7,a7 mitigate ! risks to national security id5tifi$ 9 ! assessm5t conduct$ "u p>agraph 7#b72 & 7,b7 support private companies1 academic in/itutions1 & public sector entities seek+ to acquire cov]$ biote*nology equipm5t or s]vices f alt]native entities2 & 7#d7 provide ! results ( ! analysis1 assessm5t1 & /rategy develop$ "u ?is subsection to ! ,f$]al ,acquisition ,regulatory ,c\ncil & ! appropriate congressional committees4 7i7 ,report requirem5t 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,f$]al entity %all submit to ! ,f$]al ,acquisition ,regulatory ,c\ncil & ! appropriate congressional committees a report includ+ ! foll[+3 7,a7 ,! "n ( & ju/ification = ea* entity meet+ ! crit]ia = a biote*nology company ( conc]n "u subsections 7f77#a7 & 7g74 7,b7 ,a catalog ( all active or plann$ grants or contracts any ,executive ag5cy has ) any entity det]m9$ to be a biote*nology company ( conc]n relat$ to biote*nology equipm5t or s]vices4 7,c7 ,recomm5dations1 z applicable1 on alt]native entities to a biote*nology company ( conc]n capable ( provid+ ! ,f$]al ,gov]nm5t ) requir$ biote*nology equipm5t or s]vices4 7,d7 ,recomm5dations1 z applicable1 on ! feasibility ( implem5t+ prohibitions implem5t$ 9 connection ) ! guidance e/abli%$ "u subsection 7b7 or ex]cis+ waiv] au?orities "u subsection 7e71 to ensure un9t]rupt$ ,f$]al ,gov]nm5t access to requir$ biote*nology equipm5t & s]vices1 & any fur!r *anges to legislation ne$$ to mitigate supply *a9 risks or increase availability & enhance capabilities ( biote*nology equipm5t & s]vices4 7#b7 ,=m ,! report requir$ "u p>agraph 7#a7 %all be 9 unclassifi$ =m accompani$ by a classifi$ annex4 7j7 ,def9itions ,9 ?is section3 7#a7 ,appropriate congressional committees ,! t]m appropriate congressional committees means-- 7,a7 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation1 ! ,committee on ,=eign ,relations1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate2 & 7,b7 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,=eign ,affairs1 ! ,committee on ,ov]sight & ,acc\ntability1 ! ,committee on ,en]gy & ,comm]ce1 & ! ,select ,committee on ,/rategic ,competition betwe5 ! ,unit$ ,/ates & ! ,*9ese ,communi/ ,p>ty ( ! ,h\se ( ,repres5tatives4 7#b7 ,biote*nology equipm5t or s]vice ,! t]m biote*nology equipm5t or s]vice means-- 7,a7 equipm5t1 includ+ g5etic sequ5c]s1 mass spectromet]s1 polym]ase *a9 reaction ma*9es1 or any o!r in/rum5t1 app>atus1 ma*9e1 or device1 includ+ compon5ts & accessories !re(1 t is design$ = use 9 ! rese>*1 developm5t1 production1 or analysis ( biological mat]ials1 z well z any s(tw>e1 firmw>e1 or o!r digital compon5ts t are specifically design$ = use 91 & necess>y = ! op]ation (1 su* equipm5t2 7,b7 any s]vice = ! rese>*1 developm5t1 production1 analysis1 detection1 or provision ( in=mation1 includ+ data /orage & transmission1 relat$ to biological mat]ials1 includ+-- 7i7 advis+1 consult+1 or support s]vices provid$ by a biote*nology company ( conc]n ) respect to ! use or implem5tation ( an in/rum5t1 app>atus1 ma*9e1 or device describ$ 9 subp>agraph 7,a72 or 7ii7 disease detection1 g5ealogical in=mation1 & relat$ s]vices2 & 7,c7 any o!r s]vice1 in/rum5t1 app>atus1 ma*9e1 compon5t1 accessory1 device1 s(tw>e1 or firmw>e t ! ,f$]al entity det]m9es appropriate4 7#c7 ,control ,! t]m control has ! mean+ giv5 ! t]m 9 section #hjj4bjh ( title #ca1 ,code ( ,f$]al ,regulations1 or any successor regulations4 7#d7 ,cov]$ biote*nology equipm5t or s]vice ,! t]m cov]$ biote*nology equipm5t or s]vice means a biote*nology equipm5t or s]vice produc$ or provid$ by a biote*nology company ( conc]n4 7#e7 ,executive ag5cy ,! t]m ,executive ag5cy has ! mean+ giv5 ! t]m 9 section #aje ( title #e1 ,unit$ ,/ates ,code4 7#f7 ,=eign adv]s>y ,! t]m =eign adv]s>y has ! mean+ giv5 ! t]m cov]$ nation 9 section #dhgb7;d7 ( title #aj1 ,unit$ ,/ates ,code4 7#g7 ,multiomic ,! t]m multiomic means data types t include g5omics1 epig5omics1 transcriptomics1 proteomics1 & metabolomics4 7#h7 ,ov]seas ,! t]m ov]seas means any area outside ( ! ,unit$ ,/ates1 ! ,commonweal? ( ,pu]to ,rico1 or a t]ritory or possession ( ! ,unit$ ,/ates4