,,ii #aai? ,,congress #a/ ,session ,s4 #cdfi ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #aa1 #bjbe,mr4 ,pet]s 7= himself & ,mr4 ,hag]ty7 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 ! ,,biosecure ,act ( #bjbe4 #b4 ,prohibition on contract+ ) c]ta9 biote*nology provid]s 7a7 ,9 g5]al ,! head ( an executive ag5cy may n-- 7#a7 procure or obta9 any biote*nology equipm5t or s]vice produc$ or provid$ by a biote*nology company ( conc]n2 or 7#b7 ent] into a contract1 or ext5d or r5ew a contract1 ) any entity t-- 7,a7 uses biote*nology equipm5t or s]vices produc$ or provid$ by a biote*nology company ( conc]n & acquir$ aft] ! applicable effective date 9 subsection 7c7 9 p]=mance ( ! contract ) ! executive ag5cy2 or 7,b7 ent]s into any contract ! p]=mance ( :i* su* entity kn[s w require1 9 p]=mance ( ! contract ) ! executive ag5cy1 ! use ( biote*nology equipm5t or s]vices produc$ or provid$ by a biote*nology company ( conc]n & acquir$ aft] ! applicable effective date 9 subsection 7c74 7b7 ,prohibition on loan & grant funds ,! head ( an executive ag5cy may n obligate or exp5d loan or grant funds to1 & a loan or grant recipi5t may n use loan or grant funds to-- 7#a7 procure1 obta91 or use any biote*nology equipm5t or s]vices produc$ or provid$ by a biote*nology company ( conc]n2 or 7#b7 ent] into a contract1 or ext5d or r5ew a contract1 ) an entity describ$ 9 subsection 7a77#b74 7c7 ,effective dates 7#a7 ,c]ta9 entities ,) respect to ! biote*nology companies ( conc]n cov]$ by subsection 7f77#b77;,a71 ! prohibitions "u subsections 7a7 & 7b7 %all take effect #fj days aft] ! ,f$]al ,acquisition ,regulation is revis$ pursuant to subsection 7h74 7#b7 ,o!r entities ,) respect to ! biote*nology companies ( conc]n cov]$ by subp>agraphs 7,b7 or 7,c7 ( subsection 7f77#b71 ! prohibitions "u subsections 7a7 & 7b7 %all take effect #ij days aft] ! ,f$]al ,acquisition ,regulation is revis$ pursuant to subsection 7h74 7#c7 ,rules ( con/ruction 7,a7 ,exclusions ,prior to ! date t is five ye>s aft] a revision to ! ,f$]al ,acquisition ,regulation pursuant to subsection 7h7 t id5tifies a biote*nology company ( conc]n cov]$ by subsection 7f77#b71 subsections 7a77#b7 & 7b77#b7 %all n apply to biote*nology equipm5t or s]vices produc$ or provid$ "u a contract or agreem5t1 includ+ previ\sly negotiat$ contract options1 ent]$ into be=e ! applicable effective date "u p>agraphs 7#a7 & 7#b74 7,b7 ,safe h>bor ,! t]m biote*nology equipm5t or s]vices produc$ or provid$ by a biote*nology company ( conc]n %all n be con/ru$ to ref] to any biote*nology equipm5t or s]vices t 7 =m]ly1 b are no long]1 produc$ or provid$ by biote*nology companies ( conc]n4 7d7 ,waiv] au?orities 7#a7 ,specific biote*nology exception 7,a7 ,waiv] ,! head ( ! applicable executive ag5cy may waive ! prohibition "u subsections 7a7 & 7b7 on a case-by-case basis-- 7i7 ) ! approval ( ! ,director ( ! ,(fice ( ,managem5t & ,budget2 & 7ii7 if su* head submits a notification & ju/ification to ! appropriate congressional committees n lat] ?an #cj days aft] grant+ su* waiv]4 7,b7 ,duration 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 a waiv] grant$ "u subp>agraph 7,a7 %all la/ = a p]iod ( n m ?an #cfe days4 7ii7 ,ext5sion ,! head ( ! applicable executive ag5cy1 ) ! approval ( ! ,director ( ! ,(fice ( ,managem5t & ,budget1 & 9 coord9ation ) ! ,secret>y ( ,def5se1 may ext5d a waiv] grant$ "u subp>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 & if su* head submits a notification & ju/ification to ! appropriate congressional committees n lat] ?an #aj days aft] grant+ su* waiv] ext5sion4 7#b7 ,ov]seas heal? c>e s]vices ,! head ( an executive ag5cy may waive ! prohibitions "u subsections 7a7 & 7b7 ) respect to a contract1 subcontract1 or transaction = ! acquisition or provision ( heal? c>e s]vices ov]seas on a case-by-case basis-- 7,a7 if ! head ( su* executive ag5cy det]m9es t ! waiv] is-- 7i7 necess>y to support ! mission or activities ( ! employees ( su* executive ag5cy describ$ 9 subsection 7e77#b77;,a72 & 7ii7 9 ! int]e/ ( ! ,unit$ ,/ates2 7,b7 ) ! approval ( ! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 consultation ) ! ,secret>y ( ,def5se2 & 7,c7 if su* head submits a notification & ju/ification to ! appropriate congressional committees n lat] ?an #cj days aft] grant+ su* waiv]4 7e7 ,exceptions ,! prohibitions "u subsections 7a7 & 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$ intellig5ce activities ( ! ,unit$ ,/ates2 7#b7 ! acquisition or provision ( heal? c>e s]vices ov]seas =-- 7,a7 7i7 employees ( ! ,unit$ ,/ates1 includ+ memb]s ( ! uni=m$ s]vices 7z def9$ 9 section #aja7;a7 ( title #aj1 ,unit$ ,/ates ,code71 & dep5d5ts ( su* employees2 7ii7 cov]$ b5efici>ies 7z def9$ 9 section #ajgb ( title #aj1 ,unit$ ,/ates ,code7 n o!rwise describ$ 9 clause 7i72 or 7iii7 any o!r b5efici>y if su* acquisition or provision is c>ri$ out or adm9i/]$ by ! head ( a dep>tm5t or ag5cy ( ! ,f$]al ,gov]nm5t2 or 7,b7 employees ( contractors or subcontractors ( ! ,unit$ ,/ates-- 7i7 :o are p]=m+ "u a contract t directly supports ! missions or activities ( individuals describ$ 9 subp>agraph 7,a77i72 & 7ii7 ^: prim>y duty /ations are locat$ ov]seas or are on p]missive tempor>y duty travel ov]seas2 7#c7 ! acquisition1 use1 or di/ribution ( human multiomic data1 lawfully compil$1 t is comm]cially or publicly available2 or 7#d7 ! procurem5t ( m$ical c\nt]measures1 m$ical products1 & relat$ supplies1 includ+ ancill>y m$ical supplies1 9 direct response to a public heal? em]g5cy decl>$ pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d74 7f7 ,evaluation ( c]ta9 biote*nology entities 7#a7 ,entity consid]ation ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all publi% a li/ ( ! entities t con/itute biote*nology companies ( conc]n bas$ on a li/ ( sugge/$ entities t %all be provid$ by ! ,secret>y ( ,def5se 9 coord9ation ) ! ,attorney ,g5]al1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,comm]ce1 ! ,director ( ,national ,intellig5ce1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,/ate1 & ! ,national ,cyb] ,director4 7#b7 ,biote*nology companies ( conc]n def9$ ,9 ?is section1 ! t]m biote*nology company ( conc]n means any ( ! foll[+3 7,a7 ,an entity t-- 7i7 is to any ext5t involv$ 9 ! manufactur+1 di/ribution1 provision1 or procurem5t ( any biote*nology equipm5t or s]vice1 z det]m9$ by ! process e/abli%$ 9 p>agraph 7#a72 & 7ii7 is id5tifi$ 9 ! annual li/ publi%$ 9 ! ,f$]al ,regi/] by ! ,dep>tm5t ( ,def5se ( ,*9ese milit>y companies op]at+ 9 ! ,unit$ ,/ates pursuant to section #abfj;,h ( ! ,william ,m4 7,mac7 ,?ornb]ry ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjba 7,public ,law #aaf-bhc2 #acd ,/at4 #cife2 #aj ,u4,s4,c4 #aac note74 7,b7 ,any entity t is det]m9$ by ! process e/abli%$ 9 p>agraph 7#a7 to meet ea* ( ! foll[+ crit]ia3 7i7 ,is subject to ! adm9i/rative gov]nance /ructure1 direction1 control1 or op]ates on behalf ( ! gov]nm5t ( a =eign adv]s>y4 7ii7 ,is to any ext5t involv$ 9 ! manufactur+1 di/ribution1 provision1 or procurem5t ( a biote*nology equipm5t or s]vice4 7iii7 ,poses a risk to ! national security ( ! ,unit$ ,/ates bas$ on-- 7,i7 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 7,,ii7 provid+ multiomic data obta9$ via biote*nology equipm5t or s]vices to ! gov]nm5t ( a =eign adv]s>y2 or 7,,iii7 obta9+ human multiomic data via ! biote*nology equipm5t or s]vices )\t express & in=m$ cons5t4 7,c7 ,any subsidi>y1 p>5t1 or successor ( an entity describ$ 9 subp>agraphs 7,a7 or 7,b71 provid$ x meets ! crit]ia set =? 9 clauses 7i7 ?r\gh 7iii7 ( subp>agraph 7,b71 z det]m9$ by ! process e/abli%$ 9 p>agraph 7#a74 7#c7 ,guidance ,n lat] ?an #ahj days aft] publication ( ! li/ pursuant to p>agraph 7#a71 & any update to ! li/ pursuant to p>agraph 7#d71 ! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 coord9ation ) ! ,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 & ! ,national ,cyb] ,director1 %all e/abli% guidance z necess>y to implem5t ! requirem5ts ( ?is section4 7#d7 ,updates ,! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 coord9ation ) or bas$ on a recomm5dation provid$ by ! ,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 & ! ,national ,cyb] ,director1 or ^u receipt ( a reque/ pursuant to p>agraph 7#g71 %all p]iodically1 ?\gh n less ?an annually1 review &1 z appropriate1 add entities to or remove entities f ! li/ ( biote*nology companies ( conc]n1 & notify ! appropriate congressional committees ( any su* modifications4 7#e7 ,notice ( a designation & review 7,a7 ,9 g5]al ,a notice ( a designation z a biote*nology company ( conc]n "u p>agraph 7#b77;,b7 %all be issu$ to any biote*nology company ( conc]n nam$ 9 ! designation-- 7i7 advis+ t a designation has be5 made2 7ii7 id5tify+ ! crit]ia reli$ ^u "u su* subp>agraph &1 to ! ext5t consi/5t ) national security & law en=cem5t int]e/s1 ! in=mation t =m$ ! basis = ! designation2 7iii7 advis+ t1 )9 #ij days aft] receipt ( notice1 ! biote*nology company ( conc]n may submit in=mation & argum5ts 9 opposition to ! designation2 7iv7 describ+ ! proc$ures gov]n+ ! review & possible issuance ( a designation pursuant to p>agraph 7#a72 & 7v7 :]e practicable1 id5tify+ mitigation /eps t c\ld be tak5 by ! biote*nology company ( conc]n t may result 9 ! rescission ( ! designation4 7,b7 ,congressional notification requirem5ts 7i7 ,notice ( designation ,! ,director ( ! ,(fice ( ,managem5t & ,budget %all submit ! notice requir$ "u subp>agraph 7,a7 to ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate & ! ,committee on ,ov]sight & ,gov]nm5t ,re=m ( ! ,h\se ( ,repres5tatives4 7ii7 ,in=mation & argum5t 9 opposition to designations ,n lat] ?an #g days aft] receiv+ any in=mation & argum5ts 9 opposition to a designation pursuant to subp>agraph 7,a77iii71 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all submit su* in=mation to ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate & ! ,committee on ,ov]sight & ,gov]nm5t ,re=m ( ! ,h\se ( ,repres5tatives4 7#f7 ,no imm$iate public release ,any designation made "u p>agraph 7#a7 or p>agraph 7#d7 %all n be made publicly available until ! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 coord9ation ) appropriate ag5cies1 reviews all in=mation submitt$ "u p>agraph 7#e77;,a77iii7 & issues a f9al det]m9ation t a company %all rema9 li/$ z a biote*nology company ( conc]n4 7#g7 ,removal reque/s ,if an entity on ! li/ ( biote*nology companies ( conc]n believes x no long] meets ! def9ition ( a biote*nology company ( conc]n z describ$ 9 p>agraph 7#b71 !n x may provide in=mation & argum5ts to reque/ removal f ! li/ ( biote*nology companies ( conc]n to ! ,director ( ! ,(fice ( ,managem5t & ,budget4 ,! ,director %all review su* in=mation & reply to ! entity )9 #ij days4 7g7 ,evaluation ( national security risks pos$ by =eign adv]s>y acquisition ( am]ican multiomic data 7#a7 ,assessm5t ,n lat] ?an #bgj days aft] ! enactm5t ( ?is ,act1 ! ,director ( ,national ,intellig5ce1 9 consultation ) ! ,secret>y ( ,def5se1 ! ,attorney ,g5]al ( ! ,unit$ ,/ates1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,comm]ce1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,/ate1 & ! ,national ,cyb] ,director1 %all complete an assessm5t ( risks to national security pos$ by human multiomic data f ,unit$ ,/ates citiz5s t is collect$ or /or$ by a =eign adv]s>y f ! provision ( biote*nology equipm5t or s]vices4 7#b7 ,report requirem5t ,n lat] ?an #cj days aft] ! completion ( ! assessm5t develop$ "u p>agraph 7#a71 ! ,director ( ,national ,intellig5ce %all submit a report ) su* assessm5t to ! appropriate congressional committees4 7#c7 ,=m ,! report requir$ "u p>agraph 7#b7 %all be 9 unclassifi$ =m1 b may include a classifi$ annex4 7h7 ,regulations ,n lat] ?an "o ye> aft] ! date ( e/abli%m5t ( guidance requir$ "u subsection 7f77#c71 & z necess>y = subsequ5t updates1 ! ,f$]al ,acquisition ,regulatory ,c\ncil %all revise ! ,f$]al ,acquisition ,regulation z necess>y to implem5t ! requirem5ts ( ?is section4 7i7 ,report+ on intellig5ce on nef>i\s activities ( biote*nology companies ) human multiomic data ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft]1 ! ,director ( ,national ,intellig5ce1 9 consultation ) ! heads ( executive ag5cies1 %all submit to ! appropriate congressional committees a report on any intellig5ce 9 possession ( su* ag5cies relat$ to nef>i\s activities conduct$ by biote*nology companies ) human multiomic data4 ,! report %all include in=mation p]ta9+ to pot5tial ?reats to national security or public safety f ! sell+1 resell+1 lic5s+1 trad+1 transf]r+1 %>+1 or o!rwise provid+ or mak+ available to any =eign c\ntry ( any =ms ( multiomic data ( a ,unit$ ,/ates citiz54 7j7 ,no additional funds ,no additional funds are au?oriz$ to be appropriat$ = ! purpose ( c>ry+ out ?is section4 7k7 ,def9itions ,9 ?is section3 7#a7 ,appropriate congressional committees ,! t]m appropriate congressional committees means-- 7,a7 ! ,committee on ,arm$ ,s]vices1 ! ,select ,committee on ,intellig5ce1 ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation1 & ! ,committee on ,=eign ,relations ( ! ,s5ate2 & 7,b7 ! ,committee on ,arm$ ,s]vices1 ! ,p]man5t ,select ,committee on ,intellig5ce1 ! ,committee on ,=eign ,affairs1 ! ,committee on ,ov]sight & ,gov]nm5t ,re=m1 ! ,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 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]ials 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 & transmission relat$ to biological mat]ials1 includ+-- 7i7 advis+1 consult+1 or support s]vices ) respect to ! use or implem5tation ( an in/rum5t1 app>atus1 ma*9e1 or device describ$ 9 subp>agraph 7,a72 & 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 is design$ = use 9 ! rese>*1 developm5t1 production1 or analysis ( biological mat]ials t ! ,director ( ! ,(fice ( ,managem5t & ,budget1 9 consultation ) ! heads ( executive ag5cies1 z det]m9$ appropriate by ! ,director ( ! ,(fice ( ,managem5t & ,budget1 det]m9es appropriate 9 ! int]e/ ( national security4 7#c7 ,contract ,except z ! t]m is us$ "u subsection 7b77#b7 & subsection 7c77#c71 ! t]m contract means-- 7,a7 any contract subject to ! ,f$]al ,acquisition ,regulation issu$ "u section #acjc7;a77#a7 ( title #da1 ,unit$ ,/ates ,code2 or 7,b7 any transaction 7o!r ?an a contract1 a grant1 or a coop]ative agreem5t7 ent]$ into "u section #djba ( title #aj1 ,unit$ ,/ates ,code4 7#d7 ,control ,! t]m control has ! mean+ giv5 to t t]m 9 section #hjj4bjh ( title #ca1 ,code ( ,f$]al ,regulations1 or any successor regulations4 7#e7 ,executive ag5cy ,! t]m executive ag5cy has ! mean+ giv5 ! t]m ,executive ag5cy 9 section #aje ( title #e1 ,unit$ ,/ates ,code4 7#f7 ,=eign adv]s>y ,! t]m =eign adv]s>y has ! mean+ giv5 ! t]m cov]$ nation 9 section #dhgb7;f7 ( 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 7l7 ,compliance ) limitation on drug prices ,= ! purposes ( section #aibg7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;a77#a771 a manufactur] is deem$ to meet ! requirem5ts ( section #habf ( title #ch1 ,unit$ ,/ates ,code1 includ+ ! requirem5t ( ent]+ into a ma/] agreem5t ) ! ,secret>y ( ,vet]ans ,affairs "u su* section1 if ! ,secret>y ( ,vet]ans ,affairs det]m9es t ! manufactur] w\ld comply 7& has (f]$ to comply7 ) ! provisions ( section #habf ( title #ch1 ,unit$ ,/ates ,code1 & w\ld h ent]$ into a ma/] agreem5t "u su* section1 b = ! prohibitions "u subsections 7a7 & 7b7 ( ?is section4