,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ajafd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,augu/ #bg1 #bjbf,mr4 ,latta 7= himself & ,mrs4 ,d+ell7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,secret>y ( ,comm]ce to promote competitiv5ess 9 biomanufactur+ 9 ! ,unit$ ,/ates1 id5tify supply-*a9 & comm]cialization vuln]abilities relat+ to critical biomanufactur+ inputs & dome/ic production capacity1 improve transp>5cy reg>d+ ,f$]al processes applicable to biomanufactur$ products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,biomanufactur+ ,excell5ce1 ,dome/ic ,resili5ce1 ,output1 & ,competitive ,"k-h[ ,act or ! ,,b$rock ,act4 #b4 ,activities relat$ to promot+ competitiv5ess 9 biomanufactur+ 9 ! ,unit$ ,/ates 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all designate a s5ior (ficial to-- 7#a7 lead ! activities ( ! ,dep>tm5t ( ,comm]ce relat+ to biomanufactur+ & biomanufactur$ products 9 ! ,unit$ ,/ates2 7#b7 c>ry out ! activities describ$ 9 subsection 7b72 & 7#c7 promote comm]cial competitiv5ess ) respect to su* biomanufactur+ & biomanufactur$ products4 7b7 ,activities describ$ ,! activities describ$ 9 ?is subsection are ! foll[+3 7#a7 ,id5tify ! foll[+3 7,a7 ,any ,f$]al process1 res\rce1 or publicly available in=mation relevant to promot+ comm]cial competitiv5ess ) respect to biomanufactur+ & biomanufactur$ products 9 dome/ic & =eign comm]ce4 7,b7 ,any b>ri] to private sector inve/m5t 9 biomanufactur+1 m>ket adoption ( biomanufactur$ products1 or dome/ic production ( su* products1 includ+ b>ri]s aris+ f uncle>1 duplicative1 or unpr$ictable ,f$]al processes relat$ to ! comm]cialization ( su* products4 7,c7 ,any vuln]ability1 *okepo9t1 suppli] conc5tration1 s+le po9t ( failure1 m>ket b>ri]1 or o!r con/ra9t affect+ a supply *a9 relat$ to a critical biomanufactur+ input1 includ+ any su* vuln]ability1 *okepo9t1 suppli] conc5tration1 s+le po9t ( failure1 m>ket b>ri]1 or o!r con/ra9t relat$ to a =eign adv]s>y or a =eign adv]s>y entity4 7,d7 ,any opportunity = a private sector entity or policymak] to /r5g!n dome/ic production1 suppli] div]sification1 comm]cialization1 & supply *a9 resili5ce relat$ to biomanufactur+ or biomanufactur$ products4 7,e7 ,! availability ( dome/ic production capacity1 inputs1 equipm5t1 & o!r res\rces relat$ to ! comm]cial manufactur+ ( biomanufactur$ products 9 ! ,unit$ ,/ates1 includ+ ) respect to ! foll[+3 7i7 ,am9o acids4 7ii7 ,indu/rial enzymes4 7iii7 ,microbial /ra9s4 7iv7 ,cell l9es4 7v7 ,cell banks4 7vi7 ,bioreactors4 7vii7 ,s+le-use bioprocess+ compon5ts4 7#b7 ,facilitate consultations1 on a volunt>y basis1 = p>ticipat+ non-,f$]al entities to promote comm]cial competitiv5ess ) respect to biomanufactur+ & biomanufactur$ products1 includ+ consultations requir$ pursuant to subsection 7d77#c74 7#c7 ,consult ) ! heads ( relevant ,f$]al ag5cies1 & any relevant ag5cy po9t ( contact1 includ+ ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 & ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy1 z ! ,secret>y det]m9es appropriate1 ) respect to matt]s affect+ ! competitiv5ess ( biomanufactur+1 supply-*a9 resili5ce1 & ! comm]cial manufactur+ ( biomanufactur$ products4 7#d7 ,ma9ta9 a publicly available web res\rce t consolidates or provides l9ks to publicly available ,f$]al res\rces relevant to ! comm]cialization ( biomanufactur$ products1 z det]m9$ appropriate by ! ,secret>y1 includ+ ! foll[+ in=mation & res\rces3 7,a7 ,any practice id5tifi$ & made publicly available "u subsection 7d74 7,b7 ,! report requir$ "u subsection 7e77#a74 7,c7 ,any po9t ( contact designat$ "u subsection 7e77#c7 or o!rwise made publicly available by a relevant ,f$]al ag5cy4 7#e7 ,s]ve z a po9t ( coord9ation = non-,f$]al entities seek+ publicly available in=mation relat$ to a ,f$]al process id5tifi$ "u p>agraph 7#a77;,a71 includ+ by ref]r+ su* entities to ! appropriate ,f$]al ag5cy or po9t ( contact4 7c7 ,assessm5t 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & e #b ye>s !reaft]1 ! ,secret>y1 act+ ?r\gh ! s5ior (ficial designat$ pursuant to subsection 7a71 %all conduct an assessm5t ) respect to ! foll[+3 7,a7 ,! curr5t &1 to ! ext5t practicable1 reasonably =eseeable future availability ( critical biomanufactur+ inputs & dome/ic production capacity relat$ to biomanufactur+ 9 ! ,unit$ ,/ates4 7,b7 ,! ext5t to :i* private sector entities 9 ! ,unit$ ,/ates rely on =eign adv]s>ies or =eign adv]s>y entities = critical biomanufactur+ inputs or production capacity relat$ to biomanufactur+4 7,c7 ,any vuln]ability1 *okepo9t1 s+le po9t ( failure1 suppli] conc5tration1 m>ket b>ri]1 or o!r con/ra9t impact+ ! access ( a private sector entity to critical biomanufactur+ inputs or dome/ic production capacity relat$ to biomanufactur+4 7,d7 ,! availability ( sub/itutes = critical biomanufactur+ inputs 9 ! ,unit$ ,/ates1 includ+ f o!r s\rces t are n =eign adv]s>ies or =eign adv]s>y entities4 7,e7 ,e/imat$ lead times & economic or op]ational b>ri]s to r$uc+ reliance by private sector entities on a =eign adv]s>y or a =eign adv]s>y entity = critical biomanufactur+ inputs or production capacity relat$ to biomanufactur+4 7,f7 ,any b>ri] id5tifi$ "u subsection 7b77#a77;,b71 includ+ ! foll[+3 7i7 ,any ,f$]al process = :i* a review relat$ to comm]cialization is divid$ among multiple ,f$]al ag5cies4 7ii7 ,any b>ri] aris+ f limit$ access to %>$ pilot-scale & demon/ration-scale manufactur+ capacity4 7,g7 ,any opportunity = dome/ic produc]s & suppli]s to exp& ! capacity (1 improve ! reliability (1 & div]sify supply *a9s = critical biomanufactur+ inputs4 7,h7 ,any impact on comm]ce & biomanufactur+ 9 ! ,unit$ ,/ates if a vuln]ability1 *okepo9t1 s+le po9t ( failure1 suppli] conc5tration1 m>ket b>ri]1 or o!r con/ra9t id5tifi$ "u subp>agraph 7,c7 is n address$1 includ+ any impact on relevant dome/ic supply-*a9 resili5ce & access to biomanufactur$ products4 7,i7 ,biomanufactur+ capacity locat$ outside ( ! ,unit$ ,/ates1 includ+ capacity at contract manufactur+ facilities & company-own$ facilities1 & capacity own$ or controll$ by =eign adv]s>ies or =eign adv]s>y entities1 to-- 7i7 comp>e su* biomanufactur+ capacity ) ! biomanufactur+ capacity ( ! ,unit$ ,/ates2 & 7ii7 assess ! impact ( su* capacity on dome/ic indu/ry4 7#b7 ,prioritization ,9 conduct+ ! assessm5t "u p>agraph 7#a71 ! ,secret>y1 act+ ?r\gh ! s5ior (ficial designat$ pursuant to subsection 7a71 %all prioritize ! matt]s describ$ 9 su* p>agraph bas$ on ! foll[+3 7,a7 ,! comm]cial significance ( ! relevant affect$ critical biomanufactur+ input or production capacity4 7,b7 ,pot5tial consequ5ces = comm]ce 9 ! ,unit$ ,/ates4 7,c7 ,! ext5t ( reliance on =eign adv]s>ies or =eign adv]s>y entities4 7,d7 ,e/imat$ lead times & b>ri]s to r$uc+ su* reliance4 7,e7 ,! availability ( sub/itute s\rces4 7#c7 ,prioritiz$ action plan ,bas$ on ea* assessm5t "u p>agraph 7#a71 ! ,secret>y %all prep>e & include 9 any report submitt$ & made publicly available "u subsection 7g7 a prioritiz$ action plan t-- 7,a7 ranks ea* supply-*a9 risk & comm]cialization b>ri] id5tifi$ 9 ! assessm5t by comm]cial significance & pot5tial consequ5ce = comm]ce 9 ! ,unit$ ,/ates2 7,b7 id5tifies actions ! ,secret>y may take to improve supply-*a9 visibility1 /akehold] coord9ation1 & access to in=mation relat$ to ! comm]cialization ( biomanufactur$ products2 7,c7 id5tifies exi/+ ,f$]al f9ancial assi/ance programs & o!r ,f$]al res\rces t may address any su* supply-*a9 risk or comm]cialization b>ri]2 7,d7 id5tifies any program or res\rce describ$ 9 subp>agraph 7,c7 t %\ld be add$ to ! web res\rce ma9ta9$ "u subsection 7b77#d72 & 7,e7 id5tifies opportunities = ! ,secret>y to coord9ate ) relevant ,f$]al ag5cies & non-,f$]al entities to r$uce su* risks & b>ri]s4 7d7 ,volunt>y practices 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & z ! ,secret>y det]m9es appropriate !reaft]1 ! ,secret>y %all id5tify & make publicly available indu/ry-l$1 evid5ce-bas$1 or widely accept$ practices relat$ to ! foll[+3 7,a7 ,! comm]cialization ( biomanufactur+ processes & biomanufactur$ products4 7,b7 ,! read9ess ( biomanufactur+ processes or biomanufactur$ products = comm]cial production4 7,c7 ,! reliability & op]ational consi/5cy ( biomanufactur+ processes & ! quality ( biomanufactur$ products4 7,d7 ,suppli] qualification1 suppli] div]sification1 & comm]cial supply *a9 risk managem5t = critical biomanufactur+ inputs4 7,e7 ,! volunt>y %>+ ( nonpropriet>y in=mation relat$ to biomanufactur+ process & ! supply *a9s = biomanufactur+ processes or biomanufactur$ products t is necess>y to support comm]cialization & comm]cial manufactur+1 includ+ ! secure & portable transf] ( in=mation t a process orig9ator elects to %>e ) a manufactur+ p>tn]1 z appropriate4 7,f7 ,! protection ( trade secrets1 confid5tial bus9ess in=mation1 & intellectual prop]ty relat+ to biomanufactur+4 7,g7 ,! p>ticipation ( small & m$ium-siz$ bus9esses & manufactur]s 9 biomanufactur+4 7,h7 ,! use ( biomanufactur$ products 9 dome/ic & =eign comm]ce4 7,i7 ,! use ( digital1 computational1 automat$1 or artificial intellig5ce tools 9 comm]cial biomanufactur+ to improve reliability1 effici5cy1 product quality1 & consi/5cy4 7#b7 ,exi/+ practices ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all-- 7,a7 prioritize id5tify+ exi/+ practices1 includ+ practices issu$ or ma9ta9$ by indu/ry-l$ organizations1 & mak+ su* practices publicly available2 & 7,b7 avoid unnecess>y duplication ( su* practices4 7#c7 ,consultation ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all consult ) non-,f$]al entities1 includ+ ! foll[+3 7,a7 ,! foll[+ private sector entities3 7i7 ,manufactur]s & suppli]s ( critical biomanufactur+ inputs4 7ii7 ,small & m$ium-siz$ bus9esses & manufactur]s ( biomanufactur$ products4 7iii7 ,companies seek+ to comm]cialize1 produce1 or use biomanufactur$ products4 7iv7 ,inve/ors1 accel]ators1 & o!r entities involv$ 9 comm]cialization4 7,b7 ,/ate1 local1 ,tribal1 t]ritorial1 & regional comm]ce or manufactur+ organizations4 7,c7 ,exp]ts 9 comm]cial supply-*a9 resili5ce1 manufactur+1 & competitiv5ess4 7#d7 ,prioritization ( ,unit$ ,/ates & tru/$ /akehold]s ,9 c>ry+ out p>agraph 7#c71 ! ,secret>y %all prioritize1 to ! ext5t practicable1 input f non-,f$]al entities 9 ! ,unit$ ,/ates & o!r /akehold]s t are nei!r =eign adv]s>ies nor =eign adv]s>y entities4 7#e7 ,public input 7,a7 ,9 g5]al ,! ,secret>y %all provide at lea/ #a opportunity = ! public to submit input "u ?is subsection4 7,b7 ,me?ods ,! ,secret>y may solicit public input "u ?is subsection ?r\gh mak+ reque/s = in=mation1 work%ops1 r\ndtables1 meet+s ) non-,f$]al entities1 or any o!r means ! ,secret>y det]m9es appropriate4 7e7 ,f$]al comm]cialization pa?way map2 ag5cy po9ts ( contact 7#a7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! heads ( relevant ,f$]al ag5cies1 %all submit to ! appropriate congressional committees & make publicly available a report t id5tifies & maps any ,f$]al process t may apply to ! comm]cialization ( biomanufactur$ products & critical biomanufactur+ inputs1 z ! ,secret>y det]m9es appropriate4 7#b7 ,cont5ts ,! report requir$ "u p>agraph 7#a7 %all d ! foll[+3 7,a7 ,organize any ,f$]al process id5tifi$ & mapp$ "u su* p>agraph by category ( biomanufactur$ product or critical biomanufactur+ input1 z ! ,secret>y det]m9es appropriate4 7,b7 ,id5tify ! foll[+3 7i7 ,any publicly available po9t ( contact = a ,f$]al ag5cy & any exi/+ public guidance relat$ to any su* ,f$]al process4 7ii7 ,ov]laps1 gaps1 ambiguities1 & tim+ or pr$ictability conc]ns relat$ to any su* ,f$]al process4 7iii7 ,opportunities to improve ! cl>ity & pr$ictability (1 & r$uce duplication among1 any su* ,f$]al process4 7#c7 ,ag5cy po9ts ( contact ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act-- 7,a7 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7i7 designate a po9t ( contact to assi/ non-,f$]al entities 9 id5tify+ publicly available in=mation relat$ to any process ( ! ,food & ,drug ,adm9i/ration t may apply to biomanufactur$ products or critical biomanufactur+ inputs2 & 7ii7 ensure su* po9t ( contact coord9ates1 z appropriate1 ) relevant compon5ts ( ! ,food & ,drug ,adm9i/ration 9 c>ry+ out clause 7i72 & 7,b7 ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy %all designate a po9t ( contact to assi/ non-,f$]al entities 9 id5tify+ publicly available in=mation relat$ to laws adm9i/]$ by ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy t may apply to biomanufactur$ products or critical biomanufactur+ inputs4 7#d7 ,integration ) exi/+ res\rces 7,a7 ,9 g5]al ,9 c>ry+ out p>agraphs 7#a7 & 7#b71 ! ,secret>y may incorporate or rely on a sub/antially simil> exi/+ ,f$]al res\rce1 report1 assessm5t1 map1 or o!r activity if ! ,secret>y det]m9es t x sub/antially addresses ! applicable requirem5t4 7,b7 ,inclusion 9 report ,if ! ,secret>y incorporates or relies on a sub/antially simil> exi/+ ,f$]al res\rce1 report1 assessm5t1 map1 or o!r activity "u subp>agraph 7,a71 ! ,secret>y %all include 9 ! report requir$ "u p>agraph 7#a7 ! foll[+3 7i7 ,an id5tification ( ! res\rce1 report1 assessm5t1 map1 or o!r activity4 7ii7 ,an explanation ( h[ ! res\rce1 report1 assessm5t1 map1 or o!r activity addresses ! applicable requirem5t4 7#e7 ,updates ,! ,secret>y %all update ! report requir$ "u p>agraph 7#a7 to reflect any mat]ial *ange to any ,f$]al process describ$ 9 su* p>agraph1 z ! ,secret>y det]m9es appropriate4 7f7 ,protection ( in=mation 7#a7 ,9 g5]al ,! ,secret>y may n publicly disclose any nonpublic in=mation volunt>ily submitt$ by a non-,f$]al entity "u ?is section t-- 7,a7 con/itutes a trade secret or confid5tial bus9ess in=mation2 or 7,b7 is s5sitive supply-*a9 vuln]ability in=mation4 7#b7 ,exemption f disclosure ,in=mation describ$ 9 p>agraph 7#a7 %all be exempt f disclosure "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7#c7 ,id5tification & det]m9ation 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% a process = a non-,f$]al entity t volunt>ily submits in=mation "u ?is section to id5tify :e!r ! entity consid]s su* in=mation to be nonpublic in=mation describ$ 9 p>agraph 7#a74 7,b7 ,det]m9ation ,if a non-,f$]al entity makes an id5tification "u ! process requir$ by subp>agraph 7,a71 ) respect to in=mation volunt>ily submitt$ "u ?is section by su* entity1 ! ,secret>y %all det]m9e :e!r su* in=mation is nonpublic in=mation describ$ 9 p>agraph 7#a74 7,c7 ,treatm5t p5d+ det]m9ation ,! ,secret>y may n publicly disclose any in=mation ) respect to :i* a non-,f$]al entity makes an id5tification "u p>agraph 7#c77;,a7 unless ! ,secret>y has det]m9$ su* in=mation is n nonpublic in=mation describ$ 9 p>agraph 7#a74 7g7 ,reports 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & e #b ye>s !reaft]1 ! ,secret>y1 act+ ?r\gh ! s5ior (ficial designat$ pursuant to subsection 7a71 %all submit to ! appropriate congressional committees1 & make publicly available on a website ( ! ,dep>tm5t ( ,comm]ce1 a report t includes ! foll[+3 7,a7 ,a summ>y ( any action c>ri$ out by ! ,secret>y "u ?is section4 7,b7 ,any assessm5t conduct$ "u subsection 7c74 7,c7 ,any prioritiz$ action plan prep>$ "u p>agraph 7#c7 ( su* subsection4 7,d7 ,a summ>y ( any practices id5tifi$ & made publicly available "u subsection 7d74 7,e7 ,any updates relat$ to ! report requir$ "u subsection 7e77#a74 7#b7 ,nonpublic annex ,! ,secret>y1 act+ ?r\gh ! s5ior (ficial designat$ pursuant to subsection 7a71 may submit to ! appropriate congressional committees a nonpublic annex to a report requir$ "u p>agraph 7#a7 t includes nonpublic in=mation describ$ 9 subsection 7f77#a74 7h7 ,t]m9ation ,! requirem5ts "u subsections 7a7 ?r\gh 7e7 & subsection 7g7 %all t]m9ate on ! date t is #e ye>s aft] ! date ( ! enactm5t ( ?is ,act4 7i7 ,def9itions ,9 ?is section3 7#a7 ,appropriate congressional committees ,! t]m appropriate congressional committees means-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7,b7 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate4 7#b7 ,biomanufactur$ product ,! t]m biomanufactur$ product means a comm]cial good1 mat]ial1 *emical1 prote91 compon5t1 indu/rial input1 or o!r product or sub/ance 9 comm]ce t is produc$1 process$1 purifi$1 or trans=m$ ?r\gh biomanufactur+4 7#c7 ,biomanufactur+ ,! t]m biomanufactur+ means ! use ( biological sy/ems1 includ+ cells1 cell-free sy/ems1 enzymes1 or biomolecules1 9 manufactur+ processes to produce1 process1 or trans=m comm]cial goods1 mat]ials1 *emicals1 prote9s1 compon5ts1 indu/rial inputs1 or o!r products or sub/ances 9 comm]ce4 7#d7 ,critical biomanufactur+ input ,! t]m critical biomanufactur+ input means an input1 mat]ial1 reag5t1 item ( equipm5t1 or s(tw>e us$ 9 biomanufactur+ t is comm]cially significant to biomanufactur+ 9 ! ,unit$ ,/ates & subject to supply-*a9 risk1 su* z suppli] conc5tration1 reliance on a =eign adv]s>y or =eign adv]s>y entity1 limit$ sub/itutes1 or long lead times4 7#e7 ,=eign adv]s>y ,! t]m =eign adv]s>y means a =eign gov]nm5t or =eign non-gov]nm5t p]son id5tifi$ z a =eign adv]s>y "u section #gia4d ( title #ae1 ,code ( ,f$]al ,regulations1 or any successor regulation4 7#f7 ,=eign adv]s>y entity ,! t]m =eign adv]s>y entity has ! mean+ giv5 ! t]m p]son own$ by1 controll$ by1 or subject to ! jurisdiction or direction ( a =eign adv]s>y 9 section #gia4b ( title #ae1 ,code ( ,f$]al ,regulations1 or any successor regulation4 7#g7 ,non-f$]al entity ,! t]m non-,f$]al entity means a ,/ate1 local1 ,tribal1 or t]ritorial gov]nm5t1 nonpr(it organization1 te*nical organization1 indu/ry association1 comm]ce or manufactur+ organization1 private sector entity1 or o!r /akehold]4 7#h7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,comm]ce4 7#i7 ,s5sitive supply-*a9 vuln]ability in=mation ,! t]m s5sitive supply-*a9 vuln]ability in=mation means nonpublic in=mation ) respect to :i* ! public disclosure ( su* nonpublic in=mation c\ld be reasonably expect$ to reveal a vuln]ability1 dep5d5cy1 *okepo9t1 s+le po9t ( failure1 suppli] conc5tration1 or o!r weakness 9 a supply *a9 relevant to biomanufactur+ 9 ! ,unit$ ,/ates4