,i #aai? ,,congress #b;d ,session ,h4 ,r4 #iajb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #b1 #bjbf,mr4 ,mool5a> 7= himself & ,mrs4 ,d+ell7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,f9ancial ,s]vices ,a ,,bill ,to am5d title ,,viii ( ! ,def5se ,production ,act ( #aiej to alt] ! def9itions ( prohibit$ te*nology & notifiable te*nology1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ at ! ,biote* ,inve/m5t ,national ,security ,act ( #bjbf or ! ,,b9sa ,act4 #b4 ,f9d+s ,! ,congress f9ds ! foll[+3 7#a7 ,*9a has pursu$ a delib]ate1 /ate-direct$ /rategy to dom9ate global biote*nology1 includ+ ph>maceutical developm5t1 biologics manufactur+1 & cl9ical rese>* & developm5t capabilities4 7#b7 ,unit$ ,/ates capital fl[+ to ,*9ese biote*nology companies ?r\gh lic5s+ agreem5ts1 jo9t v5tures1 & equity inve/m5ts is accel]at+ ,*9a's acquisition ( ph>maceutical intellectual prop]ty & cl9ical developm5t capabilities 9 a mann] t creates /rategic dep5d5cy risks = ! ,unit$ ,/ates4 7#c7 ,cross-bord] out-lic5s+ transactions betwe5 ,unit$ ,/ates & ,european ph>maceutical companies & ,*9ese biote*nology firms total$ approximately #acf1jjj1jjj1jjj 9 #bjbe1 repres5t+ a rapid & accel]at+ transf] ( ph>maceutical innovation capacity to entities subject to ! direction & control ( ! ,p's ,republic ( ,*9a4 7#d7 ,biote*nology1 includ+ ph>maceutical developm5t & biologics manufactur+1 has civil-milit>y dual-use applications & pres5ts /rategic dep5d5cy risks = ! ,unit$ ,/ates comp>able to ^? pres5t$ by semiconductors1 artificial intellig5ce1 & o!r te*nologies already cov]$ "u title ,,viii ( ! ,def5se ,production ,act ( #aiej4 7#e7 ,! ,,biosecure ,act1 enact$ z "p ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjbf1 recogniz$ t biote*nology is bo? a national security asset & a /rategic vuln]ability1 & t ! ,p's ,republic ( ,*9a seeks to dom9ate biote*nology z an indu/ry ( ! future4 7#f7 ,consi/5t application ( outb\nd inve/m5t scre5+ to biote*nology is necess>y to prev5t ,unit$ ,/ates capital & intellectual prop]ty f accel]at+ ,*9a's dom9ance ( ! ph>maceutical innovation supply *a9 9 a mann] t w create long-t]m /rategic dep5d5cy risks analog\s to ^? ! ,unit$ ,/ates n[ faces 9 r>e e>? elem5ts & semiconductors4 #c4 ,am5dm5ts ,section #hji ( ! ,def5se ,production ,act ( #aiej 7#ej ,u4,s4,c4 #dehi7 is am5d$-- 7#a7 9 p>agraph 7#aj77;,a71 by add+ at ! end ! foll[+3 7vi7 ,biote*nology1 mean+ ! rese>*1 developm5t1 manufactur+1 or comm]cialization (-- 7,i7 ph>maceutical products 7:i* has ! mean+ giv5 ! t]m drug 9 section #bja7;g77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7772 7,,ii7 biological products 7z su* t]m is def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7772 & 7,,iii7 !rapeutic comp\nds1 includ+ drug discov]y plat=ms1 cl9ical rese>* & developm5t capabilities1 biologics manufactur+1 & intellectual prop]ty & "k-h[ relat+ to !rapeutic comp\nds1 2 7#b7 9 p>agraph 7#g77;,a71 by add+ at ! end ! foll[+3 7vi7 ,biote*nology1 mean+ ! rese>*1 developm5t1 manufactur+1 or comm]cialization (-- 7,i7 ph>maceutical products 7:i* has ! mean+ giv5 ! t]m drug 9 section #bja7;g77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7772 7,,ii7 biological products 7z su* t]m is def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7772 & 7,,iii7 !rapeutic comp\nds1 includ+ drug discov]y plat=ms1 cl9ical rese>* & developm5t capabilities1 biologics manufactur+1 & intellectual prop]ty & "k-h[ relat+ to !rapeutic comp\nds1 2 & 7#c7 9 p>agraph 7#d77;,a71 by add+ at ! end ! foll[+3 7ix7 lic5s+ a prohibit$ te*nology f a cov]$ =eign p]son4 4 #d4 ,rulemak+ 7a7 ,9 g5]al ,! ,secret>y ( ! ,treasury %all1 n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 issue a rule to fur!r def9e ! p>amet]s ( ! area ( biote*nology z x is us$ 9 p>agraphs 7#g77;,a7 & 7#aj77;,a7 ( ! ,def5se ,production ,act ( #aiej1 z am5d$ by ?is ,act4 7b7 ,requirem5ts ,:5 def9+ ! p>amet]s ( ! area ( biote*nology pursuant to subsection 7a71 ! ,secret>y ( ! ,treasury %all-- 7#a7 consult ) ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,def5se1 & ! ,director ( ,national ,intellig5ce2 7#b7 give p>ticul> consid]ation to transactions involv+ ! lic5s+ ( intellectual prop]ty1 drug discov]y plat=ms1 cl9ical rese>* & developm5t capabilities1 & biologics manufactur+ "k-h[ to cov]$ =eign p]sons 7z su* t]m is def9$ 9 section #hji ( ! ,def5se ,production ,act ( #aiej72 7#c7 give p>ticul> consid]ation to lic5s+ transactions1 jo9t v5tures1 & equity inve/m5ts involv+ drug discov]y plat=ms1 cl9ical developm5t capabilities1 & biologics manufactur+ z priority categories = bo? ! prohibit$ & notifiable te*nology ti]s )9 ! biote*nology sector2 7#d7 consid] ! degree to :i* a transaction w\ld transf] ph>maceutical innovation capacity1 cl9ical developm5t capabilities1 or manufactur+ "k-h[ to entities subject to ! direction or control ( ! ,p's ,republic ( ,*9a2 7#e7 def9e ! biote*nology sector to include ! rese>*1 developm5t1 manufactur+1 & comm]cialization ( ph>maceutical products1 biological products1 & !rapeutic comp\nds1 includ+ drug discov]y plat=ms1 cl9ical rese>* & developm5t capabilities1 biologics manufactur+1 & relat$ intellectual prop]ty & "k-h[ transf]s2 & 7#f7 n def9e ! biote*nology sector 9 a mann] t includes or c\ld be con/ru$ to include agricultural biote*nology1 indu/rial f]m5tation unrelat$ to ph>maceutical or !rapeutic production1 or basic academic rese>* ) no direct ph>maceutical or !rapeutic application4 #e4 ,report requir$ 7a7 ,9 g5]al ,n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,def5se %all submit a report to ! appropriate congressional committees assess+ :e!r fl[s ( ,unit$ ,/ates capital into ,*9a's biote*nology sector1 includ+ ?r\gh lic5s+ transactions ) ,*9ese biote*nology firms1 negatively affect ,unit$ ,/ates national security & milit>y read9ess4 7b7 ,=m ,! report describ$ 9 subsection 7a7 %all be submitt$ 9 unclassifi$ =m b may include a classifi$ annex4 7c7 ,appropriate congressional committees def9$ ,! t]m appropriate congressional committees means-- 7#a7 ! ,committee on ,arm$ ,s]vices ( ! ,h\se ( ,repres5tatives2 7#b7 ! ,committee on ,f9ancial ,s]vices ( ! ,h\se ( ,repres5tatives2 7#c7 ! ,p]man5t ,select ,committee on ,intellig5ce ( ! ,h\se ( ,repres5tatives2 7#d7 ! ,select ,committee on ! ,/rategic ,competition betwe5 ! ,unit$ ,/ates & ! ,*9ese ,communi/ ,p>ty ( ! ,h\se ( ,repres5tatives2 7#e7 ! ,committee on ,arm$ ,s]vices ( ! ,s5ate2 7#f7 ! ,committee on ,bank+1 ,h\s+1 & ,urban ,affairs ( ! ,s5ate2 & 7#g7 ! ,select ,committee on ,intellig5ce ( ! ,s5ate4