,i #aai? ,,congress #a/ ,session ,h4 ,r4 #bbac ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #ah1 #bjbe,ms4 ,malliotakis 7= h]self & ,mr4 ,s*neid]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committee on ,rules1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to au?orize ! ,presid5t to ent] into trade agreem5ts = ! reciprocal elim9ation ( duties or o!r import re/rictions ) respect to m$ical goods to contribute to ! national security & public heal? ( ! ,unit$ ,/ates1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,supply ,*a9 ,resili5cy ,act4 #b4 ,f9d+s2 s5se ( ,congress 7a7 ,f9d+s ,congress makes ! foll[+ f9d+s3 7#a7 ,! ,,covid-#ai p&emic creat$ significant dem& pressures on ! global m$ical supply *a94 7#b7 ,accord+ to a ,decemb] #bjbj report by ! ,unit$ ,/ates ,int]national ,trade ,commission1 global dem& significantly exce$$ available supply ( _m goods critical = ! response to ! ,,covid-#ai p&emic 79 ?is section ref]r$ to z ,,covid-#ai critical goods74 ,heal? c>e provid]s 9 ! ,unit$ ,/ates fac$ difficulties 9 procur+ su* goods 9 suffici5t quantities4 ,=eign export re/rictions on f9i%$ drugs & active ph>maceutical +r$i5ts may h contribut$ to /ress on ! supply ( "s critical ,,covid-#ai treatm5t drugs 7includ+ anti-infective products71 z well z hormone m$ications & vitam9s4 7#c7 ,accord+ to ! ,mc,kinsey ,global ,in/itute1 dur+ ! #bj ye>s prec$+ ! date ( ! enactm5t ( ?is ,act1 ph>maceutical supply *a9s h become m globally disp]s$ & _m g5]ic small-molecule products h %ift$ to l[]-co/ production locations1 "s ( :i* h be5 id5tifi$ z pos+ a ?reat to ! national security ( ! ,unit$ ,/ates4 7#d7 ,accord+ to ! ,organisation = ,economic ,co-op]ation & ,developm5t1 :ile ! ,unit$ ,/ates is "o ( ! l>ge/ export]s ( ,,covid-#ai critical goods1 x is also "o ( ! l>ge/ import]s ( ^? goods4 7#e7 ,! ,_w ,trade ,organization has f\nd t1 :ile ! ,unit$ ,/ates1 ,g]many1 & ! ,p's ,republic ( ,*9a are all major produc]s & import]s ( ,,covid-#ai critical goods1 ,unit$ ,/ates import p>tn]s are less div]sifi$ comp>$ to ,g]many & ! ,p's ,republic ( ,*9a4 ,9 ! ,unit$ ,/ates1 m ?an half ( its imports ( ,,covid-#ai critical goods came f only #c p>tn]s--! ,p's ,republic ( ,*9a 7#cj4f p]c5t71 ,mexico 7#ae4c p]c5t71 & ,malaysia 7#i4j p]c5t74 7#f7 ,:ile "s ( ! c\ntries 9 :i* m$ical supply manufactur+ occurs are reliable suppli]s & allies to ! ,unit$ ,/ates1 o!rs h adopt$ or ma9ta9$ policies t make ,unit$ ,/ates supply less secure4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t1 giv5 ! ?reat to national security & public heal? t c\ld arise if ! ,unit$ ,/ates is unable to swiftly respond to significant dem& surges = m$ical products 9 a future p&emic1 x is critical t ! ,unit$ ,/ates div]sify its trade relation%ips & prioritize p>tn]s t adopt & ma9ta9 reliable supply *a9 policies4 #c4 ,purposes ,! purposes ( ?is ,act are-- 7#a7 to improve ov]all m$ical supply *a9 resili5ce = ! ,unit$ ,/ates by e/abli%+ a framework to enhance m$ical supply *a9s ) tru/$ trade p>tn]s2 7#b7 to enhance supply *a9 security relat$ to te*nology transf] & intellectual prop]ty protection2 7#c7 to div]sify & exp& suppli] networks to ensure a reliable supply ( m$ical goods1 especially 9 ! ev5t ( em]g5cy situations2 7#d7 to elim9ate unnecess>y trade b>ri]s & di/ortions t weak5 or disrupt m$ical supply *a9s2 7#e7 to exp$ite cross-bord] movem5t ( critical m$ical goods2 7#f7 to fo/] int]national collaboration1 enc\rage new inve/m5ts1 promote coop]ation & p>tn]%ip 9 public & private rese>* & developm5t ef=ts1 facilitate data fl[s = life sci5ce rese>* & developm5t1 & exp& manufactur+ capacities = m$ical devices & ph>maceutical goods2 7#g7 to promote regulatory coop]ation ) respect to manufactur+ ( m$ical goods2 7#h7 to increase access to gov]nm5t procurem5t m>kets = m$ical goods2 7#i7 to enc\rage adoption ( & adh]5ce to good regulatory practices relat$ to m$ical goods2 7#aj7 to enable great] transp>5cy1 regulatory h>monization1 & reliance 9 au?orization & lic5s+ proc$ures = m$ical devices & ph>maceutical goods2 7#aa7 to facilitate trade 9 m$ical goods to ! mo/ effici5t & practicable ext5t possible2 & 7#ab7 to id5tify curr5t production capacities1 address pot5tial weaknesses1 & improve ov]all resili5ce4 #d4 ,def9itions ,9 ?is ,act3 7#a7 ,appropriate committees ( ,congress ,! t]m appropriate committees ( ,congress means-- 7,a7 ! ,committee on ,f9ance ( ! ,s5ate2 & 7,b7 ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives4 7#b7 ,c\ntry ,! t]m c\ntry means-- 7,a7 any =eign c\ntry or t]ritory1 includ+ any ov]seas dep5d5t t]ritory or possession ( a =eign c\ntry2 or 7,b7 ! ,tru/ ,t]ritory ( ! ,pacific ,isl&s4 7#c7 ,m$ical device ,! t]m m$ical device means a device1 z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba71 t is int5d$ = use 9 humans4 7#d7 ,m$ical good ,! t]m m$ical good means any m$ical device1 ph>maceutical good1 or input = su* a device or good4 7#e7 ,m$ical supply *a9 ,! t]m m$ical supply *a9 means any activities involv+ design1 procurem5t1 manufactur+1 production1 di/ribution1 op]ation1 or managem5t relat$ to m$ical goods4 7#f7 ,ph>maceutical good ,! t]m ph>maceutical good means a drug1 z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba71 t is int5d$ = use 9 humans4 7#g7 ,trade ,repres5tative ,! t]m ,trade ,repres5tative means ! ,unit$ ,/ates ,trade ,repres5tative4 7#h7 ,tru/$ trade p>tn] ,! t]m tru/$ trade p>tn] means any c\ntry t has ent]$ into an agreem5t ) ! ,unit$ ,/ates "u section #e4 7#i7 ,tru/$ trade p>tn] agreem5t ,! t]m tru/$ trade p>tn] agreem5t means an agreem5t ent]$ into "u section #e4 #e4 ,au?ority to ent] into tru/$ trade p>tn] agreem5ts 7a7 ,9 g5]al ,:5ev] ! ,presid5t det]m9es1 bas$ on ! consid]ations set =? 9 subsection 7b71 t ! reciprocal elim9ation ( exi/+ duties or o!r import re/rictions ( a c\ntry or c\ntries & ! ,unit$ ,/ates ) respect to m$ical goods w\ld contribute to ! national security & public heal? ( ! ,unit$ ,/ates1 ! ,presid5t may1 subject to ! requirem5ts "u section #f-- 7#a7 negotiate1 ent] into1 & en=ce a tru/$ trade p>tn] agreem5t ) ! c\ntry or c\ntries2 & 7#b7 proclaim su* modification ( any exi/+ duty1 su* cont9uance ( exi/+ duty-free or excise treatm5t1 or su* additional duties1 z ! ,presid5t det]m9es to be requir$ or appropriate to c>ry out any su* trade agreem5t4 7b7 ,consid]ations ,9 det]m9+ :e!r to ent] into negotiations = a tru/$ trade p>tn] agreem5t ) a c\ntry pursuant to subsection 7a71 ! ,presid5t %all take into acc\nt :e!r ! gov]nm5t ( ! c\ntry has-- 7#a7 express$ a desire to ent] into su* an agreem5t2 7#b7 demon/rat$ a commitm5t to contribute to global heal? security1 includ+ ! national security ( ! ,unit$ ,/ates & ! heal? ( ,unit$ ,/ates citiz5s1 by ma9ta9+ op5 trade 9 m$ical goods dur+ a public heal? em]g5cy1 includ+ to enable rese>*1 developm5t1 & manufactur+ ( ^? goods2 7#c7 adh]$ to & implem5t$ ! commitm5ts & obligations "u exi/+ free trade agreem5ts to :i* t c\ntry & ! ,unit$ ,/ates are p>ties2 7#d7 implem5t$ measures to r$uce or elim9ate unnecess>y trade b>ri]s & di/ort+ practices affect+ m$ical goods2 7#e7 ma9ta9$ ! rule ( law by enact+ & en=c+ laws & regulations 9 a cle>1 publiciz$1 transp>5t1 & nondiscrim9atory mann]2 7#f7 adopt$ & en=c$ laws t provide adequate & effective protection ( intellectual prop]ty rights reflect+ a /&>d ( protection simil> to t f\nd "u ,unit$ ,/ates law2 & 7#g7 agre$ to recognize & promote good regulatory practices relat$ to m$ical goods4 7c7 ,tru/$ trade p>tn] agreem5ts ,a tru/$ trade p>tn] agreem5t may1 ) respect to m$ical goods1 provide =-- 7#a7 r$uction or elim9ation ( duties1 quotas1 & o!r trade b>ri]s t und]m9e ! national security & public heal? ( ! ,unit$ ,/ates by dis9c5tiviz+ rese>*1 developm5t1 & manufactur+ 9 ! ,unit$ ,/ates or 9 c\ntries t are reliable suppli]s ( m$ical goods to ! ,unit$ ,/ates2 7#b7 div]sification & expansion ( suppli] networks to secure a reliable supply ( m$ical goods2 7#c7 h>monization or conv]g5ce ( regulatory proc$ures1 regulatory reliance1 inspection coop]ation1 & adoption ( int]national /&>ds 7su* z to /reaml9e po/-approval *anges7 to exp$ite cross-bord] movem5t ( m$ical goods2 7#d7 increas$ access to gov]nm5t procurem5t m>kets = m$ical goods &1 9 ! case ( a multilat]al agreem5t ent]$ into "u ! auspices ( ! ,_w ,trade ,organization1 memb]%ip 9 ! ,agreem5t on ,gov]nm5t ,procurem5t ( ! ,_w ,trade ,organization ref]r$ to 9 section #aja7;d77#ag7 ( ! ,uruguay ,r\nd ,agreem5ts ,act 7#ai ,u4,s4,c4 #ceaa7;d77#ag772 7#e7 adequate & effective protection ( intellectual prop]ty rights = m$ical goods reflect+ a /&>d ( protection simil> to t f\nd "u ,unit$ ,/ates law2 7#f7 regulatory coop]ation on manufactur+ /&>ds = m$ical goods2 7#g7 a collaboration framework to promote public & private rese>* & developm5t ef=ts relat$ to m$ical goods1 includ+ facilitation ( data fl[s = life sci5ce rese>* & developm5t2 7#h7 adh]5ce to good regulatory practices = s\nd1 af=dable1 & effici5t regulation ( m$ical goods2 7#i7 promotion ( regulatory compatibility & coop]ation to facilitate trade & inve/m5t relat$ to m$ical goods & accel]ate manufactur+ ( su* goods dur+ a public heal? em]g5cy2 & 7#aj7 exemption ( p>ties to ! agreem5t f trade-re/rictive measures impos$ ) respect to m$ical goods dur+ a public heal? em]g5cy4 7d7 ,report requir$ ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 & e #ahj days !reaft]1 ! ,presid5t %all submit to ,congress a report on ! /atus ( negotiations conduct$ "u subsection 7a7 = tru/$ trade p>tn] agreem5ts4 #f4 ,congressional ov]sight1 notice1 consultations1 access to in=mation1 & review 7a7 ,notice ,n lat] ?an #fj days be=e initiat+ negotiations ) a tru/$ trade p>tn] "u section #e7;a7 = a tru/$ trade p>tn] agreem5t1 ! ,presid5t %all submit to ,congress writt5 notice ( ! int5tion ( ! ,presid5t to ent] into ! negotiations1 :i* %all include ! date negotiations w beg9 & ! tru/$ trade p>tn] ) :om ! ,presid5t seeks to ent] into ! agreem5t4 7b7 ,consultation ) memb]s ( ,congress 7#a7 ,consultation dur+ negotiations & access to in=mation ,9 ! c\rse ( negotiations "u section #e7;a7 = a tru/$ trade p>tn] agreem5t1 ! ,trade ,repres5tative %all-- 7,a7 meet ^u reque/ ) ! appropriate committees ( ,congress reg>d+ negotiat+ objectives1 ! /atus ( negotiations 9 progress1 & pot5tial effects to ! laws ( ! ,unit$ ,/ates ) respect to ! agreem5t2 7,b7 ^u reque/ by ! appropriate committees ( ,congress1 provide access to p]t95t docum5ts relat+ to ! negotiations2 & 7,c7 consult closely & on a timely basis )1 & keep fully appris$ ( ! negotiations1 ! appropriate committees ( ,congress4 7#b7 ,consultation be=e entry into agreem5t ,be=e ent]+ into a tru/$ trade p>tn] agreem5t "u section #e1 ! ,trade ,repres5tative %all consult )-- 7,a7 ! appropriate committees ( ,congress2 & 7,b7 ea* o!r committee ( ! ,s5ate & ! ,h\se ( ,repres5tatives1 & ea* jo9t committee ( ,congress1 t has jurisdiction ov] legislation involv+ a subject matt] t w\ld be affect$ by ! agreem5t4 7c7 ,consultation ) ,f$]al ag5cies ,9 ! c\rse ( negotiations "u section #e7;a7 = a tru/$ trade p>tn] agreem5t1 ! ,trade ,repres5tative %all in=m & consult ) any ,f$]al ag5cy hav+ exp]tise 9 ! matt]s be+ negotiat$1 includ+ ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7d7 ,limitation on action ,any duty elim9ation or /ag$ rate r$uction provid$ = "u section #e may be proclaim$ only if ! ,presid5t-- 7#a7 has obta9$ advice reg>d+ ! propos$ action f ! appropriate advisory committees e/abli%$ "u section #ace ( ! ,trade ,act ( #aigd 7#ai ,u4,s4,c4 #baee7 & ! ,int]national ,trade ,commission2 7#b7 has submitt$ to ! appropriate committees ( ,congress a report t sets =?-- 7,a7 ! action propos$ to be proclaim$2 7,b7 ! reasons = su* action2 & 7,c7 ! advice obta9$ "u p>agraph 7#a72 & 7#c7 has consult$ ) ! appropriate committees ( ,congress reg>d+ ! propos$ action dur+ ! #fj-;day p]iod on ! date on :i* ! ,presid5t has met ! requirem5ts "u p>agraphs 7#a7 & 7#b74 7e7 ,report to ,congress ,n lat] ?an #fj days be=e ! date on :i* ! ,presid5t ent]s into a tru/$ trade p>tn] agreem5t ) a tru/$ trade p>tn] "u section #e1 ! ,presid5t %all submit to ,congress a report describ+-- 7#a7 ! nature & scope ( ! agreem5t2 7#b7 ! propos$ duration ( ! agreem5t2 7#c7 h[ & to :at ext5t ! agreem5t w a*ieve ! applicable purposes1 policies1 priorities1 & objectives ( ?is ,act2 7#d7 :e!r suffici5t evid5ce exi/s demon/rat+ t-- 7,a7 ! tru/$ trade p>tn] satisfies ! conditions "u section #e7;b72 & 7,b7 ! reciprocal elim9ation ( exi/+ duties or o!r import re/rictions ( ! tru/$ trade p>tn] or ! ,unit$ ,/ates ) respect to m$ical goods w\ld contribute to ! national security & public heal? ( ! ,unit$ ,/ates2 & 7#e7 ! propos$ implem5tation ( ! agreem5t1 includ+ ! g5]al effect ( ! agreem5t on exi/+ laws4 7f7 ,congressional "r ,to review & disapprove 7#a7 ,9 g5]al ,a tru/$ trade p>tn] agreem5t %all n take effect until-- 7,a7 ! propos$ agreem5t has be5 submitt$ to ,congress1 toge!r ) ! report requir$ "u subsection 7e7 ) respect to t agreem5t2 & 7,b7 ! review p]iod requir$ "u p>agraph 7#b7 foll[+ ! date on :i* ! propos$ agreem5t has be5 submitt$ to ,congress "u subp>agraph 7,a7 has be5 exhau/$1 dur+ :i* p]iod a jo9t resolution is n enact$ "u p>agraph 7#d74 7#b7 ,review 7,a7 ,initial review ,unless ext5d$ "u subp>agraph 7,b7 or 7,c71 ! review p]iod "u ?is p>agraph ) respect to a tru/$ trade p>tn] agreem5t is #cj days1 dur+ :i* "t ,congress %all review ! propos$ agreem5t ) respect to :e!r-- 7i7 ! ,presid5t fail$ or refus$ to provide notice ) respect to ! agreem5t 9 accordance ) subsection 7a72 7ii7 ! ,presid5t fail$ or refus$ to consult ) respect to ! agreem5t 9 accordance ) subsections 7b7 & 7c72 7iii7 ! ,presid5t fail$ or refus$ to submit to ,congress a report ) respect to ! agreem5t 9 accordance ) subsection 7e72 or 7iv7 ! ,presid5t fail$ or refus$ to demon/rate t ! agreem5t w\ld a*ieve ! applicable purposes1 policies1 priorities1 & objectives ( ?is ,act & contribute to ! national security & public heal? ( ! ,unit$ ,/ates4 7,b7 ,fur!r review ,if1 dur+ ! #cj-;day p]iod "u subp>agraph 7,a7 ) respect to a tru/$ trade p>tn] agreem5t1 "o ,h\se ( ,congress adopts a resolution /at+ t ! ,h\se ( ,congress wi%es to fur!r review ! propos$ agreem5t1 ! review p]iod "u ?is p>agraph ) respect to ! propos$ agreem5t %all be ext5d$ by a p]iod ( #fj days1 dur+ :i* "t ! appropriate committees ( ,congress %all engage ! ,presid5t ) respect to ! propos$ agreem5t & ! failures or refusals ( ! ,presid5t specifi$ "u subp>agraph 7,a74 7,c7 ,additional p]iod ,if1 dur+ ! #fj-;day p]iod "u subp>agraph 7,b7 ) respect to a tru/$ trade p>tn] agreem5t1 "o ,h\se ( ,congress adopts a resolution /at+ t ! ,h\se ( ,congress wi%es to fur!r review ! propos$ agreem5t1 ! review p]iod "u ?is p>agraph ) respect to ! propos$ agreem5t %all be fur!r ext5d$ by a p]iod ( #cj days4 7#c7 ,proc$ures = consid]+ resolutions ,a resolution "u subp>agraph 7,b7 or 7,c7 ( p>agraph 7#b7-- 7,a7 9 ! ,s5ate-- 7i7 may be introduc$ by any ,memb] ( ! ,s5ate2 7ii7 %all be ref]r$ to ! ,committee on ,f9ance2 & 7iii7 may n be am5d$2 7,b7 9 ! ,h\se ( ,repres5tatives-- 7i7 may be introduc$ by any ,memb] ( ! ,h\se2 7ii7 %all be ref]r$ to ! ,committee on ,ways & ,means or ! ,committee on ,rules2 & 7iii7 may n be am5d$ by ei!r ,committee2 & 7,c7 ! vote on passage ( ! resolution %all occur imm$iately foll[+ ! conclusion ( ! debate on ! tru/$ trade p>tn] agreem5t at issue & a s+le quorum call at ! conclusion ( ! debate4 7#d7 ,disapproval ,if1 dur+ ! review p]iod requir$ "u p>agraph 7#b7 ) respect to a tru/$ trade p>tn] agreem5t1 a jo9t resolution is enact$ /at+ t ,congress does n favor ! agreem5t1 ! agreem5t %all n take effect4 #g4 ,monitor+ & en=cem5t ( cont9u$ compliance ) tru/$ trade p>tn] agreem5ts 7a7 ,monitor+ ,! ,trade ,repres5tative %all p]iodically monitor compliance by a tru/$ trade p>tn] ) ! commitm5ts & obligations ( ! p>tn] "u a tru/$ trade p>tn] agreem5t4 7b7 ,actions 9 response to failure ,to comply 7#a7 ,det]m9ation & report ( ,trade ,repres5tative ,if ! ,trade ,repres5tative det]m9es t a tru/$ trade p>tn] has fail$ to satisfactorily implem5t1 ma9ta91 & en=ce ! commitm5ts & obligations ( ! p>tn] "u a tru/$ trade p>tn] agreem5t1 ! ,trade ,repres5tative %all submit to ! ,presid5t a report sett+ =?-- 7,a7 ! det]m9ation & ! f9d+s t support ! det]m9ation2 & 7,b7 bas$ on su* f9d+s1 ! recomm5dations ( ! ,trade ,repres5tative = action or inaction "u ?is subsection4 7#b7 ,det]m9ation ( ,presid5t ,n lat] ?an #cj days aft] receiv+ a report "u p>agraph 7#a7 ) respect to a tru/$ trade p>tn]1 ! ,presid5t %all-- 7,a7 det]m9e :e!r ! ,presid5t concurs ) ! det]m9ation ( ! ,trade ,repres5tative set =? 9 ! report2 & 7,b7 if ! ,presid5t concurs1 det]m9e :e!r-- 7i7 to susp5d1 )draw1 or prev5t ! application ( ! tru/$ trade p>tn] agreem5t ) ! tru/$ trade p>tn]2 7ii7 to ent] into a b9d+ agreem5t ) ! p>tn] t commits ! p>tn]-- 7,i7 to elim9ate any burd5 or re/riction on ! ,unit$ ,/ates result+ f ! failure ( ! p>tn] to comply ) ! commitm5ts & obligations ( ! p>tn] "u a tru/$ trade p>tn] agreem5t2 & 7,,ii7 to provide ! ,unit$ ,/ates ) su* comp5satory trade b5efits z are negotiat$ betwe5 ! ,trade ,repres5tative & ! p>tn]2 or 7iii7 to take su* o!r actions z ! ,trade ,repres5tative consid]s necess>y to enc\rage ! p>tn] to adh]e to ! commitm5ts & obligations ( ! p>tn] "u a tru/$ trade p>tn] agreem5t1 includ+ susp5d+ ! exemption ( ! p>tn] f trade-re/rictive measures impos$ ) respect to m$ical goods dur+ a public heal? em]g5cy4 7#c7 ,timel9e = action ,if ! ,presid5t det]m9es "u p>agraph 7#b77;,b7 to take action1 ! ,presid5t %all implem5t t action by n lat] ?an ! date t is #ae days aft] ! day on :i* ! ,presid5t det]m9es to take action "u t p>agraph4