,,ii #aah? ,,congress #a/ ,session ,s4 #aifa ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #ac1 #bjbc,mr4 ,pet]s 7= himself & ,ms4 ,ern/7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to require an int]ag5cy risk assessm5t ( ! ph>maceutical supply *a9 to id5tify & mitigate heal? & national security risks1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ph>maceutical ,supply ,*a9 ,risk ,assessm5t ,act ( #bjbc4 #b4 ,risk assessm5t 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all lead1 9 coord9ation ) ! ,secret>y ( ,def5se1 ! ,secret>y ( ,homel& ,security1 & ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 a compreh5sive risk assessm5t ( ! ,unit$ ,/ates ph>maceutical supply *a9 & report to ! relevant committees ( ,congress on ! f9d+s ( ea* su* assessm5t4 ,! assessm5t %all be complet$ n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 & %all be updat$ annually !reaft]4 7b7 ,cont5ts ,at a m9imum1 ! risk assessm5t "u subsection 7a7 %all-- 7#a7 use1 z applicable1 any drugs f ! ess5tial m$ic9es li/ develop$ by ! ,food & ,drug ,adm9i/ration 9 response to ,executive ,ord] #acidd 7#he ,f$4 ,reg4 #diibi7 & any o!r relevant assessm5ts or li/s1 z appropriate1 to id5tify1 9 coord9ation ) ! private sector1 a li/ ( ess5tial m$ic9es1 to be updat$ regul>ly on a timeframe t ! ,secret>y ( ,heal? & ,human ,s]vices1 9 coord9ation ) ! ,secret>y ( ,def5se & ! ,secret>y ( ,homel& ,security1 det]m9es appropriate1 :i* %all include ! active ph>maceutical +r$i5ts & drugs t-- 7,a7 are reasonably likely to be requir$ to respond to a public heal? em]g5cy or to a *emical1 biological1 radiological1 or nucle> ?reat2 or 7,b7 ! %ortage ( :i* w\ld pose a significant ?reat to ! ,unit$ ,/ates heal? c>e sy/em or at-risk populations2 7#b7 id5tify1 = ea* ( ! active ph>maceutical +r$i5ts & drugs t are id5tifi$ "u p>agraph 7#a7-- 7,a7 ! active ph>maceutical +r$i5ts & drugs ) vuln]able supply *a9s2 7,b7 ! am\nt manufactur$ by ea* e/abli%m5t regi/]$ "u section #eaj7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b771 z report$ "u section #eaj7;j77#c7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7;j77#c771 or1 ) respect to any active ph>maceutical +r$i5t or drug = :i* su* in=mation is unavailable1 an explanation = :y ! in=mation is unavailable2 7,c7 ! drugs t are s\rc$ ei!r exclusively or prim>ily f =eign e/abli%m5ts1 includ+ drugs manufactur$ dome/ically f active ph>maceutical +r$i5ts s\rc$ exclusively or prim>ily f =eign e/abli%m5ts2 & 7,d7 ! active ph>maceutical +r$i5ts t are s\rc$ ei!r exclusively or prim>ily f =eign e/abli%m5ts2 7#c7 assess key />t+ mat]ials & excipi5ts us$ 9 manufactur+ ! active ph>maceutical +r$i5ts & drugs id5tifi$ "u p>agraph 7#a72 7#d7 assess curr5t dome/ic manufactur+ capabilities ) respect to drugs 7includ+ key />t+ mat]ials1 excipi5ts1 & active ph>maceutical +r$i5ts7 id5tifi$ "u p>agraph 7#a71 includ+ advanc$ manufactur+ capabilities2 7#e7 id5tify critical vuln]abilities1 includ+ cyb]security ?reats2 7#f7 id5tify ! exi/+ /atutory au?orities ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 & ! ,dep>tm5t ( ,homel& ,security h to address public heal? or national security risks t may arise z a result ( vuln]abilities 9 ! ph>maceutical supply *a92 & 7#g7 id5tify any defici5cies1 lack ( au?orities1 or limitations 9 policy or process t limit ! ability ( any ( ! dep>tm5ts describ$ 9 p>agraph 7#f7 to address vuln]abilities 9 ! ph>maceutical supply *a9 id5tifi$ 9 ! risk assessm5t1 & describe ! plans ( ! dep>tm5ts describ$ 9 p>agraph 7#f7 to mitigate su* vuln]abilities4 7c7 ,publication ( assessm5t ,! risk assessm5t "u subsection 7a7 7includ+ any updates7 %all be publicly available 9 an unclassifi$ =m b may include a classifi$ annex conta9+ any in=mation t ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es to be s5sitive4 7d7 ,def9itions ,9 ?is section3 7#a7 ,advanc$ manufactur+ ,! t]m advanc$ manufactur+ has ! mean+ giv5 ! t]m advanc$ & cont9u\s ph>maceutical manufactur+ 9 section #cjaf7;h7 ( ! #ba/ ,c5tury ,cures ,act 7#ba ,u4,s4,c4 #cii;h7h774 7#b7 ,cyb]security ?reat ,! t]m cyb]security ?reat has ! mean+ giv5 su* t]m 9 section #bbjj ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #fej74 7#c7 ,drug ,! t]m drug has ! mean+ giv5 su* t]m 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g774 7#d7 ,relevant committees ( congress ,! t]m relevant committees ( ,congress means ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 & ! ,committee on ,arm$ ,s]vices ( ! ,s5ate & ! ,committee on ,homel& ,security1 ! ,committee on ,en]gy & ,comm]ce1 & ! ,committee on ,arm$ ,s]vices ( ! ,h\se ( ,repres5tatives4 7e7 ,cl>ification ,! p>ticipation ( ! ,secret>y ( ,heal? & ,human ,s]vices 9 develop+ & updat+ ! li/ ( ess5tial m$ic9es "u subsection 7b77#a7 %all be deem$ to be full satisfaction ( ! requirem5ts applicable to su* secret>y "u section #c ( ,executive ,ord] #acidd 7#he ,f$4 ,reg4 #diibi74