,i #aah? ,,congress #b;d ,session ,h4 ,r4 #fiib ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #ab1 #bjbd,ms4 ,matsui 7= h]self & ,mr4 ,buc%on7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices to e/abli% a li/ ( ess5tial m$ic9es1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,mapp+ ,am]ica's ,ph>maceutical ,supply ,act or ! ,,maps ,act4 #b4 ,ess5tial m$ic9es li/ update 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all e/abli% & ma9ta9 a li/ ( ess5tial m$ic9es4 7b7 ,crit]ia ,! li/ "u subsection 7a7 %all consi/ ( drugs & active ph>maceutical +r$i5ts 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 populations4 7c7 ,selection ,! ,secret>y %all select drugs & active ph>maceutical +r$i5ts = inclusion on ! li/ "u subsection 7a7-- 7#a7 bas$ on ! crit]ia specifi$ 9 subsection 7b72 & 7#b7 f ! li/ ( ess5tial m$ic9es1 m$ical c\nt]measures1 & critical inputs develop$ by ! ,food & ,drug ,adm9i/ration 9 response to ,executive ,ord] #acidd 7#he ,f$4 ,reg4 #diibi7 & o!r relevant assessm5ts or li/s4 7d7 ,process 7#a7 ,9 g5]al ,be=e f9aliz+ ! li/ "u subsection 7a7 or any update to su* li/1 ! ,secret>y %all-- 7,a7 publi% a propos$ li/ or update1 z applicable2 & 7,b7 provide an opportunity = public comm5t on ! propos$ li/ or update4 7#b7 ,initial li/ ,! ,secret>y %all-- 7,a7 publi% ! propos$ initial li/ "u subsection 7a7 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act2 & 7,b7 publi% ! f9al initial li/ "u subsection 7a7 n lat] ?an #a ye> aft] su* date ( enactm5t4 7#c7 ,regul> review ,! ,secret>y %all regul>ly review ! li/ "u subsection 7a7 to det]m9e :e!r any updates %\ld be made pursuant to p>agraph 7#a74 7e7 ,relation to ,executive ,ord] ,! p>ticipation ( ! ,secret>y 9 e/abli%+1 ma9ta9+1 & updat+ ! li/ "u subsection 7a7 %all be deem$ to be full satisfaction ( ! requirem5ts applicable to ! ,secret>y "u section #c ( ,executive ,ord] #acidd 7#he ,f$4 ,reg4 #diibi74 #c4 ,f$]al ,unit$ ,/ates ph>maceutical supply *a9 mapp+ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 coord9ation ) ! heads ( o!r relevant ag5cies1 %all support ef=ts1 includ+ ?r\gh public-private p>tn]%ips1 to map ! entire ,unit$ ,/ates ph>maceutical supply *a91 f inception to di/ribution1 & use data analytics to id5tify supply *a9 vuln]abilities & o!r national security ?reats4 ,su* activities %all include1 at a m9imum-- 7#a7 def9+ ag5cy roles 9 monitor+ ! ph>maceutical supply *a9 & communicat+ supply *a9 vuln]abilities2 & 7#b7 ) respect to drugs & active ph>maceutical +r$i5ts on ! li/ ( ess5tial m$ic9es "u section #b7;a71 e/abli%+ a database t %all include-- 7,a7 ! location ( e/abli%m5ts regi/]$ "u subsection 7b71 7c71 or 7i7 ( section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 involv$ 9 ! production (-- 7i7 ! f9i%$ dosage =ms ( ! drugs on su* li/2 7ii7 ! active ph>maceutical +r$i5ts ( su* drugs2 or 7iii7 active ph>maceutical +r$i5ts on su* li/2 7,b7 ! am\nt ( su* f9i%$ dosage =ms & active ph>maceutical +r$i5ts produc$ at ea* su* e/abli%m5t2 7,c7 to ! ext5t available-- 7i7 ! location ( e/abli%m5ts involv$ 9 ! production ( ! key />t+ mat]ials & excipi5ts us$ to produce ! f9i%$ dosage =ms & active ph>maceutical +r$i5ts ref]r$ to 9 subp>agraph 7,a72 & 7ii7 ! am\nt ( su* mat]ials & excipi5ts produc$ at ea* su* e/abli%m5t2 & 7,d7 any regulatory actions ) respect to ! e/abli%m5ts ref]r$ to 9 subp>agraph 7,a7 or 7,c71 includ+ ) respect to-- 7i7 label+ requirem5ts2 7ii7 regi/ration & li/+ in=mation requir$ to be submitt$ "u section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj72 7iii7 inspections & relat$ regulatory activities conduct$ "u section #gjd ( su* ,act 7#ba ,u4,s4,c4 #cgd72 7iv7 ! seizure ( su* a drug or active ph>maceutical +r$i5t pursuant to section #cjd ( su* ,act 7#ba ,u4,s4,c4 #ccd72 7v7 any recalls ( a drug or active ph>maceutical +r$i5t on ! li/ ( ess5tial m$ic9es "u section #b7;a71 or a drug conta9+ an active ph>maceutical +r$i5t on su* li/2 7vi7 inclusion ( su* a drug or active ph>maceutical +r$i5t on ! drug %ortage li/ "u section #ejf;,e ( su* ,act 7#ba ,u4,s4,c4 #cef;e72 or 7vii7 prior reports ( a discont9uance or int]ruption 9 ! production ( su* a drug or active ph>maceutical +r$i5t "u #ejf;,c ( su* ,act 7#ba ,u4,s4,c4 #cef;c74 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! heads ( ag5cies ) :i* su* ,secret>y coord9ates "u subsection 7a71 %all submit a report to ,congress on-- 7#a7 progress on implem5t+ subsection 7a71 includ+ any timel9es = full implem5tation2 7#b7 gaps 9 data ne$$ = full implem5tation ( su* subsection2 7#c7 h[ ! database e/abli%$ pursuant to subsection 7a7 increases ,f$]al visibility into ! ph>maceutical supply *a92 7#d7 h[ ,f$]al ag5cies are able to use data analytics to conduct pr$ictive model+ ( anticipat$ drug %ortages or national security ?reats2 & 7#e7 ! ext5t to :i* indu/ry has coop]at$ 9 mapp+ ! ph>maceutical supply *a94 7c7 ,confid5tial comm]cial in=mation ,! ex*ange ( in=mation among ! ,secret>y ( ,heal? & ,human ,s]vices & ! heads ( o!r relevant ag5cies = purposes ( c>ry+ out ?is section %all n be a violation ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 7d7 ,cl>ification ,! in=mation 9 ! database e/abli%$ pursuant to subsection 7a7 %all n be publicly disclos$4 ,no?+ 9 ?is subsection %all be con/ru$ to relieve ! ,secret>y ( ,heal? & ,human ,s]vices f ! ,secret>y's obligation to provide in=mation to ,congress4