,,ii #aag? ,,congress #a/ ,session ,s4 #bibe ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,octob] #d1 #bjba,ms4 ,ros5 7= h]self & ,mr4 ,cassidy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = a /rategic plan = ! dome/ic manufacture ( necess>y m$ical supplies or supplies ne$$ to facilitate em]g5cy or m$ical response1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/rategic ,plann+ = ,em]g5cy ,m$ical ,manufactur+ ,act4 #b4 ,dome/ic back-up manufactur+ network ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cai;,f-#d ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 ! foll[+3 #cai;,f-#e4 ,dome/ic back-up manufactur+ network 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response 7ref]r$ to 9 ?is section z ! ,assi/ant ,secret>y71 %all develop & ma9ta9 a network ( manufactur]s-- 7#a7 ^: manufactur+ facilities are 9 ! ,unit$ ,/ates 7includ+ small bus9ess conc]ns1 z def9$ 9 section #c ( ! ,small ,bus9ess ,act72 7#b7 :o manufacture c]ta9 items id5tifi$ by ! ,assi/ant ,secret>y1 :i* %all prim>ily be m$ical supplies or supplies ne$$ to facilitate em]g5cy or m$ical response2 & 7#c7 t h volunt>ily opt$ 9 = inclusion 9 su* network1 9 ord] to provide = ! dome/ic manufacture ( necess>y supplies dur+ times ( em]g5cy or disruption ( ! usual supply *a94 7b7 ,di/ribution ( network ,! ,assi/ant ,secret>y %all make in=mation ab\t ! network describ$ 9 subsection 7a7 available to ,/ates1 local gov]nm5tal entities1 ,indian ,tribes1 ,tribal organizations1 & urban ,indian organizations1 m$ical suppli]s1 hospitals1 & o!r heal? c>e provid]s1 z ! ,assi/ant ,secret>y det]m9es appropriate1 :5 critical supply %ortfalls are anticipat$4 7c7 ,plans develop$ 9 conjunction ) p>ticipat+ manufactur]s ,dome/ic manufactur]s opt+ to p>ticipate z describ$ 9 subsection 7a7 %all develop1 9 coord9ation ) ! ,assi/ant ,secret>y1 a compreh5sive plan t id5tifies-- 7#a7 ! items t ! manufactur] c\ld produce1 :i* may include-- 7,a7 items su* manufactur] has curr5t capacity to produce1 or ! ability to rapidly exp& capacity to produce2 & 7,b7 in=mation ab\t ! manufactur]'s g5]al capacity & equipm5t & will+ness to "w ) ! ,assi/ant ,secret>y to id5tify o!r products likely to be ne$$ dur+ an em]g5cy t fit )9 ! manufactur]'s op]ational capabilities2 7#b7 manufactur+ capacity1 includ+ options = p>tial op]ations & full capacity op]ations1 & ! "t ne$$ to swit* f /&>d product manufactur+ to ! ne$$ em]g5cy supply2 7#c7 te*nical assi/ance ne$$ = production ( items ne$$ dur+ times ( em]g5cy1 su* z equipm5t1 /aff tra9+1 & regulatory compliance1 includ+ scope1 duration1 & ! appropriate ,f$]al ag5cy to provide assi/ance2 & 7#d7 ! frequ5cy ( te/+ by ! manufactur] to ensure t ! plan is op]ational & meets quality metrics & o!r obligations "u ,f$]al pur*as+ contracts 7includ+ ) respect to contracts = supplies = ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b7 or to meet o!r requirem5ts det]m9$ by ! ,assi/ant ,secret>y4 7d7 ,guidance ,! ,secret>y %all issue guidance on ! quality /&>ds = items id5tifi$ by ! ,assi/ant ,secret>y z describ$ 9 subsection 7a77#b71 by product type or category1 t apply ) respect to su* items produc$ by manufactur]s includ$ 9 ! network4 7e7 ,coord9ation ) o!r ag5cies ,! ,secret>y %all coord9ate ) o!r ,f$]al ag5cies to provide contract+ opportunities = ,f$]al pur*as+ ( items id5tifi$ by ! ,assi/ant ,secret>y z describ$ 9 subsection 7a77#b71 z su* items are ne$$1 provid$ t su* items meet all quality /&>ds & o!r requirem5ts & are produc$ z "p ( an agreem5t ) ! ,f$]al ,gov]nm5t4 7f7 ,limits on p>ticipation2 opportunities = consid]ation 7#a7 ,limits ,! ,secret>y may limit ! numb] ( manufactur]s t h active manufactur+ plans "u subsection 7c7 & manufactur]s t are active p>ticipants 9 ! network describ$ 9 subsection 7a71 tak+ into acc\nt div]sity ( product & geography ( production facilities4 7#b7 ,opportunities = future consid]ation ,all manufactur]s wi%+ to p>ticipate 9 su* network %all h access to a po9t ( contact )9 ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response &1 if n includ$ 9 su* network1 %all h ! option to add _! "n to a simplifi$ li/ = future consid]ation = su* p>ticipation1 unless ! ,assi/ant ,secret>y det]m9es !re to be any sub/antial cause = removal ( ! manufactur] f su* li/4 4