,,ii #aag? ,,congress #b;d ,session ,s4 #dbfb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #ai 7legislative day1 ,may #ag71 #bjbb,mr4 ,lee introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to tempor>ily all[ ! importation ( infant =mula free ( duty & free ( quantitative limitation1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,=mula ,act ( #bjbb4 #b4 ,increas+ ! supply ( infant =mula 7a7 ,9 g5]al ,dur+ ! #ahj day p]iod beg9n+ on ! date ( ! enactm5t ( ?is ,act1 infant =mula classifi$ "u head+ #aija4aj ( ! ,h>moniz$ ,t>iff ,s*$ule ( ! ,unit$ ,/ates %all ent] ! ,unit$ ,/ates free ( duty & free ( quantitative limitation1 if su* =mula-- 7#a7 is import$ f a c\ntry on ! li/ publi%$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u subsection 7c77#a7 or a memb] c\ntry ( ! ,european ,union2 & 7#b7 is lawfully m>ket$ 9 ! c\ntry ( orig94 7b7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection & 9 subsection 7c7 z ! ,secret>y7 %all1 n lat] ?an #g days aft] ! date ( enactm5t ( ?is ,act1 issue1 & p]iodically update1 z appropriate1 guidance = dome/ic & =eign manufactur]s ( infant =mula 9 ord] to increase availability ( su* =mula 9 ! ,unit$ ,/ates t is safe & nutritionally adequate4 7#b7 ,elem5ts ( ! guidance ,! guidance "u p>agraph 7#a7 %all address ! foll[+3 7,a7 ,in=mation to be submitt$ to ! ,secret>y by =eign & dome/ic manufactur]s ( infant =mula = consid]ation ) reg>d to ! introduction into int]/ate comm]ce 7includ+ importation7 ( infant =mula t is safe & nutritionally adequate b t may n comply ) all applicable /atutory & regulatory requirem5ts4 ,su* in=mation %all include-- 7i7 safety & nutritional adequacy ( ! infant =mula2 7ii7 product id5tification in=mation2 7iii7 ! quantity ( ! infant =mula int5d$ = introduction into int]/ate comm]ce2 7iv7 a copy ( ! label = ! infant =mula 7) in=mation on any all]g5s pres5t on ! product label & adequate in/ructions = safe product prep>ation & use7 & description ( ! packag+ ( ! infant =mula2 & 7v7 manufactur+ in=mation1 includ+ te/ results1 & facility compliance & inspection hi/ory4 7,b7 ,in=mation = manufactur]s plann+ to increase dome/ic production ( infant =mula = purposes ( address+ ! ongo+ %ortage4 7#c7 ,priority ,! guidance "u p>agraph 7#a7 %all provide = priority consid]ation = manufactur]s t are able to produce l>ge volumes ( su* infant =mula quickly4 7c7 ,importation f c\ntries meet+ c]ta9 /&>ds 7#a7 ,9 g5]al ,n lat] ?an #g days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all publi% a li/ ( c\ntries ! ,secret>y det]m9es to h manufactur+ & safety /&>ds = infant =mula t are simil>1 equival5t1 or o!rwise suitable1 z comp>$ to ,unit$ ,/ates /&>ds4 7#b7 ,p]sonal & comm]cial importation ,beg9n+ on ! date on :i* ! li/ ( c\ntries is publi%$ "u p>agraph 7#a71 = a p]iod n to exce$ #ahj days1 ! ,secret>y %all all[ p]sonal & comm]cial importation ( infant =mula f any c\ntry on su* li/1 z well z f any memb] c\ntry ( ! ,european ,union1 )\t reg>d to ! guidance "u subsection 7b77#b7 & ! requirem5ts ( section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 section #dae ( su* ,act 7#ba ,u4,s4,c4 #cej;d71 & p>ts #ajf & #ajg ( title #ba1 ,code ( ,f$]al ,regulations4 7d7 ,def9ition ,9 ?is section1 ! t]m infant =mula has ! mean+ giv5 su* t]m 9 section #bja7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7z774 #c4 ,special supplem5tal nutrition program = wom51 infants1 & *ildr5 7a7 ,access = ,,wic b5efici>ies ,not)/&+ any o!r provision ( law1 any infant =mula 7z def9$ 9 section #b7;d77 import$ into ! ,unit$ ,/ates pursuant to section #b7;c77#b7 is eligible = pur*ase us+ b5efits receiv$ "u ! special supplem5tal nutrition program = wom51 infants1 & *ildr5 e/abli%$ by section #ag ( ! ,*ild ,nutrition ,act ( #aiff 7#db ,u4,s4,c4 #aghf74 7b7 ,product recalls & supply *a9 disruptions ,section #ag ( ! ,*ild ,nutrition ,act ( #aiff 7#db ,u4,s4,c4 #aghf7 is am5d$-- 7#a7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#bd7 ,supply *a9 disruption ,! t]m supply *a9 disruption means a %ortage ( supplem5tal foods t imp$es ! r$emption ( food in/rum5ts1 z det]m9$ by ! ,secret>y4 2 & 7#b7 by add+ at ! end ! foll[+3 7r7 ,product recalls & supply *a9 disruptions 7#a7 ,def9ition ( qualifi$ adm9i/rative requirem5t ,9 ?is subsection1 ! t]m qualifi$ adm9i/rative requirem5t means-- 7,a7 a requirem5t "u ?is section2 & 7,b7 any regulatory requirem5t promulgat$ pursuant to ?is section4 7#b7 ,modification or waiv] ( requirem5ts ,not)/&+ any o!r provision ( law1 ! ,secret>y %all modify or waive a qualifi$ adm9i/rative requirem5t to all[ #a or m ,/ate ag5cies-- 7,a7 to p]mit v5dors au?oriz$ to p>ticipate 9 ! program "u ?is section to ex*ange or sub/itute au?oriz$ supplem5tal foods obta9$ ) food in/rum5ts ) food items t are n id5tical 7includ+ 9 br& & size72 7,b7 to modify or waive any requirem5t ) respect to m$ical docum5tation = ! issuance ( noncontract br& infant =mula1 except ! requirem5ts = p>ticipants receiv+ ,food ,package ,,iii 7z def9$ 9 section #bdf4aj7;e77#c7 ( title #g1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is subsection772 7,c7 to modify or waive ! maximum mon?ly all[ance = infant =mula2 7,d7 to modify or waive any additional requirem5t ) respect to supplem5tal food products provid$ "u ! program "u ?is section if ! modification or waiv]-- 7i7 may facilitate increas$ access to ^? products2 7ii7 does n sub/antially weak5 ! nutritional quality ( ^? products2 & 7iii7 is 9 accordance ) any applicable guidance or directive f ! ,adm9i/rator ( ,food & ,drugs det]m9$ to be applicable by ! ,secret>y4 7#c7 ,duration ,a modification or waiv] "u p>agraph 7#b7-- 7,a7 %all be available = a p]iod ( n m ?an #ahj days beg9n+ on ! date ( enactm5t ( ?is subsection2 & 7,b7 may be r5ew$1 subject to ! condition t ! ,secret>y %all provide notice ( ! r5ewal n less ?an #ae days be=e ! r5ewal %all take effect4 4