,i #aag? ,,congress #b;d ,session ,h4 ,r4 #ghcj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ah1 #bjbb,ms4 ,/efanik 7= h]self1 ,mrs4 ,rodg]s ( ,wa%+ton1 ,mrs4 ,h9son1 & ,mrs4 ,bice ( ,oklahoma7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to improv+ ! infant =mula supply *a91 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,babies ,ne$ ,m ,=mula ,n[ ,act ( #bjbb4 #b4 ,def9ition ,9 ?is ,act1 ! t]m infant =mula has ! mean+ giv5 to su* t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 #c4 ,importation ( infant =mula 7a7 ,waiv] ( label+ requirem5ts = imports ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,waiv] ( label+ requirem5ts = imports 7#a7 ,9 g5]al ,! ,secret>y may waive any label+ requirem5t "u ?is ,act applicable to-- 7,a7 ! importation ( infant =mula f any c\ntry t is det]m9$ by ! ,secret>y to be implem5t+ & en=c+ requirem5ts = infant =mula t provide a simil> assurance ( safety z ! regulatory requirem5ts ( ?is ,act2 or 7,b7 ! di/ribution & sale ( su* import$ infant =mula4 7#b7 ,rule ( con/ruction ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to limit ! au?ority ( ! ,secret>y to require a recall (1 or o!rwise impose re/rictions & requirem5ts "u ?is ,act ) respect to1 infant =mula t is subject to a waiv] "u p>agraph 7#a74 4 7b7 ,h>monization ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 :5 appropriate1 ent] into arrangem5ts ) o!r nations = ! purpose ( h>moniz+ ! regulatory requirem5ts ( ! ,unit$ ,/ates = infant =mula1 includ+ ) respect to inspections1 nutritional requirem5ts1 & common int]national label+1 ) ! correspond+ regulatory requirem5ts ( su* o!r nations4 7c7 ,support = ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative ,section #hjc7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7;c77#b77 is am5d$ by /rik+ foods & ins]t+ foods 7includ+ infant =mula74 7d7 ,/udy ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into an arrangem5t ) ! ,national ,academy ( ,m$ic9e 7or1 if ! ,national ,academy decl9es to ent] into su* arrangem5t1 ano!r appropriate entity7 "u :i* ! ,national ,academy 7or o!r appropriate entity7 agrees to-- 7#a7 conduct a /udy comp>+ infant =mula 9 ! ,unit$ ,/ates & infant =mula 9 ! ,european ,union1 includ+ ) respect to nutritional cont5t & applicable label+ & o!r regulatory requirem5ts2 & 7#b7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 complete su* /udy & submit a report on ! results ( su* /udy to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 #d4 ,transp>5cy to support infant =mula innovation 7a7 ,annual report to ,congress ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by section #c7;a7 ( ?is ,act1 is fur!r am5d$ by add+ at ! end ! foll[+3 7k7 ,annual report to ,congress ,n lat] ?an ,m>* #cj ( ea* ye>1 ! ,secret>y %all submit a report to ! ,congress conta9+1 ) respect to ! prec$+ cal5d> ye>1 ! foll[+ in=mation3 7#a7 ,! numb] ( submissions receiv$ by ! ,secret>y "u subsection 7d74 7#b7 ,= ea* su* submission-- 7,a7 ! am\nt ( "t tak5 by ! ,secret>y to respond2 7,b7 ! numb] ( times ! ,secret>y reque/$ additional in=mation f ! p]son mak+ su* submission2 & 7,c7 :e!r su* submission includ$ any new +r$i5ts t 7 n includ$ 9 any infant =mula already on ! m>ket4 7#c7 ,! numb] ( inspections conduct$ by ! ,food & ,drug ,adm9i/ration or any ag5t !re( to evaluate compliance ) subsection 7b77#b74 7#d7 ,! "t betwe5 any inspection ref]r$ to 9 p>agraph 7#c7 & any necess>y re9spection to evaluate compliance ) subsection 7b77#b74 4 7b7 ,m>ket+ submissions ,section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7l7 ,m>ket+ submissions 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all respond to a submission "u subsection 7d7 = infant =mula n lat] ?an #ij days aft] receiv+ su* notification4 7#b7 ,exp$it$ response ,! ,secret>y %all respond to a submission "u subsection 7d7 = infant =mula n lat] ?an #ge days aft] receiv+ su* notification if x-- 7,a7 is submitt$ by a manufactur] t is n already m>ket+ infant =mula 9 ! ,unit$ ,/ates2 or 7,b7 is = infant =mula conta9+ "o or m +r$i5ts t are n conta9$ 9 infant =mula t is already be+ m>ket$ 9 ! ,unit$ ,/ates4 7#c7 ,notification to ,congress ,:5ev] ! ,secret>y fails to respond to a submission "u subsection 7d7 by ! deadl9e applicable "u p>agraph 7#a7 or 7#b71 ! ,secret>y %all give notice ( su* failure to ! ,congress1 includ+ an explanation ( ! reasons = fail+ to meet ! deadl9e4 4 7c7 ,te*nical correction ,section #dab7;c77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7c77#a77;,b77 is am5d$ by /rik+ subsection 7c77#a7 & ins]t+ subsection 7d77#a74 #e4 ,r$uc+ b>ri]s to infant =mula competition ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue guidance on :i* types ( *anges1 if any1 9 ! +r$i5ts ( infant =mula may n require a new gr[? /udy to meet ! requirem5ts ( section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a74 #f4 ,coord9ation ( ef=ts to mitigate %ortages ( infant =mula ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all require appropriate /aff ( ! ,(fice ( ,nutrition & ,food ,label+1 & ! ,(fice ( ,compliance1 ( ! ,c5t] = ,food ,safety & ,appli$ ,nutrition1 to meet at lea/ biweekly to discuss1 ) respect to infant =mula1 p5d+ inspections1 ! f9d+s ( p5d+ & conclud$ inspections1 & any ne$ = additional inspections4 #g4 ,importation = p]sonal use 7a7 ,9 g5]al ,dur+ ! p]iod ( #ij days foll[+ ! date ( enactm5t ( ?is ,act1 a p]son may1 )\t prior notice to ! ,food & ,drug ,adm9i/ration1 import up to a ?ree-mon? supply ( infant =mula = p]sonal use f ,canada1 ! ,european ,union1 or any c\ntry t is det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 to h safety /&>ds = infant =mula simil> to su* /&>ds applicable "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7b7 ,limitations ,infant =mula may be import$ pursuant to subsection 7a7 only if ! infant =mula-- 7#a7 is exclusively = p]sonal use & w n be comm]cializ$ or promot$2 & 7#b7 does n pres5t an unreasonable risk to human heal?4 7c7 ,report+ ( adv]se ev5ts ,if a heal? c>e provid] becomes aw>e ( any adv]se ev5t :i* ! heal? c>e provid] reasonably suspects to be associat$ ) infant =mula import$ pursuant to subsection 7a71 ! heal? c>e provid] %all report su* adv]se ev5t to ! ,food & ,drug ,adm9i/ration4 7d7 ,public notice ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all po/ on ! public website ( ! ,food & ,drug ,adm9i/ration notice t-- 7#a7 infant =mula import$ pursuant to subsection 7a7 may n h be5 manufactur$ 9 a facility t has be5 inspect$ by ! ,food & ,drug ,adm9i/ration2 7#b7 ! label+ ( su* infant =mula may n meet ! /&>ds & o!r requirem5ts applicable ) respect to infant =mula "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 & 7#c7 ! nutritional cont5t ( ! infant =mula may v>y f t ( infant =mula meet+ su* /&>ds & o!r requirem5ts4 7e7 ,s5se ( ,congress ,x is ! s5se ( ,congress t p]sons consid]+ ! p]sonal importation ( infant =mula %\ld consult ) _! p$iatrician ab\t su* importation4 #h4 ,consid]ation ( supply effects prior to recomm5d+ or requir+ a recall 7a7 ,9 g5]al ,section #dab7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7f77#b77 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,be=e recomm5d+ or requir+ any recall ( infant =mula due exclusively to label+ defici5cies1 ! ,secret>y %all ensure t ! supply ( infant =mula 9 ! ,unit$ ,/ates w n be negatively affect$ by su* recall4 4 7b7 ,regulations ,n lat] ?an #c mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue or update su* regulations z may be necess>y to implem5t p>agraph 7#d7 ( section #dab7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 #i4 ,congressional notification 7a7 ,9 g5]al ,n lat] ?an #bd h\rs aft] ! initiation ( a recall ( infant =mula1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit to ! ,congress a notification ( su* recall4 7b7 ,cont5ts ,a notification "u subsection 7a7 %all include ! foll[+3 7#a7 ,if ! recall is requir$ by ! ,food & ,drug ,adm9i/ration1 a summ>y ( ! det]m9ation ( a case ( adult]at$ or misbr&$ infant =mula t pres5ts a risk to human heal?4 7#b7 ,if ! recall is volunt>ily initiat$ by ! manufactur]1 a summ>y ( ! in=mation provid$ to ! ,food & ,drug ,adm9i/ration by ! manufactur] reg>d+ infant =mula t has left ! control ( ! manufactur] t may be adult]at$ or misbr&$4 7#c7 ,specification ( :5 ! ,food & ,drug ,adm9i/ration 0 fir/ made aw>e ( ! in/ance or circum/ances surr\nd+ ! recall4 7#d7 ,an initial e/imate ( ! disruption 9 dome/ic production t may result f ! recall4 #aj4 ,report to ,congress 7a7 ,9 g5]al ,n lat] ?an #ad days aft] ! initiation ( a recall ( infant =mula1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit a report to ! ,congress reg>d+ su* recall4 7b7 ,cont5ts ,a report "u subsection 7a7 %all include ! foll[+3 7#a7 ,a plan 7includ+ an e/imat$ timel9e7 ( actions ! ,food & ,drug ,adm9i/ration & ! manufactur] w take-- 7,a7 to id5tify & address any cause ( adult]ation or misbr&+2 & 7,b7 to re/ore op]ation ( ! impact$ facilities to meet production levels 9 place prior to ! recall4 7#b7 ,! curr5t dome/ic supply ( infant =mula1 includ+-- 7,a7 a breakd[n ( ! specific types ( =mula involv$2 & 7,b7 an e/imate ( h[ long curr5t supplies w la/4 7#c7 ,9 ! case t a recall & subsequ5t actions to respond to ! recall impact ov] #aj p]c5t ( ! dome/ic production ( infant =mula1 a plan to backfill supplies if ! curr5t dome/ic supply ( infant =mula has or is expect$ to fall bel[ ! level dem&$ dur+ ! disruption 9 dome/ic production1 :i* plan %all include-- 7,a7 actions to "w ) ! impact$ manufactur] or o!r manufactur]s to increase production2 & 7,b7 specification (-- 7i7 any additional au?orities ne$$ reg>d+ production or importation to fill a supply gap2 & 7ii7 any supplem5tal fund+ necess>y to address ! %ortage4 #aa4 ,coord9ation ) manufactur] on re/or+ production 7a7 ,9 g5]al ,^u complet+ an inspection ( an infant =mula manufactur+ facility impact$ by a recall1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all provide ! manufactur] involv$ a li/ ( any actions necess>y-- 7#a7 to address defici5cies contribut+ to ! pot5tial adult]ation or misbr&+ ( product at ! facility2 & 7#b7 to safely re/>t production at ! facility4 7b7 ,response to manufactur] ,n lat] ?an #g days aft] receiv+ a writt5 communication f a manufactur] ( infant =mula reg>d+ safely re/or+ production foll[+ a recall ( su* product1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all provide a sub/antive response to su* communication1 includ+ any necess>y next /eps4