,i #aai? ,,congress #b;d ,session ,h4 ,r4 #hede ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bh1 #bjbf,ms4 ,h\lahan 7= h]self1 ,mrs4 ,bice1 & ,ms4 ,salaz>7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,education & ,work=ce1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to protect & exp& access to pa/euriz$1 donor human milk1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,access to ,donor ,milk ,act ( #bjbf4 #b4 ,def9itions ,9 ?is ,act3 7#a7 ,donor human milk ,! t]m donor human milk means human milk t is collect$1 pa/euriz$1 & disp5s$ )\t additives4 7#b7 ,donor human milk-d]iv$ product ,! t]m donor human milk-d]iv$ product means a product made pr$om9antly f donor human milk-- 7,a7 f :i* "o or m compon5ts has be5 remov$ 9 ord] to produce a specialty nutritional product2 or 7,b7 to :i* "o or m human milk or non-human milk compon5ts has be5 add$ to produce su* a product4 7#c7 ,donor human milk bank ,! t]m donor human milk bank means an organization t-- 7,a7 meets /&>ds e/abli%$ by ! ,food & ,drug ,adm9i/ration = purposes ( ensur+ ! safety ( donor human milk & human milk banks1 includ+ su* /&>ds z may be prescrib$ pursuant to section #f2 & 7,b7 collects1 te/s1 processes1 pa/eurizes1 & di/ributes1 9 compliance ) applicable ,f$]al & ,/ate law1 donor human milk or donor human milk d]iv$ products4 7#d7 ,nonpr(it donor human milk bank ,! t]m nonpr(it donor human milk bank means a donor human milk bank t is an organization-- 7,a7 describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #eja7;c77#c772 & 7,b7 exempt f taxation "u section #eja7;a7 ( su* ,code 7#bf ,u4,s4,c4 #eja7;a774 #c4 ,support = donor human milk activities ,section #ag ( ! ,*ild ,nutrition ,act ( #aiff 7#db ,u4,s4,c4 #aghf7 is am5d$-- 7#a7 9 subsection 7b77#d71 by ins]t+ 7includ+ support = donor human milk 7z def9$ 9 section #b ( ! ,access to ,donor ,milk ,act ( #bjbf7 activities7 aft] promotion2 & 7#b7 9 subsection 7h77#a77;,c7-- 7,a7 9 clause 7i71 by /rik+ clause 7ii7 & ins]t+ clauses 7ii7 & 7iii72 & 7,b7 by add+ at ! end ! foll[+3 7iii7 ,donor human milk ,a ,/ate ag5cy may use am\nts made available "u clause 7i7 =-- 7,i7 collect+ & /or+ donations ( unprocess$ human milk2 & 7,,ii7 ! transf] ( ! milk describ$ 9 subclause 7,i7 to a nonpr(it donor human milk bank 7z def9$ 9 section #b ( ! ,access to ,donor ,milk ,act ( #bjbf74 4 #d4 ,em]g5cy capacity fund+ = human milk banks 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all aw>d competitive grants1 subject to subsection 7c71 to eligible entities = exp&+ em]g5cy capacity ) respect to bank+ donor human milk4 7b7 ,application ,an eligible entity seek+ a grant "u ?is section %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7c7 ,crit]ia ,! ,secret>y may aw>d grants "u subsection 7a7 only 9 ! ev5t ( any ( ! foll[+3 7#a7 ,! ,secret>y det]m9es t exp&$ capacity is necess>y to respond to any major disa/] decl>$ by ! ,presid5t "u section #dja ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eagj7 or to any public heal? em]g5cy decl>$ "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d74 7#b7 ,! ,presid5t makes a det]m9ation describ$ 9 section #ajb7a7 ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eabb7a771 or ! ,secret>y makes su* a det]m9ation4 7#c7 ,! ,secret>y det]m9es em]g5cy capacity is ne$$ to ensure adequate supply is available to meet ! dem& = donor human milk f an eligible entity4 7d7 ,use ( funds ,exp&+ em]g5cy capacity pursuant to a grant "u ?is section may include-- 7#a7 publiciz+ ! ne$ = donor human milk1 especially = high-risk infants2 7#b7 rais+ aw>5ess & provid+ res\rces to families1 especially families ( high-risk infants1 ab\t donor human milk2 7#c7 cov]+ donor human milk collection1 /orage1 pa/eurization1 transf]1 & process+ fees2 7#d7 increas+ /aff+ & supplies ne$$ at donor human milk banks2 7#e7 pur*as+ consumable products ne$$ = donor human milk process+2 & 7#f7 acquir+ equipm5t = safety & quality process+ ( donor human milk4 7e7 ,eligible entity ,= purposes ( ?is section1 ! t]m eligible entity means an entity t-- 7#a7 is a nonpr(it donor human milk bank2 & 7#b7 9 ! application submitt$ "u subsection 7b71 demon/rates1 ) respect to su* entity-- 7,a7 a rapid increase 9 dem& = donor human milk2 or 7,b7 a %ortage ( supplies ne$$ to op]ate a donor human milk bank4 7f7 ,au?orization ( appropriations ,= ! purposes ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ #c1jjj1jjj = fiscal ye> #bjbf1 & su* sums z may be necess>y = ea* fiscal ye> !reaft]4 #e4 ,public aw>5ess campaign ) respect to donor human milk 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices-- 7#a7 %all1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 develop a public aw>5ess campaign ) respect to ! b5efits & safety ( donor human milk f donor human milk banks2 & 7#b7 may "w ) nonpr(it donor human milk banks4 7b7 ,di/ribution ( educational mat]ials ,! public aw>5ess campaign "u subsection 7a7 %all include ! di/ribution ( educational mat]ials to-- 7#a7 cl9icians1 su* z p$iatric speciali/s1 p$iatricians1 ob/etricians1 p$iatric nutritioni/s1 midwives1 & lactation consultants1 includ+ int]national bo>d-c]tifi$ lactation consultants2 7#b7 expectant & new p>5ts1 ) a focus on expectant & new p>5ts t are p>ticipat+ 9 ! special supplem5tal nutrition program = wom51 infants1 & *ildr5 program "u section #ag ( ! ,*ild ,nutrition ,act ( #aiff 7#db ,u4,s4,c4 #aghf72 & 7#c7 community-bas$ organizations4 #f4 ,regulatory /atus ( donor human milk 7a7 ,public meet+ ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 = purposes ( assi/+ ! ,secret>y 9 e/abli%+ m9imum safety /&>ds = donor human milk & donor human milk-d]iv$ products "u subsection 7c71 conv5e a public meet+4 7b7 ,safety /&>ds ,9 e/abli%+ ! safety /&>ds "u subsection 7c71 ! ,secret>y %all take into acc\nt-- 7#a7 ! unique factors relat$ to donor human milk & donor human milk-d]iv$ products2 7#b7 e?ical consid]ations2 7#c7 ! protection ( ! ,unit$ ,/ates donor milk supply2 & 7#d7 ! res\rces available to non-pr(it milk banks4 7c7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance t-- 7#a7 e/abli%es m9imum appropriate safety /&>ds = ! collection & prep>ation1 /orage1 h&l+1 & process+ ?r\gh pa/eurization1 & transf] ( donor human milk & donor human milk-d]iv$ products2 & 7#b7 consid]s ! m9imum appropriat5ess ( scre5+1 te/+1 & o!r processes1 to ensure ! safety ( donor human milk & donor human milk-d]iv$ products1 z det]m9$ by ! ,secret>y4