#aaf? ,,congress #b;d ,session ,s4 #afha ,,an ,,act ,to educate heal? c>e provid]s & ! public on biosimil> biological products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc+ ,education on ,biosimil>s ,act ( #bjbj4 #b4 ,education on biological products ,subp>t #a ( "p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by add+ at ! end ! foll[+3 #ceb;,a4 ,education on biological products 7a7 ,int]net website 7#a7 ,9 g5]al ,! ,secret>y may ma9ta9 & op]ate an int]net website to provide educational mat]ials = heal? c>e provid]s1 pati5ts1 & c>egiv]s1 reg>d+ ! mean+ ( ! t]ms1 & ! /&>ds = review & lic5s+ (1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 7#b7 ,cont5t ,educational mat]ials provid$ "u p>agraph 7#a7 may include-- 7,a7 explanations ( key /atutory & regulatory t]ms1 includ+ biosimil> & int]*angeable1 & cl>ification reg>d+ ! use ( int]*angeable biosimil> biological products2 7,b7 in=mation relat$ to developm5t programs = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products & relevant cl9ical consid]ations = prescrib]s1 :i* may include1 z appropriate & applicable1 in=mation relat$ to ! comp>ability ( su* biological products2 7,c7 an explanation ( ! process = report+ adv]se ev5ts = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products2 & 7,d7 an explanation ( ! relation%ip betwe5 biosimil> biological products & int]*angeable biosimil> biological products lic5s$ "u section #cea7k7 & ref]5ce products 7z def9$ 9 section #cea7;i771 includ+ ! /&>ds = review & lic5s+ ( ea* su* type ( biological product4 7#c7 ,=mat ,! educational mat]ials provid$ "u p>agraph 7#a7 may be-- 7,a7 9 =mats su* z web9>s1 cont9u+ education modules1 videos1 fact %eets1 infographics1 /akehold] toolkits1 or o!r =mats z appropriate & applicable2 & 7,b7 tailor$ = ! unique ne$s ( heal? c>e provid]s1 pati5ts1 c>egiv]s1 & o!r audi5ces1 z ! ,secret>y det]m9es appropriate4 7#d7 ,o!r in=mation ,9 addition to ! in=mation describ$ 9 p>agraph 7#b71 ! ,secret>y %all cont9ue to publi%-- 7,a7 ! action package ( ea* biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea2 or 7,b7 ! summ>y review ( ea* biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea4 7#e7 ,confid5tial & trade secret in=mation ,?is subsection does n au?orize ! disclosure ( any trade secret1 confid5tial comm]cial or f9ancial in=mation1 or o!r matt] describ$ 9 section #eeb7;b7 ( title #e4 7b7 ,cont9u+ education ,! ,secret>y %all advance education & aw>5ess among heal? c>e provid]s reg>d+ biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products1 z appropriate1 includ+ by develop+ or improv+ cont9u+ education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 ,pass$ ! ,s5ate ,decemb] #ag1 #bjbj4,secret>y