,i #aai? ,,congress #a/ ,session ,h4 ,r4 #cfhf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #c1 #bjbe,mr4 ,joyce ( ,p5nsylvania 7= himself1 ,mrs4 ,d+ell1 ,mr4 ,joyce ( ,ohio1 & ,ms4 ,ross7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to improve ! regulatory review process to det]m9e ! safety & effectiv5ess ( nonprescription sunscre5 active +r$i5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,support+ ,accessible1 ,flexible1 & ,effective ,sunscre5 ,/&>ds or ! ,,safe ,sunscre5 ,/&>ds ,act4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,sk9 canc] is ! mo/ common canc] 9 ! ,unit$ ,/ates4 7#b7 ,m p are diagnos$ ) sk9 canc] ea* ye> 9 ! ,unit$ ,/ates ?an all o!r canc]s comb9$4 7#c7 ,! ,unit$ ,/ates ,surgeon ,g5]al issu$ a ,call to ,action to ,prev5t ,sk9 ,canc] 9 #bjad bas$ on f9d+ t ne>ly #e1jjj1jjj ,am]icans are treat$ = sk9 canc] ea* ye> at a co/ t exce$s #h1ajj1jjj1jjj4 7#d7 ,x is e/imat$ t ! numb] ( new melanoma cases diagnos$ 9 #bjbd w increase by #g4c p]c5t1 ) an e/imat$ #bjj1cdj cases ( melanoma diagnos$4 7#e7 ,sk9 canc] is a deadly disease1 & x is expect$ t !re w be #h1bij dea?s f melanoma 9 #bjbd4 7#f7 ,sk9 canc] affects individuals ( all ages1 & melanoma is "o ( ! mo/ common canc]s 9 "y adults4 7#g7 ,9 ! ,unit$ ,/ates1 m ?an #i1ejj p are diagnos$ ) sk9 canc] e day & m ?an #b p die ( ! disease e h\r4 7#h7 ,accord+ to ! ,_w ,heal? ,organization 7,,:o71 #d out ( #e cases ( sk9 canc] c be prev5t$ by adopt+ sun-safe practices4 7#i7 ,accord+ to ! ,environm5tal ,protection ,ag5cy 7,,epa71 ! ,ultraviolet 7,,uv7 ,index 9 ! ,unit$ ,/ates cont9ues to rise1 increas+ ! risk ( melanoma & o!r sk9 canc]s = ,am]icans4 7#aj7 ,! ,,epa recomm5ds ,am]icans ,use a broad spectrum sunscre5 ) a ,sun ,protection ,factor 7,,spf7 ( at lea/ #cj to protect aga9/ ! risks ( a ris+ ,,uv ,index4 7#aa7 ,congress unanim\sly pass$ ! ,sunscre5 ,innovation ,act 9 #bjad to /reaml9e ! approval process = sunscre5 active +r$i5ts to improve access to new sunscre5s1 b no new sunscre5 active +r$i5ts h be5 approv$ ?r\gh ! ,food & ,drug ,adm9i/ration's ov]-!-c\nt] approval process s9ce #aiii4 #c4 ,regulations e/abli%+ requirem5ts = sunscre5 active +r$i5ts ,section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 is am5d$ by add+ at ! end ! foll[+3 7r7 ,regulations e/abli%+ requirem5ts = sunscre5 active +r$i5ts 7#a7 ,evid5ce & te/+ /&>ds = sunscre5 active +r$i5ts ,! ,secret>y %all e/abli%1 ?r\gh guidance or regulation1 /&>ds = evaluat+ ! safety & efficacy ( sunscre5 active +r$i5ts1 provid$ t su* /&>ds-- 7,a7 ensure ! safety ( consum]s bas$ on a compreh5sive evaluation ( sci5tific evid5ce2 7,b7 all[ = ! use ( real-_w evid5ce 7z def9$ 9 section #eje;,f7b771 obs]vational /udies1 & o!r sci5tifically valid approa*es 9 place (1 or to supplem5t1 traditional cl9ical te/s to demon/rate safety & effectiv5ess2 & 7,c7 apply subsection 7b77#f77;,c7 to ! regulation ( sunscre5 active +r$i5ts 9 demon/rat+ a prima facie safe nonprescription m>ket+ & use4 7#b7 ,non-animal te/+ me?ods = sunscre5 active +r$i5ts 7,a7 ,9 g5]al ,! ,secret>y %all consid] ! types ( noncl9ical te/s describ$ 9 p>agraphs 7#a7 ?r\gh 7#d7 ( ! fir/ subsection 7z7 ( section #eje 7z ins]t$ by section #cbji7;a77#b7 ( ! ,heal? ,ext5d]s1 ,improv+ ,access to ,m$ic>e1 ,m$icaid1 & ,,*ip1 & ,/r5g!n+ ,public ,heal? ,act ( #bjbb 7division ,,ff ( ,public ,law #aag-cbh771 or any o!r alt]native to animal te/+ t ! ,secret>y deems appropriate1 9 ! consid]ation ( sunscre5 active +r$i5ts4 7,b7 ,guidance ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all issue new guidance on h[ sponsors c use noncl9ical te/+ alt]natives to animal te/+ to meet safety & efficacy /&>ds = sunscre5 active +r$i5ts4 4 #d4 ,sunscre5 f9al adm9i/rative ord] ,! f9al adm9i/rative ord] on p5d+ ov]-!-c\nt] sunscre5 active +r$i5t submissions issu$ "u section #ched ( ! ,coronavirus ,aid1 ,relief1 & ,economic ,security ,act 7,public ,law #aaf-acf2 #ba ,u4,s4,c4 #cfj;fff-#c note7 %all-- 7#a7 acc\nt = hi/orical data demon/rat+ safe use ( sunscre5 active +r$i5ts t h previ\sly be5 accept$ = m>ket+ 9 ! ,unit$ ,/ates2 7#b7 emphasize t sunscre5 is an effective sk9 canc] prev5tion tool2 & 7#c7 incorporate ! evid5ce & te/+ /&>ds = sunscre5 active +r$i5ts detail$ 9 section #eje;,g7r7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 7z add$ by section #c74 #e4 ,report+ & transp>5cy 7a7 ,to ,congress ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all1 beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 annually submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report describ+-- 7#a7 ! /atus ( implem5tation ( evid5ce & te/+ /&>ds = sunscre5 active +r$i5ts1 includ+-- 7,a7 any adju/m5ts to evid5ce or te/+ /&>ds made "u section #eje;,g7r7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 7z add$ by section #c72 & 7,b7 ! numb] & types ( sunscre5 active +r$i5t applications review$ us+ ! /&>ds "u su* section #eje;,g7r72 & 7#b7 ! progress ( ! ,food & ,drug ,adm9i/ration 9 all[+ noncl9ical te/+ alt]natives to animal te/+ = ! consid]ation ( sunscre5 active +r$i5ts4 7b7 ,publication ,n lat] ?an #g days aft] ! date on :i* ! ,secret>y submits a report "u subsection 7a71 ! ,secret>y %all publi% su* report on ! website ( ! ,food & ,drug ,adm9i/ration4