,,ii #aag? ,,congress #a/ ,session ,s4 #cdbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #af1 #bjba,ms4 ,coll9s 7= h]self & ,mr4 ,lujn7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to au?orize ! ,secret>y ( ,heal? & ,human ,s]vices to e/abli% a ,neurosci5ce ,c5t] ( ,excell5ce4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,neurosci5ce at ! ,food & ,drug ,adm9i/ration encompasses a broad range ( neurological & psy*iatric diseases & disord]s1 includ+-- 7,a7 addiction2 7,b7 ,alzheim]'s disease & o!r neurodeg5]ative conditions t cause dem5tia2 7,c7 amyotrophic lat]al scl]osis2 7,d7 autism spectrum disord]1 ,d[n syndrome1 & o!r neurodevelopm5tal disord]s2 7,e7 bipol> disord]2 7,f7 bra9 aneurysms2 7,g7 bra9 tumors2 7,h7 c]ebral palsy2 7,i7 anxiety & depression2 7,j7 dyspraxia2 7,k7 dy/onia2 7,l7 epilepsy & o!r seizure disord]s2 7,m7 h]$it>y bra9 & c5tral n]v\s sy/em diseases2 7,n7 heada*es & migra9e disease2 7,o7 ,hunt+ton's disease2 7,p7 multiple scl]osis2 7,q7 pa92 7,r7 ,p>k9son's disease & o!r movem5t disord]s1 includ+ p>k9sonisms2 7,s7 p]sonality disord]s2 7,t7 psy*otic disord]s2 7,u7 traumatic bra9 injury & *ronic traumatic encephalopa?y2 & 7,v7 r>e diseases t impact ! bra9 & c5tral n]v\s sy/em4 7#b7 ,neurological & psy*iatric diseases & disord]s are highly preval5t4 ,accord+ to ! ,national ,in/itutes ( ,heal?1 neurological disord]s affect an e/imat$ #ej1jjj1jjj p 9 ! ,unit$ ,/ates ea* ye>1 & #ea1ejj1jjj adults 9 ! ,unit$ ,/ates live ) a m5tal illness4 7#c7 ,! preval5ce ( neurosci5ce diseases & disord]s cont9ues to gr[4 ,! ,c5t]s = ,disease ,control & ,prev5tion =eca/s t ! burd5 ( dem5tias 9 ! ,unit$ ,/ates w d\ble by #bjfj to #ac1ijj1jjj p1 :i* w be #c4c p]c5t ( ! population4 7#d7 ,neurological & psy*iatric diseases & disord]s h a significant impact on heal? c>e exp5ditures & ! ,unit$ ,/ates economy z a :ole4 ,! impact ( common neurological diseases1 includ+ ,alzheim]'s disease & ,p>k9son's disease1 on ! ,unit$ ,/ates economy is e/imat$ by ! ,am]ican ,neurological ,association at ov] #ghi1jjj1jjj1jjj4 7#e7 ,factors associat$ ) ! ,,covid-#ai p&emic1 includ+ job loss & social isolation1 h exac]bat$ ! preval5ce & impact ( psy*iatric diseases & disord]s4 ,accord+ to ! ,c5t]s = ,disease ,control & ,prev5tion1 dur+ ! p&emic1 m ?an "o-?ird ( adults 9 ! ,unit$ ,/ates report$ symptoms ( anxiety or depression4 7#f7 ,! ,national ,in/itute ( ,neurological ,disord]s & ,/roke has recogniz$ t ! ,,s>s-,co,v-#b virus c lead to s]i\s neurological complications1 su* z anosmia1 heada*e1 impair$ consci\sness1 & /roke1 :i* may affect individuals' ability to function or "w aft] ! p&emic ends4 7#g7 ,despite ! l>ge societal ne$1 m$ical products = neurological & psy*iatric diseases & disord]s are approv$ by ! ,food & ,drug ,adm9i/ration at a mu* l[] rate ?an products = o!r disease areas4 ,accord+ to a #bjah /udy conduct$ by ! ,tufts ,c5t] = ! ,/udy ( ,drug ,developm5t1 c5tral n]v\s sy/em drugs take #bj p]c5t long] to develop & approve ?an non-c5tral n]v\s sy/em drugs4 #c4 ,e/abli%m5t ( a ,neurosci5ce ,c5t] ( ,excell5ce 7a7 ,e/abli%m5t requir$ ,! fir/ s5t5ce ( section #ajad7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7a77 is am5d$ by ins]t+ 1 at lea/ #a ( :i* %all be focus$ on neurosci5ce diseases & disord]s 7z def9$ 9 section #ajae7 be=e ! p]iod at ! end4 7b7 ,tim+ ( e/abli%m5t ,subsection 7c7 ( section #ajad ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7c77 is am5d$ to read z foll[s3 7c7 ,tim+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all e/abli%1 9 accordance ) ?is section & section #ajae1 an ,in/itute "u subsection 7a7 focus$ on neurosci5ce diseases & disord]s1 to be kn[n z ! ,neurosci5ce ,c5t] ( ,excell5ce4 4 7c7 ,activities ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajae4 ,neurosci5ce ,c5t] ( ,excell5ce 7a7 ,activities ,! ,neurosci5ce ,c5t] ( ,excell5ce e/abli%$ "u section #ajad7;a71 %all-- 7#a7 c>ry out ! activities describ$ 9 section #ajad7;a72 7#b7 coord9ate collaborations among ! ,c5t]s 7)9 ! mean+ ( section #ajad7;a77 & /akehold]s to support ! developm5t ( m$ical products = neurosci5ce diseases & disord]s2 7#c7 e/abli% & c>ry out ! programs describ$ 9 subsection 7c72 & 7#d7 issue reports to ,congress on ! activities ( ! ,neurosci5ce ,c5t] ( ,excell5ce1 z describ$ 9 subsection 7d74 7b7 ,def9itions ,9 ?is section3 7#a7 ,neurosci5ce diseases & disord]s ,! t]m neurosci5ce diseases & disord]s means-- 7,a7 addiction2 7,b7 ,alzheim]'s disease & o!r neurodeg5]ative conditions t cause dem5tia2 7,c7 amyotrophic lat]al scl]osis2 7,d7 autism spectrum disord]1 ,d[n syndrome1 & o!r neurodevelopm5tal disord]s2 7,e7 bipol> disord]2 7,f7 bra9 aneurysms2 7,g7 bra9 tumors2 7,h7 c]ebral palsy2 7,i7 anxiety & depression2 7,j7 dyspraxia2 7,k7 dy/onia2 7,l7 epilepsy & o!r seizure disord]s2 7,m7 h]$it>y bra9 & c5tral n]v\s sy/em diseases2 7,n7 heada*es & migra9e disease2 7,o7 ,hunt+ton's disease2 7,p7 multiple scl]osis2 7,q7 pa92 7,r7 ,p>k9son's disease & o!r movem5t disord]s1 includ+ p>k9sonisms2 7,s7 p]sonality disord]s2 7,t7 psy*otic disord]s2 7,u7 traumatic bra9 injury & *ronic traumatic encephalopa?y2 & 7,v7 r>e diseases t impact ! bra9 & c5tral n]v\s sy/em4 7#b7 ,m$ical product ,! t]m m$ical product means a drug1 biological product1 or device1 or a comb9ation product describ$ 9 section #ejc7;g74 7#c7 ,pati5t exp]i5ce data ,! t]m pati5t exp]i5ce data has ! mean+ giv5 su* t]m 9 section #efi;,c7c74 7c7 ,programs ,! ,neurosci5ce ,c5t] ( ,excell5ce %all e/abli% & implem5t ! foll[+ programs3 7#a7 ,neurosci5ce !rapeutics program 7,a7 ,public engagem5t 7i7 ,public meet+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 & n less ?an once p] ye> !reaft]1 ! ,secret>y %all conv5e a public meet+ ( /akehold]s 7includ+ sci5ti/s1 rese>*]s1 pati5t advocacy organizations1 disease rese>* f\ndations1 & repres5tatives ( ! drug & device indu/ries7 to id5tify & make recomm5dations to address curr5t & em]g+ regulatory sci5ce & public policy *all5ges associat$ ) develop+ m$ical products = neurosci5ce diseases & disord]s4 ,issues address$ dur+ su* meet+s %all include-- 7,i7 me?ods to support ! accel]at$ qualification ( appropriate biom>k]s & endpo9ts1 includ+ pr$ictive biom>k]s & endpo9ts1 = neurosci5ce diseases & disord]s2 & 7,,ii7 novel drug developm5t me?odologies & /udy designs to bett] support ! rapid developm5t & approval ( m$ical products = neurosci5ce diseases & disord]s4 7ii7 ,report ,n lat] ?an #c mon?s aft] ! conclusion ( ea* public meet+ "u clause 7i71 ! ,secret>y %all publi% a report id5tify+ ! *all5ges & opportunities = rapid improvem5t discuss$ dur+ su* public meet+1 & z applicable1 any recomm5dations to ,congress reg>d+ h[ to address su* *all5ges & ensure t pati5ts b5efit f optimiz+ developm5t ( m$ical products = neurosci5ces diseases & disord]s4 ,! ,secret>y %all make su* report public on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,b7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all issue "o or m f9al guidances t address-- 7i7 recomm5dations to sponsors ( m$ical products = neurosci5ce diseases & disord]s reg>d+ ma/] protocols to simultane\sly evaluate m ?an #a inve/igational m$ical product or m ?an #a type ( disease or disord] )9 ! same ov]all trial /ructure1 z well z o!r novel or collaborative /udy designs & approa*es2 & 7ii7 approa*es t may be us$ to incorporate cl9ical outcome assessm5ts1 includ+ pati5t-report$ outcomes1 into endpo9ts = ! developm5t ( m$ical products = neurosci5ce diseases & disord]s4 7#b7 ,neurosci5ce pati5t-focus$ drug developm5t program 7,a7 ,9 g5]al ,! ,secret>y %all e/abli%1 )9 ! ,neurosci5ce ,c5t] ( ,excell5ce1 a program to facilitate ! collection ( pati5t exp]i5ce data1 & ! sy/ematic use ( su* data & relat$ in=mation1 9 ! developm5t ( m$ical products = neurosci5ce diseases & disord]s4 7,b7 ,public engagem5t ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 & n less ?an once p] ye> !reaft]1 ! ,secret>y %all conv5e /akehold]s 7includ+ pati5t advocacy gr\ps & disease rese>* f\ndations7 = a public work%op4 ,su* work%op %all-- 7i7 educate /akehold]s on curr5t initiatives & activities at ! ,neurosci5ce ,c5t] ( ,excell5ce2 7ii7 solicit fe$back f /akehold]s on ongo+ initiatives & activities at ! ,neurosci5ce ,c5t] ( ,excell5ce2 & 7iii7 provide an opportunity = /akehold]s to discuss _! p]sonal exp]i5ces1 includ+ ) respect to symptoms1 daily impact1 & curr5t approa*es to treatm5t = neurosci5ce diseases & disord]s4 7,c7 ,/udy ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all conduct a /udy on me?ods to assess ! pati5t exp]i5ce 9 ! developm5t ( m$ical products = neurosci5ce diseases & disord]s4 ,! ,secret>y %all make a report summ>iz+ ! results ( su* /udy public on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,d7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all issue f9al guidance ) recomm5dations on ! collection ( pati5t exp]i5ce data 7z def9$ 9 section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 & ! use ( su* data & relat$ in=mation1 9 ! developm5t ( m$ical products = neurosci5ce diseases & disord]s4 7#c7 ,neurosci5ce natural hi/ory /udies program 7,a7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all issue f9al guidance ) recomm5dations = sponsors on implem5t+ natural hi/ory /udies t c be us$ to support ! developm5t ( m$ical products = neurosci5ce diseases & disord]s4 7,b7 ,def9ition ,9 ?is p>agraph1 ! t]m natural hi/ory /udy means a preplann$ obs]vational /udy int5d$ to track ! c\rse ( ! disease4 7#d7 ,digital heal? te*nologies program 7,a7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all issue f9al guidance address+ approa*es to-- 7i7 us+ digital te*nologies & digital endpo9ts 9 cl9ical trials evaluat+ m$ical products = neurosci5ce diseases & disord]s2 & 7ii7 us+ digital te*nologies = ! treatm5t ( su* diseases & disord]s4 7#e7 ,,covid-#ai impacts program 7,a7 ,public meet+ 7i7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all conv5e n few] ?an #b public meet+s = /akehold]s 7includ+ sci5ti/s1 rese>*]s1 heal? c>e provid]s1 academics1 memb]s ( ! regulat$ indu/ry1 pati5t advocacy organizations1 & disease rese>* f\ndations7 to discuss ! impact ( ,,covid-#ai on neurosci5ce diseases & disord]s4 7ii7 ,topics ,! topics discuss$ at ! meet+ "u clause 7i7 %all include-- 7,i7 ! impact ( ! ,,s>s-,co,v-#b virus on pati5ts diagnos$ ) su* diseases & disord]s1 )\t reg>d to :e!r su* diagnoses occurr$ be=e or aft] su* pati5t contract$ ! ,,s>s-,co,v-#b virus2 7,,ii7 ! indirect impact ( ! ,,covid-#ai p&emic on su* diseases & disord]s1 includ+ ! effects ( social isolation & height5$ levels ( /ress & anxiety = ^? ) neurosci5ce disease & disord] diagnoses2 & 7,,iii7 /rategies = ! rapid developm5t ( m$ical products to address ! direct & indirect impacts ( ,,covid-#ai on su* diseases & disord]s1 includ+ real-_w data collection & real-_w evid5ce developm5t4 7,b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all publi% a report on ! direct & indirect impacts ( ,,covid-#ai on neurosci5ce diseases & disord]s includ+1 z applicable1 any recomm5dations to ,congress on ! developm5t ( m$ical products int5d$ to address ! impact ( ,,covid-#ai = individuals ) su* conditions4 ,! ,secret>y %all make su* report public on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#f7 ,ensur+ equity 9 neurosci5ce program 7,a7 ,public meet+ ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all conv5e a public meet+ ( /akehold]s ^: exp]i5ce directly relates to pati5ts ) neurosci5ce diseases & disord]s 7includ+ sci5ti/s1 heal? c>e provid]s1 academics1 memb]s ( ! regulat$ indu/ry1 pati5t advocacy organizations1 & disease rese>* f\ndations7 to discuss h[ to promote equity & inclusion ( traditionally und]repres5t$ populations 9 ! rese>* & developm5t ( m$ical products = neurosci5ce diseases & disord]s4 7,b7 ,guidance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 ! ,secret>y %all issue guidance = indu/ry on h[ to ensure great] div]sity 9 cl9ical trials = neurosci5ce diseases & disord]s m$ical products4 ,su* guidance %all consid] ! fe$back & recomm5dations f ! public meet+ "u subp>agraph 7,a7 ! /udy "u section #c7;d7 ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba4 7d7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,neurosci5ce ,c5t] ( ,excell5ce ,act ( #bjba1 & annually !reaft]1 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! activities ( ! ,neurosci5ce ,c5t] ( ,excell5ce4 ,su* report %all include-- 7#a7 ! numb] ( m$ical products = neurosci5ce diseases & disord]s t 7 approv$ by ! ,food & ,drug ,adm9i/ration 9 ! previ\s #e cal5d> ye>s2 7#b7 a summ>y ( *all5ges to develop+ m$ical products = neurosci5ce diseases & disord]s1 & z applicable1 recomm5dations to ,congress on h[ to address su* *all5ges2 & 7#c7 ! direct & indirect impacts ( ! ,,covid-#ai p&emic on neurosci5ce diseases & disord]s4 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #be1jjj1jjj = ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbg4 4 7d7 ,,gao /udy ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 complete a /udy t reviews ! p>ticipation ( traditionally und]repres5t$ populations 9 cl9ical trials = m$ical products 7z def9$ 9 section #ajae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c7 = ! treatm5t or diagnosis ( neurosci5ce diseases & disord]s 7z def9$ 9 su* section #ajae72 & 7#b7 submit a report to ,congress on ! results ( su* /udy1 includ+ recomm5dations on pot5tial *anges 9 practices & policies to improve p>ticipation by populations t h be5 traditionally und]repres5t$ 9 su* trials4