,i #aag? ,,congress #b;d ,session ,h4 ,r4 #fehd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #c1 #bjbb,ms4 ,e%oo 7= h]self1 ,mr4 ,fitzpatrick1 & ,ms4 ,kelly ( ,ill9ois7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,commission] ( ,food & ,drugs to am5d c]ta9 regulations to increase cl9ical trial div]sity1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,div]se & ,equitable ,p>ticipation 9 ,cl9ical ,trials ,act or ! ,,depict ,act4 #b4 ,prem>ket report+ ( div]sity plans = cl9ical trials & /udies 7a7 ,drugs ,! ,commission] ( ,food & ,drugs %all issue regulations revis+ "p #cab ( title #ba1 ,code ( ,f$]al ,regulations1 to require sponsors ( applications = an exemption = inve/igational use ( a drug to include-- 7#a7 9 any su* application-- 7,a7 ! e/imat$ preval5ce 9 ! ,unit$ ,/ates ( ! disease or condition = :i* ! drug is be+ develop$ or inve/igat$1 disaggregat$ by demographic subgr\p1 :]e su* data is available1 includ+ age gr\p1 sex1 race1 & e?nicity2 7,b7 ! sponsor's t>gets = enrollm5t 9 ! cl9ical trial or trials involv$1 disaggregat$ by age gr\p1 sex1 race1 & e?nicity2 7,c7 ! rationale = ! sponsor's enrollm5t t>gets ref]r$ to 9 subp>agraph 7,b71 :i* may include-- 7i7 ! e/imat$ preval5ce ref]r$ to 9 subp>agraph 7,a72 7ii7 :at is kn[n ab\t ! disease or condition = :i* ! drug is be+ develop$ or inve/igat$2 7iii7 any relevant ph>macok9etic or ph>macog5omic data2 7iv7 :at is kn[n ab\t ! pati5t population1 includ+ co-morbidities & pot5tial b>ri]s to enroll+ div]se p>ticipants1 su* z pati5t population size & geographic location2 & 7v7 any o!r data or in=mation ! sponsors deems relevant to select+ appropriate enrollm5t t>gets1 disaggregat$ by demographic subgr\p2 & 7,d7 a div]sity action plan = h[ ! sponsor w meet su* t>gets1 includ+ demographic-specific outrea* & enrollm5t /rategies1 /udy-site selection1 cl9ical trial inclusion & exclusion practices1 & any div]sity tra9+ = trial p]sonnel2 & 7#b7 9 an annual report describ$ 9 section #cab4cc ( title #ba1 ,code ( ,f$]al ,regulations-- 7,a7 ! sponsor's progress 9 meet+ ! t>gets ref]r$ to 9 p>agraph 7#a77;,b72 & 7,b7 if ! sponsor does n expect to meet ^? t>gets ref]r$ to 9 p>agraph 7#a77;,b7-- 7i7 any updates ne$$ to be made to ! div]sity action plan ref]r$ to 9 p>agraph 7#a77;,d7 to meet su* t>gets2 or 7ii7 ! sponsor's ju/ification = :y ! sponsor does n expect to meet su* t>gets1 includ+-- 7,i7 any factors outside ( ! sponsor's control1 includ+ a lack ( ret5tion ( p>ticipants2 7,,ii7 any diff]5ces 9 ! enrollm5t t>gets1 disaggregat$ by demographic subgr\p1 & actual enrollm5t t ! sponsor det]m9es are insignificant 9 nature2 7,,iii7 pot5tial = selection bias2 & 7,,iv7 in=mation n available to ! sponsor at ! "t su* t>gets 7 *os51 b t impact$ enrollm5t ( div]se p>ticipants4 7b7 ,devices ,! ,commission] ( ,food & ,drugs %all issue regulations revis+ "p #hab ( title #ba1 ,code ( ,f$]al ,regulations1 to require sponsors ( applications = an exemption = inve/igational use ( a device to include-- 7#a7 9 any su* application-- 7,a7 a description ( ! pati5t population 9 ! ,unit$ ,/ates expect$ to use ! device1 disaggregat$ by demographic subgr\p1 :]e su* data is available1 includ+ age gr\p1 sex1 race1 & e?nicity2 7,b7 ! sponsor's t>gets = enrollm5t 9 ! cl9ical trial or trials involv$1 disaggregat$ by age gr\p1 sex1 race1 & e?nicity2 7,c7 ! rationale = ! sponsor's enrollm5t t>gets ref]r$ to 9 subp>agraph 7,b71 :i* may include-- 7i7 ! e/imat$ preval5ce ref]r$ to 9 subp>agraph 7,a72 7ii7 :at is kn[n ab\t ! disease or condition = :i* ! drug is be+ develop$ or inve/igat$2 7iii7 any relevant ph>macok9etic or ph>macog5omic data2 7iv7 :at is kn[n ab\t ! pati5t population1 includ+ co-morbidities & pot5tial b>ri]s to enroll+ div]se p>ticipants1 su* z pati5t population size & geographic location2 & 7v7 any o!r data or in=mation ! sponsors deems relevant to select+ appropriate enrollm5t t>gets1 disaggregat$ by demographic subgr\p2 & 7,d7 a div]sity action plan = h[ ! sponsor w meet su* t>gets1 includ+ demographic-specific outrea* & enrollm5t /rategies1 /udy-site selection1 cl9ical trial inclusion & exclusion practices1 & any div]sity tra9+ = trial p]sonnel2 & 7#b7 9 an annual report describ$ 9 section #hab4aej ( title #ba1 ,code ( ,f$]al ,regulations-- 7,a7 ! sponsor's progress 9 meet+ ^? t>gets ref]r$ to 9 p>agraph 7#a77;,b72 & 7,b7 if ! sponsor does n expect to meet ^? t>gets ref]r$ to 9 p>agraph 7#a77;,b7-- 7i7 any updates ne$$ to be made to ! div]sity action plan ref]r$ to 9 p>agraph 7#a77;,d7 to meet su* t>gets2 or 7ii7 ! sponsor's ju/ification = :y ! sponsor does n expect to meet su* t>gets1 includ+-- 7,i7 any factors outside ( ! sponsor's control1 includ+ a lack ( ret5tion ( p>ticipants2 7,,ii7 any diff]5ces 9 ! enrollm5t t>gets1 disaggregat$ by demographic subgr\p1 & actual enrollm5t t ! sponsor det]m9es are insignificant 9 nature2 7,,iii7 pot5tial = selection bias2 & 7,,iv7 in=mation n available to ! sponsor at ! "t su* t>gets 7 *os51 b t impact$ enrollm5t ( div]se p>ticipants4 7c7 ,additional cl9ical trial data ,! ,commission] ( ,food & ,drugs %all issue regulations revis+ sections #hjg4ib & #had4bj ( title #ba1 ,code ( ,f$]al ,regulations1 to require t applications = devices approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 & devices cle>$ "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k77 ^: submission includes cl9ical data-- 7#a7 a description ( ! pati5t population 9 ! ,unit$ ,/ates expect$ to use ! device1 disaggregat$ by demographic subgr\p1 :]e su* data is available1 includ+ age gr\p1 sex1 race1 & e?nicity2 & 7#b7 9 summ>iz+ ! cl9ical inve/igations involv+ human subjects 9 su* applications1 a description ( /udy subjects by demographic subgr\p1 includ+ age gr\p1 sex1 race1 & e?nicity4 7d7 ,deadl9e = promulgation ,! ,commission] ( ,food & ,drugs %all issue-- 7#a7 any propos$ rules requir$ "u ?is section n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act2 & 7#b7 any f9al rules requir$ "u ?is section n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act4 #c4 ,,fda au?ority to m&ate po/approval /udies or po/m>ket surveillance due to insuffici5t demographic subgr\p data 7a7 ,drugs 7#a7 ,9 g5]al ,section #eje7o77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,b77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,to provide safety & effectiv5ess data = ! drug involv$ = a demographic subgr\p or subgr\ps1 if-- 7,i7 ! cl9ical trials conduct$ 9 support ( ! approval ( ! drug did n meet ! applicable t>gets ( enrollm5t1 z describ$ 9 section #b ( ! ,,depict ,act2 & 7,,ii7 9 ! judgm5t ( ! ,secret>y1 additional data c\ld in=m drug label+4 4 7#b7 ,waiv] ,section #eje7o77#c77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,d77 is am5d$ by add+ at ! end ! foll[+3 7iii7 ,cl9ical trial div]sity enrollm5t ,! ,secret>y may n require po/approval /udies or po/approval cl9ical trials = ! purpose specifi$ "u subp>agraph 7,b77iv7 if ! sponsor provides to ! ,secret>y a suffici5t ju/ification = n meet+ ! enrollm5t t>gets ref]r$ to 9 su* subp>agraph1 :i* may include-- 7,i7 factors outside ( ! sponsor's control1 su* z a lack ( ret5tion ( p>ticipants2 7,,ii7 diff]5ces 9 ! enrollm5t t>gets1 disaggregat$ by demographic subgr\p1 & actual enrollm5t t are det]m9$ by ! ,secret>y to be insignificant 9 nature2 7,,iii7 in=mation n available to ! sponsor at ! "t su* enrollm5t t>gets 7 *os51 b t impact$ enrollm5t ( div]se p>ticipants2 7,,iv7 pot5tial = selection bias2 & 7,v7 any o!r reason t ! ,secret>y det]m9es is suffici5t ju/ification4 4 7#c7 ,use ( real _w evid5ce ,section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77 is am5d$ by add+ at ! end ! foll[+3 7,g7 ,use ( real _w evid5ce ,real _w evid5ce 7z def9$ 9 section #eje;,f7b77 may be us$ to support or satisfy ! requirem5ts "u ?is p>agraph4 4 7b7 ,devices ,section #ebb7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjl7a77#a77;,a77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 9 clause 7ii71 by /rik+ or at ! end2 7,b7 9 clause 7iii77,,ii71 by /rik+ facility4 & ins]t+ facility2 or2 & 7,c7 by add+ at ! end ! foll[+3 7iv7 ) respect to :i*-- 7,i7 cl9ical /udies submitt$ to support t approval or cle>ance did n meet ! applicable t>gets ( enrollm5t1 z describ$ 9 section #b ( ! ,,depict ,act2 & 7,,ii7 ) respect to :i* a ju/ification describ$ 9 subp>agraph 7,d7 is n provid$4 2 & 7#b7 by add+ at ! end ! foll[+3 7,c7 ,use ( real _w evid5ce ,real _w evid5ce 7z def9$ 9 section #eje;,f7b77 may be us$ to support or satisfy ! requirem5ts "u ?is p>agraph4 7,d7 ,cl9ical trial div]sity enrollm5t ,! ,secret>y may n require a manufactur] to conduct po/m>ket surveillance "u subp>agraph 7,a7 ) respect to a device = ! purpose specifi$ 9 clause 7iv7 ( su* subp>agraph if ! manufactur] provides to ! ,secret>y a suffici5t ju/ification = n meet+ ! enrollm5t t>gets ref]r$ to 9 su* subp>agraph1 :i* may include-- 7i7 factors outside ( ! manufactur]'s control1 su* z a lack ( ret5tion ( p>ticipants2 7ii7 diff]5ces 9 ! enrollm5t t>gets1 disaggregat$ by demographic subgr\p1 & actual enrollm5t t are det]m9$ by ! ,secret>y to be insignificant 9 nature2 7iii7 in=mation n available to ! manufactur] at ! "t su* enrollm5t t>gets 7 *os51 b t impact$ enrollm5t ( div]se p>ticipants2 7iv7 pot5tial = selection bias2 & 7v7 any o!r reason t ! ,secret>y det]m9es is suffici5t ju/ification4 4 7c7 ,reports = c]ta9 devices ,! ,commission] ( ,food & ,drugs %all issue regulations revis+ section #had4hd ( title #ba1 ,code ( ,f$]al ,regulations1 to require hold]s ( an application approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 to include 9 ! reports submitt$ "u su* section #had4hd1 to ! ext5t possible1 any data n previ\sly submitt$ "u su* section #had4hd t may in=m ! safety & effectiv5ess ( ! device involv$ 9 und]repres5t$ demographic subgr\ps4 7d7 ,regi/ry & results data bank inclusion ,section #djb7;j77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#bhb7;j77#a77;,a77 is am5d$-- 7#a7 9 clause 7ii7-- 7,a7 9 subclause 7,i71 by /rik+ & at ! end2 7,b7 9 subclause 7,,ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,iii7 po/m>ket surveillance = any device z requir$ "u clause 7iv7 ( section #ebb7;a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 2 & 7#b7 9 clause 7iii77,i71 by /rik+ ! p]iod at ! end & ins]t+ ! foll[+3 1 includ+ any po/approval /udy or po/approval cl9ical trial = a drug z requir$ "u section #eje7o77#c77;,b77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act44 7e7 ,public meet+ 7#a7 ,9 g5]al ,n lat] ?an #bgj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 & 9 consultation ) drug sponsors1 m$ical device manufactur]s1 pati5ts1 & o!r /akehold]s1 %all conv5e a public meet+ to consid] ! ways by :i*-- 7,a7 drug sponsors & m$ical device manufactur]s may dissem9ate in=mation to ! public on cl9ical trial enrollm5t demographic data 9 a timely & accessible mann]2 7,b7 drug & device sponsors1 9 consultation ) ! ,commission] ( ,food & ,drugs1 may publicly dissem9ate in=mation on subgr\p analyses conduct$ by ! sponsors 9 cases :]e-- 7i7 su* data is n suffici5t = ! purpose ( updat+ drug & device labels2 or 7ii7 su* analyses d n %[ significant diff]5ces betwe5 demographic subgr\ps2 & 7,c7 drug & device sponsors1 9 consultation ) ! ,commission] ( ,food & ,drugs1 may collect & publicly dissem9ate real _w evid5ce t may provide in=mation on ! safety & effectiv5ess ( drugs or devices = a demographic subgr\p or subgr\ps4 7#b7 ,report ,n lat] ?an #ahj days aft] ! date on :i* ! public meet+ is conv5$ "u p>agraph 7#a71 ! ,secret>y %all make available on ! website ( ! ,food & ,drug ,adm9i/ration a report on ! topics discuss$ at su* meet+4 ,! report %all include a summ>y (1 & response to1 recomm5dations rais$ 9 su* meet+4 #d4 ,annual report on progress to increase div]sity 9 cl9ical trials & /udies 7a7 ,9 g5]al ,beg9n+ n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 & ea* ye> !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit to ,congress1 & publi% on ! public website ( ! ,food & ,drug ,adm9i/ration1 a report t addresses progress on increas+ div]sity 9 cl9ical trial & /udy enrollm5t4 7b7 ,cont5ts ( report ,! report submitt$ "u subsection 7a7 %all include1 ) respect to applications = drugs or devices approv$ or cle>$ "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 or #cfj;e7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 dur+ ! cal5d> ye> t imm$iately prec$es ! ye> 9 :i* ! report is submitt$-- 7#a7 an analysis ( ! ext5t to :i* cl9ical trials conduct$ ) respect to su* applications h met ! demographic subgr\p enrollm5t t>gets = cl9ical trials & /udies requir$ by ! regulations am5d$ pursuant to section #b & ! am5dm5ts made by section #c2 7#b7 ! frequ5cy ) :i* enrollm5t t>gets by demographic subgr\p set = a cl9ical trial conduct$ "u an exemption = inve/igational use ( a drug "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or an exemption = inve/igational use ( a device "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 d n adequately reflect ! incid5ce 9 ! ,unit$ ,/ates population ( ! disease or condition be+ /udi$ 9 ! cl9ical trial & a summ>y ( ! rationales provid$ = enrollm5t t>gets by demographic subgr\p 9 su* cases2 7#c7 a summ>y ( ! ju/ifications sponsors provid$ 9 ! cases :]e sponsors did n meet ! enrollm5t t>gets specifi$ pursuant to section #b1 disaggregat$ by demographic subgr\p2 & 7#d7 ! ,secret>y's recomm5dations1 z appropriate1 = /rategies pres5t$ 9 su* div]sity plans to atta9 enrollm5t t>gets t %\ld be adopt$ by sponsors z be/ practices4 7c7 ,po/m>ket /udies ,beg9n+ #c ye>s aft] ! fir/ in/ance 9 :i* ! ,secret>y requires ! sponsor ( an application = a drug or device approv$ or cle>$ "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 or #cfj;e7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 to conduct po/m>ket /udies or po/m>ket surveillance "u clause 7iv7 ( section #eje7o77#c77;,b7 & clause 7iv7 ( section #ebb7;a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsections 7a7 & 7b7 ( section #c71 & ea* ye> !reaft]1 ! report submitt$ "u subsection 7a7 %all also include-- 7#a7 ! numb] ( su* applications t 7 requir$ to initiate po/m>ket /udies or surveillance 9 ! previ\s cal5d> ye> "u clause 7iv7 ( section #eje7o77#c77;,b7 & clause 7iv7 ( section #ebb7;a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsections 7a7 & 7b7 ( section #c71 ! numb]s ( su* applications t h1 z ( ! end ( ! cal5d> ye> imm$iately prec$+ ! ye> 9 :i* ! report is submitt$1 9-progress po/m>ket requirem5ts1 & ! numb] ( su* applications t h complet$ po/m>ket requirem5ts = ea* ye>1 beg9n+ on ! date ( ! enactm5t ( ?is ,act2 7#b7 an analysis ( ! av]age am\nt ( "t = completion ( su* po/m>ket requirem5ts1 disaggregat$ by type ( application & type ( po/m>ket requirem5t2 7#c7 an analysis ( h[ ! imposition ( su* po/m>ket requirem5ts has impact$ ! availability ( demographic subgr\p-specific safety & efficacy data = drugs1 biologics1 & devices2 & 7#d7 ! ,secret>y's recomm5dations1 z appropriate1 = additional guidance or po/m>ket requirem5ts to facilitate ! collection & report+ ( repres5tative demographic subgr\p data 9 support ( applications = ! approval or cle>ance (1 or updates to ! label+ (1 drugs & devices "u section #eje1 #eaj7k71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 or #cfj;e7 or lic5sure ( biological products "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7d7 ,confid5tiality ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 #e4 ,public meet+ on cl9ical trial flexibilities initiat$ 9 response to ,,covid-#ai p&emic 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date on :i* ! ,,covid-#ai em]g5cy p]iod ends1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ to discuss ! regulatory flexibilities adopt$ by ! ,food & ,drug ,adm9i/ration dur+ ! ,,covid-#ai em]g5cy p]iod to mitigate disruption ( cl9ical /udies & cl9ical trials1 includ+ flexibilities detail$ 9 ! ,m>* #bjbj guidance entitl$ ,conduct ( ,cl9ical ,trials ( ,m$ical ,products ,dur+ ! ,,covid-#ai ,public ,heal? ,em]g5cy1 ,guidance = ,indu/ry1 ,inve/igators1 & ,in/itutional ,review ,bo>ds1 & any subsequ5t updates to su* guidance4 ,! ,secret>y %all invite to su* meet+ repres5tatives f ! ph>maceutical & m$ical device indu/ries :o sponsor$ cl9ical trials & cl9ical /udies dur+ ! ,,covid-#ai em]g5cy p]iod & organizations repres5t+ pati5ts4 7b7 ,topics ,n lat] ?an #ij days aft] ! date on :i* ! public meet+ "u subsection 7a7 is conv5$1 ! ,secret>y %all make available on ! public website ( ! ,food & ,drug ,adm9i/ration a report on ! topics discuss$ at su* meet+4 ,su* topics %all include discussion (-- 7#a7 ! actions drug sponsors took to utilize su* regulatory flexibilities & ! frequ5cy at :i* su* flexibilities 7 employ$2 7#b7 ! *>act]i/ics ( ! sponsors1 trials1 & pati5t populations impact$ by su* regulatory flexibilities2 7#c7 a consid]ation ( h[ regulatory flexibilities to mitigate disruption ( cl9ical trials dur+ ! ,,covid-#ai em]g5cy p]iod1 includ+ dec5traliz$ cl9ical trials1 may h affect$ access to cl9ical /udies & trials = c]ta9 pati5t populations1 especially unrepres5t$ racial & e?nic m9orities2 & 7#d7 recomm5dations = incorporat+ c]ta9 cl9ical trial disruption mitigation flexibilities into curr5t or additional guidance to improve cl9ical trial access & enrollm5t ( div]se pati5t populations4 7c7 ,,covid-#ai em]g5cy p]iod def9$ ,9 ?is section1 ! t]m ,,covid-#ai em]g5cy p]iod has ! mean+ giv5 ! t]m em]g5cy p]iod 9 section #aace7;g77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 #f4 ,community engagem5t & outrea* to improve inclusion ( und]repres5t$ m9orities 9 cl9ical trials & rese>* 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all conduct1 coord9ate1 & support activities = purposes ( community engagem5t )1 & outrea* to1 und]s]v$ communities to facilitate inclusion ( und]repres5t$ m9orities 9 cl9ical rese>* & cl9ical trials4 7b7 ,activities ,activities conduct$1 coord9at$1 or support$ "u ?is section may be = any ( ! foll[+ purposes3 7#a7 ,develop+ & dissem9at+ be/ practices = community engagem5t & outrea* & = inclusive p>ticipation 9 cl9ical rese>* & trials4 7#b7 ,creat+ & provid+ tools & educational res\rces-- 7,a7 to facilitate adoption ( su* be/ practices by rese>*]s & cl9ical trial sponsors2 & 7,b7 to enc\rage aw>5ess (1 & p>ticipation 91 cl9ical trials & rese>* among und]repres5t$ m9orities4 7#c7 ,engag+ community /akehold]s 9 und]repres5t$ racial & e?nic m9ority communities & fo/]+ p>tn]%ips ) community-bas$ organizations s]v+ und]repres5t$ racial & e?nical m9ority populations to enc\rage p>ticipation 9 cl9ical trials & rese>*4 7#d7 ,conduct+ & support+ community engagem5t rese>*4 7c7 ,supplem5t1 n supplant ,grants "u ?is subsection %all be us$ to supplem5t & n supplant exi/+ initiatives & programs at ! ,national ,in/itutes ( ,heal? to improve div]sity 9 cl9ical trials & rese>*4 #g4 ,grants to increase ! capacity ( community heal? c5t]s to p>ticipate 9 cl9ical trials & rese>* 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration & 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all aw>d grants to1 & ent] into coop]ative agreem5ts )1 qualifi$ entities to increase capacity at su* qualifi$ entities to p>ticipate 9 cl9ical trials & rese>* by-- 7#a7 enhanc+ & exp&+ infra/ructure at community heal? c5t]s to support p>ticipation 9 cl9ical trials & rese>*1 includ+ in=mation te*nology improvem5ts & ! hir+ & tra9+ ( heal?c>e p]sonnel1 su* z pati5t navigators & culturally tra9$ site p]sonnel to conduct1 or recruit =1 cl9ical trials2 7#b7 reimburs+ adm9i/rative co/s & pati5t c>e co/s incurr$ by qualifi$ entities 9 ! c\rse ( cl9ical rese>* & trials t are n o!rwise reimbursable by exi/+ pay]s2 & 7#c7 implem5t+ community education & outrea* /rategies4 7b7 ,qualifi$ entities def9$ ,9 ?is section1 ! t]m qualifi$ entity means-- 7#a7 rural heal? cl9ics1 z def9$ 9 section #ahfa7;aa77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#b772 7#b7 f$]ally-qualifi$ heal? c5t]s describ$ 9 section #ahfa7;aa77#d77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#d77;,b772 7#c7 facilities op]at$ by ! ,indian ,heal? ,s]vice1 an ,indian ,tribe1 ,tribal ,organization1 or an ,urban ,indian organization1 z ^? t]ms are def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act 7#be ,u4,s4,c4 #afjc72 & 7#d7 entities eligible to receive funds "u section #ccj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;b74 #h4 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is ,act1 #ajj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbb ?r\gh #bjbe4