,i #aad? ,,congress #b;d ,session ,h4 ,r4 #fbbd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #bh1 #bjaf,mrs4 ,beatty 7= h]self1 ,ms4 ,sewell ( ,alabama1 & ,mr4 ,"y ( ,i[a7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to promote ! inclusion ( m9orities & wom5 9 cl9ical rese>*1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,enhanc+ ,m9ority & ,wom5 ,repres5tation 9 ,,nih ,m$ical ,rese>* ,act ( #bjaf4 #b4 ,collaboration to enhance div]sity 9 cl9ical rese>* ,section #djb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b77 is am5d$-- 7#a7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 %all assemble accurate data to be us$ to assess rese>* priorities1 includ+-- 7,a7 in=mation to bett] evaluate sci5tific opportunity1 public heal? burd5s1 & progress 9 r$uc+ heal? disp>ities2 & 7,b7 data on /udy populations ( cl9ical rese>*1 fund$ by or conduct$ at ea* national rese>* in/itute & national c5t]1 :i*-- 7i7 specifies ! inclusion (-- 7,i7 wom52 7,,ii7 memb]s ( m9ority gr\ps2 7,,iii7 relevant age categories2 & 7,,iv7 o!r demographic v>iables det]m9$ to be necess>y by ! ,director ( ,,nih2 7ii7 is disaggregat$ by rese>* area1 condition1 & disease categories2 & 7iii7 is to be made publicly available on ! ,int]net website ( ! ,national ,in/itutes ( ,heal?2 2 & 7#b7 9 p>agraph 7#h7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 & 7,b7 by add+ at ! end ! foll[+3 7,c7 fo/] collaboration betwe5 cl9ical rese>* projects fund$ by ! respective national rese>* in/itutes & national c5t]s t-- 7i7 conduct rese>* involv+ human subjects2 & 7ii7 collect simil> data2 & 7,d7 enc\rage ! collaboration describ$ 9 subp>agraph 7,c7 to-- 7i7 all[ = an increase 9 ! numb] ( subjects /udi$2 & 7ii7 utilize div]se /udy populations1 ) special consid]ation to biological1 social1 & o!r det]m9ants ( heal? t contribute to heal? disp>ities2 4 #c4 ,promot+ inclusion 9 cl9ical rese>* 7a7 ,/rategic plan ,section #dib;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;a77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,/rategic plann+ 7,a7 ,9 g5]al ,! directors ( ! national in/itutes & national c5t]s %all consult at lea/ once annually ) ! ,director ( ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities & ! ,director ( ! ,(fice ( ,rese>* on ,wom5's ,heal? reg>d+ objectives ( ! national in/itutes & national c5t]s to ensure t future activities by su* in/itutes & c5t]s take into acc\nt wom5 & m9orities & are focus$ on r$uc+ heal? disp>ities4 7,b7 ,/rategic plans ,any /rategic plan issu$ by a national in/itute or national c5t] %all include details on ! objectives describ$ 9 subp>agraph 7,a74 4 7b7 ,cl>ification ( requirem5ts ,section #dib;,b7c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;c77 is am5d$-- 7#a7 by /rik+ ,9 ! case & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,9 ! case 2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 ,report+ requirem5ts ,= any new & compet+ project ( cl9ical rese>* subject to ! requirem5ts "u ?is section t receives a grant aw>d #a ye> aft] ! date ( enactm5t ( ! ,enhanc+ ,m9ority & ,wom5 ,repres5tation 9 ,,nih ,m$ical ,rese>* ,act ( #bjaf1 or any date !reaft]1 = :i* a valid analysis is provid$ "u p>agraph 7#a7-- 7,a7 & :i* is an applicable cl9ical trial z def9$ 9 section #djb7;j71 ! entity conduct+ su* cl9ical rese>* %all submit ! results ( su* valid analysis to ! cl9ical trial regi/ry data bank exp&$ "u #djb7;j77#c71 & ! ,director ( ,,nih %all1 z appropriate1 consid] :e!r su* entity has compli$ ) ! report+ requirem5t describ$ 9 ?is subp>agraph 9 aw>d+ any future grant to su* entity1 includ+ pursuant to section #djb7;j77#e77;,a77ii7 :5 applicable2 & 7,b7 ! ,director ( ,,nih %all enc\rage ! report+ ( ! results ( su* valid analysis describ$ 9 p>agraph 7#a7 ?r\gh any additional means det]m9$ appropriate by ! ,director4 4 7c7 ,report+ ,section #dib;,b7f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;f77 is am5d$-- 7#a7 by /rik+ bi5nial ea* place su* t]m appe>s & ins]t+ tri5nial 9 ea* su* place2 7#b7 by /rik+ ,! advisory c\ncil & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! advisory c\ncil 2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 ,cont5ts ,ea* tri5nial report prep>$ by an advisory c\ncil ( ea* national rese>* in/itute z describ$ 9 p>agraph 7#a7 %all include ea* ( ! foll[+3 7,a7 ,! numb] ( wom5 includ$ z subjects1 & ! proportion ( subjects t are wom51 9 any project ( cl9ical rese>* conduct$ dur+ ! applicable report+ p]iod1 disaggregat$ by categories ( rese>* area1 condition1 or disease1 & acc\nt+ = s+le-sex /udies4 7,b7 ,! numb] ( memb]s ( m9ority gr\ps includ$ z subjects1 & ! proportion ( subjects t are memb]s ( m9ority gr\ps1 9 any project ( cl9ical rese>* conduct$ dur+ ! applicable report+ p]iod1 disaggregat$ by categories ( rese>* area1 condition1 or disease & acc\nt+ = s+le-race & s+le-e?nicity /udies4 7,c7 ,= ! applicable report+ p]iod1 ! numb] ( projects ( cl9ical rese>* t include wom5 & memb]s ( m9ority gr\ps & t-- 7i7 h be5 complet$ dur+ su* report+ p]iod2 & 7ii7 are be+ c>ri$ out dur+ su* report+ p]iod & h n be5 complet$4 7,d7 ,! numb] ( /udies complet$ dur+ ! applicable report+ p]iod = :i* report+ has be5 submitt$ 9 accordance ) subsection 7c77#b77;,a74 4 7d7 ,coord9ation ,section #dhf7;c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg;d7c77#b77 is am5d$ by /rik+ designees & ins]t+ s5ior-level /aff designees4 #d4 ,improv+ coord9ation relat$ to m9ority heal? & heal? disp>ities ,section #dfdz-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhet7 is am5d$-- 7#a7 by r$esignat+ subsection 7h71 relat+ to int]ag5cy coord9ation1 t foll[s subsection 7j7 z subsection 7k72 & 7#b7 9 subsection 7k7 7z s r$esignat$7-- 7,a7 9 ! subsection head+1 by /rik+ ,int]ag5cy & ins]t+ ,intra-,,nih2 7,b7 by /rik+ z ! prim>y ,f$]al (ficials & ins]t+ z ! prim>y ,f$]al (ficial2 7,c7 by ins]t+ a comma aft] review2 7,d7 by /rik+ ,in/itutes & ,c5t]s ( ! ,national ,in/itutes ( ,heal? & ins]t+ national rese>* in/itutes & national c5t]s2 & 7,e7 by add+ at ! end ! foll[+3 ,! ,director ( ! ,in/itute may fo/] p>tn]%ips betwe5 ! national rese>* in/itutes & national c5t]s & may enc\rage ! fund+ ( collaborative rese>* projects to a*ieve ! goals ( ! ,national ,in/itutes ( ,heal? t are relat$ to m9ority heal? & heal? disp>ities44 #e4 ,wom5 & m9orities 9 rese>* 7a7 ,basic rese>* 7#a7 ,develop+ policies ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? 7ref]r$ to 9 ?is section z ! ,director ( ,,nih7 %all develop policies = projects ( basic rese>* fund$ by ,national ,in/itutes ( ,heal? to assess-- 7,a7 relevant biological v>iables includ+ sex1 z appropriate2 & 7,b7 h[ diff]5ces betwe5 male & female cells1 tissues1 or animals may be exam9$ & analyz$4 7#b7 ,revis+ policies ,! ,director ( ,,nih may update or revise ! policies develop$ "u p>agraph 7#a7 z appropriate4 7#c7 ,consultation & outrea* ,9 develop+1 updat+1 or revis+ ! policies "u ?is section1 ! ,director ( ,,nih-- 7,a7 %all consult )-- 7i7 ! ,(fice ( ,rese>* on ,wom5's ,heal?2 7ii7 ! ,(fice ( ,laboratory ,animal ,welf>e2 & 7iii7 appropriate memb]s ( ! sci5tific & academic communities2 & 7,b7 %all conduct outrea* to solicit fe$back f memb]s ( ! sci5tific & academic communities on ! influ5ce ( sex z a v>iable 9 basic rese>*1 includ+ fe$back on :5 x is appropriate = projects ( basic rese>* involv+ cells1 tissues1 or animals to include bo? male & female cells1 tissues1 or animals4 7#d7 ,additional requirem5ts ,! ,director ( ,,nih %all-- 7,a7 ensure t projects ( basic rese>* fund$ by ! ,national ,in/itutes ( ,heal? are conduct$ 9 accordance ) ! policies develop$1 updat$1 or revis$ "u ?is section1 z applicable2 & 7,b7 enc\rage t ! results ( su* rese>*1 :5 publi%$ or report$1 be disaggregat$ z appropriate ) respect to ! analysis ( any sex diff]5ces4 7b7 ,cl9ical rese>* 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ,,nih1 9 consultation ) ! ,director ( ! ,(fice ( ,rese>* on ,wom5's ,heal? & ! ,director ( ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities1 %all update ! guidel9es e/abli%$ "u section #dib;,b7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b7;d77 9 accordance ) p>agraph 7#b74 7#b7 ,requirem5ts ,! updat$ guidel9es describ$ 9 p>agraph 7#a7 %all-- 7,a7 reflect ! sci5ce reg>d+ sex diff]5ces2 7,b7 improve adh]5ce to ! requirem5ts "u section #dib;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b71 includ+ ! report+ requirem5ts "u subsection 7f7 ( su* section2 & 7,c7 cl>ify ! circum/ances "u :i* /udies %\ld be design$ to support ! conduct ( analyses to detect significant diff]5ces 9 ! int]v5tion effect due to demographic factors relat$ to section #dib;,b ( ! ,public ,heal? ,s]vice ,act1 includ+ 9 ! abs5ce ( prior /udies t demon/rate a diff]5ce 9 /udy outcomes on ! basis ( su* factors & consid]+ ! effects ( ! abs5ce ( su* analyses on ! availability ( data relat$ to demographic diff]5ces4