,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #cjhe  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #aa1 #bjba,ms4   
,blunt ,ro*e/] 7= h]self1 ,ms4 ,h]r]a   
,beutl]1 ,mr4 ,curtis1 ,mr4 ,smi? ( ,new
 ,j]sey1 & ,ms4 ,wat]s7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to improve ! div]sity (    
p>ticipants 9 rese>* on ,alzheim]'s     
disease1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,equity 
9 ,neurosci5ce & ,alzheim]'s ,cl9ical   
,trials ,act ( #bjba or ! ,,enact ,act (
 #bjba4  #b4 ,inc5tives1 improvem5ts1 & 
outrea* to increase div]sity 9          
,alzheim]'s disease rese>*  7a7 ,improv+
 access = & outrea* to und]repres5t$    
populations  7#a7 ,exp&+ access to      
,alzheim]'s rese>* c5t]s  7,a7 ,9 g5]al 
,section #dde7;a77#a7 ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4            
#bhe;e-#b7;a77#a77 is am5d$-- 7i7 by    
/rik+ 7a77#a7 ,! ,director ( ! ,in/itute

 may & ins]t+ ! foll[+3  7a7 7#a7 ,!    
,director ( ! ,in/itute-- 7,a7 may  2   
7ii7 by /rik+ disease4 & ins]t+ disease2
 &2 &  7iii7 by add+ at ! end ! foll[+3 
7,b7 beg9n+ ,janu>y #a1 #bjbb1 %all ent]
 into coop]ative agreem5ts & make grants
 to public or private nonpr(it entities 
"u ?is subsection = ! plann+1           
e/abli%m5t1 & op]ation ( new su* c5t]s t
 are locat$ 9 areas ) a high]           
conc5tration ( m9ority gr\ps 7z det]m9$ 
"u section #ddd7;d77#c77;,d771 su* z    
entities t are hi/orically ,black       
colleges & univ]sities1 ,hispanic-s]v+  
in/itutions1 ,tribal colleges &         
univ]sities1 or c5t]s ( excell5ce = o!r 
m9ority populations4  4  7,b7 ,use (    
fund+ = cl9ics to op]ate cl9ical trials 
,section #dde7;b7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#bhe;e-#b7;b77 is am5d$ by add+ at ! end
 ! foll[+3  7#c7 ,f$]al paym5ts made "u 
a coop]ative agreem5t or grant "u       
subsection 7a7 f funds made available "u
 section #b7;g7 ( ! ,,enact ,act ( #bjba

 %all1 ) respect to ,alzheim]'s disease1
 be us$ 9 "p to e/abli% & op]ate        
diagno/ic & treatm5t cl9ics design$--   
7,a7 to meet ! special ne$s ( m9ority & 
rural populations & o!r und]s]v$        
populations2 &  7,b7 to op]ate cl9ical  
trials  4  7#b7 ,outrea*  7,a7          
,alzheim]'s disease c5t]s ,section      
#dde7;b7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bhe;e-#b7;b771 z am5d$ 
by p>agraph 7#a77;,b71 is fur!r am5d$ by
 add+ at ! end ! foll[+ new p>agraph3   
7#d7 ,f$]al paym5ts made "u a coop]ative
 agreem5t or grant "u subsection 7a7    
%all be us$ to e/abli% engagem5t c5t]s  
to c>ry out public outrea*1 education   
ef=ts1 & dissem9ation ( in=mation =     
memb]s ( m9ority gr\ps ab\t cl9ical     
trial p>ticipation4 ,activities fund$   
pursuant to ! prec$+ s5t5ce %all        
include-- 7,a7 us+ e/abli%$ me*anisms to
 enc\rage memb]s ( m9ority gr\ps to     
p>ticipate 9 cl9ical trials on          
,alzheim]'s disease2  7,b7 exp&+        
education ef=ts to make memb]s ( m9ority

 gr\ps aw>e ( ongo+ cl9ical trials2     
7,c7 work+ ) trial sponsors to increase 
! numb] ( recruitm5t ev5ts = memb]s (   
m9ority gr\ps2  7,d7 conduct+ outrea* to
 national1 ,/ate1 & local physician     
pr(essional organizations1 especially = 
memb]s ( su* organizations :o are prim>y
 c>e physicians or physicians :o        
specialize 9 dem5tia1 to increase       
aw>5ess ( cl9ical rese>* opportunities =
 memb]s ( m9ority gr\ps2 &  7,e7 us+    
community-bas$ p>ticipatory rese>*      
me?odologies to engage ) m9ority        
populations4  4  7,b7 ,res\rce c5t]s =  
m9ority ag+ rese>* ,section #ddd7;c7 ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bhe;e-#a7;c77 is am5d$-- 7i7 
by /rik+ 7c7 & ins]t+ 7c77#a7 2 &  7ii7 
by add+ at ! end ! foll[+ new p>agraph3 
7#b7 ,! ,director1 act+ ?r\gh ! ,res\rce
 ,c5t]s = ,m9ority ,ag+ ,rese>* ( !     
,in/itute1 %all c>ry out public outrea*1
 education ef=ts1 & dissem9ation (      
in=mation = memb]s ( m9ority gr\ps ab\t 
p>ticipation 9 cl9ical rese>* on        

,alzheim]'s disease c>ri$ out or        
support$ "u ?is subp>t4  4  7b7         
,inc5tives to increase div]sity 9       
,alzheim]'s disease rese>* ?r\gh        
pr9cipal inve/igators & rese>*]s f      
und]repres5t$ populations  7#a7         
,alzheim]'s cl9ical rese>* & tra9+ aw>ds
 ,section #dde;,i ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#bhe;e-#aj;a7 is am5d$ by add+ at ! end 
! foll[+ new subsection3  7d7 ,enhanc+ !
 p>ticipation ( pr9cipal inve/igators & 
rese>*]s :o are memb]s ( und]repres5t$  
populations  7#a7 ,9 g5]al ,! ,director 
%all enhance div]sity 9 ! conduct or    
support ( cl9ical rese>* on ,alzheim]'s 
disease "u ?is subp>t by enc\rag+ !     
p>ticipation ( individuals f gr\ps t are
 und]repres5t$ 9 ! biom$ical1 cl9ical1  
behavioral1 & social sci5ces z pr9cipal 
inve/igators ( su* cl9ical rese>*1 z    
rese>*]s = su* cl9ical rese>*1 or bo?4  
7#b7 ,tra9+ = pr9cipal inve/igators ,!  
,director ( ! ,in/itute %all provide    
tra9+ = pr9cipal inve/igators :o are    

memb]s ( a m9ority gr\p ) respect to    
skills =-- 7,a7 ! design & conduct (    
cl9ical rese>* & cl9ical protocols2     
7,b7 apply+ = grants = cl9ical rese>*2 &
  7,c7 su* o!r areas z ! ,director      
det]m9es to be appropriate4  4  7#b7    
,s5ior rese>*] aw>ds ,section #dde;,b7a7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bhe;e-#d7;a77 is am5d$ by    
ins]t+ 1 includ+ s5ior rese>*]s :o are  
memb]s ( a m9ority gr\p be=e ! p]iod at 
! end ( ! fir/ s5t5ce4  7c7 ,inc5tives  
to increase div]sity 9 ,alzheim]'s      
disease rese>* ?r\gh trial sites        
,section #ddd7;d7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#bhe;e-#a7;d77 is am5d$-- 7#a7 by /rik+ 
7d7 & ins]t+ 7d77#a7 2 &  7#b7 by add+  
at ! end ! foll[+ new p>agraphs3  7#b7  
,9 conduct+ or support+ cl9ical rese>*  
on ,alzheim]'s disease = purposes ( ?is 
subp>t1 9 addition to requirem5ts       
o!rwise impos$ "u ?is title1 includ+ "u 
section #dib;,b1 ! ,director ( !        
,in/itute %all increase ! p>ticipation (

 memb]s ( m9ority gr\ps 9 su* cl9ical   
rese>* ?r\gh "o or m ( ! activities     
describ$ 9 p>agraph 7#c74  7#c7 7,a7 ,! 
,director ( ! ,in/itute %all provide    
inc5tives = ! support ( cl9ical rese>*  
on ,alzheim]'s disease ) cl9ical trial  
sites e/abli%$ 9 areas ) a high]        
conc5tration ( m9ority gr\ps1 includ+   
rural areas if practicable4  7,b7 ,9    
det]m9+ :e!r to conduct or support      
cl9ical rese>* on ,alzheim]'s disease1 !
 ,director ( ! ,in/itute %all enc\rage !
 conduct ( cl9ical rese>* ) cl9ical     
trial sites 9 areas describ$ 9          
subp>agraph 7,a7 z a high]-level        
priority crit]ion among ! crit]ia       
e/abli%$ to evaluate :e!r to conduct or 
support cl9ical rese>*4  7,c7 ,9 det]m9+
 ! am\nt ( fund+ to be provid$ = !      
conduct or support ( su* cl9ical rese>*1
 ! ,director ( ! ,in/itute %all provide 
additional fund+ = ! conduct ( su*      
cl9ical rese>* ) cl9ical trial sites 9  
areas describ$ 9 subp>agraph 7,a74  7,d7
 ,9 det]m9+ :e!r an area is an area ) a 

high] conc5tration ( m9ority gr\ps1 !   
,director ( ! ,in/itute-- 7i7 %all      
consid] ! mo/ rec5t data collect$ by !  
,bureau ( ! ,c5sus2 &  7ii7 may also    
consid]-- 7,i7 data f ! ,c5t]s = ,m$ic>e
  ,m$icaid ,s]vices on ! incid5ce (     
,alzheim]'s disease 9 ! ,unit$ ,/ates by
 region2 &  7,,ii7 su* o!r data z !     
,director det]m9es appropriate4  7#d7 ,9
 ord] to facilitate ! p>ticipation (    
memb]s ( m9ority gr\ps 9 cl9ical rese>* 
support$ "u ?is subp>t1 9 addition to   
activities describ$ 9 p>agraph 7#c71 !  
,director ( ! ,in/itute %all-- 7,a7     
ensure t su* cl9ical rese>* uses        
community-bas$ p>ticipatory rese>*      
me?odologies2 &  7,b7 enc\rage ! use (  
remote heal? te*nologies1 includ+       
teleheal?1 remote pati5t monitor+1 &    
mobile te*nologies1 t r$uce or elim9ate 
b>ri]s to p>ticipation ( memb]s (       
m9ority gr\ps 9 su* cl9ical rese>*4     
7#e7 7,a7 ,cl9ical rese>* on ,alzheim]'s
 disease conduct$ or support$ "u ?is    
subp>t %all ensure t su* rese>* includes

 outrea* activities design$ to increase 
! p>ticipation ( memb]s ( m9ority gr\ps 
9 su* rese>*4  7,b7 7i7 ,ea* applicant =
 a grant "u ?is subp>t = cl9ical rese>* 
on ,alzheim]'s disease %all submit to ! 
,director ( ! ,in/itute 9 ! application 
= su* grant-- 7,i7 a budget = outrea*   
activities to memb]s ( m9ority          
populations ) respect to p>ticipation 9 
su* cl9ical rese>*2 &  7,,ii7 a         
description ( ! plan to conduct su*     
outrea*4  7ii7 ,! ,director ( !         
,in/itute %all enc\rage applicants =1 & 
recipi5ts (1 grants "u ?is subp>t to    
conduct cl9ical rese>* on ,alzheim]'s   
disease to engage ) community-bas$      
organizations to increase p>ticipation (
 m9ority populations 9 su* rese>*4  7#f7
 ,= purposes ( ?is subp>t3 7,a7 ,! t]m  
cl9ical rese>* includes a cl9ical trial4
  7,b7 ,! t]m m9ority gr\p has ! mean+  
giv5 su* t]m by reason ( section        
#dib;,b7g74  4  7d7 ,p>ticipant         
eligibility crit]ia ,section #dde;,i ( !
 ,public ,heal? ,s]vice ,act 7#db       

,u4,s4,c4 #bhe;e-#aj;a71 z am5d$ by     
subsection 7b77#a71 is fur!r am5d$ by   
add+ at ! end ! foll[+ new subsection3  
7e7 ,p>ticipant eligibility crit]ia ,!  
,director ( ! ,in/itute %all take su*   
actions z are necess>y to ensure t      
cl9ical rese>* on ,alzheim]'s disease   
conduct$ or support$ "u ?is subp>t is   
design$ ) eligibility crit]ia t ensure !
 cl9ical trial population reflects !    
div]sity ( ! prospective pati5t         
population4 ,su* actions may include !  
foll[+3 7#a7 ,exam9ation ( crit]ia  7,a7
 ,9 g5]al ,an exam9ation ( ea* exclusion
 crit]ion to det]m9e if ! crit]ion is   
necess>y to ensure ! safety ( trial     
p>ticipants or to a*ieve ! /udy         
objectives4  7,b7 ,modification (       
crit]ia ,9 ! case ( an exclusion        
crit]ion t is n necess>y to ensure !    
safety ( trial p>ticipants or to a*ieve 
! /udy objectives-- 7i7 enc\rag+ !      
modification or elim9ation ( ! crit]ion2
 or  7ii7 enc\rag+ tailor+ ! crit]ion z 
n>r[ly z possible to avoid unnecess>y   

limits to ! population ( ! cl9ical /udy4
  7#b7 ,requirem5t = /rong ju/ification 
= exclusion ,a review ( ea* exclusion   
crit]ion to ensure t populations are    
includ$ 9 cl9ical trials1 su* z old]    
adults1 individuals ) a mild =m (       
disease1 individuals at ! extremes ( !  
weight range1 or *ildr51 unless !re is a
 /rong cl9ical or sci5tific ju/ification
 to exclude !m4  7#c7 ,use ( adaptive   
design ,enc\rag+ ! use ( an adaptive    
cl9ical trial design t-- 7,a7 />ts ) a  
def9$ population :]e !re are conc]ns    
ab\t safety2 &  7,b7 may exp& to a      
broad] population bas$ on initial data f
 ! trial & ext]nal data4  4  7e7        
,res\rce c5t] = successful /rategies to 
increase p>ticipation ( und]repres5t$   
populations 9 ,alzheim]'s disease       
cl9ical rese>* ,section #ddd ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bhe;e-#a7 is am5d$ by add+ at ! end !  
foll[+ new subsection3  7e7 7#a7 ,act+  
?r\gh ! ,(fice ( ,special ,populations &
 9 consultation ) ! ,division (         

,extramural ,activities1 ! ,director ( !
 ,in/itute %all support res\rce         
in=mation & te*nical assi/ance to       
grantees "u section #dde 7relat+ to     
,alzheim]'s disease c5t]s71 o!r         
grantees1 & prospective grantees1       
design$ to increase ! p>ticipation (    
m9ority populations 9 cl9ical rese>* on 
,alzheim]'s disease conduct$ or support$
 "u ?is subp>t4  7#b7 ,! res\rce        
in=mation & te*nical assi/ance provid$  
"u p>agraph 7#a7 %all include !         
ma9t5ance ( a c5tral res\rce libr>y 9   
ord] to collect1 prep>e1 analyze1 &     
dissem9ate in=mation relat+ to /rategies
 & be/ practices us$ by recipi5ts (     
grants "u ?is subp>t & o!r rese>*]s 9 ! 
developm5t ( ! cl9ical rese>* design$ to
 increase ! p>ticipation ( m9ority      
populations 9 su* cl9ical rese>*4  4    
7f7 ,annual reports ,section #ddd ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhe;e-#a71 z am5d$ by        
subsection 7e71 is fur!r am5d$ by add+  
at ! end ! foll[+ new subsection3  7f7  

7#a7 7,a7 ,! ,director ( ! ,in/itute    
%all submit annual reports to !         
,congress on ! impact ( ! am5dm5ts made 
to ?is subp>t by ! ,,enact ,act ( #bjba4
  7,b7 ,! ,secret>y %all transmit a copy
 ( ea* su* report to ! ,advisory ,c\ncil
 on ,alzheim]'s ,rese>*1 ,c>e1 &        
,s]vices e/abli%$ "u section #b7;e7 ( ! 
,national ,alzheim]'s ,project ,act     
7,public ,law #aaa-cge74  7#b7 ,9 ea*   
report "u p>agraph 7#a71 ! ,director ( !
 ,in/itute %all include in=mation & data
 on ! foll[+ matt]s ) respect to cl9ical
 trials on ,alzheim]'s disease conduct$ 
dur+ ! prec$+ ye>3 7,a7 ,! numb] (      
p>ticipants :o are memb]s ( a m9ority   
gr\p 9 su* cl9ical trials4  7,b7 ,!     
numb] ( su* cl9ical trials = :i*        
inc5tives "u subsection 7d77#c7 7 made  
available1 ! nature ( su* inc5tives1 !  
am\nt ( increas$ fund+ 7if any7 made    
available = rese>* on ,alzheim]'s       
disease1 & ! tra9+ provid$ to pr9cipal  
inve/igators :o are memb]s ( a m9ority  
gr\p & ! am\nt ( fund+ 7if any7 = su*   

tra9+4  7,c7 ,! numb] ( su* cl9ical     
trials = :i* ! pr9cipal inve/igator is a
 memb] ( a m9ority gr\p4  7,d7 ,! numb] 
( su* cl9ical trials = :i* a significant
 p]c5tage ( rese>*]s are memb]s ( a     
m9ority gr\p4  7,e7 ,modifications to   
pati5t eligibility crit]ia 9 cl9ical    
trial designs "u section #dde;,i7e74    
7,f7 ,outrea* & education ef=ts conduct$
 "u section #dde7;b77#c74  7#c7 ,!      
,director ( ! ,in/itute %all make ea*   
report "u p>agraph 7#a7 available to !  
public1 includ+ ?r\gh po/+ on !         
appropriate website ( ! ,dep>tm5t (     
,heal? & ,human ,s]vices4  4  7g7       
,au?orization ( appropriations ,= ea* ( 
fiscal ye>s #bjbb ?r\gh #bjbf1 !re is   
au?oriz$ to be appropriat$ to !         
,secret>y ( ,heal? & ,human ,s]vices    
#fj1jjj1jjj to c>ry out ! am5dm5ts made 
by ?is section1 to rema9 available until
 exp5d$4