,,ii  #aad? ,,congress  #b;d ,session   
,s4 #bgde  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #e1 #bjaf ,ms4  
,coll9s 7= h]self1 ,ms4 ,w>r51 ,mr4     
,kirk1 ,ms4 ,baldw91 ,mr4 ,alex&]1 &    
,mrs4 ,murray7 introduc$ ! foll[+ bill2 
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,public ,heal? ,s]vice ,act to promote
 ! inclusion ( m9orities 9 cl9ical      
rese>*1 & = o!r purposes4  #a4 ,%ort    
title  ,?is ,act may be cit$ z !        
,advanc+ ,,nih ,/rategic ,plann+ &      
,repres5tation 9 ,m$ical ,rese>* ,act4  
#b4 ,,nih /rategic plan  7a7 ,/rategic  
plan ,section #djb ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bhb7 is    
am5d$-- 7#a7 9 subsection 7b77#e71 by   
ins]t+ be=e ! semicolon ! foll[+3 1 &   
?r\gh ! developm5t1 implem5tation1 &    
updat+ ( ! /rategic plan develop$ "u    
subsection 7m72 &  7#b7 by add+ at ! end
 ! foll[+3  7m7 ,,nih /rategic plan     
7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] !

 date ( enactm5t ( ! ,advanc+ ,,nih     
,/rategic ,plann+ & ,repres5tation 9    
,m$ical ,rese>* ,act1 & once e #f ye>s  
!reaft]1 ! ,director ( ,,nih1 9         
consultation ) ! directors ( ! national 
rese>* in/itutes & national c5t]s1 %all 
develop & submit to ! appropriate       
committees ( ,congress & po/ on !       
,int]net website ( ! ,national          
,in/itutes ( ,heal?1 a #f-ye> coord9at$ 
/rategy 7to be kn[n z ! ,,nih ,/rategic 
,plan7 to provide direction to !        
biom$ical rese>* inve/m5ts made by !    
,national ,in/itutes ( ,heal?1 to       
facilitate collaboration across !       
in/itutes & c5t]s1 to lev]age sci5tific 
opportunity1 & to advance biom$ic9e4    
7#b7 ,requirem5ts ,! /rategy "u p>agraph
 7#a7 %all-- 7,a7 id5tify /rategic      
rese>* priorities & objectives across   
biom$ical rese>*1 includ+--  7i7 an     
assessm5t ( ! /ate ( biom$ical &        
behavioral rese>*1 includ+ areas (      
opportunity ) respect to basic1 cl9ical1
 & translational rese>*2  7ii7          

priorities & objectives to advance !    
treatm5t1 cure1 & prev5tion ( heal?     
conditions2  7iii7 em]g+ sci5tific      
opportunities1 ris+ public heal?        
*all5ges1 & sci5tific k gaps2 &  7iv7 ! 
id5tification ( ne>-1 mid-1 & long-t]m  
sci5tific ne$s2  7,b7 consid]1 9 c>ry+  
out subp>agraph 7,a7--  7i7 disease     
burd5 9 ! ,unit$ ,/ates2  7ii7 r>e      
diseases & conditions2  7iii7           
biological1 social1 & o!r det]m9ants (  
heal? t contribute to heal? disp>ities2 
&  7iv7 o!r factors ! ,director ( ,,nih 
det]m9es appropriate2  7,c7 include     
multi-in/itute priorities1 includ+      
coord9ation ( rese>* among in/itutes &  
c5t]s2  7,d7 include /rategic priorities
 = fund+ rese>* ?r\gh ! ,common ,fund1 9
 accordance ) section                   
#djb;,a7c77#a77;,c72  7,e7 address !    
ag5cy's propos$ & ongo+ activities      
relat$ to tra9+ & ! biom$ical work=ce2 &
  7,f7 describe opportunities =         
collaboration ) o!r ag5cies & dep>tm5ts1
 z appropriate4  7#c7 ,use ( plans      

,/rategic plans develop$ & updat$ by !  
national rese>* in/itutes & national    
c5t]s ( ! ,national ,in/itutes ( ,heal? 
%all be prep>$ regul>ly & 9 su* a mann] 
t su* plans w be in=m$ by ! /rategic    
plans develop$ & updat$ "u ?is          
subsection4  4  7b7 ,con=m+ am5dm5t     
,section #djb;,a7c77#a77;,c7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bhb;a7c77#a77;,c77 is am5d$ by /rik+ ,n
 lat] ?an ,june #a1 #bjjg1 & e #b ye>s  
!reaft]1 & ins]t+ ,z "p ( ! ,,nih       
,/rategic ,plan requir$ "u section      
#djb7m714  #c4 ,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  #d4 
,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$-- 7#a7
 by /rik+ ,9 ! case & ins]t+ ! foll[+3  
7#a7 ,9 g5]al ,9 ! case  2 &  7#b7 by   
add+ at ! end ! foll[+3  7#b7 ,report+  
requirem5ts  ,= any new & compet+       
project ( cl9ical rese>* subject to !   
requirem5ts "u ?is section t receives a 
grant aw>d #a ye> aft] ! date ( enactm5t
 ( ! ,advanc+ ,,nih ,/rategic ,plann+ & 
,repres5tation 9 ,m$ical ,rese>* ,act1  
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 section #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  #e4 ,improv+ rese>* relat$  
to sexual & g5d] m9ority populations    
7a7 ,9 g5]al ,"p ,a ( title ,,iv ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bha et seq47 is am5d$ by add+

 at ! end ! foll[+3  #djd,m4 ,rese>*    
relat$ to sexual & g5d] m9ority         
populations  ,! ,director ( ,,nih %all1 
z appropriate1 enc\rage ef=ts to improve
 rese>* relat$ to ! heal? ( sexual &    
g5d] m9ority populations1 includ+ by--  
7#a7 facilitat+ increas$ p>ticipation ( 
sexual & g5d] m9ority populations 9     
cl9ical rese>* support$ by ! ,national  
,in/itutes ( ,heal?1 & report+ on su*   
p>ticipation1 z applicable2  7#b7       
facilitat+ ! developm5t ( valid &       
reliable me?ods = rese>* relevant to    
sexual & g5d] m9ority populations2 &    
7#c7 address+ me?odological *all5ges4  4
  7b7 ,report+  7#a7 ,9 g5]al ,!        
,secret>y1 9 collaboration ) ! ,director
 ( ! ,national ,in/itutes ( ,heal?1 %all
 z appropriate--  7,a7 cont9ue to       
support rese>* = ! developm5t (         
appropriate measures relat$ to report+  
heal? in=mation ab\t sexual & g5d]      
m9ority populations2 &  7,b7 n lat] ?an 
#b ye>s aft] ! date ( enactm5t ( ?is    
,act1 dissem9ate & make public su*      

measures4  7#b7 ,national ,academy (    
,m$ic9e recomm5dations ,9 develop+ !    
measures describ$ 9 p>agraph 7#a77;,a71 
! ,secret>y %all take into acc\nt       
recomm5dations made by ! ,national      
,academy ( ,m$ic9e4  #f4 ,improv+       
coord9ation relat$ 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$7--    
7,a7 9 ! head+1 by /rik+ ,int]ag5cy &   
ins]t+ ,intra-,,nih2  7,b7 by /rik+ z ! 
prim>y ,f$]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  #g4 
,enhanc+ ! rigor & reproducibility (    
sci5tific rese>*  7a7 ,e/abli%m5t ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 act+ ?r\gh ! ,director ( !   
,national ,in/itutes ( ,heal?1 %all     
conv5e a work+ gr\p "u ! ,advisory      
,committee to ! ,director ( ! ,national 
,in/itutes ( ,heal?1 appo9t$ "u section 
#bbb ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bag;a71 to develop &    
issue recomm5dations = a =mal policy1   
:i* may incorporate or be in=m$ by      
relevant exi/+ & ongo+ activities1 to   
enhance rigor & reproducibility (       
sci5tific rese>* fund$ by ! ,national   
,in/itutes ( ,heal?4  7b7 ,consid]ations
 ,9 develop+ & issu+ ! recomm5dations "u
 subsection 7a71 ! work+ gr\p e/abli%$  
"u su* subsection %all consid]1 z       

appropriate--  7#a7 precl9ical exp]im5t 
design1 includ+ analysis ( sex z a      
biological v>iable2  7#b7 cl9ical       
exp]im5t design1 includ+--  7,a7 !      
div]sity ( populations /udi$ = cl9ical  
rese>*1 ) respect to biological1 social1
 & o!r det]m9ants ( heal? t contribute  
to heal? disp>ities2  7,b7 !            
circum/ances "u :i* summ>y in=mation    
reg>d+ biological1 social1 & o!r factors
 t contribute to heal? disp>ities %\ld  
be report$2 &  7,c7 ! circum/ances "u   
:i* cl9ical /udies1 includ+ cl9ical     
trials1 %\ld conduct an analysis ( !    
data collect$ dur+ ! /udy on ! basis (  
biological1 social1 & o!r factors t     
contribute to heal? disp>ities2  7#c7   
applicable levels ( rigor 9 /ati/ical   
me?ods1 me?odology1 & analysis2  7#d7   
data & in=mation %>+ 9 accordance )     
applicable privacy laws & regulations2 &
  7#e7 any o!r matt] det]m9$ relevant by
 ! work+ gr\p4  7c7 ,policies ,n lat]   
?an #ah mon?s aft] ! date ( enactm5t (  
?is ,act1 ! ,director ( ! ,national     

,in/itutes ( ,heal? %all consid] !      
recomm5dations develop$ by ! work+ gr\p 
"u subsection 7a7 & develop or update   
policies z appropriate4  7d7 ,report ,n 
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 ! ,director ( ! ,national   
,in/itutes ( ,heal?1 act+ ?r\gh ! work+ 
gr\p e/abli%$ "u subsection 7a71 %all   
issue a report to ! ,secret>y ( ,heal? &
 ,human ,s]vices1 ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate1 & ! ,committee on ,en]gy &   
,comm]ce ( ! ,h\se ( ,repres5tatives    
reg>d+ recomm5dations develop$ "u su*   
subsection & any subsequ5t policy *anges
 implem5t$1 to enhance rigor &          
reproducibility 9 sci5tific rese>* fund$
 by ! ,national ,in/itutes ( ,heal?4    
7e7 ,confid5tiality ,no?+ 9 ?is section 
%all au?orize ! ,secret>y ( ,heal? &    
,human ,s]vices to disclose any         
in=mation t is a trade secret1 or o!r   
privileg$ or confid5tial in=mation1     
describ$ 9 section #eeb7;b77#d7 ( title 
#e1 ,unit$ ,/ates ,code1 or section     

#aije ( title #ah1 ,unit$ ,/ates ,code4 
#h4 ,task ,=ce on rese>* specific to    
pregnant wom5 & lactat+ wom5  7a7 ,task 
=ce on rese>* specific to pregnant wom5 
& lactat+ wom5  7#a7 ,e/abli%m5t ,n lat]
 ?an #ij days aft] ! date ( enactm5t (  
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y7 %all e/abli% a task =ce1 9   
accordance ) ! ,f$]al ,advisory         
,committee ,act 7#e ,u4,s4,c4 ,app471 to
 be kn[n z ! ,task ,=ce on ,rese>*      
,specific to ,pregnant ,wom5 & ,lactat+ 
,wom5 79 ?is section ref]r$ to z ! ,task
 ,=ce74  7#b7 ,duties ,! ,task ,=ce %all
 provide advice & guidance to !         
,secret>y reg>d+ ,f$]al activities      
relat$ to id5tify+ & address+ gaps 9 k &
 rese>* reg>d+ safe & effective !rapies 
= pregnant wom5 & lactat+ wom51 includ+ 
! developm5t ( su* !rapies & !          
collaboration on & coord9ation ( su*    
activities4  7#c7 ,memb]%ip  7,a7 ,f$]al
 memb]s ,! ,task ,=ce %all be compos$ ( 
ea* ( ! foll[+ ,f$]al memb]s1 or !      

designee ( su* memb]3  7i7 ,! ,director 
( ! ,c5t]s = ,disease ,control &        
,prev5tion4  7ii7 ,! ,director ( !      
,national ,in/itutes ( ,heal?1 !        
,director ( ! ,eunice ,k5n$y ,%riv]     
,national ,in/itute ( ,*ild ,heal? &    
,human ,developm5t1 & ! directors ( su* 
o!r appropriate national rese>*         
in/itutes4  7iii7 ,! ,commission] (     
,food & ,drugs4  7iv7 ,! ,director ( !  
,(fice on ,wom5's ,heal?4  7v7 ,!       
,director ( ! ,national ,vacc9e ,program
 ,(fice4  7vi7 ,! head ( any o!r        
rese>*-relat$ ag5cy or dep>tm5t n       
describ$ 9 clauses 7i7 ?r\gh 7v7 t !    
,secret>y det]m9es appropriate1 :i* may 
include ! ,dep>tm5t ( ,vet]ans ,affairs 
& ! ,dep>tm5t ( ,def5se4  7,b7          
,non-,f$]al memb]s ,! ,task ,=ce %all be
 compos$ ( ea* ( ! foll[+ non-,f$]al    
memb]s1 includ+-- 7i7 repres5tatives f  
relevant m$ical societies ) subject     
matt] exp]tise on pregnant wom51 lactat+
 wom51 or *ildr52  7ii7 nonpr(it        
organizations ) exp]tise relat$ to !    

heal? ( wom5 & *ildr52  7iii7 relevant  
indu/ry repres5tatives2 &  7iv7 o!r     
repres5tatives1 z appropriate4  7,c7    
,limitations ,! non-,f$]al memb]s       
describ$ 9 subp>agraph 7,b7 %all--  7i7 
compose n m ?an "o-half1 & n less ?an   
"o-?ird1 ( ! total memb]%ip ( ! ,task   
,=ce2 &  7ii7 be appo9t$ by ! ,secret>y4
  7#d7 ,t]m9ation  7,a7 ,9 g5]al        
,subject to subp>agraph 7,b71 ! ,task   
,=ce %all t]m9ate on ! date t is #b ye>s
 aft] ! date on :i* ! ,task ,=ce is     
e/abli%$ "u p>agraph 7#a74  7,b7        
,ext5sion ,! ,secret>y may ext5d !      
op]ation ( ! ,task ,=ce = "o additional 
#b-ye> p]iod foll[+ ! #b-ye> p]iod      
describ$ 9 subp>agraph 7,a71 if !       
,secret>y det]m9es t ! ext5sion is      
appropriate = c>ry+ out ! purpose ( ?is 
section4  7#e7 ,meet+s ,! ,task ,=ce    
%all meet n less ?an #b times ea* ye> & 
%all conv5e public meet+s1 z            
appropriate1 to fulfill its duties "u   
p>agraph 7#b74  7#f7 ,task =ce report to
 ,congress ,n lat] ?an #ah mon?s aft] ! 

date on :i* ! ,task ,=ce is e/abli%$ "u 
p>agraph 7#a71 ! ,task ,=ce %all prep>e 
& submit to ! ,secret>y1 ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
( ! ,s5ate1 & ! ,committee on ,en]gy &  
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report t includes ea* ( ! foll[+3  7,a7 
,a plan to id5tify & address gaps 9 k & 
rese>* reg>d+ safe & effective !rapies =
 pregnant wom5 & lactat+ wom51 includ+ !
 developm5t ( su* !rapies4  7,b7 ,e?ical
 issues surr\nd+ ! inclusion ( pregnant 
wom5 & lactat+ wom5 9 cl9ical rese>*4   
7,c7 ,effective communication /rategies 
) heal? c>e provid]s & ! public on      
in=mation relevant to pregnant wom5 &   
lactat+ wom54  7,d7 ,id5tification (    
,f$]al activities1 includ+-- 7i7 ! /ate 
( rese>* on pregnancy & lactation2  7ii7
 recomm5dations = ! coord9ation (1 &    
collaboration on rese>* relat$ to       
pregnant wom5 & lactat+ wom52  7iii7    
dissem9ation ( rese>* f9d+s & in=mation 
relevant to pregnant wom5 & lactat+ wom5
 to provid]s & ! public2 &  7iv7 exi/+  

,f$]al ef=ts & programs to improve !    
sci5tific und]/&+ ( ! heal? impacts on  
pregnant wom51 lactat+ wom5 &1 relat$   
bir? & p$iatric outcomes1 includ+ )     
respect to ph>macok9etics1              
ph>macodynamics1 & toxicities4  7,e7    
,recomm5dations to improve ! developm5t 
( safe & effective !rapies = pregnant   
wom5 & lactat+ wom54  7b7               
,confid5tiality ,no?+ 9 ?is section %all
 au?orize ! ,secret>y ( ,heal? & ,human 
,s]vices to disclose any in=mation t is 
a trade secret1 or o!r privileg$ or     
confid5tial in=mation1 describ$ 9       
section #eeb7;b77#d7 ( title #e1 ,unit$ 
,/ates ,code1 or section #aije ( title  
#ah1 ,unit$ ,/ates ,code4  7c7 ,updat+  
protections = pregnant wom5 & lactat+   
wom5 9 rese>*  7#a7 ,9 g5]al ,n lat] ?an
 #b ye>s aft] ! date ( enactm5t ( ?is   
,act1 ! ,secret>y1 consid]+ any         
recomm5dations ( ! ,task ,=ce available 
at su* "t & 9 consultation ) ! heads (  
relevant ag5cies ( ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices1 %all1 z appropriate1 

update regulations & guidance1 z        
applicable1 reg>d+ ! inclusion (        
pregnant wom5 & lactat+ wom5 9 cl9ical  
rese>*4  7#b7 ,crit]ia = exclud+        
pregnant or lactat+ wom5 ,9 updat+ any  
regulations or guidance describ$ 9      
p>agraph 7#a71 ! ,secret>y %all consid] 
any appropriate crit]ia to be us$ by    
in/itutional review bo>ds & individuals 
review+ grant proposals = exclud+       
pregnant wom5 or lactat+ wom5 z a /udy  
population requir+ additional           
protections f p>ticipat+ 9 human subject
 rese>*4  #i4 ,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 ( ,,nih71  
tak+ into consid]ation ! f9d+s ( ! work+
 gr\p e/abli%$ "u section #g1 %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