,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #dhgi  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #ag1 #bjad ,mr4 
,coop] 7= himself & ,mrs4 ,lummis7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = exp$it$   
review ( drugs & biological products to 
provide saf] or m effective treatm5t =  
males or females1 to am5d ! ,public     
,heal? ,s]vice ,act to enhance !        
consid]ation ( sex diff]5ces 9 basic &  
cl9ical rese>*1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,rese>* = ,all ,act ( #bjad 4  #b4      
,suffici5cy ( design & size ( cl9ical   
trials dur+ exp$it$ review ,! ,secret>y 
( ,heal? & ,human ,s]vices1 act+ ?r\gh !
 ,commission] ( ,food & ,drugs1 %all    
review & develop policies1 z            
appropriate1 to ensure t ! design & size
 ( cl9ical trials = products grant$     
exp$it$ approval pursuant to section    
#ejf ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 are 
suffici5t to det]m9e ! safety &         
effectiv5ess ( su* products = m5 & wom5 
us+ subgr\p analysis4  #c4 ,exp$it$     
review ( drugs & biological products to 
provide saf] or m effective treatm5t =  
males or females  7a7 ,9 g5]al ,section 
#ejf ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is  
am5d$ by add+ at ! end ! foll[+3  7g7   
,exp$it$ review ( drugs & biological    
products ,to provide saf] or m effective
 treatm5t = males or females  7#a7      
,eligible product ,! ,secret>y %all1 at 
! reque/ ( ! sponsor ( a new drug1      
facilitate ! developm5t & exp$ite !     
review ( su* drug if ! drug--  7,a7 is  
int5d$--  7i7 to avoid s]i\s adv]se     
ev5ts2 or  7ii7 to treat a s]i\s or     
life-?reat5+ disease or condition2  7,b7
 :e!r alone or 9 comb9ation ) "o or m   
o!r drugs or biological products1 is    
int5d$ = saf] or m effective treatm5t = 
m5 or wom5 ?an a curr5tly available     
product approv$ to treat ! g5]al        

population or ! o!r sex2 &  7,c7 is     
support$ by results ( cl9ical trials t  
include & sep>ately exam9e outcomes =   
bo? m5 & wom54  7#b7 ,designation ,at ! 
reque/ ( ! sponsor ( an eligible product
 describ$ 9 p>agraph 7#a71 ! ,secret>y  
%all designate ! drug z an exp$it$      
product to provide saf] or m effective  
treatm5t = males or females4  7#c7 ,e>ly
 & frequ5t communication ,! ,secret>y   
%all1 ) respect to ea* exp$it$ product  
designat$ "u ?is subsection1 provide    
e>ly & frequ5t communication & review ( 
incomplete applications to ! same ext5t 
& 9 ! same mann] z is provid$ "u        
subsections 7b7 & 7d74  7#d7 ,rule (    
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$--  7,a7 to less5 or o!rwise  
alt] ! /&>d ( safety & effectiv5ess     
requir$ = ! approval or lic5s+ ( drugs  
or biological products "u section #eje (
 ?is ,act or section #cea ( ! ,public   
,heal? ,s]vice ,act2 or  7,b7 to        
au?orize application ( ! provisions (   
subsection 7c7 7relat+ to ! use (       

surrogate endpo9ts7 to exp$it$ products 
designat$ "u ?is subsection4  4  7b7    
,te*nical corrections ,subsection 7f7 ( 
section #ejf ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7     
7relat+ to aw>5ess ef=ts71 z designat$  
by section #ijb7;a7 ( ,public ,law      
#aab-add1 is am5d$--  7#a7 9 p>agraph   
7#a71 by /rik+ & & & ins]t+ &2 &  7#b7  
by mov+ su* subsection 7f7 s t x foll[s 
subsection 7e7 ( su* section #ejf4  #d4 
,rese>* on sex diff]5ces  7a7 ,inclusion
 9 ,,nih rese>*  7#a7 ,9 g5]al ,section 
#dib;,b ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bhi;a-#b7 is am5d$--    
7,a7 by r$esignat+ subsections 7b7 ?r\gh
 7g7 z subsections 7c7 ?r\gh 7h71       
respectively2 &  7,b7 by ins]t+ aft]    
subsection 7a7 ! foll[+3  7b7 ,inclusion
 ( sex diff]5ces 9 basic rese>*  7#a7   
,applicability to basic rese>*  7,a7 ,9 
g5]al ,! ,director ( ,,nih %all det]m9e 
:5 x is appropriate = projects ( basic  
rese>* involv+ cells1 tissues or animals
 to include bo? male & female cells1    

tissues1 or animals4  7,b7 ,deadl9e =   
initial det]m9ation2 updates ,!         
,director ( ,,nih--  7i7 %all make !    
initial det]m9ations requir$ by         
subp>agraph 7,a7 n lat] ?an "o ye> aft] 
! date ( enactm5t ( ! ,rese>* = ,all    
,act ( #bjad2 &  7ii7 may subsequ5tly   
update or revise su* det]m9ations z !   
,director det]m9es appropriate4  7,c7   
,consultation ,9 mak+ ! initial         
det]m9ations requir$ by subp>agraph     
7,a71 ! ,director ( ,,nih--  7i7 %all   
consult ) ! ,(fice ( ,rese>* on ,wom5's 
,heal?1 ! ,in/itute ( ,m$ic9e1 ! ,(fice 
( ,laboratory ,animal ,welf>e1 &        
appropriate memb]s ( ! sci5tific &      
academic communities2 &  7ii7 may       
conduct outrea* & educational           
initiatives )9 ! sci5tific & academic   
communities on ! influ5ce ( sex z a     
v>iable 9 basic rese>* 9 ord] to develop
 a cons5sus )9 su* communities on :5 x  
is appropriate = projects ( basic rese>*
 involv+ cells1 tissues or animals to   
include bo? male & female cells1        

tissues1 or animals4  7#b7 ,inclusion   
,beg9n+ on ! date t is #a ye> aft] !    
date ( enactm5t ( ! ,rese>* = ,all ,act 
( #bjad1 9 conduct+ or support+ basic   
rese>* 9 accordance ) p>agraph 7#a71 !  
,director ( ,,nih %all1 subject to      
p>agraph 7#c71 ensure t--  7,a7 9 ! case
 ( rese>* on cells or tissues--  7i7    
cells or tissues1 z applicable1 are     
d]iv$ f bo? male & female organisms 9   
ea* project ( su* rese>*2 &  7ii7 !     
results are disaggregat$ accord+ to :e!r
 ! cells or tissues are d]iv$ f male or 
female organisms2 &  7,b7 9 ! case (    
animal rese>*--  7i7 bo? male & female  
animals are includ$ z subjects 9 ea*    
project ( su* rese>*2 &  7ii7 ! results 
are disaggregat$ accord+ to :e!r !      
subjects are male or female4  7#c7      
,exception ,p>agraph 7#b7 %all n apply  
to a project ( basic rese>* if !        
,director ( ,,nih det]m9es t ! inclusion
 ( cells or tissues d]iv$ f bo? male &  
female organisms1 or ! inclusion ( bo?  
male & female animals z subjects1 z     

applicable1 is inappropriate 9 ! case ( 
su* project4  4  7#b7 ,design ( rese>*  
,subsection 7d7 ( section #dib;,b ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhi;a-#b71 z r$esignat$1 is  
am5d$--  7,a7 by /rik+ 7d7 & all t      
foll[s ?r\gh ,9 ! case & ins]t+ !       
foll[+3  7d7 ,design ( rese>*  7#a7     
,cl9ical trials ,9 ! case  2 &  7,b7 by 
add+ at ! end ! foll[+3  7#b7 ,basic    
rese>* ,9 ! case ( basic rese>* 9 :i*   
cells or tissues d]iv$ f bo? male &     
female organisms w be includ$ 9         
accordance ) subsection 7b77#b77;,a7 or 
bo? male & female animals w be includ$ z
 subjects 9 accordance ) subsection     
7b77#b77;,b71 ! ,director ( ,,nih %all  
ensure t sex diff]5ces are exam9$ &     
analyz$1 z appropriate4  4  7#c7 ,updat+
 guidel9es = cl9ical & basic rese>*     
,section #dib;,b7f77#a7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bhi;a-#b71 z r$esignat$1 is am5d$ to   
read z foll[s3  7#a7 ,date c]ta92 update
 ,! guidel9es requir$ 9 subsection 7e7  

reg>d+ ! requirem5ts ( ?is section =    
cl9ical & basic rese>* %all--  7,a7 be  
updat$ & publi%$ 9 ! ,f$]al ,regi/] n   
lat] ?an #a ye> aft] ! date ( enactm5t (
 ! ,rese>* = ,all ,act ( #bjad2  7,b7   
reflect ! gr[+ und]/&+ t sex diff]5ces  
matt]2  7,c7 ensure bett] en=cem5t ( !  
requirem5ts ( ?is section by ! p]sonnel 
( ! ag5cies ( ! ,national ,in/itutes (  
,heal? responsible = review+ grant      
proposals2 &  7,d7 include guidance on  
:5 rese>* /rongly supports or /rongly   
negates ! conclusion t !re is a         
significant diff]5ce 9 h[ ! v>iables be+
 /udi$ affect wom5 or memb]s ( m9ority  
gr\ps1 z ! case may be1 relative to h[  
su* v>iables affect o!r subjects 9 !    
rese>*4  4  7#d7 ,applicability ,section
 #dib;,b7f77#b7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bhi;a-#b71 
z r$esignat$1 is am5d$ by add+ at ! end 
! foll[+3 ,= fiscal ye> #bjaf &         
subsequ5t fiscal ye>s1 ! ,director (    
,,nih may n approve any proposal ( basic
 rese>* to be conduct$ or support$ by   

any ag5cy ( ! ,national ,in/itutes (    
,heal? unless ! proposal specifies !    
mann] 9 :i* ! rese>* w comply ) ?is     
section44  7#e7 ,con=m+ *anges ,section 
#dib;,b ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bhi;a-#b7 is am5d$--    
7,a7 9 ! head+ ( subsection 7a71 by     
/rik+ ,requirem5t ( inclusion & ins]t+  
,inclusion 9 cl9ical rese>*2  7,b7 9    
subsection 7a77#a71 by /rik+ subsection 
7b7 & ins]t+ subsection 7c72  7,c7 9    
subsection 7e77#a77;,a71 z r$esignat$1  
by /rik+ subsection 7b7 & ins]t+        
subsection 7c72  7,d7 9 subsection      
7e77#a77;,b71 z r$esignat$1 by /rik+    
subsection 7c7 & ins]t+ subsection 7d72 
&  7,e7 9 subsection 7e77#b71 z         
r$esignat$1 by /rik+ subsection 7b7 &   
ins]t+ subsection 7c74  7b7 ,bi5nial    
reports ( ,director ( ,,nih ,subp>agraph
 7,c7 ( section #djc7;a77#d7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bhc7;a77#d77 is am5d$--  7#a7 by       
r$esignat+ clause 7vi7 z clause 7vii72 &
  7#b7 by ins]t+ aft] clause 7v7 !      

foll[+3  7vi7 ,basic rese>*1 includ+ a  
breakd[n ( ! sex ( organisms f :i* cells
 & tissues are d]iv$1 a breakd[n ( ! sex
 ( animal subjects1 & su* o!r in=mation 
z may be necess>y to demon/rate         
compliance ) section #dib;,b 7reg>d+ sex
 diff]5ces 9 basic rese>*74  4  7c7     
,special ,c5t]s ( ,rese>* on ,sex       
,diff]5ces ,"p ,h ( title ,,iv ( !      
,public ,heal? ,s]vice ,act is am5d$ by 
ins]t+ aft] section #dib;,b ( su* ,act  
7#db ,u4,s4,c4 #bhi;a-#b7 ! foll[+3     
#dib;,c4 ,special ,c5t]s ( ,rese>* on   
,sex ,diff]5ces ,! ,secret>y may aw>d   
grants or o!r support to entities = !   
cont9u$ op]ation & expansion ( ,special 
,c5t]s ( ,rese>* on ,sex ,diff]5ces4  4 
7d7 ,rule ( con/ruction ,no?+ 9 ?is ,act
 or ! am5dm5ts made by ?is ,act %all be 
con/ru$ to less5 any /&>d or requirem5t 
set =? 9 "p #a1 #b1 or #c ( sub*apt] ,a 
( *apt] ,i ( title #i1 ,code ( ,f$]al   
,regulations4  #e4 ,,gao reports ,n lat]
 ?an #a ye> aft] ! date ( enactm5t ( !  
,rese>* = ,all ,act ( #bjad1 !          

,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all--  7#a7 submit to ! ,congress      
updat$ v]sions ( ! reports ( ! ,gov]nm5t
 ,acc\ntability ,(fice entitl$ ,wom5's  
,heal?3 ,,nih ,has ,increas$ ,its ,ef=ts
 ,to ,include ,wom5 9 ,rese>* 7publi%$ 9
 ,may #bjjj2 ,,gao_/,,hehs-#jj-if7 &    
,wom5's ,heal?3 ,wom5 ,suffici5tly      
,repres5t$ 9 ,new ,drug ,te/+1 ,b ,,fda 
,ov]sight ,ne$s ,improvem5t 7publi%$ 9  
,july #bjja2 ,,gao-#ja-ged72 &  7#b7 9  
su* updat$ reports--  7,a7 exam9e !     
inclusion ( wom51 female animals1 &     
female-d]iv$ cells & tissues 9 f$]ally  
fund$ rese>* ov] ! pa/ decade2  7,b7    
exam9e h[ ,f$]al ag5cies report &       
analyze subgr\p in=mation & translate   
any diff]5ces to ! m$ical community &   
pati5ts2  7,c7 det]m9e :e!r ! quality ( 
c>e :i* wom5 receive is be+ negatively  
impact$ by inclusion rates 9 basic &    
cl9ical rese>*2 &  7,d7 address curr5t  
ef=ts )9 ,national ,in/itutes ( ,heal? &
 o!r gov]nm5t ag5cies to enc\rage ! %>+ 
( rese>* data on sex diff]5ces &        

evaluate me*anisms to improve su* %>+1  
includ+ a publicly accessible onl9e     
sy/em t w con=m ) policies protect+     
comm]cial1 propriet>y1 or private       
in=mation4