,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #hfea  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #d1 #bjbf,ms4    
,ca/or ( ,florida 7= h]self1 ,mr4       
,fitzpatrick1 & ,ms4 ,und]wood7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to implem5t c]ta9              
recomm5dations to promote ! inclusion ( 
pregnant & lactat+ wom5 9 cl9ical       
rese>*1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z ! ,advanc+
 ,safe ,m$ications = ,moms & ,babies    
,act ( #bjbf4  #b4 ,updat+ ,,fda        
regulations to include pregnant wom5 9  
cl9ical trials  7a7 ,purposes ,!        
purposes ( ?is section are--  7#a7 to   
facilitate compliance ) applicable      
,f$]al regulations relat+ to !          
protection ( pregnant wom5 p>ticipat+ 9 
rese>* z subjects2 &  7#b7 to promote ! 
inclusion ( pregnant wom5 9 cl9ical     
rese>*4  7b7 ,h>monization ,= ! purposes
 specifi$ 9 subsection 7a71 ! ,secret>y 
( ,heal? & ,human ,s]vices 7ref]r$ to 9 

?is ,act z ! ,secret>y71 act+ ?r\gh !   
,commission] ( ,food & ,drugs1 %all1 to 
! ext5t practicable & consi/5t ) o!r    
applicable ,f$]al /atutory law1 issue   
su* regulations z may be appropriate to 
h>monize ! regulations ( ! ,food & ,drug
 ,adm9i/ration relat+ to ! protection ( 
human subjects1 includ+ p>ts #ej & #ef (
 title #ba1 ,code ( ,f$]al ,regulations1
 ) ! regulations ( ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices relat+ to ! inclusion 
( pregnant wom5 z subjects 9 cl9ical    
rese>*4  7c7 ,deadl9e ,! ,secret>y (    
,heal? & ,human ,s]vices %all f9alize ! 
regulations requir$ by subsection 7b7 n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ?is ,act4  #c4 ,rais+ aw>5ess
 ( rese>* t includes pregnant & lactat+ 
wom5  7a7 ,9 g5]al ,! ,secret>y ( ,heal?
 & ,human ,s]vices 7ref]r$ to 9 ?is     
section z ! ,secret>y71 9 consultation )
 ! heads ( o!r relevant ,f$]al ag5cies1 
includ+ ! ,director ( ! ,c5t]s =        
,disease ,control & ,prev5tion & !      
,director ( ! ,national ,in/itutes (    

,heal?1 %all e/abli% & implem5t an      
education campaign design$ to educate   
pati5ts1 _! families1 heal? c>e         
provid]s1 & o!r t>get audi5ces on-- 7#a7
 h[ includ+ pregnant & lactat+ wom5 9   
cl9ical rese>* c b5efit mat]nal & infant
 heal?2  7#b7 available regi/ries &     
cl9ical trials t include pregnant &     
lactat+ wom52  7#c7 ! role regi/ries &  
o!r po/m>ket surveillance activities h 9
 /udy+ drugs us$ by pregnant & lactat+  
wom52 &  7#d7 h[ pregnant & lactat+ wom5
 c easily id5tify & enroll 9 cl9ical    
trials or regi/ries4  7b7 ,consultation 
,9 c>ry+ out ?is section1 ! ,secret>y   
%all consult )--  7#a7 organizations )  
exp]tise relat$ to ! heal? ( wom5 &     
infants1 includ+ su* organizations      
repres5t+ populations ) high rates (    
mat]nal mortality & morbidity2  7#b7    
repres5tatives f relevant m$ical        
societies ) subject matt] exp]tise on   
pregnant wom51 lactat+ wom51 or infants2
  7#c7 relevant indu/ry repres5tatives2 
&  7#d7 o!r repres5tatives1 z           

appropriate4  7c7 ,plann+ ,9 e/abli%+ ! 
campaign "u subsection 7a71 ! ,secret>y1
 9 consultation ) ! heads ( o!r relevant
 ,f$]al ag5cies1 %all-- 7#a7 conduct a  
ne$s assessm5t to--  7,a7 evaluate exi/+
 res\rces2 &  7,b7 id5tify b>ri]s to    
aw>5ess & opportunities to fill gaps &  
address b>ri]s2  7#b7 id5tify t>get     
audi5ces = ! campaign2  7#c7 id5tify    
res\rce ne$s = ea* t>get audi5ce & be/  
practices to rea* ea* su* audi5ce2 &    
7#d7 te/ appropriate messag+ /rategies1 
includ+ risk communication messag+1 =   
ea* t>get audi5ce4  7d7 ,dissem9ation ,!
 ,secret>y %all publi% on a public      
website1 & regul>ly update1 ! campaign  
mat]ials describ$ 9 ?is section1 & %all 
ensure t su* website--  7#a7 includes   
in=mation on cl9ical trials & regi/ries 
enroll+ pregnant & lactat+ wom52 &  7#b7
 provides a us]-fri5dly int]face =      
pati5ts1 _! families1 heal? c>e         
provid]s1 & o!r t>get audi5ces4  7e7    
,au?orization ( appropriations ,!re is  
au?oriz$ to be appropriat$ to c>ry out  

?is section #e1jjj1jjj = ea* ( fiscal   
ye>s #bjbg ?r\gh #bjca4  #d4 ,rese>*    
prioritization process = pregnant &     
lactat+ wom5 at ! ,eunice ,k5n$y ,%riv] 
,national ,in/itute ( ,*ild ,heal? &    
,human ,developm5t  7a7 ,9 g5]al ,!     
,director ( ! ,national ,in/itutes (    
,heal?1 act+ ?r\gh ! ,director ( !      
,eunice ,k5n$y ,%riv] ,national         
,in/itute ( ,*ild ,heal? & ,human       
,developm5t 7ref]r$ to 9 ?is section z  
,,ni*d71 %all c>ry out priority rese>*  
projects on exi/+ & new drugs prescrib$ 
= pregnant & lactat+ wom54  7b7 ,rese>* 
prioritization process ,! ,director ( ! 
,national ,in/itutes ( ,heal? %all      
e/abli% a rese>* prioritization process 
to det]m9e :i* propos$ rese>* projects  
%\ld receive priority fund+ "u ?is      
section4 ,su* rese>* prioritization     
process %all take into acc\nt ! foll[+  
factors3 7#a7 ,! available evid5ce1     
includ+ :e!r !re is an unmet m$ical ne$ 
or gap 9 sci5tific in=mation relevant to
 treatm5t ( pregnant & lactat+ wom5 )   

specific diseases or conditions4  7#b7  
,! feasibility ( rese>*1 includ+ !      
preval5ce ( a disease or condition 9    
pregnant & lactat+ wom5 & ! availability
 ( inve/igators ) exp]tise 9 /udy+ su*  
disease or condition4  7#c7 ,! pot5tial 
impact ( rese>*1 includ+ ! sev]ity ( !  
disease or condition 9 pregnant &       
lactat+ wom51 ! curr5t co/ ( treat+ !   
disease or condition 9 pregnant &       
lactat+ wom51 ! frequ5cy ( use ( ! drug 
9 pregnant & lactat+ wom51 & !          
availability ( alt]native treatm5ts = ! 
disease or condition 9 pregnant &       
lactat+ wom54  7c7 ,consultation ,9     
develop+ ! rese>* prioritization process
 describ$ 9 subsection 7b71 ! ,director 
( ! ,national ,in/itutes ( ,heal? %all  
seek fe$back f-- 7#a7 ! exi/+ rese>*    
networks ( ! ,,ni*d ) exp]tise 9 cl9ical
 rese>* involv+ pregnant & lactat+ wom52
  7#b7 relevant m$ical societies )      
subject matt] exp]tise on pregnant wom51
 lactat+ wom51 or *ildr52 &  7#c7       
organizations ) exp]tise relat$ to !    

heal? ( pregnant wom51 lactat+ wom51 or 
*ildr51 includ+ su* organizations       
repres5t+ populations ) high rates (    
mat]nal mortality & morbidity4  7d7     
,rese>* requirem5ts ,! ,director ( !    
,national ,in/itutes ( ,heal? %all      
ensure t-- 7#a7 rese>* projects c>ri$   
out "u subsection 7a7 are conduct$ by   
individuals :o h ! exp]tise to rigor\sly
 evaluate ! be/-available sci5tific     
rese>*2 &  7#b7 ! f9d+s f su* rese>*    
projects are bas$ on a prepond]ance ( ! 
be/-available1 pe]-review$ sci5tific    
evid5ce4  7e7 ,public comm5t ,!         
,secret>y %all provide an opportunity = 
public comm5t on ! program "u ?is       
section4  7f7 ,acc\ntability & ov]sight 
7#a7 ,"w plan ,n lat] ?an #ahj days aft]
 ! date ( enactm5t ( ?is ,act1 !        
,director ( ! ,national ,in/itutes (    
,heal? %all submit to ! ,committee on   
,heal?1 ,education1 ,labor1 & ,p5sions &
 ! ,committee on ,appropriations ( !    
,s5ate & ! ,committee on ,en]gy &       
,comm]ce & ! ,committee on              

,appropriations ( ! ,h\se (             
,repres5tatives a "w plan =-- 7,a7 fund+
 priority rese>* projects "u subsection 
7a72 &  7,b7 develop+ ! rese>*          
prioritization process "u subsection    
7b74  7#b7 ,reports ,n lat] ?an ,octob] 
#a ( ea* fiscal ye> = ! #e fiscal ye>s  
beg9n+ imm$iately aft] ! date ( enactm5t
 ( ?is ,act1 ! ,director ( ! ,national  
,in/itutes ( ,heal? %all submit to !    
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions & ! ,committee on    
,appropriations ( ! ,s5ate & !          
,committee on ,en]gy & ,comm]ce & !     
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives a report on ! program 
"u ?is section1 includ+--  7,a7 ! am\nt 
( money obligat$ or exp5d$ 9 ! prior    
fiscal ye> = ea* priority rese>* project
 "u subsection 7a72  7,b7 a description 
( ea* su* project2 &  7,c7 ! rationale =
 prioritiz+ ea* su* project accord+ to !
 process "u subsection 7b74  7g7        
,au?orization ( appropriations ,!re is  
au?oriz$ to be appropriat$ to c>ry out  

?is section su* sums z may be necess>y =
 ea* ( fiscal ye>s #bjbg ?r\gh #bjca4