,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #idhg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #ab1         
#bjbb,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$ications = ,moms & ,babies    
,act ( #bjbb4  #b4 ,updat+ ,,fda        
regulations to remove pregnant wom5 z a 
vuln]able rese>* population  7a7        
,purposes ,! purposes ( ?is section     
are--  7#a7 to facilitate compliance )  
applicable ,f$]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 79 ?is ,act  

ref]r$ to z ! ,secret>y7 %all1 to !     
ext5t practicable & consi/5t ) o!r      
applicable /atutes1 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$]al ,regulations1
 ) ! late/ regulations ( ! ,dep>tm5t (  
,heal? & ,human ,s]vices relat+ to !    
inclusion ( pregnant wom5 z subjects 9  
cl9ical rese>*4  7c7 ,deadl9e ,!        
,secret>y ( ,heal? & ,human ,s]vices    
%all f9alize ! regulations requir$ by   
subsection 7b7 n lat] ?an #ahj days aft]
 ! date ( enactm5t ( ?is ,act4  #c4     
,cle>+h\se ( cl9ical trials & regi/ries 
7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! 
,director ( ! ,national ,in/itutes (    
,heal?1 & 9 consultation ) !            
,commission] ( ,food & ,drugs & ! heads 
( o!r relevant ,f$]al dep>tm5ts &       
ag5cies1 %all e/abli% & ma9ta9 a        
national cle>+h\se ( educational        
mat]ials & curr5t in=mation on regi/ries

 & cl9ical trials t enroll pregnant &   
lactat+ wom5 9 ord] to-- 7#a7 enable    
pregnant & lactat+ wom51 _! families1 & 
heal? c>e pr(essionals to easily id5tify
 & enroll 9 regi/ries & cl9ical trials2 
7#b7 educate pregnant & lactat+ wom51 _!
 families1 & heal? c>e pr(essionals on !
 importance ( enroll+ 9 regi/ries &     
cl9ical trials2 &  7#c7 in=m pregnant & 
lactat+ wom51 _! families1 & heal? c>e  
pr(essionals ab\t ! g5]al requirem5ts1  
commitm5ts1 & b5efits associat$ )       
p>ticipat+ 9 a regi/ry or cl9ical trial4
  7b7 ,requirem5ts ,! ,secret>y1 act+   
?r\gh ! ,director ( ! ,national         
,in/itutes ( ,heal?1 & 9 consultation ) 
! ,commission] ( ,food & ,drugs & !     
heads ( o!r relevant ,f$]al dep>tm5ts & 
ag5cies1 %all ensure t ! cle>+h\se "u   
subsection 7a7-- 7#a7 is accessible by  
means ( ! int]net2  7#b7 is updat$ on a 
regul> basis1 n less ?an qu>t]ly2  7#c7 
is design$ = consum]s1 incorporates a   
us]-fri5dly int]face1 & is se>*able2    
7#d7 includes l9ks to relat$ public &   

private sector res\rces on regi/ries &  
cl9ical trials describ$ 9 subsection    
7a72 &  7#e7 is available to ! public by
 ,octob] #a1 #bjbe4  7c7 ,plann+  7#a7  
,9 g5]al ,9 e/abli%+ ! cle>+h\se "u     
subsection 7a71 ! ,secret>y1 %all-- 7,a7
 develop crit]ia = :i* regi/ries &      
cl9ical trials are eligible = li/+ 9 !  
cle>+h\se "u subsection 7a72  7,b7      
e/abli% a proc$ure = ar*iv+ clos$       
regi/ries & cl9ical trials2 &  7,c7     
id5tify educational res\rces ne$$ = !   
cle>+h\se4  7#b7 ,public input ,!       
,secret>y %all solicit public input on  
cont5t to be includ$ 9 ! cle>+h\se "u   
subsection 7a74  7d7 ,au?orization (    
appropriations ,to c>ry out ?is section1
 !re are au?oriz$ to be appropriat$--   
7#a7 #d1jjj1jjj = ! p]iod ( fiscal ye>s 
#bjbc ?r\gh #bjbd2 &  7#b7 #c1jjj1jjj = 
! p]iod ( fiscal ye>s #bjbe ?r\gh #bjbg4
  #d4 ,coord9at+ ,committee on ,rese>*  
,specific to ,pregnant & ,lactat+ ,wom5 
7a7 ,e/abli%m5t ,n lat] ?an #ij days    
aft] ! date ( enactm5t ( ?is ,act1 !    

,secret>y %all e/abli% a committee1 9   
accordance ) ! ,f$]al ,advisory         
,committee ,act 7#e ,u4,s4,c4 ,app471 to
 be kn[n z ! ,committee on ,rese>*      
,specific to ,pregnant & ,lactat+ ,wom5 
or ! ,,prglac ,committee 79 ?is section 
ref]r$ to z ! ,committee7 to advise on  
coord9at+ ,f$]al activities to address  
gaps 9 k & rese>* reg>d+ safe &         
effective !rapies = pregnant & lactat+  
wom54  7b7 ,duties ,! ,committee %all-- 
7#a7 advise on coord9at+ ,f$]al         
activities to promote ! inclusion (     
pregnant & lactat+ wom5 9 cl9ical       
rese>*2  7#b7 promote opportunities =   
,f$]al ag5cies & private actors to      
advance ! inclusion ( pregnant & lactat+
 wom5 9 cl9ical rese>*2  7#c7 develop & 
annually update a summ>y ( ,f$]al ag5cy 
progress t[>d implem5t+ recomm5dations  
includ$ 9 ! ,septemb] #bjah ,report to !
 ,secret>y ( ,heal? & ,human ,s]vices1 &
 ! ,augu/ #bjbj ,report ,implem5tation  
,plan to ! ,secret>y ( ,heal? & ,human  
,s]vices1 prep>$ by ! ,task ,=ce on     

,rese>* ,specific to ,pregnant ,wom5 &  
,lactat+ ,wom52  7#d7 id5tify new       
recomm5dations = ! ,secret>y reg>d+     
,f$]al activities to address gaps 9 k & 
rese>* reg>d+ safe & effective !rapies =
 pregnant & lactat+ wom52 &  7#e7       
receive updates on private sector &     
int]national ef=ts to include pregnant &
 lactat+ wom5 9 cl9ical rese>*4  7c7    
,memb]%ip  7#a7 ,9 g5]al ,! ,committee  
%all be compos$ (--  7,a7 ! ,f$]al      
memb]s li/$ 9 p>agraph 7#b72 &  7,b7 !  
non-,f$]al memb]s appo9t$ pursuant to   
p>agraph 7#c74  7#b7 ,f$]al memb]s ,!   
,f$]al memb]s ( ! ,committee %all consi/
 ( ! foll[+ ,f$]al (ficials 7or _!      
designees73 7,a7 ,! ,director ( ! ,c5t]s
 = ,disease ,control & ,prev5tion4  7,b7
 ,! ,director ( ! ,national ,in/itutes (
 ,heal?1 ! ,director ( ! ,eunice ,k5n$y 
,%riv] ,national ,in/itute ( ,*ild      
,heal? & ,human ,developm5t1 ! ,director
 ( ! ,(fice ( ,rese>* on ,wom5's ,heal? 
( ! ,national ,in/itutes ( ,heal?1 & !  
directors ( su* o!r national rese>*     

in/itutes & national c5t]s ( ! ,national
 ,in/itutes ( ,heal? z ! ,secret>y      
det]m9es appropriate4  7,c7 ,!          
,commission] ( ,food & ,drugs4  7,d7 ,! 
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality4  7,e7 ,! ,director ( !     
,(fice on ,wom5's ,heal? ( ! ,dep>tm5t (
 ,heal? & ,human ,s]vices4  7,f7 ,!     
,director ( ! ,national ,vacc9e         
,program4  7,g7 ,! ,director ( ! ,(fice 
= ,human ,rese>* ,protections ( !       
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7,h7 ,! ,adm9i/rator ( ,heal? ,res\rces 
& ,s]vices ,adm9i/ration4  7,i7 ,! head 
( any o!r rese>*-relat$ ag5cy or        
dep>tm5t n describ$ 9 subp>agraphs 7,a7 
?r\gh 7,h7 z ! ,secret>y det]m9es       
appropriate1 :i* may include ! ,dep>tm5t
 ( ,vet]ans ,affairs & ! ,dep>tm5t (    
,def5se4  7#c7 ,non-,f$]al memb]s  7,a7 
,9 g5]al ,! non-,f$]al memb]s ( !       
,committee %all consi/ (-- 7i7          
repres5tatives f relevant m$ical        
societies ) subject matt] exp]tise on   
pregnant wom51 lactat+ wom51 or *ildr52 

7ii7 repres5tatives f nonpr(it          
organizations ) exp]tise relat$ to !    
heal? ( wom5 & *ildr52  7iii7 relevant  
indu/ry repres5tatives2  7iv7           
individuals ) e?ical & legal exp]tise 9 
cl9ical trials & rese>*2  7v7           
repres5tatives f relevant nonpr(it      
organizations ) exp]tise 9 cl9ical      
rese>*2 &  7vi7 o!r repres5tatives1 z ! 
,secret>y det]m9es appropriate4  7,b7   
,limitations ,! non-,f$]al memb]s ( !   
,committee %all compose n m ?an "o-half1
 & n less ?an "o-?ird1 ( ! total        
memb]%ip ( ! ,committee4  7,c7          
,appo9tm5t ,! ,secret>y %all appo9t !   
non-,f$]al memb]s ( ! ,committee4  7,d7 
,t]ms ,! non-,f$]al memb]s ( !          
,committee %all s]ve = a t]m ( #d ye>s1 
& may be reappo9t$ = #a additional      
#d-ye> t]m4 ,any non-,f$]al memb]       
appo9t$ to fill a vacancy = an unexpir$ 
t]m %all be appo9t$ = ! rema9d] ( su*   
t]m4 ,a non-,f$]al memb] may s]ve aft] !
 expiration ( ! memb]'s t]m until a     
successor has tak5 (fice4  7d7          

,adm9i/rative support ,! ,secret>y %all 
provide ! ,committee su* adm9i/rative   
support z ! ,secret>y det]m9es to be    
necess>y = c>ry+ out ?is section4  7e7  
,meet+s ,! ,committee %all meet at lea/ 
#b times ea* ye> & %all conv5e public   
meet+s1 z appropriate1 to fulfill its   
duties "u subsection 7b74  7f7 ,report  
to ,congress  7#a7 ,9 g5]al ,n lat] ?an 
#a ye> aft] ! date ( enactm5t ( ?is     
,act1 & e o!r ye> !reaft]1 ! ,committee 
%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 on--   
7,a7 ! progress ( ,f$]al ag5cies 9      
implem5t+ ! recomm5dations &            
implem5tation plan describ$ 9 subsection
 7b77#c72  7,b7 ,f$]al activities       
und]tak5 to advance ! inclusion (       
pregnant & lactat+ wom5 9 cl9ical       
rese>*2 &  7,c7 additional              
recomm5dations = ! ,secret>y reg>d+     
,f$]al activities to address gaps 9 k & 

rese>* reg>d+ safe & effective !rapies =
 pregnant & lactat+ wom54  7#b7 ,public 
availability ,! ,secret>y %all make !   
reports requir$ by p>agraph 7#a7        
available on a public website ( !       
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7g7 ,supplem5tal report on ,dep>tm5t    
guidance  7#a7 ,9 g5]al ,n lat] ?an #b  
ye>s aft] ! date ( enactm5t ( ?is ,act1 
! ,committee %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 to in=m guidance ( ! ,dep>tm5t ( 
,heal? & ,human ,s]vices to facilitate !
 conduct ( cl9ical rese>* involv+       
pregnant & lactat+ wom54  7#b7 ,cont5ts 
,! report "u p>agraph 7#a7 %all         
include-- 7,a7 in=mation on :i* cl9ical 
/udies require cons5t f bo? biological  
p>5ts1 includ+ in=mation quantify+ h[   
requir+ cons5t f bo? biological p>5ts   
limits p>ticipation 9 su* cl9ical       
/udies2  7,b7 be/ practices &           

recomm5dations = in/itutional review    
bo>ds relat$ to ! inclusion ( pregnant &
 lactat+ wom5 9 cl9ical rese>*1 includ+ 
in=mation on successes & *all5ges ( us+ 
a c5traliz$ in/itutional review bo>d2 & 
7,c7 an evaluation ( /atutory programs  
enact$ to spur p$iatric-specific        
in=mation 9 ,food & ,drug               
,adm9i/ration-approv$ !rapies1 su* z !  
,be/ ,ph>maceuticals = ,*ildr5 ,act     
7,public ,law #ajg-aji7 & ! ,p$iatric   
,rese>* ,equity ,act ( #bjjh 7,public   
,law #ajh-aee71 & h[ approa*es tak5 9   
su* programs c be appli$ to cl9ical     
rese>* includ+ pregnant & lactat+ wom54 
7#c7 ,public availability ,! ,secret>y  
%all make ! report requir$ by p>agraph  
7#a7 available on a public website ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7h7 ,t]m9ation  7#a7 ,9 g5]al ,!        
,committee %all t]m9ate on ! date t is  
#e ye>s aft] ! date on :i* ! ,committee 
is e/abli%$ "u subsection 7a74  7#b7    
,ext5sion ,! ,secret>y may ext5d !      
op]ation ( ! ,committee = up to #c      

additional #b-ye> p]iods foll[+ ! #e-ye>
 p]iod describ$ 9 p>agraph 7#a7 if !    
,secret>y det]m9es t ! ext5sion is      
appropriate to monitor ! implem5tation (
 ! recomm5dations & implem5tation plan  
describ$ 9 subsection 7b77#c7 or any    
additional recomm5dations made by !     
,committee4  #e4 ,rais+ aw>5ess ( rese>*
 t includes pregnant & lactat+ wom5 9   
cl9ical rese>*  7a7 ,9 g5]al ,!         
,secret>y1 act+ ?r\gh ! ,director ( !   
,national ,in/itutes ( ,heal?1 9        
consultation ) ! heads ( o!r relevant   
,f$]al ag5cies1 %all e/abli% & implem5t 
an education campaign design$ to--  7#a7
 educate ! public on ! importance (--   
7,a7 includ+ pregnant & lactat+ wom5 9  
cl9ical rese>* to bett] in=m heal? c>e  
decisions on ! safety & effectiv5ess (  
m$ications = pregnant & lactat+ wom5    
be=e1 dur+1 & aft] pregnancy2  7,b7     
regi/ries & cl9ical trials t include    
pregnant & lactat+ wom52  7#b7 enc\rage 
& facilitate p>ticipation by pregnant & 
lactat+ wom5 9 cl9ical rese>*2  7#c7    

improve ! g5]al und]/&+ ( ! critical    
role regi/ries & o!r po/m>ket           
surveillance activities h 9 collect+    
data relat$ to ! use ( m$ications by    
pregnant & lactat+ wom52  7#d7 improve !
 und]/&+ ( available cl9ical trials &   
regi/ries t enroll pregnant & lactat+   
wom52  7#e7 enc\rage pregnant & lactat+ 
wom5 to seek additional in=mation ab\t  
su* opportunities to p>ticipate 9       
cl9ical rese>*2  7#f7 enc\rage heal? c>e
 provid]s to make in=mation on cl9ical  
rese>* available to pregnant & lactat+  
wom52 &  7#g7 facilitate access to &    
enrollm5t 9 su* rese>* by pregnant &    
lactat+ wom54  7b7 ,consultation ,9     
c>ry+ out ?is section1 ! ,secret>y %all 
consult )--  7#a7 nonpr(it organizations
 ) exp]tise relat$ to ! heal? ( wom5 &  
*ildr51 includ+ ^? 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 *ildr52  7#c7 relevant indu/ry

 repres5tatives2 &  7#d7 o!r            
repres5tatives1 z appropriate4  7c7     
,plann+ ,9 e/abli%+ ! campaign "u       
subsection 7a71 ! ,secret>y1 act+ ?r\gh 
! ,director ( ! ,national ,in/itutes (  
,heal?1 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 be/ practices to rea* ea*  
su* t>get audi5ce2  7#d7 te/ appropriate
 messag+ /rategies1 includ+ risk        
communication messag+1 = ea* t>get      
audi5ce2 &  7#e7 coord9ate ) ! cle>+h\se
 e/abli%$ "u section #c4  7d7           
,au?orization ( appropriations ,to c>ry 
out ?is section1 !re is au?oriz$ to be  
appropriat$ #e1jjj1jjj = ! p]iod (      
fiscal ye>s #bjbc ?r\gh #bjbg4  #f4     
,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 
m$ications prescrib$ = 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$back f-- 7#a7 ! exi/+ rese>*    
networks ( ! ,national ,in/itute ( ,*ild
 ,heal? & ,human ,developm5t ) exp]tise 
9 cl9ical rese>* involv+ pregnant &     
lactat+ wom52  7#b7 relevant m$ical     
societies ) subject matt] exp]tise on   
pregnant wom51 lactat+ wom51 or *ildr52 
&  7#c7 nonpr(it organizations )        
exp]tise relat$ to ! heal? ( pregnant   
wom51 lactat+ wom51 or *ildr51 includ+  
^? repres5t+ populations ) high rates ( 

mat]nal mortality & morbidity4  7d7     
,public comm5t ,! ,secret>y %all provide
 an opportunity = public comm5t on !    
program "u ?is section4  7e7            
,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>s #bjbc
 ?r\gh #bjbg1 ! ,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  7f7        
,au?orization ( appropriations ,to c>ry 
out ?is section1 !re is au?oriz$ to be  
appropriat$ #ej1jjj1jjj = ! p]iod (     
fiscals ye> #bjbc ?r\gh #bjbg4