,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #ebai  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ab1 #bjaf ,ms4  
,h]r]a ,beutl] 7= h]self & ,ms4 ,ca/or (
 ,florida7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to provide = !    
e/abli%m5t ( ! ,task ,=ce on ,rese>*    
,specific to ,pregnant ,wom5 & ,lactat+ 
,wom51 to require an annual report to   
,congress on approv$ new drug           
applications ) in=mation on pregnancy & 
lactation1 & = o!r purposes4  #a4 ,%ort 
title ,?is ,act may be cit$ z ! ,safe   
,m$ications = ,moms & ,babies ,act (    
#bjaf4  #b4 ,task ,=ce on rese>*        
specific to pregnant wom5 & lactat+ wom5
  7a7 ,task =ce  7#a7 ,e/abli%m5t ,n    
lat] ?an #ij days aft] ! date ( enactm5t
 ( ?is ,act1 ! ,secret>y ( ,heal? &     
,human ,s]vices 79 ?is section ref]r$ to
 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$]al
 memb]s ,! ,f$]al memb]s ( ! ,task ,=ce 
%all be compos$ ( ! foll[+ memb]s 7or _!
 designees73  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    
national rese>* in/itutes z ! ,secret>y 
det]m9es appropriate4  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$]al memb]s ,! non-,f$]al memb]s 
( ! ,task ,=ce %all be compos$ ( !      
foll[+ memb]s3 7i7 ,repres5tatives f    
relevant m$ical societies ) subject     
matt] exp]tise on pregnant wom51 lactat+
 wom51 or *ildr54  7ii7 ,nonpr(it       
organizations ) exp]tise relat$ to !    
heal? ( wom5 & *ildr54  7iii7 ,relevant 
indu/ry repres5tatives4  7iv7           
,repres5tatives ( pati5t or consum]     
advocacy organizations4  7v7 ,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 & n lat] ?an #cf & #dh   
mon?s aft] su* date if ! ,secret>y      
ext5ds ! op]ation ( ! ,task ,=ce        
pursuant to p>agraph 7#d77;,b71 ! ,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 on gaps 9 k & rese>* reg>d+ safe 
& effective !rapies = pregnant wom5 &   
lactat+ wom54 ,ea* su* report %all1 at a
 m9imum1 include 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$]al activities1 includ+-- 7i7 ! /ate 
( rese>* involv+ pregnant & lactat+     
wom52  7ii7 recomm5dations = !          
coord9ation (1 & collaboration on1      
rese>* relat$ 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 ( !rapies on pregnant 

wom5 & lactat+ wom5 & relat$ bir? &     
p$iatric outcomes1 includ+ ) respect to 
ph>macok9etics1 ph>macodynamics1 &      
toxicities4  7,e7 ,recomm5dations to    
improve ! developm5t ( safe & effective 
!rapies = pregnant wom5 & lactat+ wom54 
7b7 ,confid5tiality ,no?+ 9 ?is section 
au?orizes ! ,secret>y to disclose any   
in=mation t is a trade secret1 or o!r   
privileg$ 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 & n lat] ?an #c &  
#d ye>s aft] su* date if ! ,secret>y    
ext5ds ! op]ation ( ! ,task ,=ce        
pursuant to subsection 7a77#d77;,b71 !  
,secret>y1 tak+ into consid]ation 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+ f     
p>ticipat+ 9 human subject rese>*       
pregnant wom5 or lactat+ wom5 z a /udy  
population requir+ additional           
protections4  #c4 ,annual report f ,,fda
 on approv$ new drug applications )     
in=mation on pregnancy & lactation ,n   
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 & n less ?an annually = !    
succe$+ #i ye>s1 ! ,commission] ( ,food 
& ,drugs %all submit to ! appropriate   
committees ( ! ,congress a report on--  
7#a7 ! numb] ( new drug applications &  
supplem5ts to su* applications approv$  
or lic5s$ by ! ,food & ,drug            
,adm9i/ration "u section #eje7;c7 ( !   

,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea7;a7 ( ! ,public ,heal?    
,s]vices ,act 7#db ,u4,s4,c4 #bfb7;a77  
bas$ on rese>* t includ$ pregnant wom5  
or lactat+ wom5 9 trials2  7#b7 ! numb] 
( new drug applications & supplem5ts to 
su* applications s approv$ or lic5s$ t  
includ$ data on ! excretion ( ! drug 9  
brea/ milk2  7#c7 ! numb] ( new drug    
applications & supplem5ts to su*        
applications s approv$ or lic5s$ )      
requir$ po/m>ket /udies 9 pregnant or   
brea/fe$+ wom52 &  7#d7 ! numb] ( drugs 
) respect to :i* a label+ *ange is made 
to include new in=mation reg>d+ use 9   
pregnant or brea/fe$+ wom54