,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #dfbf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #ac1 #bjbc,mrs4 
,mill]-,meeks 7= h]self1 ,mrs4 ,kiggans 
( ,virg9ia1 ,ms4 ,gre5e ( ,georgia1     
,mrs4 ,bice1 ,ms4 ,salaz>1 ,mrs4        
,*avez-,de,remer1 ,ms4 ,malliotakis1    
,mrs4 ,kim ( ,cali=nia1 ,mrs4 ,h>%b>g]1 
& ,ms4 ,mace7 introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to enc\rage      
sponsors ( oral contraceptive drugs to  
submit applications = ! approval ( su*  
drugs z ov]-!-c\nt]1 & = o!r purposes4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,orally ,tak5 ,contraception ,act (   
#bjbc or ! ,,otc ,act ( #bjbc4  #b4     
,,fda guidance on *ang+ m>ket+ /atus (  
contraceptive drugs to ov]-!-c\nt]  7a7 
,9 g5]al ,n lat] ?an #a ye> aft] ! date 
( ! enactm5t ( ?is ,act1 ! ,secret>y (  
,heal? & ,human ,s]vices act+ ?r\gh !   
,commission] ( ,food & ,drugs1 =        
purposes ( enc\rag+ sponsors ( oral     
contraceptive drugs to submit           

applications = ! approval ( oral        
contraceptive drugs to be m>ket$ )\t be+
 subject to section #ejc7;b77#a7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec7;b77#a771 %all issue
 guidance t--  7#a7 provides a detail$  
description ( ! review process = !--    
7,a7 approval ( drugs "u section #eje ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee72  7,b7 m>ket+      
au?orization ( ov]-!-c\nt] drugs "u     
section #eje;,g ( su* ,act 7#ba         
,u4,s4,c4 #cee;h72 &  7,c7 lic5sure (   
biological products "u section #cea ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb72  7#b7 provides =       
backgr\nd in=mation on oral             
contraceptive drugs1 includ+-- 7,a7 !   
hi/ory ( approval1 m>ket+ au?orization1 
or lic5sure ( oral contraceptive drugs  
"u ! provisions ( law specifi$ 9        
p>agraph 7#a72  7,b7 ! /&>ds us$ to     
grant su* approval1 m>ket+ au?orization1
 or lic5sure2 &  7#c7 specifies !       
b5efit-risk consid]ations t ! ,secret>y 

uses to det]m9e :e!r to approve1        
au?orize = m>ket+1 or lic5se oral       
contraceptive drugs2 &  7#d7 details !  
,secret>y's ef=ts to facilitate !       
developm5t ( oral contraceptive drugs to
 be m>ket$ )\t be+ subject to section   
#ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cec7;b77#a774  7b7 ,label+ compreh5sion
 /udy  7#a7 ,9 g5]al ,! ,secret>y (     
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
complete a /udy on consum] compreh5sion 
( ! label+ ( oral contraceptive drugs4  
7#b7 ,issues to be /udi$ ,! /udy requir$
 by p>agraph 7#a7 %all address h[ !     
label+ ( oral contraceptive drugs c\ld  
be improv$ to increase consum]          
compreh5sion ( ! in=mation convey$ 9 su*
 label+1 includ+ ! prop] use ( su* drugs
 & = :om su* drugs are indicat$4  7#c7  
,completion2 publication ,! ,secret>y ( 
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all--   
7,a7 n lat] ?an #a ye> aft] ! date ( !  

enactm5t ( ?is ,act1 complete ! /udy    
requir$ by p>agraph 7#a72 &  7,b7 publi%
 ! results ( su* /udy 9 conjunction ) ! 
issuance ( ! guidance requir$ by        
subsection 7a74  7c7 ,oral contraceptive
 drug def9$ ,9 ?is section1 ! t]m oral  
contraceptive drug means a drug 7z def9$
 9 section #bja7;g77#a7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7;g77#a77 t-- 7#a7 is us$ 
to prev5t f]tilization2  7#b7 is        
adm9i/]$ orally2  7#c7 is solely int5d$ 
= r\t9e use & n z an em]g5cy            
contraceptive2  7#d7 does n include any 
drug1 sub/ance1 or comb9ation ( drugs or
 sub/ances us$ aft] f]tilization2 &     
7#e7 does n include any drug or o!r     
me?od us$ to t]m9ate a pregnancy4