,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #hjch  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #ac1 #bjbb,mr4  
,johnson ( ,s\? ,dakota 7= himself1 ,ms4
 ,spanb]g]1 ,mrs4 ,bice ( ,oklahoma1 &  
,ms4 ,s*ri]7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to au?orize !    
,food & ,drug ,adm9i/ration to require  
manufactur]s ( infant =mula to w>n ab\t 
a discont9uance or int]ruption 9 !      
production ( infant =mula1 & = o!r      
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,=mula ,%ortage ,report+   
,act ( #bjbb4  #b4 ,requirem5t to w>n   
ab\t discont9uance or int]ruption 9 !   
production ( infant =mula  7a7 ,9 g5]al 
,section #dab ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7  
is am5d$ by add+ at ! end ! foll[+3  7j7
 7#a7 ,a manufactur] ( infant =mula %all
 notify ! ,secret>y1 9 accordance )     
p>agraph 7#b71 ( a p]man5t discont9uance
 9 ! manufacture ( ! infant =mula or an 
int]ruption ( ! manufacture ( ! infant  

=mula t is likely to lead to a mean+ful 
disruption 9 ! supply ( t infant =mula 9
 ! ,unit$ ,/ates1 or a p]man5t          
discont9uance 9 ! manufacture ( an      
infant =mula compon5t or an int]ruption 
9 ! manufacture ( an infant =mula       
compon5t t is likely to lead to a       
mean+ful disruption 9 ! supply ( !      
infant =mula compon5t1 & ! reasons = su*
 discont9uance or int]ruption4          
,notification "u ?is subsection %all    
include disclosure (-- 7,a7 reasons = ! 
discont9uance or int]ruption2  7,b7 if  
an infant =mula compon5t is a reason =1 
or a risk factor 91 su* discont9uance or
 int]ruption1 ! s\rce ( ! infant =mula  
compon5t & any alt]native s\rces = !    
infant =mula compon5t kn[n by !         
manufactur]2  7,c7 :e!r any associat$   
device us$ = prep>ation or adm9i/ration 
includ$ 9 ! infant =mula is a reason =1 
or a risk factor 91 su* discont9uance or
 int]ruption2  7,d7 9 ! case ( an       
int]ruption1 ! expect$ duration ( !     
int]ruption2 &  7,e7 su* o!r in=mation z

 ! ,secret>y may require4  7#b7 ,a      
notice requir$ "u p>agraph 7#a7 %all be 
submitt$ to ! ,secret>y-- 7,a7 at lea/  
#gb h\rs prior to ! date ( !            
discont9uance or int]ruption2 or  7,b7  
if compliance ) subp>agraph 7,a7 is n   
possible1 z soon z practicable4  7#c7   
,if a manufactur] ( infant =mula        
det]m9es t compliance ) p>agraph        
7#b77;,a7 is n possible1 ! manufactur]  
%all submit su* det]m9ation 9 writ+ to !
 ,secret>y & ! ju/ification = su*       
det]m9ation4  7#d7 ,to ! maximum ext5t  
practicable1 ! ,secret>y %all di/ribute 
to heal? c>e provid]s :o treat pregnant 
wom5 & *ildr5 "u ! age ( #b1 & make     
publicly available on ! website ( !     
,food & ,drug ,adm9i/ration1 in=mation  
on ! discont9uance or int]ruption ( !   
manufacture ( ! infant =mula describ$ 9 
p>agraph 7#a74  7#e7 ,no?+ 9 ?is        
subsection %all be con/ru$ z au?oriz+ ! 
,secret>y to disclose any in=mation t is
 a trade secret or confid5tial in=mation
 subject to section #eeb7;b77#d7 ( title

 #e1 ,unit$ ,/ates ,code1 or section    
#aije ( title #ah1 ,unit$ ,/ates ,code4 
7#f7 ,! ,secret>y %all f9d a manufactur]
 ( infant =mula to be 9 violation ( ?is 
section if-- 7,a7 ! ,secret>y det]m9es  
t-- 7i7 ! manufactur] has fail$ to      
submit ! notice requir$ by p>agraph 7#b7
 & ! det]m9ation & ju/ification requir$ 
by p>agraph 7#c72 or  7ii7 ! det]m9ation
 & ju/ification submitt$ by !           
manufactur] are insuffici5t2  7,b7 !    
,secret>y issues a lett] to su*         
manufactur]-- 7i7 in=m+ su* manufactur] 
( su* failure or insuffici5cy2 &  7ii7  
giv+ su* manufactur] a p]iod ( n m ?an  
#cj cal5d> days to correct su* failure  
or insuffici5cy2 &  7,c7 ! ,secret>y    
det]m9es su* manufactur] has fail$ to   
correct su* failure or insuffici5cy by !
 end ( su* p]iod4  7#g7 ,= purposes (   
?is subsection-- 7,a7 ! t]m infant =mula
 compon5t means a raw or 9-process      
mat]ial1 +r$i5t1 conta9]1 or closure us$
 9 ! manufactur+ or process+ ( infant   
=mula2  7,b7 ! t]m infant =mula %ortage 

or %ortage1 ) respect to an infant      
=mula1 means a p]iod ( "t :5 ! dem& or  
project$ dem& = ! infant =mula )9 !     
,unit$ ,/ates exce$s ! supply ( ! infant
 =mula2 &  7,c7 ! t]m mean+ful          
disruption-- 7i7 means a *ange 9        
production t is reasonably likely to    
lead to a r$uction 9 ! supply ( an      
infant =mula by a manufactur] t is m ?an
 negligible & affects ! ability ( !     
manufactur] to fill ord]s or meet       
expect$ dem& = its product2 &  7ii7 does
 n include int]ruptions 9 manufactur+   
due to matt]s su* z r\t9e ma9t5ance or  
insignificant *anges 9 manufactur+ s    
long z ! manufactur] expects to resume  
op]ations 9 a %ort p]iod ( "t4  4  7b7  
,prohibit$ act ,section #cja ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca7 is am5d$ by add+ at !   
end ! foll[+3  7fff7 ,! failure by a    
manufactur] ( infant =mula1 ) respect to
 a notice ( discont9uance or            
int]ruption1 to make a correction z     
requir$ by section #dab7;j77#f77;,c74  4