,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #cgic  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #e1 #bjbc,ms4   
,slotk9 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
require manufactur]s ( life-sav+ drugs  
to submit data & in=mation to assess !  
/ability ( ! drugs & det]m9e _! longe/  
support$ expiration date1 & = o!r       
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,ensur+ ,access to         
,lifesav+ ,drugs ,act ( #bjbc4  #b4     
,ext5d$ expiration dates = life-sav+    
drugs  7a7 ,9 g5]al ,! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq47 is am5d$ by ins]t+ aft]   
section #ejf,l ( su* ,act 7#ba ,u4,s4,c4
 #cefl7 ! foll[+ new section3  #ejf,m4  
,ext5d$ expiration dates = life-sav+    
drugs  7a7 ,9 g5]al ,a manufactur] ( a  
life-sav+ drug %all-- 7#a7 submit to !  
,secret>y data & in=mation z requir$ by 
subsection 7b77#a72  7#b7 conduct &     

submit ! results1 data1 & in=mation     
g5]at$ by any /udies requir$ "u         
subsection 7b77#b72 &  7#c7 make any    
label+ *ange describ$ 9 subsection 7c7  
by ! date specifi$ by ! ,secret>y       
pursuant to su* subsection4  7b7 ,data &
 in=mation  7#a7 ,9 g5]al ,! ,secret>y  
may issue an ord] requir+ ! manufactur] 
( a life-sav+ drug to submit1 9 su*     
mann] z ! ,secret>y may prescribe1 data 
& in=mation f any /age ( developm5t ( ! 
drug t are adequate to assess ! /ability
 ( ! drug to det]m9e ! longe/ support$  
expiration date4  7#b7 ,lack ( data &   
in=mation ,if ! data & in=mation requir$
 pursuant to an ord] issu$ "u p>agraph  
7#a7 are n available or are insuffici5t1
 z det]m9$ by ! ,secret>y1 ! ,secret>y  
may issue an ord] requir+ ! manufactur] 
( ! drug--  7,a7 to conduct /udies1 :i* 
may be a cont9uation ( ongo+ /udies1 to 
provide data & in=mation adequate to    
assess ! /ability ( ! drug & to det]m9e 
! longe/ support$ expiration date2 &    
7,b7 to submit su* data & in=mation to !

 ,secret>y 9 su* mann] z ! ,secret>y may
 prescribe 9 ! ord]4  7c7 ,label+ ,!    
,secret>y may issue an ord] requir+ !   
manufactur] ( a life-sav+ drug1 by a    
date det]m9$ by ! ,secret>y 9           
consultation ) ! sponsor ( ! drug1 to   
make any label+ *ange reg>d+ !          
expiration date or /orage & h&l+ ( !    
drug t ! ,secret>y det]m9es to be       
appropriate bas$ on ! data & in=mation  
requir$ to be submitt$ "u ?is section or
 any o!r data & in=mation available to !
 ,secret>y4  7d7 ,def9itions ,9 ?is     
section3  7#a7 ,life-sav+ drug ,! t]m   
life-sav+ drug means a drug1 t is-- 7,a7
 7i7 a m$ical c\nt]measure2 or  7ii7 on 
! drug %ortage li/ "u section #ejf;,e or
 det]m9$ by ! ,secret>y to be at risk ( 
%ortage2 &  7,b7 7i7 life-support+2     
7ii7 life-su/a9+2 or  7iii7 int5d$ = use
 9 ! prev5tion or treatm5t ( a          
debilitat+ disease or condition 9 humans
 or animals1 includ+ any su* drug us$ 9 
em]g5cy m$ical c>e or dur+ surg]y or any
 su* drug t is critical to ! public     

heal? dur+ a public heal? em]g5cy decl>$
 by ! ,secret>y "u section #cai ( !     
,public ,heal? ,s]vice ,act4  7#b7      
,m$ical c\nt]measure ,! t]m m$ical      
c\nt]measure means a c\nt]measure z     
def9$ 9 section #efe7;a74  7e7          
,confid5tiality ,no?+ 9 ?is section %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  4  7b7 
,prohibit$ act ,section #cja ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca71 z am5d$ by section     
#cejc7;a77#a77;,a7 ( division ,,ff (    
,public ,law #aag-cbh1 is am5d$ by      
ins]t+ at ! end ! foll[+ new subsection3
  7jjj7 ,! failure to comply ) any ord] 
issu$ "u section #ejf,m4  4  7c7        
,p5alties ,subsection 7b7 ( section #cjc
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #ccc7 is am5d$ by   
ins]t+ at ! end ! foll[+3  7#i7 ,if a   

manufactur] ( a life-sav+ drug fails to 
submit data & in=mation z requir$ "u    
section #ejf,m7b77#a71 fails to conduct 
or submit ! data & in=mation g5]at$ by  
/udies z requir$ "u section             
#ejf,m7b77#b71 or fails to make a label+
 *ange z requir$ "u section #ejf,m7c71  
su* manufactur] %all be subject to a    
civil p5alty ( n m ?an #aj1jjj = ! fir/ 
day on :i* ! violation occurs & n m ?an 
#aj1jjj = ea* subsequ5t day on :i* !    
violation is n correct$4  4