,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #fffj  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #a1 #bjbj,ms4    
,blunt ,ro*e/] 7= h]self & ,mr4 ,c>t] ( 
,georgia7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
require ! hold]s ( approv$ applications 
= drugs to conduct a risk assessm5t to  
id5tify & evaluate risks to _! supply   
*a9 & develop1 ma9ta91 & implem5t risk  
mitigation plans to address su* risks1 &
 = o!r purposes4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,limit ,ongo+      
,%ortages & ,/abilize ,supply ,act (    
#bjbj or ! ,,loss ,act ( #bjbj4  #b4    
,risk assessm5ts & risk mitigation plans
 = drugs  7a7 ,9 g5]al ,! ,f$]al ,food1 
,drug1 & ,cosmetic ,act is am5d$ by     
ins]t+ aft] section #ejf;,c-#a ( su*    
,act 7#ba ,u4,s4,c4 #cef;c-#a7 ! foll[+ 
new section3  #ejf;,c-#b4 ,risk         
assessm5ts & risk mitigation plans =    
drugs  7a7 ,cov]$ drug def9$ ,9 ?is     

section1 ! t]m cov]$ drug-- 7#a7 means a
 drug t-- 7,a7 is describ$ 9 section    
#ejf;,c7a72 or  7,b7 is includ$1 or 0   
includ$ at any po9t dur+ ! prec$+ #e    
ye>s1 9 ! drug %ortage li/ 9 effect "u  
section #ejf;,e2 &  7#b7 includes any   
su* drug t is n requir$ to be approv$   
pursuant to an application "u subsection
 7b7 or 7j7 ( section #eje ( ?is ,act or
 subsection 7a7 or 7k7 ( section #cea ( 
! ,public ,heal? ,s]vice ,act to be     
lawfully m>ket$4  7b7 ,requirem5t ,!    
manufactur] ( a cov]$ drug %all-- 7#a7  
conduct a risk assessm5t t id5tifies &  
evaluates risks to ! supply ( ! drug1   
includ+ vuln]abilities t w\ld likely    
lead to a mean+ful disruption 9 ! supply
 ( ! drug 9 ! ,unit$ ,/ates2  7#b7      
develop & ma9ta9 a risk mitigation plan 
to ensure ! supply ( ! drug dur+ su* a  
%ortage2 &  7#c7 implem5t su* plan dur+ 
su* a %ortage4  7c7 ,confid5tiality ,!  
,secret>y %all-- 7#a7 ma9ta9 !          
confid5tiality ( any risk assessm5t1 &  
any risk mitigation plan1 "u ?is        

section2 &  7#b7 limit ! use by !       
,secret>y ( in=mation 9 su* an assessm5t
 or plan to prev5t+1 mitigat+1 or       
respond+ to a drug %ortage4  7d7        
,guidance ,! ,secret>y %all publi%      
guidance on-- 7#a7 h[ manufactur]s %\ld 
"w ) _! supply *a9 p>tn]s 9 develop+ !  
requir$ risk assessm5ts & risk          
mitigation plans2  7#b7 ! elem5ts ( a   
risk mitigation plan "u ?is section2 &  
7#c7 ! =m & mann] ( develop+ & ma9ta9+  
su* plan4  7e7 ,inspection ,a risk      
mitigation plan "u ?is section %all be  
subject to inspection & copy+ by !      
,secret>y "u section #gjd4  7f7 ,exp$it$
 inspections & reviews ,! ,secret>y may 
conduct an exp$it$ inspection or review 
z describ$ 9 section #ejf;,c7g7 = !     
purpose ( facilitat+ ! implem5tation ( a
 risk managem5t plan develop$ pursuant  
to ?is section4  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 to conduct a risk assessm5t1 

or to develop1 ma9ta91 & implem5t a risk
 mitigation plan1 9 accordance ) section
 #ejf;,c-#b4  4  7c7 ,applicability ,!  
am5dm5ts made by ?is section apply      
beg9n+ on ! date t is #bd mon?s aft] !  
date ( enactm5t ( ?is ,act1 except t !  
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all h discretion to all[ p]sons
 subject to su* am5dm5ts additional "t  
to comply ) su* am5dm5ts z ! ,secret>y  
det]m9es necess>y4  #c4 ,discont9uance  
or int]ruption 9 production  7a7 ,active
 ph>maceutical +r$i5ts  7#a7 ,active    
ph>maceutical +r$i5ts ,section #ejf;,c (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cef;c7 is am5d$ by add+
 at ! end ! foll[+3  7j7 ,applicability 
) respect to active ph>maceutical       
+r$i5ts ,?is section %all apply )       
respect to an active ph>maceutical      
+r$i5t 9 a drug describ$ 9 subsection   
7a7 9 ! same mann] & to ! same ext5t z  
?is section applies ) respect to a drug 
describ$ 9 subsection 7a71 except t     

subsection 7i7 %all n apply ) respect to
 active ph>maceutical +r$i5ts4  4  7#b7 
,guidance  7,a7 ,issuance ,n lat] ?an   
#bd mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all issue f9al guidance
 on implem5t+ ! am5dm5t made by p>agraph
 7#a74  7,b7 ,cont5ts ,! guidance       
requir$ by subp>agraph 7,a7 %all        
specify-- 7i7 ! =m & mann] ( !          
disclosures requir$ by ! am5dm5t made by
 p>agraph 7#a72 &  7ii7 ! details t ne$ 
to be includ$ 9 su* disclosures4  7b7   
,prohibit$ acts ) respect to drugs &    
active ph>maceutical +r$i5ts ,section   
#cja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z  
am5d$ by section #b7;b71 is fur!r am5d$ 
by add+ at ! end ! foll[+3  7ggg7 ,!    
failure ( a manufactur] ( a drug        
describ$ 9 section #ejf;,c7a7 or an     
active ph>maceutical +r$i5t ( su* a     
drug1 )\t a reasonable basis z det]m9$  
by ! ,secret>y1 to notify ! ,secret>y ( 

a p]man5t discont9uance or an           
int]ruption1 & ! reasons = su*          
discont9uance or int]ruption1 z requir$ 
by section #ejf;,c4  4  7c7             
,applicability ,! am5dm5ts made by      
subsections 7a7 & 7b7 apply beg9n+ on ! 
date t is #ahj days aft] ! date (       
enactm5t ( ?is ,act4