,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gfdi  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #c1 #bjbb,mr4    
,joyce ( ,p5nsylvania 7= himself1 ,ms4  
,matsui1 & ,mr4 ,griffi?7 introduc$ !   
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to direct ! ,secret>y ( ,heal? 
& ,human ,s]vices to op5 a public docket
 = ! submission ( public comm5ts reg>d+ 
factors t %\ld be tak5 into consid]ation
 :5 review+ a propos$ modification to an
 approv$ risk evaluation & mitigation   
/rategy1 & = o!r purposes4  #a4 ,public 
docket on propos$ modifications to      
approv$ /rategies  7a7 ,9 g5]al ,n lat] 
?an #ij days aft] ! date ( ! enactm5t ( 
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices %all op5 a public docket = !   
submission ( public comm5ts reg>d+      
factors t %\ld be tak5 into consid]ation
 :5 a propos$ modification to an approv$
 risk evaluation & mitigation /rategy is
 review$ "u section #eje-a7;h7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #bee-a7;h771 includ+     
factors relat$ to pati5t access to !    
drug t is ! subject ( ! /rategy &       
provid] adm9i/ration4 ,! ,secret>y may  
close su* public docket n e>li] ?an #ij 
days aft] su* docket is op5$4  7b7 ,,gao
 report ,n lat] ?an ,decemb] #ca1 #bjbf1
 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 
%all submit to ! ,committee on ,en]gy & 
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
on-- 7#a7 ! numb] ( propos$             
modifications to an approv$ risk        
evaluation & mitigation /rategy !       
,secret>y has grant$ "u section         
#eje-a7;h7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#bee-a7;h772  7#b7 any issues affect+   
pati5t access to ! drug t is ! subject (
 ! /rategy or provid] adm9i/ration t    
arose z a result ( su* modifications2 & 
7#c7 h[ su* issues 7 resolv$1 z         
applicable4