,,ii  #aag? ,,congress  #a/ ,session    
,s4 #efb  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #c1 #bjba,mrs4    
,%ahe5 7= h]self1 ,mr4 ,cassidy1 ,mr4   
,b5net1 & ,mr4 ,rubio7 introduc$ !      
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
) respect to citiz5 petitions4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,ensur+ ,timely ,access to ,g5]ics ,act 
( #bjba4  #b4 ,ensur+ timely access to  
g5]ics ,section #eje7q7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7q77 is am5d$-- 7#a7 9    
p>agraph 7#a7-- 7,a7 9 subp>agraph      
7,a77i71 by ins]t+ 1 #aj4ca1 aft]       
#aj4cj2  7,b7 9 subp>agraph 7,e7-- 7i7  
by /rik+ application & & ins]t+         
application or2  7ii7 by /rik+ ,if !    
,secret>y & ins]t+ ! foll[+3  7i7 ,9    
g5]al ,if ! ,secret>y  2 &  7iii7 by    
/rik+ ! second s5t5ce & ins]t+ ! foll[+3
  7ii7 ,prim>y purpose ( delay+  7,i7 ,9

 g5]al ,9 det]m9+ :e!r a petition 0     
submitt$ ) ! prim>y purpose ( delay+ an 
application1 ! ,secret>y may consid] !  
foll[+ factors3 7aa7 ,:e!r ! petition 0 
submitt$ 9 accordance ) p>agraph        
7#b77;,b71 bas$ on :5 ! petition] knew  
or reasonably %\ld h kn[n ! relevant    
in=mation reli$ ^u to =m ! basis ( su*  
petition4  7bb7 ,:e!r ! petition] has   
submitt$ multiple or s]ial petitions or 
supplem5ts to petitions rais+ issues t  
reasonably c\ld h be5 kn[n to !         
petition] at ! "t ( submission ( ! e>li]
 petition or petitions4  7cc7 ,:e!r !   
petition 0 submitt$ close 9 "t to a     
kn[n1 fir/ date ^u :i* an application "u
 subsection 7b77#b7 or 7j7 ( ?is section
 or section #cea7k7 ( ! ,public ,heal?  
,s]vice ,act c\ld be approv$4  7dd7     
,:e!r ! petition 0 submitt$ )\t relevant
 data or in=mation 9 support ( !        
sci5tific positions =m+ ! basis ( su*   
petition4  7ee7 ,:e!r ! petition raises 
! same or sub/antially simil> issues z a
 prior petition to :i* ! ,secret>y has  

respond$ sub/antively already1 includ+  
if ! subsequ5t submission foll[s su*    
response f ! ,secret>y closely 9 "t4    
7ff7 ,:e!r ! petition reque/s *ang+ !   
applicable /&>ds t o!r applicants are   
requir$ to meet1 includ+ reque/+ te/+1  
data1 or label+ /&>ds t are m on]\s or  
rigor\s ?an ! /&>ds ! ,secret>y has     
det]m9$ to be applicable to ! li/$ drug1
 ref]5ce product1 or petition]'s v]sion 
( ! same drug4  7gg7 ,! petition]'s     
record ( submitt+ petitions to ! ,food &
 ,drug ,adm9i/ration t h be5 det]m9$ by 
! ,secret>y to h be5 submitt$ ) ! prim>y
 purpose ( delay4  7hh7 ,o!r relevant & 
appropriate factors1 :i* ! ,secret>y    
%all describe 9 guidance4  7,,ii7       
,guidance ,! ,secret>y may issue or     
update guidance1 z appropriate1 to      
describe factors ! ,secret>y consid]s 9 
accordance ) subclause 7,i74  2  7,c7 by
 add+ at ! end ! foll[+3  7iii7 ,ref]ral
 to ! ,f$]al ,trade ,commission ,!      
,secret>y %all e/abli% proc$ures =      
ref]r+ to ! ,f$]al ,trade ,commission   

any petition or supplem5t to a petition 
t ! ,secret>y det]m9es 0 submitt$ ) !   
prim>y purpose ( delay+ approval ( an   
application4 ,su* proc$ures %all include
 notification to ! petition] by !       
,secret>y4  2  7,d7 by /rik+ subp>agraph
 7,f72  7,e7 by r$esignat+ subp>agraphs 
7,g7 ?r\gh 7,i7 z subp>agraphs 7,f7     
?r\gh 7,h71 respectively2 &  7,f7 9     
subp>agraph 7,h71 z s r$esignat$1 by    
/rik+ submission ( ?is petition & ins]t+
 submission ( ?is docum5t2  7#b7 9      
p>agraph 7#b7-- 7,a7 by r$esignat+      
subp>agraphs 7,a7 ?r\gh 7,c7 z          
subp>agraphs 7,c7 ?r\gh 7,e71           
respectively2  7,b7 by ins]t+ be=e      
subp>agraph 7,c71 z s r$esignat$1 !     
foll[+3  7,a7 ,9 g5]al ,a p]son %all    
submit a petition to ! ,secret>y "u     
p>agraph 7#a7 be=e fil+ a civil action 9
 :i* ! p]son seeks to set aside1 delay1 
resc9d1 )draw1 or prev5t submission1    
review1 or approval ( an application    
submitt$ "u subsection 7b77#b7 or 7j7 ( 
?is section or section #cea7k7 ( !      

,public ,heal? ,s]vice ,act4 ,su*       
petition & any supplem5t to su* a       
petition %all describe all in=mation &  
argum5ts t =m ! basis ( ! relief reque/$
 9 any civil action describ$ 9 ! previ\s
 s5t5ce4  7,b7 ,timely submission (     
citiz5 petition ,a petition & any       
supplem5t to a petition %all be submitt$
 )9 #fj days aft] ! p]son knew1 or      
reasonably %\ld h kn[n1 ! in=mation t   
=ms ! basis ( ! reque/ made 9 ! petition
 or supplem5t4  2  7,c7 9 subp>agraph   
7,c71 z s r$esignat$-- 7i7 9 ! head+1 by
 /rik+ )9 #aej days2  7ii7 9 clause 7i71
 by /rik+ dur+ ! #aej-;day p]iod ref]r$ 
to 9 p>agraph 7#a77;,f712 &  7iii7 by   
am5d+ clause 7ii7 to read z foll[s3     
7ii7 on or aft] ! date t is #aea days   
aft] ! date ( submission ( ! petition1 !
 ,secret>y approves or has approv$ !    
application t is ! subject ( ! petition 
)\t hav+ made su* a f9al decision4  2   
7,d7 by am5d+ subp>agraph 7,d71 z s     
r$esignat$1 to read z foll[s3  7,d7     
,dismissal ( c]ta9 civil actions  7i7   

,petition ,if a p]son files a civil     
action aga9/ ! ,secret>y 9 :i* a p]son  
seeks to set aside1 delay1 resc9d1      
)draw1 or prev5t submission1 review1 or 
approval ( an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( ?is section 
or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act )\t comply+ ) ! requirem5ts
 ( subp>agraph 7,a71 ! c\rt %all dismiss
 )\t prejudice ! action = failure to    
exhau/ adm9i/rative rem$ies4  7ii7      
,timel9ess ,if a p]son files a civil    
action aga9/ ! ,secret>y 9 :i* a p]son  
seeks to set aside1 delay1 resc9d1      
)draw1 or prev5t submission1 review1 or 
approval ( an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( ?is section 
or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act )\t comply+ ) ! requirem5ts
 ( subp>agraph 7,b71 ! c\rt %all dismiss
 ) prejudice ! action = failure to      
timely file a petition4  7iii7 ,f9al    
response ,if a civil action is fil$     
aga9/ ! ,secret>y ) respect to any issue
 rais$ 9 a petition timely fil$ "u      

p>agraph 7#a7 9 :i* ! petition] reque/s 
t ! ,secret>y take any =m ( action t    
c\ld1 if tak51 set aside1 delay1 resc9d1
 )draw1 or prev5t submission1 review1 or
 approval ( an application submitt$ "u  
subsection 7b77#b7 or 7j7 ( ?is section 
or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act be=e ! ,secret>y has tak5  
f9al ag5cy action on ! petition )9 !    
mean+ ( subp>agraph 7,c71 ! c\rt %all   
dismiss )\t prejudice ! action = failure
 to exhau/ adm9i/rative rem$ies4  2 &   
7,e7 9 clause 7iii7 ( subp>agraph 7,e71 
z s r$esignat$1 by /rik+ z def9$ "u     
subp>agraph 7#b77;,a7 & ins]t+ )9 !     
mean+ ( subp>agraph 7,c72 &  7#c7 9     
p>agraph 7#d7-- 7,a7 by /rik+           
,exceptions & all t foll[s ?r\gh ,?is   
subsection does & ins]t+                
,exceptions4--,?is subsection does2     
7,b7 by /rik+ subp>agraph 7,b72 &  7,c7 
by r$esignat+ clauses 7i7 & 7ii7 z      
subp>agraphs 7,a7 & 7,b71 respectively1 
& adju/+ ! m>g9s accord+ly4