,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #aafi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #aa1 #bjai ,mr4 
,g>dn] 7= himself1 ,mrs4 ,%ahe51 ,mr4   
,cassidy1 & ,mr4 ,b5net7 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 
( #bjai4  #b4 ,citiz5 petitions ,section
 #eje7q77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7q77#a77 is am5d$--  7#a7 9         
subp>agraph 7,e7-- 7,a7 by /rik+ ,if !  
,secret>y & ins]t+ ! foll[+3  7i7 ,9    
g5]al ,if ! ,secret>y  2  7,b7 by /rik+ 
! second s5t5ce & ins]t+ ! foll[+3  7ii7
 ,factors ,9 det]m9+ :e!r a petition 0  
submitt$ ) ! prim>y purpose ( delay+ !  
approval ( an application1 ! ,secret>y  
%all consid]--  7,i7 :e!r x appe>s1 bas$
 on ! date t relevant in=mation reli$ ^u

 9 ! petition became kn[n to ! petition]
 7or reasonably %\ld h be5 kn[n to !    
petition]71 z c]tifi$ by ! petition] 9  
accordance ) subp>agraph 7,h71 t !      
petition] has tak5 an unreasonable l5g? 
( "t to submit ! petition2  7,,ii7 :e!r 
! petition] has submitt$ multiple or    
s]ial petitions rais+ issues t          
reasonably c\ld h be5 kn[n to !         
petition] at ! "t ( submission ( ! e>li]
 petition or petitions2  7,,iii7 :e!r ! 
petition 0 submitt$ close 9 "t to a     
kn[n1 fir/ date ^u :i* an application "u
 subsection 7b77#b7 ( ?is section or    
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act c\ld be approv$2  7,,iv7   
:e!r ! petition 0 submitt$ )\t any data 
or in=mation 9 support ( ! sci5tific    
positions set =? 9 ! petition2  7,v7    
:e!r ! petition raises ! same or        
sub/antially simil> issues z a prior    
petition to :i* ! ,secret>y has respond$
 sub/antively already1 p>ticul>ly if !  
subsequ5t submission foll[s ! e>li]     
response closely 9 "t2  7,,vi7 :e!r !   

petition conc]ns /&>ds = approval ( a   
drug = :i* ! ,secret>y has provid$ an   
opportunity = public input1 su* z draft 
or f9al product-specific guidance       
applicable to ! drug1 & ! petition] has 
n provid$ comm5t o!r ?an ?r\gh !        
petition2  7,,vii7 :e!r ! petition      
reque/s t o!r applicants meet /&>ds =   
te/+1 data1 or label+ = a drug t are m  
on]\s or rigor\s ?an ! /&>ds applicable 
to1 z applicable1 ! li/$ drug1 ref]5ce  
product1 or petition]'s v]sion ( ! same 
drug2  7,,viii7 ! hi/ory ( ! petition] )
 ! ,food & ,drug ,adm9i/ration1 su* z   
:e!r ! petition] has a hi/ory ( submitt+
 petitions t ! ,secret>y has det]m9$ 7  
submitt$ ) ! prim>y purpose ( delay2 &  
7,,ix7 o!r relevant consid]ations1 z !  
,secret>y may describe 9 guidance4  2 & 
7,c7 by add+ at ! end ! foll[+3  7iii7  
,public availability ,! ,secret>y %all  
publi% on ! int]net website ( ! ,food & 
,drug ,adm9i/ration a li/ ( any         
petitions t ! ,secret>y det]m9es 7      
submitt$ = ! prim>y purpose ( delay+ !  

approval ( an application4  7iv7        
,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$ures %all include
 notification to ! petition] & an       
opportunity = ! petition] to respond to 
! ,secret>y prior to ref]ral to ! ,f$]al
 ,trade ,commission4  2 &  7#b7 by add+ 
at ! end ! foll[+3  7,j7 ,timel9e =     
submitt+ petitions ,! ,secret>y may     
e/abli% a "t p]iod aft] ! relevant      
in=mation reli$ ^u 9 a petition became  
kn[n to ! petition] 7or reasonably %\ld 
h be5 kn[n to a petition]71 z c]tifi$ by
 ! petition] 9 accordance ) subp>agraph 
7,h71 & any petition t is submitt$ aft] 
su* "t p]iod has pass$ %all be summ>ily 
d5i$4  4