,,ii  #aae? ,,congress  #a/ ,session    
,s4 #ajfb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #d1 #bjag,mr4     
,burr 7= himself & ,mr4 ,"y7 introduc$ !
 foll[+ bill2 :i* 0 read twice & ref]r$ 
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
increase report+ transp>5cy &           
acc\ntability ) respect to ,food & ,drug
 ,adm9i/ration us] fees4  #a4 ,%ort     
title ,?is ,act may be cit$ z ! ,,fda   
,report+ ,transp>5cy & ,acc\ntability   
,act4  #b4 ,/reaml9+ & improv+ consi/5cy
 9 p]=mance report+  7a7 ,,pdufa        
,section #gcf;,b7a7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;h-#b7;a77 is am5d$--  7#a7 9       
p>agraph 7#a77;,b7-- 7,a7 9 ea* (       
clauses 7i71 7ii71 & 7v71 by ins]t+ & ! 
numb] ( complete response lett]s issu$ =
 su* applications be=e ! semicolon2     
7,b7 9 ea* ( clauses 7iii7 & 7iv71 by   
ins]t+ & ! numb] ( complete response    
lett]s issu$ = su* supplem5ts be=e !    
semicolon2  7,c7 9 clause 7vi71 by      

ins]t+ & ! numb] ( designations & d5ials
 issu$ by ! ag5cy = su* applications    
be=e ! semicolon2  7,d7 9 clause 7vii71 
by /rik+ 2 & & ins]t+ & ! numb] (       
designations & d5ials issu$ by ! ag5cy =
 su* applications22 &  7,e7 9 clause    
7viii7 by /rik+ ! p]iod & ins]t+ & !    
numb] ( designations & d5ials issu$ by !
 ag5cy = su* applications22 &  7#b7 by  
ins]t+ aft] p>agraph 7#b7 ! foll[+3     
7#c7 ,real "t report+  7,a7 ,9 g5]al    
,beg9n+ ) fiscal ye> #bjah1 e #cj cal5d>
 days1 ! ,secret>y %all po/ ! data      
describ$ 9 subp>agraph 7,b7 on !        
,int]net website ( ! ,food & ,drug      
,adm9i/ration & remove f su* website    
duplicative data f ! annual p]=mance    
report4  7,b7 ,data ,! foll[+ data is   
requir$ to be po/$ 9 accordance )       
subp>agraph 7,a73 7i7 ,! numb] & titles 
( draft & f9al guidance issu$ by ! ,c5t]
 = ,drug ,evaluation & ,rese>* or !     
,c5t] = ,biologics ,evaluation &        
,rese>*1 & ! ju/ification = ! issuance &
 f9alization ( ea* su* guidance4  7ii7  

,! numb] & titles ( public meet+s held  
by ! ,c5t] = ,drug ,evaluation & ,rese>*
 & ! ,c5t] = ,biologics ,evaluation &   
,rese>* ea* fiscal ye>4  7iii7 ,! li/ ( 
/&>d new drug applications & biologics  
lic5se applications1 by fiscal ye> (    
receipt4  7iv7 ,! numb] ( fil$          
applications by ea* review division4    
7#d7 ,capacity plann+ & improv$ "t      
report+ ,beg9n+ ) fiscal ye> #bjbj1 !   
,secret>y %all include 9 ! annual report
 "u p>agraph 7#a7--  7,a7 ! numb] (     
full-"t equival5ts agre$ ^u & ! numb] ( 
appropriat$ full "t equival5ts at !     
,food & ,drug ,adm9i/ration by ea*      
division )9 ! ,c5t] = ,drug ,evaluation 
& ,rese>*1 ! ,c5t] = ,biologics         
,evaluation & ,rese>*1 ! ,(fice (       
,regulatory ,affairs1 & ! ,(fice ( !    
,commission]2  7,b7 id5tification by "n 
( all "t report+ categories t ,food &   
,drug ,adm9i/ration uses = capacity     
plann+ & "t report+ ) respect to ! ,c5t]
 = ,drug ,evaluation & ,rese>*1 ! ,c5t] 
= ,biologics ,evaluation & ,rese>*1 !   

,(fice ( ,regulatory ,affairs1 & !      
,(fice ( ! ,commission]1 pursuant to !  
res\rce capacity plann+ & mod]niz$ "t   
report+ implem5tation plan2  7,c7 !     
processes by :i* ! ,c5t] = ,drug        
,evaluation & ,rese>*1 ! ,c5t] =        
,biologics ,evaluation & ,rese>*1 !     
,(fice ( ,regulatory ,affairs1 & !      
,(fice ( ! ,commission] require report+ 
on ! am\nt ( an employee's "t t is      
d$icat$ to ! review ( human drug        
applications1 includ+ in=mation reg>d+  
employees d$icat$ to su* activities on a
 full-"t basis1 & employees d$icat$ to  
su* activities on a "p-"t basis2 &  7,d7
 = ea* ( ! ,c5t] = ,drug ,evaluation &  
,rese>*1 ! ,c5t] = ,biologics           
,evaluation & ,rese>*1 ! ,(fice (       
,regulatory ,affairs1 & ! ,(fice ( !    
,commission]1 ! numb] ( employees       
describ$ 9 subp>agraph 7,c7 7bo? full-"t
 equival5ts & employees d$icat$ to su*  
activities on a "p-"t basis7 = :om "t   
report+ is requir$ z describ$ 9         
subp>agraph 7,c71 & ! numb] ( su*       

employees requir$ to e/imate "t d$icat$ 
to ! review ( human drug applications4  
4  7b7 ,,mdufa ,section                 
#gch;,a7a77#a77;,a7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#a7;a77#a77;,a77 is am5d$--  7#a7
 by /rik+ ,beg9n+ ) & ins]t+ ! foll[+3  
7i7 ,g5]al requirem5ts ,beg9n+ )  2 &   
7#b7 by add+ at ! end ! foll[+3  7ii7   
,additional in=mation ,beg9n+ ) fiscal  
ye> #bjah1 ! annual report "u ?is       
subp>agraph %all include ! progress ( ! 
,c5t] = ,devices & ,radiological ,heal? 
9 a*iev+ ! goals1 & future plans = meet+
 ! goals1 includ+1 = ea* review         
division--  7,i7 ! numb] ( prem>ket     
applications fil$ "u section #eae p]    
fiscal ye> = ea* review division1 & !   
numb] ( approvable lett]s1 major        
defici5cy lett]s1 n approvable lett]s1 &
 d5ials = su* applications2  7,,ii7 !   
numb] ( reports fil$ "u section #eaj7k7 
p] fiscal ye> = ea* review division & ! 
numb] ( devices cle>$ or n sub/antially 
equival5t = su* reports2 &  7,,iii7 !   

numb] ( exp$it$ access pa?way           
designations = a fiscal ye> = ea* review
 division & ! numb] ( cle>$ or approv$  
devices or d5ials = su* applications4   
7iii7 ,real "t report+  7,i7 ,9 g5]al   
,beg9n+ ) fiscal ye> #bjah1 ! ,secret>y 
%all1 e #cj cal5d> days1 po/ ! data     
describ$ 9 subclause 7,,ii7 on !        
,int]net website ( ! ,food & ,drug      
,adm9i/ration & remove f su* website    
duplicative data f ! annual report "u   
?is subp>agraph4  7,,ii7 ,data ,! foll[+
 data is requir$ to be po/$ 9 accordance
 ) subclause 7,i73 7aa7 ,! numb] &      
titles ( draft & f9al guidance issu$ by 
! ,c5t] = ,devices & ,radiological      
,heal? & ! ju/ification = ! issuance &  
f9alization ( su* guidance4  7bb7 ,!    
numb] & titles ( public meet+s held by !
 ,c5t] = ,devices & ,radiological ,heal?
 ea* fiscal ye>4  4  7c7 ,,gdufa        
,section #gdd;,c7a7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#dc7;a77 is am5d$-- 7#a7 by /rik+
 ,beg9n+ ) & ins]t+ ! foll[+3  7#a7     

,g5]al requirem5ts ,beg9n+ )  2 &  7#b7 
by add+ at ! end ! foll[+3  7#b7        
,additional in=mation ,beg9n+ ) fiscal  
ye> #bjah1 ! report "u ?is subsection   
%all include ! progress ( ! ,(fice (    
,g5]ic ,drugs 9 a*iev+ ! goals1 & future
 plans = meet+ ! goals1 includ+--  7,a7 
! numb] ( orig9al abbreviat$ new drug   
applications fil$ p] fiscal ye>2  7,b7 !
 numb] ( am5dm5ts to abbreviat$ new drug
 applications fil$ p] fiscal ye>2 &     
7,c7 ! numb] ( actions tak5 del9eat$ by 
! type ( action1 includ+ f9al approvals1
 t5tative approvals1 complete response  
lett]s1 & ! numb] ( refuse to receive   
lett]s issu$ by ! ,food & ,drug         
,adm9i/ration p] fiscal ye>4  7#c7 ,real
 "t report+  7,a7 ,9 g5]al ,beg9n+ )    
fiscal ye> #bjah1 ! ,secret>y %all1 e   
#cj cal5d> days1 po/ ! data describ$ 9  
subp>agraph 7,b7 on ! ,int]net website (
 ! ,food & ,drug ,adm9i/ration & remove 
f su* website duplicative data f !      
annual report "u ?is subsection4  7,b7  
,data ,! foll[+ data is requir$ to be   

po/$ 9 accordance ) subp>agraph 7,a73   
7i7 ,! numb] & titles ( draft & f9al    
guidance issu$ by ! ,(fice ( ,g5]ic     
,drugs & ! ju/ification = ! issuance &  
f9alization ( su* guidance4  7ii7 ,!    
numb] & titles ( public meet+s held by !
 ,(fice ( ,g5]ic ,drugs ea* fiscal ye>4 
4  7d7 ,bs,u,f,a ,section #gdd;,i7a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 is       
am5d$--  7#a7 by /rik+ ,beg9n+ ) &      
ins]t+ ! foll[+3  7#a7 ,g5]al           
requirem5ts ,beg9n+ )  2 &  7#b7 by add+
 at ! end ! foll[+3  7#b7 ,additional   
in=mation ,beg9n+ ) fiscal ye> #bjah1 ! 
report "u ?is subsection %all include ! 
progress ( ! ,c5t] = ,biologics         
,evaluation & ,rese>* 9 a*iev+ ! goals1 
& future plans = meet+ ! goals1         
includ+--  7,a7 in=mation on all previ\s
 cohorts = :i* ! ,secret>y has n giv5 a 
complete response on all biosimil>      
biological product applications &       
supplem5ts 9 ! cohort2  7,b7 ! numb] (  
orig9al biosimil> biological product    

applications fil$ p] fiscal ye>1 & !    
numb] ( approvals or complete response  
lett]s issu$ by ! ag5cy = su*           
applications2 &  7,c7 ! numb] (         
resubmitt$ orig9al biosimil> biological 
product applications fil$ p] fiscal ye> 
& ! numb] ( approvals or complete       
response lett]s issu$ by ! ag5cy = su*  
applications4  7#c7 ,real "t report+    
7,a7 ,9 g5]al ,beg9n+ ) fiscal ye>      
#bjah1 ! ,secret>y %all1 e #cj cal5d>   
days1 po/ ! data describ$ 9 subp>agraph 
7,b7 on ! ,int]net website ( ! ,food &  
,drug ,adm9i/ration & remove f su*      
website duplicative data f ! annual     
report "u ?is subsection4  7,b7 ,data ,!
 foll[+ data is requir$ to be po/$ 9    
accordance ) subp>agraph 7,a73 7i7 ,!   
numb] & titles ( draft & f9al guidance  
issu$ by ! ,c5t] = ,drug ,evaluation &  
,rese>* & ! ,c5t] = ,biologics          
,evaluation & ,rese>* & ! ju/ification =
 ! issuance & f9alization ( su*         
guidance4  7ii7 ,! numb] & titles (     
public meet+s held by ! ,c5t] = ,drug   

,evaluation & ,rese>* & ! ,c5t] =       
,biologic ,evaluation & ,rese>* ea*     
fiscal ye>4  4  7#d7 ,capacity plann+ & 
"t report+ ,beg9n+ ) fiscal ye> #bjbj1 !
 ,secret>y %all include 9 ! annual      
report "u ?is subsection--  7,a7 ! numb]
 ( full-"t equival5ts agre$ ^u & ! numb]
 ( appropriat$ full "t equival5ts at !  
,food & ,drug ,adm9i/ration by ea*      
division )9 ! ,c5t] = ,drug ,evaluation 
& ,rese>*1 ! ,c5t] = ,biologics         
,evaluation & ,rese>*1 ! ,(fice (       
,regulatory ,affairs1 & ! ,(fice ( !    
,commission]2  7,b7 id5tification by "n 
( all "t report+ categories t ! ,food & 
,drug ,adm9i/ration uses = capacity     
plann+ & "t report+ "u ! res\rce        
capacity plann+ & mod]niz$ "t report+   
implem5tation plan = ! ,c5t] = ,drug    
,evaluation & ,rese>*1 ! ,c5t] =        
,biologics ,evaluation & ,rese>*1 !     
,(fice ( ,regulatory ,affairs & ! ,(fice
 ( ! ,commission]2  7,c7 ! process by   
:i* ! ,c5t] = ,drug ,evaluation &       
,rese>*1 ! ,c5t] = ,biologics           

,evaluation & ,rese>*1 ! ,(fice (       
,regulatory ,affairs1 & ! ,(fice ( !    
,commission] require report+ on ! am\nt 
( an employee's "t t is d$icat$ to !    
review ( biosimil> biological product   
applications1 includ+ in=mation reg>d+  
bo? employees d$icat$ to su* activities 
on a full-"t basis1 & employees d$icat$ 
to su* activities on a "p-"t basis2 &   
7,d7 = ea* ( ! ,c5t] = ,drug ,evaluation
 & ,rese>*1 ! ,c5t] = ,biologics        
,evaluation & ,rese>*1 ! ,(fice (       
,regulatory ,affairs1 & ! ,(fice ( !    
,commission]1 ! actual numb] ( employees
 describ$ 9 subp>agraph 7,c7 7bo?       
full-"t equival5ts & employees d$icat$  
to su* activities on a "p-"t basis7 =   
:om "t report+ is requir$ z describ$ 9  
subp>agraph 7,c71 & ! numb] ( su*       
employees requir$ to e/imate "t d$icat$ 
to ! review ( biosimil> biological      
product applications4  4  #c4 ,,fda     
analysis ( use ( funds  7a7 ,,pdufa     
reports  7#a7 ,analysis 9 ,,pdufa       
p]=mance reports ,section #gcf;,b7a7 ( !

 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;h-#b7;a771 z am5d$  
by section #b7;a71 is fur!r am5d$ by    
add+ at ! end ! foll[+3  7#e7 ,analysis 
,= ea* fiscal ye>1 ! ,secret>y %all     
include 9 ! report an analysis ( !      
foll[+3 7,a7 ,! diff]5ce betwe5 ! numb] 
( human drug applications fil$ & ! numb]
 ( approvals or complete response lett]s
 issu$ by ! ag5cy1 acc\nt+ =--  7i7 su* 
applications fil$ dur+ "o fiscal ye> =  
:i* a decision is n s*$ul$ to be made   
until ! foll[+ fiscal ye>2  7ii7 su*    
applications p5d+ ) ! ,c5t] = ,drug     
,evaluation & ,rese>* & ! ,c5t] =       
,biologics ,evaluation & ,rese>* t did n
 meet ! goals = ! correspond+ fiscal ye>
 & ! future plans ( ! ,food & ,drug     
,adm9i/ration to meet ^! goals2 &  7iii7
 ! mo/ common causes )9 ! ag5cy = miss+ 
su* goals4  7,b7 ,relevant data to      
det]m9e :e!r ! ,c5t] = ,drug ,evaluation
 & ,rese>* & ! ,c5t] = ,biologics       
,evaluation & ,rese>* h met p]=mance    
enhancem5t goals = ! correspond+ fiscal 

ye>4  7,c7 ,ext]nal or o!r circum/ances 
impact+ ! ,c5t] = ,drug ,evaluation &   
,rese>*1 ! ,c5t] = ,biologics           
,evaluation & ,rese>*1 or ! ,food &     
,drug ,adm9i/ration1 t impact$ ! ability
 ( ! ag5cy to meet review "t & p]=mance 
enhancem5t goals4  4  7#b7 ,issuance (  
corrective action reports ,section      
#gcf;,b ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7
 is am5d$-- 7,a7 by r$esignat+          
subsections 7c7 & 7d7 z subsections 7e7 
& 7f71 respectively2 &  7,b7 ins]t+ aft]
 subsection 7b7 ! foll[+3  7c7          
,corrective action report ,beg9n+ )     
fiscal ye> #bjah1 & = ea* fiscal ye> =  
:i* fees are collect$ "u ?is "p1 !      
,secret>y %all prep>e & submit a        
corrective action report to ! ,committee
 on ,en]gy & ,comm]ce & ! ,committee on 
,appropriations ( ! ,h\se (             
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions &
 ! ,committee on ,appropriations ( !    
,s5ate ^u submission ( ! p]=mance report

 9 subsection 7a7 = ! correspond+ fiscal
 ye>4 ,! report %all include ! foll[+   
in=mation1 z applicable3  7#a7 ,goals   
met ,= ea* fiscal ye>1 if ! ,secret>y   
det]m9es1 bas$ on ! analysis "u         
subsection 7a77#c71 t ea* ( ! goals = ! 
correspond+ fiscal ye> h be5 met1 !     
corrective action report %all include a 
summ>y ( goals met1 & recomm5dations on 
ways 9 :i* ! ,secret>y c improve &      
/reaml9e ! human drug application review
 process4  7#b7 ,goals miss$ ,= ea* ( ! 
goals = ! correspond+ fiscal ye> t !    
,secret>y det]m9es to n h be5 met1 !    
corrective action report %all include a 
detail$ ju/ification = su* det]m9ation  
&--  7,a7 a detail$ description ( !     
circum/ances "u :i* ea* drug application
 t miss$ ! review goal "t 0 approv$ dur+
 ! fir/ cycle review1 z applicable2     
7,b7 aggregate data on ! circum/ances = 
all unapprov$ drug applications = :i* ! 
review goal "t 0 miss$2 &  7,c7 !       
p]=mance enhancem5t goals t 7 n a*iev$  
dur+ ! previ\s fiscal ye> & a detail$   

description ( ef=ts ! ag5cy has put 9   
place = ! curr5t fiscal ye> to improve !
 ability ( ! ag5cy to meet ea* su* goal1
 :ile ma9ta9+ /&>ds ( approval1 = !     
curr5t fiscal ye>4  7d7 ,enhanc$        
communication  7#a7 ,communications )   
,congress ,ea* fiscal ye>1 z applicable1
 repres5tatives f ! ,c5t] = ,drug       
,evaluation & ,rese>* & ! ,c5t] =       
,biologics ,evaluation & ,rese>* %all   
meet ) repres5tatives f ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives    
reg>d+ ! cont5ts ( ! corrective action  
reports describ$ 9 subsection 7c77#b7 & 
! annual p]=mance reports "u subsection 
7a74  7#b7 ,p>ticipation 9              
,congressional he>+ ,ea* fiscal ye>1 z  
applicable1 repres5tatives f ! ,c5t] =  
,drug ,evaluation & ,rese>* & ! ,c5t] = 
,biologics ,evaluation & ,rese>* %all   
p>ticipate 9 a public he>+ be=e !       
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       

,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 reg>d+ !       
reports "u ?is section4 ,su* he>+ %all  
occur n lat] ?an #abj days aft] ! end ( 
ea* fiscal ye> = :i* fees are collect$  
"u ?is "p4  7#c7 ,publicly available    
updates ,! ,secret>y %all provide an    
update on progress made = ! corrective  
action report dur+ ! foll[+ fiscal ye>  
on ! publicly available ,int]net website
 ( ! ,food & ,drug ,adm9i/ration e #cj  
bus9ess days4  4  7b7 ,,mdufa reports   
7#a7 ,analysis 9 ,,mdufa p]=mance       
reports ,section #gch;,a7a77#a77;,a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 
z am5d$ by section #b7;b71 is fur!r     
am5d$ by add+ at ! end ! foll[+3  7iv7  
,analysis ,= ea* fiscal ye>1 ! ,secret>y
 %all include 9 ! report an analysis ( !
 foll[+3 7,i7 ,! diff]5ce betwe5 ! numb]
 ( prem>ket applications fil$ "u section
 #eae & applications fil$ "u section    
#eaj7k7 & ! numb] ( major defici5cy     
lett]s1 n approvable lett]s1 & d5ials = 

su* applications issu$ by ! ag5cy1      
acc\nt+ =--  7aa7 su* applications fil$ 
dur+ "o fiscal ye> = :i* a decision is n
 s*$ul$ to be made until ! foll[+ fiscal
 ye>2  7bb7 su* applications p5d+ ) !   
,c5t] = ,devices & ,radiological ,heal? 
t did n meet ! goals = ! correspond+    
fiscal ye> & ! future plans ( ! ,food & 
,drug ,adm9i/ration to meet ^! goals2 & 
7cc7 ! mo/ common causes )9 ! ag5cy =   
miss+ su* goals4  7,,ii7 ,relevant data 
to det]m9e :e!r ! ,c5t] ,devices &      
,radiological ,heal? h met p]=mance     
enhancem5t goals = ! correspond+ fiscal 
ye>4  7,,iii7 ,ext]nal or o!r           
circum/ances impact+ ! ,c5t] ,devices & 
,radiological ,heal? or ! ,food & ,drug 
,adm9i/ration t impact$ ! ability ( !   
ag5cy to meet review "t & p]=mance      
enhancem5t goals4  4  7#b7 ,issuance (  
corrective action reports ,section      
#gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;h-#b7;a77 is am5d$--  7,a7 by      
r$esignat+ p>agraphs 7#b7 & 7#c7 z      

p>agraphs 7#d7 & 7#e71 respectively2 &  
7,b7 by ins]t+ aft] p>agraph 7#a7 !     
foll[+3  7#b7 ,corrective action report 
,beg9n+ ) fiscal ye> #bjah1 & = ea*     
fiscal ye> = :i* fees are collect$ "u   
?is "p1 ! ,secret>y %all prep>e & submit
 a corrective action report to !        
,committee on ,en]gy & ,comm]ce & !     
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives & ! ,committee on     
,heal?1 ,education1 ,labor1 & ,p5sions &
 ! ,committee on ,appropriations ( !    
,s5ate ^u submission ( ! p]=mance report
 9 p>agraph 7#a77;,a7 = ! correspond+   
fiscal ye>4 ,! report %all include !    
foll[+ in=mation1 z applicable3  7,a7   
,goals met ,= ea* fiscal ye>1 if !      
,secret>y det]m9es1 bas$ on ! analysis  
"u p>agraph 7#a77;,a77iii71 t ea* ( !   
goals = ! correspond+ fiscal ye> h be5  
met1 ! corrective action report %all    
include a summ>y ( goals met1 &         
recomm5dations on ways 9 :i* ! ,secret>y
 c improve & /reaml9e ! m$ical device   
application review process4  7,b7 ,goals

 miss$ ,= ea* ( ! goals = ! correspond+ 
fiscal ye> t ! ,secret>y det]m9es to n h
 be5 met1 ! corrective action report    
%all include a detail$ ju/ification =   
su* det]m9ation &--  7i7 a detail$      
description ( ! circum/ances "u :i* ea* 
application or report submitt$ "u       
section #eae or section #eaj7k7 miss$ ! 
review goal "t b 0 approv$ dur+ ! fir/  
cycle review1 z applicable2  7ii7       
aggregate data on ! circum/ances = all  
unapprov$ m$ical device applications =  
:i* ! review goal "t 0 miss$2 &  7iii7 !
 p]=mance enhancem5t goals t 7 n a*iev$ 
dur+ ! previ\s fiscal ye> & a detail$   
description ( ef=ts ! ag5cy has put 9   
place = ! curr5t fiscal ye> to improve !
 ability ( ! ag5cy to meet ea* su* goal1
 :ile ma9ta9+ /&>ds ( approval1 = !     
curr5t fiscal ye>4  7#c7 ,enhanc$       
communication  7,a7 ,communications )   
congress ,ea* fiscal ye>1 z applicable1 
repres5tatives f ! ,c5t] = ,devices &   
,radiological ,heal? %all meet )        
repres5tatives f ! ,committee on ,heal?1

 ,education1 ,labor1 & ,p5sions ( !     
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives    
reg>d+ ! cont5ts ( ! corrective action  
reports describ$ 9 p>agraph 7#b7 & !    
annual p]=mance reports "u p>agraph     
7#a74  7,b7 ,p>ticipation 9             
congressional he>+ ,ea* fiscal ye>1 z   
applicable1 repres5tatives f ! ,c5t] =  
,devices & ,radiological ,heal? %all    
p>ticipate 9 a public he>+ be=e !       
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 to report on ! 
cont5ts describ$ 9 ! corrective action  
reports "u p>agraph 7#b74 ,su* he>+ %all
 occur n lat] ?an #abj days aft] ! end (
 ea* fiscal ye> = :i* fees are collect$ 
"u ?is "p4  7,c7 ,publicly available    
updates ,! ,secret>y %all provide an    
update on progress made = ! corrective  
action report dur+ ! foll[+ fiscal ye>  
on ! publicly available ,int]net website
 ( ! ,food & ,drug ,adm9i/ration e #cj  

bus9ess days4  4  7c7 ,,gdufa reports   
7#a7 ,analysis 9 ,,gdufa p]=mance       
reports ,section #gdd;,c7a7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#dc7;a771 z am5d$ by   
section #b7;c7 is fur!r am5d$ by add+ at
 ! end ! foll[+3  7#d7 ,analysis ,= ea* 
fiscal ye>1 ! ,secret>y %all include 9 !
 report an analysis ( ! foll[+3 7,a7 ,! 
diff]5ce betwe5 ! numb] ( abbreviat$ new
 drug applications fil$ & ! numb] (     
approvals or complete response lett]s   
issu$ by ! ag5cy1 acc\nt+ =--  7i7 su*  
applications fil$ dur+ "o fiscal ye> =  
:i* a decision is n s*$ul$ to be made   
until ! foll[+ fiscal ye>2  7ii7 su*    
applications p5d+ ) ! ,(fice ( ,g5]ic   
,drugs t did n meet ! goals = !         
correspond+ fiscal ye> & ! future plans 
( ! ,food & ,drug ,adm9i/ration to meet 
^! goals2 &  7iii7 ! mo/ common causes  
)9 ! ag5cy = miss+ su* goals4  7,b7     
,relevant data to det]m9e :e!r ! ,(fice 
( ,g5]ic ,drugs has met ! p]=mance      
enhancem5t goals = ! correspond+ fiscal 

ye>4  7,c7 ,ext]nal or o!r circum/ances 
impact+ ! ,(fice ( ,g5]ic ,drugs or !   
,food & ,drug ,adm9i/ration t impact$ ! 
ability ( ! ag5cy to meet review "t &   
p]=mance enhancem5t goals4  4  7#b7     
,issuance ( corrective action reports   
,section #gdd;,c ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#dc7 is am5d$-- 7,a7 by          
r$esignat+ subsections 7c7 & 7d7 z      
subsections 7e7 & 7f71 respectively2 &  
7,b7 ins]t+ aft] subsection 7b7 !       
foll[+3  7c7 ,corrective action report  
,beg9n+ ) fiscal ye> #bjah1 & = ea*     
fiscal ye> = :i* fees are collect$ "u   
?is "p1 ! ,secret>y %all prep>e & submit
 a corrective action report to !        
,committee on ,en]gy & ,comm]ce & !     
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives & ! ,committee on     
,heal?1 ,education1 ,labor1 & ,p5sions &
 ! ,committee on ,appropriations ( !    
,s5ate ^u submission ( ! p]=mance report
 9 section #gdd;,c7a7 = ! correspond+   
fiscal ye>4 ,! report %all include !    

foll[+ in=mation1 z applicable3  7#a7   
,goals met ,= ea* fiscal ye>1 if !      
,secret>y det]m9es1 bas$ on ! analysis  
"u subsection 7a77#d71 t ea* ( ! goals =
 ! correspond+ fiscal ye> h be5 met1 !  
corrective action report %all include a 
summ>y ( goals met1 & recomm5dations on 
ways 9 :i* ! ,secret>y c improve &      
/reaml9e ! abbreviat$ new drug          
application review process4  7#b7 ,goals
 miss$ ,= ea* ( ! goals = ! correspond+ 
fiscal ye> t ! ,secret>y det]m9es to n h
 be5 met1 ! corrective action report    
%all include a detail$ ju/ification =   
su* det]m9ation &--  7,a7 a detail$     
description ( ! circum/ances "u :i* ea* 
abbreviat$ new drug application miss$ ! 
review goal "t b 0 approv$ dur+ ! fir/  
cycle review1 z applicable2  7,b7       
aggregate data on ! circum/ances = all  
unapprov$ abbreviat$ new drug           
applications = :i* ! review goal "t 0   
miss$2 &  7,c7 ! p]=mance enhancem5t    
goals t 7 n a*iev$ dur+ ! previ\s fiscal
 ye> & a detail$ description ( ef=ts !  

ag5cy has put 9 place = ! curr5t fiscal 
ye> to improve ! ability ( ! ag5cy to   
meet ea* su* goal = ! curr5t fiscal ye>4
  7d7 ,enhanc$ communication  7#a7      
,communications ) congress ,ea* fiscal  
ye>1 z applicable1 repres5tatives f !   
,(fice ( ,g5]ic ,drugs %all meet )      
repres5tatives f ! ,committee on ,heal?1
 ,education1 ,labor1 & ,p5sions ( !     
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives    
reg>d+ ! cont5ts ( ! corrective action  
reports describ$ 9 subsection 7c77#b7 & 
! annual p]=mance reports "u subsection 
7a74  7#b7 ,p>ticipation 9 congressional
 he>+ ,ea* fiscal ye>1 z applicable1    
repres5tatives f ! ,c5t] = ,drug        
,evaluation & ,rese>* %all p>ticipate 9 
a public he>+ be=e ! ,committee on      
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives1 to
 report on ! cont5ts describ$ 9 !       
reports "u ?is section4 ,su* he>+ %all  
occur n lat] ?an #abj days aft] ! end ( 

ea* fiscal ye> = :i* fees are collect$  
"u ?is "p4  7#c7 ,publicly available    
updates ,! ,secret>y %all provide an    
update on progress made = ! corrective  
action report dur+ ! foll[+ fiscal ye>  
on ! publicly available ,int]net website
 ( ! ,food & ,drug ,adm9i/ration e #cj  
bus9ess days4  4  7d7 ,bs,u,f,a reports 
7#a7 ,analysis 9 ,bs,u,f,a p]=mance     
reports ,section #gdd;,i7a7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ec7;a77 z am5d$ by    
section #b7;d7 is fur!r am5d$ by add+ at
 ! end ! foll[+3  7#e7 ,analysis ,= ea* 
fiscal ye>1 ! ,secret>y %all include 9 !
 report an analysis ( ! foll[+3 7,a7 ,! 
diff]5ce betwe5 ! numb] ( biosimil>     
biological product applications &       
supplem5ts fil$ & ! numb] ( approvals or
 complete response lett]s issu$ by !    
ag5cy1 acc\nt+ =--  7i7 su* applications
 fil$ dur+ "o fiscal ye> = :i* a        
decision is n s*$ul$ to be made until ! 
foll[+ fiscal ye>2  7ii7 su*            
applications p5d+ ) ! ,c5t] = ,drug     

,evaluation & ,rese>* or ! ,c5t] =      
,biologics ,evaluation & ,rese>* t did n
 meet ! goals = ! correspond+ fiscal ye>
 & ! future plans ( ! ,food & ,drug     
,adm9i/ration to meet ^! goals2 &  7iii7
 ! mo/ common causes )9 ! ag5cy = miss+ 
su* goals4  7,b7 ,relevant data to      
det]m9e :e!r ! ,c5t] = ,drug ,evaluation
 & ,rese>* & ! ,c5t] = ,biologics       
,evaluation & ,rese>* h met ! p]=mance  
enhancem5t goals = ! correspond+ fiscal 
ye>4  7,c7 ,ext]nal or o!r circum/ances 
impact+ ! ,c5t] = ,drug ,evaluation &   
,rese>*1 ! ,c5t] = ,biologics           
,evaluation & ,rese>*1 & ! ,food & ,drug
 ,adm9i/ration t impact$ ! ability ( !  
ag5cy to meet review "t & p]=mance      
enhancem5t goals4  4  7#b7 ,issuance (  
corrective action reports ,section      
#gdd;,i ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#ec7 is am5d$-- 7,a7 by          
r$esignat+ subsections 7c71 7d71 & 7e7 z
 subsections 7d71 7e71 & 7f71           
respectively2 &  7,b7 ins]t+ aft]       

subsection 7a7 ! foll[+3  7b7           
,corrective action report ,beg9n+ )     
fiscal ye> #bjah1 & = ea* fiscal ye> =  
:i* fees are collect$ "u ?is "p1 !      
,secret>y %all prep>e & submit a        
corrective action report to ! ,committee
 on ,en]gy & ,comm]ce & ,committee on   
,appropriations ( ! ,h\se (             
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions &
 ,committee on ,appropriations ( !      
,s5ate ^u submission ( ! p]=mance report
 9 section #gdd;,i7a7 = ! correspond+   
fiscal ye>4 ,! report %all include !    
foll[+ in=mation1 z applicable3  7#a7   
,goals met ,= ea* fiscal ye>1 if !      
,secret>y det]m9es1 bas$ on ! analysis  
"u subsection 7a77#e71 t ea* ( ! goals =
 ! correspond+ fiscal ye> h be5 met1 !  
corrective action report %all include a 
summ>y ( goals met1 & recomm5dations on 
ways 9 :i* ! ,secret>y c improve &      
/reaml9e ! biosimil> biological product 
application review process4  7#b7 ,goals
 miss$ ,= ea* ( ! goals = ! correspond+ 

fiscal ye> t ! ,secret>y det]m9es to n h
 be5 met1 ! corrective action report    
%all include a detail$ ju/ification =   
su* det]m9ation &--  7,a7 a detail$     
description ( ! circum/ances "u :i* ea* 
biosimil> biological product application
 miss$ ! review goal "t b 0 approv$ dur+
 ! fir/ cycle review1 z applicable2     
7,b7 aggregate data on ! circum/ances = 
all biosimil> biological product        
applications = :i* ! review goal "t 0   
miss$2 &  7,c7 ! p]=mance enhancem5t    
goals t 7 n a*iev$ dur+ ! previ\s fiscal
 ye> & a detail$ description ( ef=ts !  
ag5cy has put 9 place = ! curr5t fiscal 
ye> to improve ! ability ( ! ag5cy to   
meet ea* su* goal = ! curr5t fiscal ye>4
  7c7 ,enhanc$ communication  7#a7      
,communications ) congress ,ea* fiscal  
ye>1 z applicable1 repres5tatives f !   
,c5t] = ,drug ,evaluation & ,rese>* & ! 
,c5t] = ,biologics ,evaluation & ,rese>*
 %all meet ) repres5tatives f !         
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       

,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives reg>d+ ! cont5ts
 ( ! corrective action reports describ$ 
9 subsection 7b7 & ! annual p]=mance    
reports "u subsection 7a74  7#b7        
,p>ticipation 9 congressional he>+ ,ea* 
fiscal ye>1 z applicable1 repres5tatives
 f ! ,c5t] = ,drug ,evaluation & ,rese>*
 & ! ,c5t] = ,biologics ,evaluation &   
,rese>* %all p>ticipate 9 a public he>+ 
be=e ! ,committee on ,heal?1 ,education1
 ,labor1 & ,p5sions ( ! ,s5ate & !      
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 to report on ! 
cont5ts describ$ 9 ! reports "u ?is     
section4 ,su* he>+ %all occur n lat] ?an
 #abj days aft] ! end ( ea* fiscal ye> =
 :i* fees are collect$ "u ?is "p4  7#c7 
,publicly available updates ,! ,secret>y
 %all provide an update on progress made
 = ! corrective action report dur+ !    
foll[+ fiscal ye> on ! publicly         
available ,int]net website ( ! ,food &  
,drug ,adm9i/ration e #cj bus9ess days4 
4  #d4 ,prohibit+ use ( funds = facility

 ma9t5ance  7a7 ,,pdufa ,section        
#gce7g77;,c7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;g7#g77;,c77 is am5d$ by /rik+      
r5ovation1 & repair ( facilities &      
acquisition1 ma9t5ance1 & repair (      
fixtures1 furniture1 sci5tific equipm5t1
 & o!r necess>y mat]ials & supplies &   
ins]t+ & necess>y sci5tific equipm5t4   
7b7 ,,mdufa ,section #gcg7i77;,c7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;i7#i77 is am5d$ by  
/rik+ r5ovation1 & repair ( facilities &
 acquisition1 ma9t5ance1 & repair (     
fixtures1 furniture1 sci5tific equipm5t1
 & o!r necess>y mat]ials & supplies &   
ins]t+ & necess>y sci5tific equipm5t4   
7c7 ,,gdufa ,section #gdd;,a7#aa77;,c7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgi;j-#da7aa77;,c77 is 
am5d$ by /rik+ r5ovation1 & repair (    
facilities & acquisition1 ma9t5ance1 &  
repair ( fixtures1 furniture1 sci5tific 
equipm5t1 & o!r necess>y mat]ials &     
supplies & ins]t+ & necess>y sci5tific  

equipm5t4  7d7 ,bs,u,f,a ,section       
#gdd;,g7#i77;,c7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#ea7i77;,c77 is am5d$ by /rik+   
r5ovation1 & repair ( facilities &      
acquisition1 ma9t5ance1 & repair (      
fixtures1 furniture1 sci5tific equipm5t1
 & o!r necess>y mat]ials & supplies &   
ins]t+ & necess>y sci5tific equipm5t4   
#e4 ,in=mation on ,,x contract+ ,section
 #gcf;,b7b7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgh;h-#b7;b77 is am5d$-- 7#a7 by /rik+ 
report on ! & ins]t+ 8report on--  7#a7 
!  2  7#b7 by /rik+ ! p]iod at ! end &  
ins]t+ 2 &2 &  7#c7 by add+ at ! end !  
foll[+3  7#b7 ! am\nt ( ! fees collect$ 
t are inve/$ 9 ! in=mation te*nology    
infra/ructure ( ! ,food & ,drug         
,adm9i/ration1 ! entities receiv+       
contracts to develop su* infra/ructure1 
! l5g? ( su* contracts 7includ+         
r5ewals71 & ! progress su* entities h   
made t[>d meet+ ! goals describ$ 9 su*  
contracts4  4