#aac? ,,congress  #a/ ,session  ,s4 #fbb
  ,,an ,,act  ,to am5d ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act to reau?orize   
us] fee programs relat+ to new animal   
drugs & g5]ic new animal drugs4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,animal ,drug & ,animal ,g5]ic ,drug    
,us] ,fee ,reau?orization ,act ( #bjac4 
#b4 ,table ( cont5ts2 ref]5ces 9 ,act   
7a7 ,table ( cont5ts ,! table ( cont5ts 
( ?is ,act is z foll[s3  ,sec4 #a4 ,%ort
 title4 ,sec4 #b4 ,table ( cont5ts2     
ref]5ces 9 ,act4 ,,title ,i--,fees      
relat+ to animal drugs ,sec4 #aja4 ,%ort
 title2 f9d+4 ,sec4 #ajb4 ,def9itions4  
,sec4 #ajc4 ,au?ority to assess & use   
animal drug fees4 ,sec4 #ajd4           
,reau?orization2 report+ requirem5ts4   
,sec4 #aje4 ,sav+s clause4 ,sec4 #ajf4  
,effective date4 ,sec4 #ajg4 ,sunset    
dates4 ,,title ,,ii--,fees relat+ to    
g5]ic animal drugs ,sec4 #bja4 ,%ort    
title2 f9d+4 ,sec4 #bjb4 ,au?ority to   
assess & use g5]ic new animal drug fees4
 ,sec4 #bjc4 ,reau?orization2 report+   

requirem5ts4 ,sec4 #bjd4 ,sav+s clause4 
,sec4 #bje4 ,effective date4 ,sec4 #bjf4
 ,sunset dates4  7b7 ,ref]5ces 9 ,act   
,except z o!rwise specifi$1 am5dm5ts    
made by ?is ,act to a section or o!r    
provision ( law are am5dm5ts to su*     
section or o!r provision ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq474  ,i ,fees      
relat+ to animal drugs  #aja4 ,%ort     
title2 f9d+  7a7 ,%ort title ,?is title 
may be cit$ z ! ,animal ,drug ,us] ,fee 
,am5dm5ts ( #bjac4  7b7 ,f9d+ ,congress 
f9ds t ! fees au?oriz$ by ! am5dm5ts    
made 9 ?is title w be d$icat$ t[>d      
exp$it+ ! animal drug developm5t process
 & ! review ( new & supplem5tal animal  
drug applications & inve/igational      
animal drug submissions z set =? 9 !    
goals id5tifi$1 = purposes ( "p #d (    
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act1 9 !     
lett]s f ! ,secret>y ( ,heal? & ,human  
,s]vices to ! ,*airman ( ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          

,repres5tatives & ! ,*airman ( !        
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate z set =? 9
 ! ,congressional ,record4  #ajb4       
,def9itions ,section #gci ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#aa7 is am5d$ to read z
 foll[s3  #gci4 ,def9itions ,= purposes 
( ?is "p3  7#a7 ,! t]m animal drug      
application means an application =      
approval ( any new animal drug submitt$ 
"u section #eab7;b77#a74 ,su* t]m does n
 include ei!r a new animal drug         
application submitt$ "u section         
#eab7;b77#b7 or a supplem5tal animal    
drug application4  7#b7 ,! t]m          
supplem5tal animal drug application     
means--  7,a7 a reque/ to ! ,secret>y to
 approve a *ange 9 an animal drug       
application :i* has be5 approv$2 or     
7,b7 a reque/ to ! ,secret>y to approve 
a *ange to an application approv$ "u    
section #eab7;c77#b7 = :i* data )       
respect to safety or effectiv5ess are   
requir$4  7#c7 ,! t]m animal drug       

product means ea* specific /r5g? or     
pot5cy ( a p>ticul> active +r$i5t or    
+r$i5ts 9 f9al dosage =m m>ket$ by a    
p>ticul> manufactur] or di/ributor1 :i* 
is uniquely id5tifi$ by ! label] code & 
product code portions ( ! national drug 
code1 & = :i* an animal drug application
 or a supplem5tal animal drug           
application has be5 approv$4  7#d7 ,!   
t]m animal drug e/abli%m5t means a =eign
 or dome/ic place ( bus9ess :i* is at "o
 g5]al physical location consi/+ ( "o or
 m build+s all ( :i* are )9 #e miles (  
ea* o!r1 at :i* "o or m animal drug     
products are manufactur$ 9 f9al dosage  
=m4  7#e7 ,! t]m inve/igational animal  
drug submission means--  7,a7 ! fil+ ( a
 claim = an inve/igational exemption "u 
section #eab7;j7 = a new animal drug    
int5d$ to be ! subject ( an animal drug 
application or a supplem5tal animal drug
 application2 or  7,b7 ! submission (   
in=mation = ! purpose ( enabl+ !        
,secret>y to evaluate ! safety or       
effectiv5ess ( an animal drug           

application or supplem5tal animal drug  
application 9 ! ev5t ( _! fil+4  7#f7 ,!
 t]m animal drug sponsor means ei!r an  
applicant nam$ 9 an animal drug         
application t has n be5 )drawn by !     
applicant & = :i* approval has n be5    
)drawn by ! ,secret>y1 or a p]son :o has
 submitt$ an inve/igational animal drug 
submission t has n be5 t]m9at$ or       
o!rwise r5d]$ inactive by ! ,secret>y4  
7#g7 ,! t]m f9al dosage =m means1 )     
respect to an animal drug product1 a    
f9i%$ dosage =m :i* is approv$ =        
adm9i/ration to an animal )\t sub/antial
 fur!r manufactur+4 ,su* t]m includes   
animal drug products int5d$ = mix+ 9    
animal fe$s4  7#h7 ,! t]m process = !   
review ( animal drug applications means 
! foll[+ activities ( ! ,secret>y )     
respect to ! review ( animal drug       
applications1 supplem5tal animal drug   
applications1 & inve/igational animal   
drug submissions3  7,a7 ,! activities   
necess>y = ! review ( animal drug       
applications1 supplem5tal animal drug   

applications1 & inve/igational animal   
drug submissions4  7,b7 ,! issuance (   
action lett]s :i* approve animal drug   
applications or supplem5tal animal drug 
applications or :i* set =? 9 detail !   
specific defici5cies 9 animal drug      
applications1 supplem5tal animal drug   
applications1 or inve/igational animal  
drug submissions &1 :]e appropriate1 !  
actions necess>y to place su*           
applications1 supplem5ts or submissions 
9 condition = approval4  7,c7 ,!        
inspection ( animal drug e/abli%m5ts &  
o!r facilities und]tak5 z "p ( !        
,secret>y's review ( p5d+ animal drug   
applications1 supplem5tal animal drug   
applications1 & inve/igational animal   
drug submissions4  7,d7 ,monitor+ (     
rese>* conduct$ 9 connection ) ! review 
( animal drug applications1 supplem5tal 
animal drug applications1 &             
inve/igational animal drug submissions4 
7,e7 ,! developm5t ( regulations &      
policy relat$ to ! review ( animal drug 
applications1 supplem5tal animal drug   

applications1 & inve/igational animal   
drug submissions4  7,f7 ,developm5t (   
/&>ds = products subject to review4     
7,g7 ,meet+s betwe5 ! ag5cy & ! animal  
drug sponsor4  7,h7 ,review ( adv]tis+ &
 label+ prior to approval ( an animal   
drug application or supplem5tal animal  
drug application1 b n aft] su*          
application has be5 approv$4  7#i7 ,!   
t]m co/s ( res\rces allocat$ = ! process
 = ! review ( animal drug applications  
means ! exp5ses 9 connection ) ! process
 = ! review ( animal drug applications  
=--  7,a7 (fic]s & employees ( ! ,food &
 ,drug ,adm9i/ration1 contractors ( !   
,food & ,drug ,adm9i/ration1 advisory   
committees consult$ ) respect to !      
review ( specific animal drug           
applications1 supplem5tal animal drug   
applications1 or inve/igational animal  
drug submissions1 & co/s relat$ to su*  
(fic]s1 employees1 committees1 &        
contractors1 includ+ co/s = travel1     
education1 & recruitm5t & o!r p]sonnel  
activities2  7,b7 managem5t ( in=mation 

& ! acquisition1 ma9t5ance1 & repair (  
comput] res\rces2  7,c7 leas+1          
ma9t5ance1 r5ovation1 & repair (        
facilities & acquisition1 ma9t5ance1 &  
repair ( fixtures1 furniture1 sci5tific 
equipm5t1 & o!r necess>y mat]ials &     
supplies2 &  7,d7 collect+ fees "u      
section #gdj & acc\nt+ = res\rces       
allocat$ = ! review ( animal drug       
applications1 supplem5tal animal drug   
applications1 & inve/igational animal   
drug submissions4  7#aj7 ,! t]m adju/m5t
 factor applicable to a fiscal ye> ref]s
 to ! =mula set =? 9 section #gce7h7 ) !
 base or comp>ator mon? be+ ,octob]     
#bjjb4  7#aa7 ,! t]m p]son includes an  
affiliate !re(4  7#ab7 ,! t]m affiliate 
ref]s to ! def9ition set =? 9 section   
#gce7aa74  4  #ajc4 ,au?ority to assess 
& use animal drug fees ,section #gdj ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;j-#ab7 is am5d$ to  
read z foll[s3  #gdj4 ,au?ority to      
assess & use animal drug fees  7a7      
,types ( fees ,beg9n+ 9 fiscal ye>      

#bjjd1 ! ,secret>y %all assess & collect
 fees 9 accordance ) ?is section z      
foll[s3  7#a7 ,animal drug application &
 supplem5t fee  7,a7 ,9 g5]al ,ea* p]son
 t submits1 on or aft] ,septemb] #a1    
#bjjc1 an animal drug application or a  
supplem5tal animal drug application %all
 be subject to a fee z foll[s3  7i7 ,a  
fee e/abli%$ 9 subsection 7c7 = an      
animal drug application1 except an      
animal drug application subject to !    
crit]ia set =? 9 section #eab7;d77#d74  
7ii7 ,a fee e/abli%$ 9 subsection 7c71 9
 an am\nt t is equal to #ej p]c5t ( !   
am\nt ( ! fee "u clause 7i71 =--  7,i7 a
 supplem5tal animal drug application =  
:i* safety or effectiv5ess data are     
requir$2 &  7,,ii7 an animal drug       
application subject to ! crit]ia set =? 
9 section #eab7;d77#d74  7,b7 ,paym5t ,!
 fee requir$ by subp>agraph 7,a7 %all be
 due ^u submission ( ! animal drug      
application or supplem5tal animal drug  
application4  7,c7 ,exception =         
previ\sly fil$ application or supplem5t 

,if an animal drug application or a     
supplem5tal animal drug application 0   
submitt$ by a p]son t paid ! fee = su*  
application or supplem5t1 0 accept$ =   
fil+1 & 0 n approv$ or 0 )drawn 7)\t a  
waiv] or refund71 ! submission ( an     
animal drug application or a supplem5tal
 animal drug application = ! same       
product by ! same p]son 7or ! p]son's   
lic5see1 assignee1 or successor7 %all n 
be subject to a fee "u subp>agraph 7,a74
  7,d7 ,refund ( fee if application     
refus$ = fil+ ,! ,secret>y %all refund  
#ge p]c5t ( ! fee paid "u subp>agraph   
7,b7 = any animal drug application or   
supplem5tal animal drug application :i* 
is refus$ = fil+4  7,e7 ,refund ( fee if
 application )drawn ,if an animal drug  
application or a supplem5tal animal drug
 application is )drawn aft] !           
application or supplem5t 0 fil$1 !      
,secret>y may refund ! fee or portion ( 
! fee paid "u subp>agraph 7,b7 if no    
sub/antial "w 0 p]=m$ on ! application  
or supplem5t aft] ! application or      

supplem5t 0 fil$4 ,! ,secret>y %all h ! 
sole discretion to refund ! fee "u ?is  
p>agraph4 ,a det]m9ation by ! ,secret>y 
conc]n+ a refund "u ?is p>agraph %all n 
be reviewable4  7#b7 ,animal drug       
product fee  7,a7 ,9 g5]al ,ea* p]son-- 
7i7 :o is nam$ z ! applicant 9 an animal
 drug application or supplem5tal animal 
drug application = an animal drug       
product :i* has be5 submitt$ = li/+ "u  
section #eaj2 &  7ii7 :o1 aft] ,septemb]
 #a1 #bjjc1 _h p5d+ be=e ! ,secret>y an 
animal drug application or supplem5tal  
animal drug application1  %all pay = ea*
 su* animal drug product ! annual fee   
e/abli%$ 9 subsection 7c74  7,b7        
,paym5t2 fee due date ,su* fee %all be  
payable = ! fiscal ye> 9 :i* ! animal   
drug product is fir/ submitt$ = li/+ "u 
section #eaj1 or is submitt$ = reli/+ "u
 section #eaj if ! animal drug product  
has be5 )drawn f li/+ & reli/$4 ,aft]   
su* fee is paid = t fiscal ye>1 su* fee 
%all be due ea* subsequ5t fiscal ye> t !
 product rema9s li/$1 ^u ! lat] (--  7i7

 ! fir/ bus9ess day aft] ! date (       
enactm5t ( an appropriations ,act       
provid+ = ! collection & obligation (   
fees = su* fiscal ye> "u ?is section2 or
  7ii7 ,janu>y #ca ( ea* ye>4  7,c7     
,limitation ,su* fee %all be paid only  
once = ea* animal drug product = a      
fiscal ye> 9 :i* ! fee is payable4  7#c7
 ,animal drug e/abli%m5t fee  7,a7 ,9   
g5]al ,ea* p]son--  7i7 :o owns or      
op]ates1 directly or ?r\gh an affiliate1
 an animal drug e/abli%m5t2  7ii7 :o is 
nam$ z ! applicant 9 an animal drug     
application or supplem5tal animal drug  
application = an animal drug product :i*
 has be5 submitt$ = li/+ "u section     
#eaj2 &  7iii7 :o1 aft] ,septemb] #a1   
#bjjc1 _h p5d+ be=e ! ,secret>y an      
animal drug application or supplem5tal  
animal drug application1  %all be       
assess$ an annual e/abli%m5t fee z      
e/abli%$ 9 subsection 7c7 = ea* animal  
drug e/abli%m5t li/$ 9 its approv$      
animal drug application z an e/abli%m5t 
t manufactures ! animal drug product    

nam$ 9 ! application4  7,b7 ,paym5t2 fee
 due date ,! annual e/abli%m5t fee %all 
be assess$ 9 ea* fiscal ye> 9 :i* !     
animal drug product nam$ 9 ! application
 is assess$ a fee "u p>agraph 7#b7      
unless ! animal drug e/abli%m5t li/$ 9 !
 application does n engage 9 !          
manufacture ( ! animal drug product dur+
 ! fiscal ye>4 ,! fee "u ?is p>agraph = 
a fiscal ye> %all be due ^u ! lat] (--  
7i7 ! fir/ bus9ess day aft] ! date (    
enactm5t ( an appropriations ,act       
provid+ = ! collection & obligation (   
fees = su* fiscal ye> "u ?is section2 or
  7ii7 ,janu>y #ca ( ea* ye>4  7,c7     
,limitation  7i7 ,9 g5]al ,an e/abli%m5t
 %all be assess$ only "o fee p] fiscal  
ye> "u ?is section1 subject to clause   
7ii74  7ii7 ,c]ta9 manufactur]s ,if a   
s+le e/abli%m5t manufactures bo? animal 
drug products & prescription drug       
products1 z def9$ 9 section #gce7c71 su*
 e/abli%m5t %all be assess$ bo? ! animal
 drug e/abli%m5t fee & ! prescription   
drug e/abli%m5t fee1 z set =? 9 section 

#gcf7;a77#b71 )9 a s+le fiscal ye>4     
7#d7 ,animal drug sponsor fee  7,a7 ,9  
g5]al ,ea* p]son--  7i7 :o meets !      
def9ition ( an animal drug sponsor )9 a 
fiscal ye>2 &  7ii7 :o1 aft] ,septemb]  
#a1 #bjjc1 _h p5d+ be=e ! ,secret>y an  
animal drug application1 a supplem5tal  
animal drug application1 or an          
inve/igational animal drug submission1  
%all be assess$ an annual sponsor fee z 
e/abli%$ "u subsection 7c74  7,b7       
,paym5t2 fee due date ,! fee "u ?is     
p>agraph = a fiscal ye> %all be due ^u !
 lat] (--  7i7 ! fir/ bus9ess day aft] !
 date ( enactm5t ( an appropriations    
,act provid+ = ! collection & obligation
 ( fees = su* fiscal ye> "u ?is section2
 or  7ii7 ,janu>y #ca ( ea* ye>4  7,c7  
,limitation ,ea* animal drug sponsor    
%all pay only "o su* fee ea* fiscal ye>4
  7b7 ,fee rev5ue am\nts  7#a7 ,9 g5]al 
,subject to subsections 7c71 7d71 7f71 &
 7g7--  7,a7 = fiscal ye> #bjad1 ! fees 
requir$ "u subsection 7a7 %all be       
e/abli%$ to g5]ate a total rev5ue am\nt 

( #bc1fjj1jjj2 &  7,b7 = ea* ( fiscal   
ye>s #bjae ?r\gh #bjah1 ! fees requir$  
"u subsection 7a7 %all be e/abli%$ to   
g5]ate a total rev5ue am\nt (           
#ba1fjj1jjj4  7#b7 ,types ( fees ,( !   
total rev5ue am\nt det]m9$ = a fiscal   
ye> "u p>agraph 7#a7--  7,a7 #bj p]c5t  
%all be d]iv$ f fees "u subsection      
7a77#a7 7relat+ to animal drug          
applications & supplem5ts72  7,b7 #bg   
p]c5t %all be d]iv$ f fees "u subsection
 7a77#b7 7relat+ to animal drug         
products72  7,c7 #bf p]c5t %all be d]iv$
 f fees "u subsection 7a77#c7 7relat+ to
 animal drug e/abli%m5ts72 &  7,d7 #bg  
p]c5t %all be d]iv$ f fees "u subsection
 7a77#d7 7relat+ to animal drug         
sponsors74  7c7 ,annual fee sett+2      
adju/m5ts  7#a7 ,annual fee sett+ ,!    
,secret>y %all e/abli%1 #fj days be=e ! 
/>t ( ea* fiscal ye> beg9n+ aft]        
,septemb] #cj1 #bjjc1 = t fiscal ye>1   
animal drug application fees1           
supplem5tal animal drug application     
fees1 animal drug sponsor fees1 animal  

drug e/abli%m5t fees1 & animal drug     
product fees bas$ on ! rev5ue am\nts    
e/abli%$ "u subsection 7b7 & ! adju/m5ts
 provid$ "u ?is subsection4  7#b7       
,inflation adju/m5t ,= fiscal ye> #bjae 
& subsequ5t fiscal ye>s1 ! rev5ue am\nts
 e/abli%$ 9 subsection 7b7 %all be      
adju/$ by ! ,secret>y by notice1 publi%$
 9 ! ,f$]al ,regi/]1 = a fiscal ye>1 by 
an am\nt equal to ! sum (--  7,a7 "o2   
7,b7 ! av]age annual p]c5t *ange 9 !    
co/1 p] full-"t equival5t position ( !  
,food & ,drug ,adm9i/ration1 ( all      
p]sonnel comp5sation & b5efits paid )   
respect to su* positions = ! fir/ #c ( !
 prec$+ #d fiscal ye>s = :i* data are   
available1 multipli$ by ! av]age        
proportion ( p]sonnel comp5sation &     
b5efits co/s to total ,food & ,drug     
,adm9i/ration co/s = ! fir/ #c ye>s ( ! 
prec$+ #d fiscal ye>s = :i* data are    
available2 &  7,c7 ! av]age annual p]c5t
 *ange t occurr$ 9 ! ,consum] ,price    
,index = urban consum]s                 
7,wa%+ton-,baltimore1                   

,,dc-,,md-,,va-,,wv2 n seasonally       
adju/$2 all items less food & en]gy2    
annual index7 = ! fir/ #c ye>s ( !      
prec$+ #d ye>s = :i* data are available 
multipli$ by ! av]age proportion ( all  
co/s o!r ?an p]sonnel comp5sation &     
b5efits co/s to total ,food & ,drug     
,adm9i/ration co/s = ! fir/ #c ye>s ( ! 
prec$+ #d fiscal ye>s = :i* data are    
available4  ,! adju/m5t made ea* fiscal 
ye> "u ?is p>agraph %all be add$ on a   
comp\nd$ basis to ! sum ( all adju/m5ts 
made ea* fiscal ye> aft] fiscal ye>     
#bjad "u ?is p>agraph4  7#c7 ,workload  
adju/m5t ,= fiscal ye> #bjae & subsequ5t
 fiscal ye>s1 aft] ! rev5ue am\nts      
e/abli%$ 9 subsection 7b7 are adju/$ =  
inflation 9 accordance ) p>agraph 7#b71 
! rev5ue am\nts %all be fur!r adju/$ =  
su* fiscal ye> to reflect *anges 9 !    
workload ( ! ,secret>y = ! process = !  
review ( animal drug applications4 ,)   
respect to su* adju/m5t--  7,a7 su*     
adju/m5t %all be det]m9$ by ! ,secret>y 
bas$ on a weight$ av]age ( ! *ange 9 !  

total numb] ( animal drug applications1 
supplem5tal animal drug applications =  
:i* data ) respect to safety or         
effectiv5ess are requir$1 manufactur+   
supplem5tal animal drug applications1   
inve/igational animal drug /udy         
submissions1 & inve/igational animal    
drug protocol submissions submitt$ to ! 
,secret>y2  7,b7 ! ,secret>y %all publi%
 9 ! ,f$]al ,regi/] ! fees result+ f su*
 adju/m5t & ! support+ me?odologies2 &  
7,c7 "u no circum/ances %all su*        
adju/m5t result 9 fee rev5ues = a fiscal
 ye> t are less ?an ! fee rev5ues = t   
fiscal ye> e/abli%$ 9 subsection 7b71 z 
adju/$ = inflation "u p>agraph 7#b74    
7#d7 ,f9al ye> adju/m5t ,= fiscal ye>   
#bjah1 ! ,secret>y may1 9 addition to   
o!r adju/m5ts "u ?is subsection1 fur!r  
increase ! fees "u ?is section1 if su*  
an adju/m5t is necess>y1 to provide = up
 to #c mon?s ( op]at+ res]ves ( c>ryov] 
us] fees = ! process = ! review ( animal
 drug applications = ! fir/ #c mon?s (  
fiscal ye> #bjai4 ,if ! ,food & ,drug   

,adm9i/ration has c>ryov] balances = !  
process = ! review ( animal drug        
applications 9 excess ( #c mon?s ( su*  
op]at+ res]ves1 !n ?is adju/m5t w n be  
made4 ,if ?is adju/m5t is necess>y1 !n !
 rationale = ! am\nt ( ! increase %all  
be conta9$ 9 ! annual notice sett+ fees 
= fiscal ye> #bjah4  7#e7 ,limit ,!     
total am\nt ( fees *>g$1 z adju/$ "u ?is
 subsection1 = a fiscal ye> may n exce$ 
! total co/s = su* fiscal ye> = !       
res\rces allocat$ = ! process = ! review
 ( animal drug applications4  7d7 ,fee  
waiv] or r$uction  7#a7 ,9 g5]al ,!     
,secret>y %all grant a waiv] f or a     
r$uction ( "o or m fees assess$ "u      
subsection 7a7 :]e ! ,secret>y f9ds t-- 
7,a7 ! assessm5t ( ! fee w\ld pres5t a  
significant b>ri] to innovation because 
( limit$ res\rces available to su* p]son
 or o!r circum/ances2  7,b7 ! fees to be
 paid by su* p]son w exce$ ! anticipat$ 
pres5t & future co/s incurr$ by !       
,secret>y 9 conduct+ ! process = !      
review ( animal drug applications = su* 

p]son2  7,c7 ! animal drug application  
or supplem5tal animal drug application  
is int5d$ solely to provide = use ( !   
animal drug 9--  7i7 a ,type ,b m$icat$ 
fe$ 7z def9$ 9 section #eeh4c7;b77#c7 ( 
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulation77 int5d$ = 
use 9 ! manufacture ( ,type ,c          
free-*oice m$icat$ fe$s2 or  7ii7 a     
,type ,c free-*oice m$icat$ fe$ 7z def9$
 9 section #eeh4c7;b77#d7 ( title #ba1  
,code ( ,f$]al ,regulations 7or any     
successor regulation772  7,d7 ! animal  
drug application or supplem5tal animal  
drug application is int5d$ solely to    
provide = a m9or use or m9or species    
indication2 or  7,e7 ! sponsor involv$  
is a small bus9ess submitt+ its fir/    
animal drug application to ! ,secret>y =
 review4  7#b7 ,use ( /&>d co/s ,9 mak+ 
! f9d+ 9 p>agraph 7#a77;,b71 ! ,secret>y
 may use /&>d co/s4  7#c7 ,rules = small
 bus9esses  7,a7 ,def9ition ,9 p>agraph 
7#a77;,e71 ! t]m small bus9ess means an 
entity t has few] ?an #ejj employees1   

includ+ employees ( affiliates4  7,b7   
,waiv] ( application fee ,! ,secret>y   
%all waive "u p>agraph 7#a77;,e7 !      
application fee = ! fir/ animal drug    
application t a small bus9ess or its    
affiliate submits to ! ,secret>y =      
review4 ,aft] a small bus9ess or its    
affiliate is grant$ su* a waiv]1 ! small
 bus9ess or its affiliate %all pay      
application fees = all subsequ5t animal 
drug applications & supplem5tal animal  
drug applications = :i* safety or       
effectiv5ess data are requir$ 9 ! same  
mann] z an entity t does n qualify z a  
small bus9ess4  7,c7 ,c]tification ,!   
,secret>y %all require any p]son :o     
applies = a waiv] "u p>agraph 7#a77;,e7 
to c]tify _! qualification = ! waiv]4 ,!
 ,secret>y %all p]iodically publi% 9 !  
,f$]al ,regi/] a li/ ( p]sons mak+ su*  
c]tifications4  7e7 ,effect ( failure   
,to pay fees ,an animal drug application
 or supplem5tal animal drug application 
submitt$ by a p]son subject to fees "u  
subsection 7a7 %all be consid]$         

incomplete & %all n be accept$ = fil+ by
 ! ,secret>y until all fees ow$ by su*  
p]son h be5 paid4 ,an inve/igational    
animal drug submission "u section       
#gci7e77;,b7 t is submitt$ by a p]son   
subject to fees "u subsection 7a7 %all  
be consid]$ incomplete & %all n be      
accept$ = review by ! ,secret>y until   
all fees ow$ by su* p]son h be5 paid4 ,!
 ,secret>y may discont9ue review ( any  
animal drug application1 supplem5tal    
animal drug application or              
inve/igational animal drug submission f 
a p]son if su* p]son has n submitt$ =   
paym5t all fees ow$ "u ?is section by   
#cj days aft] ! date ^u :i* !y are due4 
7f7 ,assessm5t ( fees  7#a7 ,limitation 
,fees may n be assess$ "u subsection 7a7
 = a fiscal ye> beg9n+ aft] fiscal ye>  
#bjjc unless appropriations = sal>ies & 
exp5ses ( ! ,food & ,drug ,adm9i/ration 
= su* fiscal ye> 7exclud+ ! am\nt ( fees
 appropriat$ = su* fiscal ye>7 are equal
 to or great] ?an ! am\nt (             
appropriations = ! sal>ies & exp5ses ( !

 ,food & ,drug ,adm9i/ration = ! fiscal 
ye> #bjjc 7exclud+ ! am\nt ( fees       
appropriat$ = su* fiscal ye>7 multipli$ 
by ! adju/m5t factor applicable to !    
fiscal ye> involv$4  7#b7 ,au?ority ,if 
! ,secret>y does n assess fees "u       
subsection 7a7 dur+ any portion ( a     
fiscal ye> because ( p>agraph 7#a7 & if 
at a lat] date 9 su* fiscal ye> !       
,secret>y may assess su* fees1 !        
,secret>y may assess & collect su* fees1
 )\t any modification 9 ! rate1 = animal
 drug applications1 supplem5tal animal  
drug applications1 inve/igational animal
 drug submissions1 animal drug sponsors1
 animal drug e/abli%m5ts & animal drug  
products at any "t 9 su* fiscal ye>     
not)/&+ ! provisions ( subsection 7a7   
relat+ to ! date fees are to be paid4   
7g7 ,cr$it+ & availability ( fees  7#a7 
,9 g5]al ,subject to p>agraph 7#b77;,c71
 fees au?oriz$ "u subsection 7a7 %all be
 collect$ & available = obligation only 
to ! ext5t & 9 ! am\nt provid$ 9 advance
 9 appropriations ,acts4 ,su* fees are  

au?oriz$ to be appropriat$ to rema9     
available until exp5d$4 ,su* sums z may 
be necess>y may be transf]r$ f ! ,food &
 ,drug ,adm9i/ration sal>ies & exp5ses  
appropriation acc\nt )\t fiscal ye>     
limitation to su* appropriation acc\nt =
 sal>y & exp5ses ) su* fiscal ye>       
limitation4 ,! sums transf]r$ %all be   
available solely = ! process = ! review 
( animal drug applications4  7#b7       
,collections & appropriation acts  7,a7 
,9 g5]al ,! fees au?oriz$ by ?is        
section--  7i7 subject to subp>agraph   
7,c71 %all be collect$ & available 9 ea*
 fiscal ye> 9 an am\nt n to exce$ !     
am\nt specifi$ 9 appropriation ,acts1 or
 o!rwise made available = obligation =  
su* fiscal ye>1 &  7ii7 %all be         
available to defray increases 9 ! co/s (
 ! res\rces allocat$ = ! process = !    
review ( animal drug applications       
7includ+ increases 9 su* co/s = an      
additional numb] ( full-"t equival5t    
positions 9 ! ,dep>tm5t ( ,heal? &      
,human ,s]vices to be engag$ 9 su*      

process7 ov] su* co/s1 exclud+ co/s paid
 f fees collect$ "u ?is section1 =      
fiscal ye> #bjjc multipli$ by ! adju/m5t
 factor4  7,b7 ,compliance ,! ,secret>y 
%all be consid]$ to h met ! requirem5ts 
( subp>agraph 7,a77ii7 9 any fiscal ye> 
if ! co/s fund$ by appropriations &     
allocat$ = ! process = ! review ( animal
 drug applications--  7i7 are n m ?an #c
 p]c5t bel[ ! level specifi$ 9          
subp>agraph 7,a77ii72 or  7ii7 7,i7 are 
m ?an #c p]c5t bel[ ! level specifi$ 9  
subp>agraph 7,a77ii71 & fees assess$ = !
 fiscal ye> foll[+ ! subsequ5t fiscal   
ye> are decreas$ by ! am\nt 9 excess (  
#c p]c5t by :i* su* co/s fell bel[ !    
level specifi$ 9 subp>agraph 7,a77ii72 &
  7,,ii7 su* co/s are n m ?an #e p]c5t  
bel[ ! level specifi$ 9 subp>agraph     
7,a77ii74  7,c7 ,provision = e>ly       
paym5ts ,paym5t ( fees au?oriz$ "u ?is  
section = a fiscal ye>1 prior to ! due  
date = su* fees1 may be accept$ by !    
,secret>y 9 accordance ) au?ority       
provid$ 9 advance 9 a prior ye>         

appropriations ,act4  7#c7 ,au?orization
 ( appropriations ,= ea* ( ! fiscal ye>s
 #bjad ?r\gh #bjah1 !re is au?oriz$ to  
be appropriat$ = fees "u ?is section an 
am\nt equal to ! total rev5ue am\nt     
det]m9$ "u subsection 7b7 = ! fiscal    
ye>1 z adju/$ or o!rwise affect$ "u     
subsection 7c7 & p>agraph 7#d74  7#d7   
,(fset ( ov]collections2 recov]y (      
collection %ortfalls  7,a7 ,(fset (     
ov]collections ,if ! sum ( ! cumulative 
am\nt ( fees collect$ "u ?is section =  
fiscal ye>s #bjad ?r\gh #bjaf & ! am\nt 
( fees e/imat$ to be collect$ "u ?is    
section = fiscal ye> #bjag 7includ+ any 
increas$ fee collections attributable to
 subp>agraph 7,b771 exce$s ! cumulative 
am\nt appropriat$ pursuant to p>agraph  
7#c7 = ! fiscal ye>s #bjad ?r\gh #bjag1 
! excess am\nt %all be cr$it$ to !      
appropriation acc\nt ( ! ,food & ,drug  
,adm9i/ration z provid$ 9 p>agraph 7#a71
 & %all be subtract$ f ! am\nt ( fees t 
w\ld o!rwise be au?oriz$ to be collect$ 
"u ?is section pursuant to appropriation

 ,acts = fiscal ye> #bjah4  7,b7        
,recov]y ( collection %ortfalls  7i7    
,fiscal ye> #bjaf ,= fiscal ye> #bjaf1 !
 am\nt ( fees o!rwise au?oriz$ to be    
collect$ "u ?is section %all be increas$
 by ! am\nt1 if any1 by :i* ! am\nt     
collect$ "u ?is section & appropriat$ = 
fiscal ye> #bjad falls bel[ ! am\nt (   
fees au?oriz$ = fiscal ye> #bjad "u     
p>agraph 7#c74  7ii7 ,fiscal ye> #bjag  
,= fiscal ye> #bjag1 ! am\nt ( fees     
o!rwise au?oriz$ to be collect$ "u ?is  
section %all be increas$ by ! am\nt1 if 
any1 by :i* ! am\nt collect$ "u ?is     
section & appropriat$ = fiscal ye> #bjae
 falls bel[ ! am\nt ( fees au?oriz$ =   
fiscal ye> #bjae "u p>agraph 7#c74      
7iii7 ,fiscal ye> #bjah ,= fiscal ye>   
#bjah1 ! am\nt ( fees o!rwise au?oriz$  
to be collect$ "u ?is section 7includ+  
any r$uction 9 ! au?oriz$ am\nt "u      
subp>agraph 7,a771 %all be increas$ by !
 cumulative am\nt1 if any1 by :i* !     
am\nt collect$ "u ?is section &         
appropriat$ = fiscal ye>s #bjaf & #bjag 

7includ+ e/imat$ collections = fiscal   
ye> #bjag7 falls bel[ ! cumulative am\nt
 ( fees au?oriz$ "u p>agraph 7#c7 =     
fiscal ye>s #bjaf & #bjag4  7h7         
,collection ( unpaid fees ,9 any case   
:]e ! ,secret>y does n receive paym5t ( 
a fee assess$ "u subsection 7a7 )9 #cj  
days aft] x is due1 su* fee %all be     
treat$ z a claim ( ! ,unit$ ,/ates      
,gov]nm5t subject to sub*apt] ,,ii (    
*apt] #cg ( title #ca1 ,unit$ ,/ates    
,code4  7i7 ,writt5 reque/s = waiv]s1   
r$uctions1 & refunds ,to qualify =      
consid]ation = a waiv] or r$uction "u   
subsection 7d71 or = a refund ( any fee 
collect$ 9 accordance ) subsection 7a71 
a p]son %all submit to ! ,secret>y a    
writt5 reque/ = su* waiv]1 r$uction1 or 
refund n lat] ?an #ahj days aft] su* fee
 is due4  7j7 ,con/ruction ,?is section 
may n be con/ru$ to require t ! numb] ( 
full-"t equival5t positions 9 !         
,dep>tm5t ( ,heal? & ,human ,s]vices1 = 
(fic]s1 employees1 & advisory committees
 n engag$ 9 ! process ( ! review (      

animal drug applications1 be r$uc$ to   
(fset ! numb] ( (fic]s1 employees1 &    
advisory committees s engag$4  7k7      
,abbreviat$ new animal drug applications
 ,! ,secret>y %all--  7#a7 to ! ext5t   
practicable1 segregate ! review (       
abbreviat$ new animal drug applications 
f ! process = ! review ( animal drug    
applications2 &  7#b7 adopt o!r         
adm9i/rative proc$ures to ensure t      
review times ( abbreviat$ new animal    
drug applications d n increase f _!     
curr5t level due to activities "u ! us] 
fee program4  4  #ajd4 ,reau?orization2 
report+ requirem5ts ,section #gdj;,a ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;j-#ac7 is am5d$ to  
read z foll[s3  #gdj;,a4                
,reau?orization2 report+ requirem5ts    
7a7 ,p]=mance report ,beg9n+ ) fiscal   
ye> #bjad1 n lat] ?an #abj days aft] !  
end ( ea* fiscal ye> dur+ :i* fees are  
collect$ "u ?is "p1 ! ,secret>y %all    
prep>e & submit to ! ,committee on      
,heal?1 ,education1 ,labor1 & ,p5sions (

 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report conc]n+ ! progress ( ! ,food &   
,drug ,adm9i/ration 9 a*iev+ ! goals    
id5tifi$ 9 ! lett]s describ$ 9 section  
#aja7;b7 ( ! ,animal ,drug ,us] ,fee    
,am5dm5ts ( #bjac t[>d exp$it+ ! animal 
drug developm5t process & ! review ( !  
new & supplem5tal animal drug           
applications & inve/igational animal    
drug submissions dur+ su* fiscal ye>1 ! 
future plans ( ! ,food & ,drug          
,adm9i/ration = meet+ ! goals1 ! review 
times = abbreviat$ new animal drug      
applications1 & ! adm9i/rative proc$ures
 adopt$ by ! ,food & ,drug ,adm9i/ration
 to ensure t review times = abbreviat$  
new animal drug applications are n      
increas$ f _! curr5t level due to       
activities "u ! us] fee program4  7b7   
,fiscal report ,beg9n+ ) fiscal ye>     
#bjad1 n lat] ?an #abj days aft] ! end (
 ea* fiscal ye> dur+ :i* fees are       
collect$ "u ?is "p1 ! ,secret>y %all    
prep>e & submit to ! ,committee on      

,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report on ! implem5tation ( ! au?ority =
 su* fees dur+ su* fiscal ye> & ! use1  
by ! ,food & ,drug ,adm9i/ration1 ( !   
fees collect$ dur+ su* fiscal ye> = :i* 
! report is made4  7c7 ,public          
availability ,! ,secret>y %all make !   
reports requir$ "u subsections 7a7 & 7b7
 available to ! public on ! ,int]net    
,web site ( ! ,food & ,drug             
,adm9i/ration4  7d7 ,reau?orization     
7#a7 ,consultation ,9 develop+          
recomm5dations to pres5t to ! ,congress 
) respect to ! goals1 & plans = meet+ ! 
goals1 = ! process = ! review ( animal  
drug applications = ! fir/ #e fiscal    
ye>s aft] fiscal ye> #bjah1 & = !       
reau?orization ( ?is "p = su* fiscal    
ye>s1 ! ,secret>y %all consult )--  7,a7
 ! ,committee on ,heal?1 ,education1    
,labor1 & ,p5sions ( ! ,s5ate2  7,b7 !  
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives2  7,c7 sci5tific

 & academic exp]ts2  7,d7 vet]9>y       
pr(essionals2  7,e7 repres5tatives (    
pati5t & consum] advocacy gr\ps2 &  7,f7
 ! regulat$ indu/ry4  7#b7 ,prior public
 input ,prior to beg9n+ negotiations ) !
 regulat$ indu/ry on ! reau?orization ( 
?is "p1 ! ,secret>y %all--  7,a7 publi% 
a notice 9 ! ,f$]al ,regi/] reque/+     
public input on ! reau?orization2  7,b7 
hold a public meet+ at :i* ! public may 
pres5t its views on ! reau?orization1   
includ+ specific sugge/ions = *anges to 
! goals ref]r$ to 9 subsection 7a72     
7,c7 provide a p]iod ( #cj days aft] !  
public meet+ to obta9 writt5 comm5ts f !
 public sugge/+ *anges to ?is "p2 &     
7,d7 publi% ! comm5ts on ! ,food & ,drug
 ,adm9i/ration's ,int]net ,web site4    
7#c7 ,p]iodic consultation ,n less      
frequ5tly ?an once e #d mon?s dur+      
negotiations ) ! regulat$ indu/ry1 !    
,secret>y %all hold discussions )       
repres5tatives ( vet]9>y1 pati5t1 &     
consum] advocacy gr\ps to cont9ue       
discussions ( _! views on !             

reau?orization & _! sugge/ions = *anges 
to ?is "p z express$ "u p>agraph 7#b74  
7#d7 ,public review ( recomm5dations    
,aft] negotiations ) ! regulat$ indu/ry1
 ! ,secret>y %all--  7,a7 pres5t !      
recomm5dations develop$ "u p>agraph 7#a7
 to ! ,congressional committees specifi$
 9 su* p>agraph2  7,b7 publi% su*       
recomm5dations 9 ! ,f$]al ,regi/]2  7,c7
 provide = a p]iod ( #cj days = ! public
 to provide writt5 comm5ts on su*       
recomm5dations2  7,d7 hold a meet+ at   
:i* ! public may pres5t its views on su*
 recomm5dations2 &  7,e7 aft]           
consid]ation ( su* public views &       
comm5ts1 revise su* recomm5dations z    
necess>y4  7#e7 ,transmittal (          
recomm5dations ,n lat] ?an ,janu>y #ae1 
#bjah1 ! ,secret>y %all transmit to     
,congress ! revis$ recomm5dations "u    
p>agraph 7#d7 a summ>y ( ! views &      
comm5ts receiv$ "u su* p>agraph1 & any  
*anges made to ! recomm5dations 9       
response to su* views & comm5ts4  7#f7  
,m9utes ( negotiation meet+s  7,a7      

,public availability ,be=e pres5t+ !    
recomm5dations develop$ "u p>agraphs    
7#a7 ?r\gh 7#e7 to ,congress1 !         
,secret>y %all make publicly available1 
on ! ,int]net ,web site ( ! ,food &     
,drug ,adm9i/ration1 m9utes ( all       
negotiation meet+s conduct$ "u ?is      
subsection betwe5 ! ,food & ,drug       
,adm9i/ration & ! regulat$ indu/ry4     
7,b7 ,cont5t ,! m9utes describ$ "u      
subp>agraph 7,a7 %all summ>ize any      
sub/antive proposal made by any p>ty to 
! negotiations z well z significant     
controv]sies or diff]5ces ( op9ion dur+ 
! negotiations & _! resolution4  4      
#aje4 ,sav+s clause ,not)/&+ ! am5dm5ts 
made by ?is title1 "p #d ( sub*apt] ,c (
 *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa
 et seq471 z 9 effect on ! day be=e !   
date ( ! enactm5t ( ?is title1 %all     
cont9ue to be 9 effect ) respect to     
animal drug applications & supplem5tal  
animal drug applications 7z def9$ 9 su* 
"p z ( su* day7 t on or aft] ,octob] #a1

 #bjjh1 b be=e ,octob] #a1 #bjac1 7     
accept$ by ! ,food & ,drug ,adm9i/ration
 = fil+ ) respect to assess+ & collect+ 
any fee requir$ by su* "p = a fiscal ye>
 prior to fiscal ye> #bjad4  #ajf4      
,effective date ,! am5dm5ts made by ?is 
title %all take effect on ,octob] #a1   
#bjac1 or ! date ( enactm5t ( ?is ,act1 
:i*ev] is lat]1 except t fees "u "p #d (
 sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act1 z am5d$ 
by ?is title1 %all be assess$ = all     
animal drug applications & supplem5tal  
animal drug applications receiv$ on or  
aft] ,octob] #a1 #bjac1 reg>dless ( !   
date ( ! enactm5t ( ?is ,act4  #ajg4    
,sunset dates  7a7 ,au?orization        
,section #gdj ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cgi;j-#ab7 %all cease to be effective  
,octob] #a1 #bjah4  7b7 ,report+        
requirem5ts ,section #gdj;,a ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ac7 %all cease to be  
effective ,janu>y #ca1 #bjai4  7c7      

,previ\s sunset provision  7#a7 ,9 g5]al
 ,section #ajh ( ! ,animal ,drug ,us]   
,fee ,am5dm5ts ( #bjjh 7,public ,law    
#aaj-caf7 is repeal$4  7#b7 ,con=m+     
am5dm5t ,! ,animal ,drug ,us] ,fee      
,am5dm5ts ( #bjjh 7,public ,law         
#aaj-caf7 is am5d$ 9 ! table ( cont5ts 9
 section #a1 by /rik+ ! item relat+ to  
section #ajh4  7d7 ,te*nical            
cl>ification ,effective ,novemb] #ah1   
#bjjc1 section #e ( ! ,animal ,drug ,us]
 ,fee ,act ( #bjjc 7,public ,law        
#ajh-acj7 is repeal$4  ,,ii ,fees relat+
 to g5]ic animal drugs  #bja4 ,%ort     
title2 f9d+  7a7 ,%ort title ,?is title 
may be cit$ z ! ,animal ,g5]ic ,drug    
,us] ,fee ,am5dm5ts ( #bjac4  7b7 ,f9d+ 
,! fees au?oriz$ by ?is title w be      
d$icat$ t[>d exp$it+ ! g5]ic new animal 
drug developm5t process & ! review (    
abbreviat$ applications = g5]ic new     
animal drugs1 supplem5tal abbreviat$    
applications = g5]ic new animal drugs1 &
 inve/igational submissions = g5]ic new 
animal drugs z set =? 9 ! goals id5tifi$

 9 ! lett]s f ! ,secret>y ( ,heal? &    
,human ,s]vices to ! ,*airman ( !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,*airman ( !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate z set =? 9
 ! ,congressional ,record4  #bjb4       
,au?ority to assess & use g5]ic new     
animal drug fees ,section #gda ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#ba7 is am5d$ to  
read z foll[s3  #gda4 ,au?ority to      
assess & use g5]ic new animal drug fees 
7a7 ,types ( fees ,beg9n+ ) respect to  
fiscal ye> #bjji1 ! ,secret>y %all      
assess & collect fees 9 accordance ) ?is
 section z foll[s3  7#a7 ,abbreviat$    
application fee  7,a7 ,9 g5]al ,ea*     
p]son t submits1 on or aft] ,july #a1   
#bjjh1 an abbreviat$ application = a    
g5]ic new animal drug %all be subject to
 a fee z e/abli%$ 9 subsection 7c7 = su*
 an application4  7,b7 ,paym5t ,! fee   
requir$ by subp>agraph 7,a7 %all be due 
^u submission ( ! abbreviat$            

application4  7,c7 ,exceptions  7i7     
,previ\sly fil$ application ,if an      
abbreviat$ application 0 submitt$ by a  
p]son t paid ! fee = su* application1 0 
accept$ = fil+1 & 0 n approv$ or 0      
)drawn 7)\t a waiv] or refund71 !       
submission ( an abbreviat$ application =
 ! same product by ! same p]son 7or !   
p]son's lic5see1 assignee1 or successor7
 %all n be subject to a fee "u          
subp>agraph 7,a74  7ii7 ,c]ta9          
abbreviat$ applications involv+         
comb9ation animal drugs ,an abbreviat$  
application :i* is subject to ! crit]ia 
9 section #eab7;d77#d7 & submitt$ on or 
aft] ,octob] #a1 #bjac %all be subject  
to a fee equal to #ej p]c5t ( ! am\nt ( 
! abbreviat$ application fee e/abli%$ 9 
subsection 7c74  7,d7 ,refund ( fee if  
application refus$ = fil+ ,! ,secret>y  
%all refund #ge p]c5t ( ! fee paid "u   
subp>agraph 7,b7 = any abbreviat$       
application :i* is refus$ = fil+4  7,e7 
,refund ( fee if application )drawn ,if 
an abbreviat$ application is )drawn aft]

 ! application 0 fil$1 ! ,secret>y may  
refund ! fee or portion ( ! fee paid "u 
subp>agraph 7,b7 if no sub/antial "w 0  
p]=m$ on ! application aft] !           
application 0 fil$4 ,! ,secret>y %all h 
! sole discretion to refund ! fee "u ?is
 subp>agraph4 ,a det]m9ation by !       
,secret>y conc]n+ a refund "u ?is       
subp>agraph %all n be reviewable4  7#b7 
,g5]ic new animal drug product fee  7,a7
 ,9 g5]al ,ea* p]son--  7i7 :o is nam$ z
 ! applicant 9 an abbreviat$ application
 or supplem5tal abbreviat$ application =
 a g5]ic new animal drug product :i* has
 be5 submitt$ = li/+ "u section #eaj2 & 
7ii7 :o1 aft] ,septemb] #a1 #bjjh1 _h   
p5d+ be=e ! ,secret>y an abbreviat$     
application or supplem5tal abbreviat$   
application1  %all pay = ea* su* g5]ic  
new animal drug product ! annual fee    
e/abli%$ 9 subsection 7c74  7,b7        
,paym5t2 fee due date ,su* fee %all be  
payable = ! fiscal ye> 9 :i* ! g5]ic new
 animal drug product is fir/ submitt$ = 
li/+ "u section #eaj1 or is submitt$ =  

reli/+ "u section #eaj if ! g5]ic new   
animal drug product has be5 )drawn f    
li/+ & reli/$4 ,aft] su* fee is paid = t
 fiscal ye>1 su* fee %all be due ea*    
subsequ5t fiscal ye> t ! product rema9s 
li/$1 ^u ! lat] (--  7i7 ! fir/ bus9ess 
day aft] ! date ( enactm5t ( an         
appropriations ,act provid+ = !         
collection & obligation ( fees = su*    
fiscal ye> "u ?is section2 or  7ii7     
,janu>y #ca ( ea* ye>4  7,c7 ,limitation
 ,su* fee %all be paid only once = ea*  
g5]ic new animal drug product = a fiscal
 ye> 9 :i* ! fee is payable4  7#c7      
,g5]ic new animal drug sponsor fee  7,a7
 ,9 g5]al ,ea* p]son--  7i7 :o meets !  
def9ition ( a g5]ic new animal drug     
sponsor )9 a fiscal ye>2 &  7ii7 :o1    
aft] ,septemb] #a1 #bjjh1 _h p5d+ be=e !
 ,secret>y an abbreviat$ application1 a 
supplem5tal abbreviat$ application1 or  
an inve/igational submission1  %all be  
assess$ an annual g5]ic new animal drug 
sponsor fee z e/abli%$ "u subsection    
7c74  7,b7 ,paym5t2 fee due date ,su*   

fee %all be due ea* fiscal ye> ^u ! lat]
 (--  7i7 ! fir/ bus9ess day aft] ! date
 ( enactm5t ( an appropriations ,act    
provid+ = ! collection & obligation (   
fees = su* fiscal ye> "u ?is section2 or
  7ii7 ,janu>y #ca ( ea* ye>4  7,c7     
,am\nt ( fee ,ea* g5]ic new animal drug 
sponsor %all pay only #a su* fee ea*    
fiscal ye>1 z foll[s3  7i7 #ajj p]c5t ( 
! am\nt ( ! g5]ic new animal drug       
sponsor fee publi%$ = t fiscal ye> "u   
subsection 7c7 = an applicant ) m ?an #f
 approv$ abbreviat$ applications4  7ii7 
#ge p]c5t ( ! am\nt ( ! g5]ic new animal
 drug sponsor fee publi%$ = t fiscal ye>
 "u subsection 7c7 = an applicant ) m   
?an #a & few] ?an #g approv$ abbreviat$ 
applications4  7iii7 #ej p]c5t ( ! am\nt
 ( ! g5]ic new animal drug sponsor fee  
publi%$ = t fiscal ye> "u subsection 7c7
 = an applicant ) #a or few] approv$    
abbreviat$ applications4  7b7 ,fee      
am\nts ,subject to subsections 7c71 7d71
 7f71 & 7g71 ! fees requir$ "u          
subsection 7a7 %all be e/abli%$ to      

g5]ate fee rev5ue am\nts z foll[s3  7#a7
 ,total fee rev5ues = application fees  
,! total fee rev5ues to be collect$ 9   
abbreviat$ application fees "u          
subsection 7a77#a7 %all be #a1hcb1jjj = 
fiscal ye> #bjad1 #a1gcf1jjj = fiscal   
ye> #bjae1 #a1heg1jjj = fiscal ye>      
#bjaf1 #a1ihd1jjj = fiscal ye> #bjag1 & 
#b1aag1jjj = fiscal ye> #bjah4  7#b7    
,total fee rev5ues = product fees ,!    
total fee rev5ues to be collect$ 9 g5]ic
 new animal drug product fees "u        
subsection 7a77#b7 %all be #b1gdh1jjj = 
fiscal ye> #bjad1 #b1fjd1jjj = fiscal   
ye> #bjae1 #b1ghf1jjj = fiscal ye>      
#bjaf1 #b1igf1jjj = fiscal ye> #bjag1 & 
#c1age1jjj = fiscal ye> #bjah4  7#c7    
,total fee rev5ues = sponsor fees ,!    
total fee rev5ues to be collect$ 9 g5]ic
 new animal drug sponsor fees "u        
subsection 7a77#c7 %all be #b1gdh1jjj = 
fiscal ye> #bjad1 #b1fjd1jjj = fiscal   
ye> #bjae1 #b1ghf1jjj = fiscal ye>      
#bjaf1 #b1igf1jjj = fiscal ye> #bjag1 & 
#c1age1jjj = fiscal ye> #bjah4  7c7     

,annual fee sett+2 adju/m5ts  7#a7      
,annual fee sett+ ,! ,secret>y %all     
e/abli%1 #fj days be=e ! />t ( ea*      
fiscal ye> beg9n+ aft] ,septemb] #cj1   
#bjjh1 = t fiscal ye>1 abbreviat$       
application fees1 g5]ic new animal drug 
sponsor fees1 & g5]ic new animal drug   
product fees1 bas$ on ! rev5ue am\nts   
e/abli%$ "u subsection 7b7 & ! adju/m5ts
 provid$ "u ?is subsection4  7#b7       
,workload adju/m5t ,! fee rev5ues %all  
be adju/$ ea* fiscal ye> aft] fiscal ye>
 #bjad to reflect *anges 9 review       
workload4 ,) respect to su* adju/m5t3   
7,a7 ,?is adju/m5t %all be det]m9$ by ! 
,secret>y bas$ on a weight$ av]age ( !  
*ange 9 ! total numb] ( abbreviat$      
applications = g5]ic new animal drugs1  
manufactur+ supplem5tal abbreviat$      
applications = g5]ic new animal drugs1  
inve/igational g5]ic new animal drug    
/udy submissions1 & inve/igational g5]ic
 new animal drug protocol submissions   
submitt$ to ! ,secret>y4 ,! ,secret>y   
%all publi% 9 ! ,f$]al ,regi/] ! fees   

result+ f ?is adju/m5t & ! support+     
me?odologies4  7,b7 ,"u no circum/ances 
%all ?is workload adju/m5t result 9 fee 
rev5ues = a fiscal ye> t are less ?an ! 
fee rev5ues = t fiscal ye> e/abli%$ 9   
subsection 7b74  7#c7 ,f9al ye> adju/m5t
 ,= fiscal ye> #bjah1 ! ,secret>y may1 9
 addition to o!r adju/m5ts "u ?is       
subsection1 fur!r increase ! fees "u ?is
 section1 if su* an adju/m5t is         
necess>y1 to provide = up to #c mon?s ( 
op]at+ res]ves ( c>ryov] us] fees = !   
process = ! review ( abbreviat$         
applications = g5]ic new animal drugs = 
! fir/ #c mon?s ( fiscal ye> #bjai4 ,if 
! ,food & ,drug ,adm9i/ration has       
c>ryov] balances = ! process = ! review 
( abbreviat$ applications = g5]ic new   
animal drugs 9 excess ( #c mon?s ( su*  
op]at+ res]ves1 !n ?is adju/m5t %all n  
be made4 ,if ?is adju/m5t is necess>y1  
!n ! rationale = ! am\nt ( ! increase   
%all be conta9$ 9 ! annual notice sett+ 
fees = fiscal ye> #bjah4  7#d7 ,limit ,!
 total am\nt ( fees *>g$1 z adju/$ "u   

?is subsection1 = a fiscal ye> may n    
exce$ ! total co/s = su* fiscal ye> = ! 
res\rces allocat$ = ! process = ! review
 ( abbreviat$ applications = g5]ic new  
animal drugs4  7d7 ,fee waiv] or        
r$uction ,! ,secret>y %all grant a waiv]
 f or a r$uction ( #a or m fees assess$ 
"u subsection 7a7 :]e ! ,secret>y f9ds t
 ! g5]ic new animal drug is int5d$      
solely to provide = a m9or use or m9or  
species indication4  7e7 ,effect (      
failure ,to pay fees ,an abbreviat$     
application = a g5]ic new animal drug   
submitt$ by a p]son subject to fees "u  
subsection 7a7 %all be consid]$         
incomplete & %all n be accept$ = fil+ by
 ! ,secret>y until all fees ow$ by su*  
p]son h be5 paid4 ,an inve/igational    
submission = a g5]ic new animal drug t  
is submitt$ by a p]son subject to fees  
"u subsection 7a7 %all be consid]$      
incomplete & %all n be accept$ = review 
by ! ,secret>y until all fees ow$ by su*
 p]son h be5 paid4 ,! ,secret>y may     
discont9ue review ( any abbreviat$      

application = a g5]ic new animal drug1  
supplem5tal abbreviat$ application = a  
g5]ic new animal drug1 or inve/igational
 submission = a g5]ic new animal drug f 
a p]son if su* p]son has n submitt$ =   
paym5t all fees ow$ "u ?is section by   
#cj days aft] ! date ^u :i* !y are due4 
7f7 ,assessm5t ( fees  7#a7 ,limitation 
,fees may n be assess$ "u subsection 7a7
 = a fiscal ye> beg9n+ aft] fiscal ye>  
#bjjh unless appropriations = sal>ies & 
exp5ses ( ! ,food & ,drug ,adm9i/ration 
= su* fiscal ye> 7exclud+ ! am\nt ( fees
 appropriat$ = su* fiscal ye>7 are equal
 to or great] ?an ! am\nt (             
appropriations = ! sal>ies & exp5ses ( !
 ,food & ,drug ,adm9i/ration = ! fiscal 
ye> #bjjc 7exclud+ ! am\nt ( fees       
appropriat$ = su* fiscal ye>7 multipli$ 
by ! adju/m5t factor applicable to !    
fiscal ye> involv$4  7#b7 ,au?ority ,if 
! ,secret>y does n assess fees "u       
subsection 7a7 dur+ any portion ( a     
fiscal ye> because ( p>agraph 7#a7 & if 
at a lat] date 9 su* fiscal ye> !       

,secret>y may assess su* fees1 !        
,secret>y may assess & collect su* fees1
 )\t any modification 9 ! rate1 =       
abbreviat$ applications1 g5]ic new      
animal drug sponsors1 & g5]ic new animal
 drug products at any "t 9 su* fiscal   
ye> not)/&+ ! provisions ( subsection   
7a7 relat+ to ! date fees are to be     
paid4  7g7 ,cr$it+ & availability ( fees
  7#a7 ,9 g5]al ,subject to p>agraph    
7#b77;,c71 fees au?oriz$ "u subsection  
7a7 %all be collect$ & available =      
obligation only to ! ext5t & 9 ! am\nt  
provid$ 9 advance 9 appropriations      
,acts4 ,su* fees are au?oriz$ to be     
appropriat$ to rema9 available until    
exp5d$4 ,su* sums z may be necess>y may 
be transf]r$ f ! ,food & ,drug          
,adm9i/ration sal>ies & exp5ses         
appropriation acc\nt )\t fiscal ye>     
limitation to su* appropriation acc\nt =
 sal>y & exp5ses ) su* fiscal ye>       
limitation4 ,! sums transf]r$ %all be   
available solely = ! process = ! review 
( abbreviat$ applications = g5]ic new   

animal drugs4  7#b7 ,collections &      
appropriation acts  7,a7 ,9 g5]al ,!    
fees au?oriz$ by ?is section--  7i7     
subject to subp>agraph 7,c71 %all be    
collect$ & available 9 ea* fiscal ye> 9 
an am\nt n to exce$ ! am\nt specifi$ 9  
appropriation ,acts1 or o!rwise made    
available = obligation = su* fiscal ye>2
 &  7ii7 %all be available to defray    
increases 9 ! co/s ( ! res\rces allocat$
 = ! process = ! review ( abbreviat$    
applications = g5]ic new animal drugs   
7includ+ increases 9 su* co/s = an      
additional numb] ( full-"t equival5t    
positions 9 ! ,dep>tm5t ( ,heal? &      
,human ,s]vices to be engag$ 9 su*      
process7 ov] su* co/s1 exclud+ co/s paid
 f fees collect$ "u ?is section1 =      
fiscal ye> #bjjh multipli$ by ! adju/m5t
 factor4  7,b7 ,compliance ,! ,secret>y 
%all be consid]$ to h met ! requirem5ts 
( subp>agraph 7,a77ii7 9 any fiscal ye> 
if ! co/s fund$ by appropriations &     
allocat$ = ! process = ! review (       
abbreviat$ applications = g5]ic new     

animal drugs--  7i7 are n m ?an #c p]c5t
 bel[ ! level specifi$ 9 subp>agraph    
7,a77ii72 or  7ii7 7,i7 are m ?an #c    
p]c5t bel[ ! level specifi$ 9           
subp>agraph 7,a77ii71 & fees assess$ = !
 fiscal ye> foll[+ ! subsequ5t fiscal   
ye> are decreas$ by ! am\nt 9 excess (  
#c p]c5t by :i* su* co/s fell bel[ !    
level specifi$ 9 subp>agraph 7,a77ii72 &
  7,,ii7 su* co/s are n m ?an #e p]c5t  
bel[ ! level specifi$ 9 subp>agraph     
7,a77ii74  7,c7 ,provision = e>ly       
paym5ts ,paym5t ( fees au?oriz$ "u ?is  
section = a fiscal ye>1 prior to ! due  
date = su* fees1 may be accept$ by !    
,secret>y 9 accordance ) au?ority       
provid$ 9 advance 9 a prior ye>         
appropriations ,act4  7#c7 ,au?orization
 ( appropriations ,!re are au?oriz$ to  
be appropriat$ = fees "u ?is section--  
7,a7 #g1cbh1jjj = fiscal ye> #bjad2     
7,b7 #f1idd1jjj = fiscal ye> #bjae2     
7,c7 #g1dbi1jjj = fiscal ye> #bjaf2     
7,d7 #g1icf1jjj = fiscal ye> #bjag2 &   
7,e7 #h1dfg1jjj = fiscal ye> #bjah2  z  

adju/$ to reflect adju/m5ts 9 ! total   
fee rev5ues made "u ?is section & *anges
 9 ! total am\nts collect$ by abbreviat$
 application fees1 g5]ic new animal drug
 sponsor fees1 & g5]ic new animal drug  
product fees4  7#d7 ,(fset ,if ! sum ( !
 cumulative am\nt ( fees collect$ "u ?is
 section = ! fiscal ye>s #bjad ?r\gh    
#bjaf & ! am\nt ( fees e/imat$ to be    
collect$ "u ?is section = fiscal ye>    
#bjag exce$s ! cumulative am\nt         
appropriat$ "u p>agraph 7#c7 = ! fiscal 
ye>s #bjad ?r\gh #bjag1 ! excess am\nt  
%all be cr$it$ to ! appropriation acc\nt
 ( ! ,food & ,drug ,adm9i/ration z      
provid$ 9 p>agraph 7#a71 & %all be      
subtract$ f ! am\nt ( fees t w\ld       
o!rwise be au?oriz$ to be collect$ "u   
?is section pursuant to appropriation   
,acts = fiscal ye> #bjah4  7h7          
,collection ( unpaid fees ,9 any case   
:]e ! ,secret>y does n receive paym5t ( 
a fee assess$ "u subsection 7a7 )9 #cj  
days aft] x is due1 su* fee %all be     
treat$ z a claim ( ! ,unit$ ,/ates      

,gov]nm5t subject to sub*apt] ,,ii (    
*apt] #cg ( title #ca1 ,unit$ ,/ates    
,code4  7i7 ,writt5 reque/s = waiv]s1   
r$uctions1 & refunds ,to qualify =      
consid]ation = a waiv] or r$uction "u   
subsection 7d71 or = a refund ( any fee 
collect$ 9 accordance ) subsection 7a71 
a p]son %all submit to ! ,secret>y a    
writt5 reque/ = su* waiv]1 r$uction1 or 
refund n lat] ?an #ahj days aft] su* fee
 is due4  7j7 ,con/ruction ,?is section 
may n be con/ru$ to require t ! numb] ( 
full-"t equival5t positions 9 !         
,dep>tm5t ( ,heal? & ,human ,s]vices1 = 
(fic]s1 employees1 & advisory committees
 n engag$ 9 ! process ( ! review (      
abbreviat$ applications = g5]ic new     
animal drugs1 be r$uc$ to (fset ! numb] 
( (fic]s1 employees1 & advisory         
committees s engag$4  7k7 ,def9itions ,9
 ?is section & section #gdb3  7#a7      
,abbreviat$ application = a g5]ic new   
animal drug ,! t]ms abbreviat$          
application = a g5]ic new animal drug & 
abbreviat$ application mean an          

abbreviat$ application = ! approval (   
any g5]ic new animal drug submitt$ "u   
section #eab7;b77#b74 ,su* t]m does n   
include a supplem5tal abbreviat$        
application = a g5]ic new animal drug4  
7#b7 ,adju/m5t factor ,! t]m adju/m5t   
factor applicable to a fiscal ye> is !  
,consum] ,price ,index = all urban      
consum]s 7all items2 ,unit$ ,/ates city 
av]age7 = ,octob] ( ! prec$+ fiscal ye> 
divid$ by--  7,a7 = purposes (          
subsection 7f77#a71 su* ,index = ,octob]
 #bjjb2 &  7,b7 = purposes ( subsection 
7g77#b77;,a77ii71 su* ,index = ,octob]  
#bjjg4  7#c7 ,co/s ( res\rces allocat$ =
 ! process = ! review ( abbreviat$      
applications = g5]ic new animal drugs ,!
 t]m co/s ( res\rces allocat$ = !       
process = ! review ( abbreviat$         
applications = g5]ic new animal drugs   
means ! exp5ses 9 connection ) ! process
 = ! review ( abbreviat$ applications = 
g5]ic new animal drugs =--  7,a7 (fic]s 
& employees ( ! ,food & ,drug           
,adm9i/ration1 contractors ( ! ,food &  

,drug ,adm9i/ration1 advisory committees
 consult$ ) respect to ! review (       
specific abbreviat$ applications1       
supplem5tal abbreviat$ applications1 or 
inve/igational submissions1 & co/s      
relat$ to su* (fic]s1 employees1        
committees1 & contractors1 includ+ co/s 
= travel1 education1 & recruitm5t & o!r 
p]sonnel activities2  7,b7 managem5t (  
in=mation1 & ! acquisition1 ma9t5ance1 &
 repair ( comput] res\rces2  7,c7 leas+1
 ma9t5ance1 r5ovation1 & repair (       
facilities & acquisition1 ma9t5ance1 &  
repair ( fixtures1 furniture1 sci5tific 
equipm5t1 & o!r necess>y mat]ials &     
supplies2 &  7,d7 collect+ fees "u ?is  
section & acc\nt+ = res\rces allocat$ = 
! review ( abbreviat$ applications1     
supplem5tal abbreviat$ applications1 &  
inve/igational submissions4  7#d7 ,f9al 
dosage =m ,! t]m f9al dosage =m means1 )
 respect to a g5]ic new animal drug     
product1 a f9i%$ dosage =m :i* is       
approv$ = adm9i/ration to an animal )\t 
sub/antial fur!r manufactur+4 ,su* t]m  

includes g5]ic new animal drug products 
int5d$ = mix+ 9 animal fe$s4  7#e7      
,g5]ic new animal drug ,! t]m g5]ic new 
animal drug means a new animal drug t is
 ! subject ( an abbreviat$ application4 
7#f7 ,g5]ic new animal drug product ,!  
t]m g5]ic new animal drug product means 
ea* specific /r5g? or pot5cy ( a        
p>ticul> active +r$i5t or +r$i5ts 9 f9al
 dosage =m m>ket$ by a p>ticul>         
manufactur] or di/ributor1 :i* is       
uniquely id5tifi$ by ! label] code &    
product code portions ( ! national drug 
code1 & = :i* an abbreviat$ application 
= a g5]ic new animal drug or a          
supplem5tal abbreviat$ application has  
be5 approv$4  7#g7 ,g5]ic new animal    
drug sponsor ,! t]m g5]ic new animal    
drug sponsor means ei!r an applicant    
nam$ 9 an abbreviat$ application = a    
g5]ic new animal drug t has n be5 )drawn
 by ! applicant & = :i* approval has n  
be5 )drawn by ! ,secret>y1 or a p]son :o
 has submitt$ an inve/igational         
submission = a g5]ic new animal drug t  

has n be5 t]m9at$ or o!rwise r5d]$      
inactive by ! ,secret>y4  7#h7          
,inve/igational submission = a g5]ic new
 animal drug ,! t]ms inve/igational     
submission = a g5]ic new animal drug &  
inve/igational submission mean--  7,a7 !
 fil+ ( a claim = an inve/igational     
exemption "u section #eab7;j7 = a g5]ic 
new animal drug int5d$ to be ! subject (
 an abbreviat$ application or a         
supplem5tal abbreviat$ application2 or  
7,b7 ! submission ( in=mation = !       
purpose ( enabl+ ! ,secret>y to evaluate
 ! safety or effectiv5ess ( a g5]ic new 
animal drug 9 ! ev5t ( ! fil+ ( an      
abbreviat$ application or supplem5tal   
abbreviat$ application = su* drug4  7#i7
 ,p]son ,! t]m p]son includes an        
affiliate !re( 7z su* t]m is def9$ 9    
section #gce7aa774  7#aj7 ,process = !  
review ( abbreviat$ applications = g5]ic
 new animal drugs ,! t]m process = !    
review ( abbreviat$ applications = g5]ic
 new animal drugs means ! foll[+        
activities ( ! ,secret>y ) respect to ! 

review ( abbreviat$ applications1       
supplem5tal abbreviat$ applications1 &  
inve/igational submissions3  7,a7 ,!    
activities necess>y = ! review (        
abbreviat$ applications1 supplem5tal    
abbreviat$ applications1 &              
inve/igational submissions4  7,b7 ,!    
issuance ( action lett]s :i* approve    
abbreviat$ applications or supplem5tal  
abbreviat$ applications or :i* set =? 9 
detail ! specific defici5cies 9         
abbreviat$ applications1 supplem5tal    
abbreviat$ applications1 or             
inve/igational submissions &1 :]e       
appropriate1 ! actions necess>y to place
 su* applications1 supplem5tal          
applications1 or submissions 9 condition
 = approval4  7,c7 ,! inspection ( g5]ic
 new animal drug e/abli%m5ts & o!r      
facilities und]tak5 z "p ( ! ,secret>y's
 review ( p5d+ abbreviat$ applications1 
supplem5tal abbreviat$ applications1 &  
inve/igational submissions4  7,d7       
,monitor+ ( rese>* conduct$ 9 connection
 ) ! review ( abbreviat$ applications1  

supplem5tal abbreviat$ applications1 &  
inve/igational submissions4  7,e7 ,!    
developm5t ( regulations & policy relat$
 to ! review ( abbreviat$ applications1 
supplem5tal abbreviat$ applications1 &  
inve/igational submissions4  7,f7       
,developm5t ( /&>ds = products subject  
to review4  7,g7 ,meet+s betwe5 ! ag5cy 
& ! g5]ic new animal drug sponsor4  7,h7
 ,review ( adv]tis+ & label+ prior to   
approval ( an abbreviat$ application or 
supplem5tal abbreviat$ application1 b n 
aft] su* application has be5 approv$4   
7#aa7 ,supplem5tal abbreviat$           
application = g5]ic new animal drug ,!  
t]ms supplem5tal abbreviat$ application 
= a g5]ic new animal drug & supplem5tal 
abbreviat$ application mean a reque/ to 
! ,secret>y to approve a *ange 9 an     
approv$ abbreviat$ application4  4      
#bjc4 ,reau?orization2 report+          
requirem5ts ,section #gdb ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#bb7 is am5d$ to read z
 foll[s3  #gdb4 ,reau?orization2 report+

 requirem5ts  7a7 ,p]=mance reports     
,beg9n+ ) fiscal ye> #bjad1 n lat] ?an  
#abj days aft] ! end ( ea* fiscal ye>   
dur+ :i* fees are collect$ "u ?is "p1 ! 
,secret>y %all prep>e & submit to !     
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate1 & !      
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report conc]n+
 ! progress ( ! ,food & ,drug           
,adm9i/ration 9 a*iev+ ! goals id5tifi$ 
9 ! lett]s describ$ 9 section #bja7;b7 (
 ! ,animal ,g5]ic ,drug ,us] ,fee       
,am5dm5ts ( #bjac t[>d exp$it+ ! g5]ic  
new animal drug developm5t process & !  
review ( abbreviat$ applications = g5]ic
 new animal drugs1 supplem5tal          
abbreviat$ applications = g5]ic new     
animal drugs1 & inve/igational          
submissions = g5]ic new animal drugs    
dur+ su* fiscal ye>4  7b7 ,fiscal report
 ,beg9n+ ) fiscal ye> #bjad1 n lat] ?an 
#abj days aft] ! end ( ea* fiscal ye>   
dur+ :i* fees are collect$ "u ?is "p1 ! 
,secret>y %all prep>e & submit to       

,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report on !   
implem5tation ( ! au?ority = su* fees   
dur+ su* fiscal ye> & ! use1 by ! ,food 
& ,drug ,adm9i/ration1 ( ! fees collect$
 dur+ su* fiscal ye> = :i* ! report is  
made4  7c7 ,public availability ,!      
,secret>y %all make ! reports requir$ "u
 subsections 7a7 & 7b7 available to !   
public on ! ,int]net ,web site ( ! ,food
 & ,drug ,adm9i/ration4  7d7            
,reau?orization  7#a7 ,consultation ,9  
develop+ recomm5dations to pres5t to    
,congress ) respect to ! goals1 & plans 
= meet+ ! goals1 = ! process = ! review 
( abbreviat$ applications = g5]ic new   
animal drugs = ! fir/ #e fiscal ye>s    
aft] fiscal ye> #bjah1 & = !            
reau?orization ( ?is "p = su* fiscal    
ye>s1 ! ,secret>y %all consult )--  7,a7
 ! ,committee on ,en]gy & ,comm]ce ( !  
,h\se ( ,repres5tatives2  7,b7 !        
,committee on ,heal?1 ,education1       

,labor1 & ,p5sions ( ! ,s5ate2  7,c7    
sci5tific & academic exp]ts2  7,d7      
vet]9>y pr(essionals2  7,e7             
repres5tatives ( pati5t & consum]       
advocacy gr\ps2 &  7,f7 ! regulat$      
indu/ry4  7#b7 ,prior public input      
,prior to beg9n+ negotiations ) !       
regulat$ indu/ry on ! reau?orization (  
?is "p1 ! ,secret>y %all--  7,a7 publi% 
a notice 9 ! ,f$]al ,regi/] reque/+     
public input on ! reau?orization2  7,b7 
hold a public meet+ at :i* ! public may 
pres5t its views on ! reau?orization1   
includ+ specific sugge/ions = *anges to 
! goals ref]r$ to 9 subsection 7a72     
7,c7 provide a p]iod ( #cj days aft] !  
public meet+ to obta9 writt5 comm5ts f !
 public sugge/+ *anges to ?is "p2 &     
7,d7 publi% ! comm5ts on ! ,food & ,drug
 ,adm9i/ration's ,int]net ,web site4    
7#c7 ,p]iodic consultation ,n less      
frequ5tly ?an once e #d mon?s dur+      
negotiations ) ! regulat$ indu/ry1 !    
,secret>y %all hold discussions )       
repres5tatives ( vet]9>y1 pati5t1 &     

consum] advocacy gr\ps to cont9ue       
discussions ( _! views on !             
reau?orization & _! sugge/ions = *anges 
to ?is "p z express$ "u p>agraph 7#b74  
7#d7 ,public review ( recomm5dations    
,aft] negotiations ) ! regulat$ indu/ry1
 ! ,secret>y %all--  7,a7 pres5t !      
recomm5dations develop$ "u p>agraph 7#a7
 to ! congressional committees specifi$ 
9 su* p>agraph2  7,b7 publi% su*        
recomm5dations 9 ! ,f$]al ,regi/]2  7,c7
 provide = a p]iod ( #cj days = ! public
 to provide writt5 comm5ts on su*       
recomm5dations2  7,d7 hold a meet+ at   
:i* ! public may pres5t its views on su*
 recomm5dations2 &  7,e7 aft]           
consid]ation ( su* public views &       
comm5ts1 revise su* recomm5dations z    
necess>y4  7#e7 ,transmittal (          
recomm5dations ,n lat] ?an ,janu>y #ae1 
#bjah1 ! ,secret>y %all transmit to     
,congress ! revis$ recomm5dations "u    
p>agraph 7#d71 a summ>y ( ! views &     
comm5ts receiv$ "u su* p>agraph1 & any  
*anges made to ! recomm5dations 9       

response to su* views & comm5ts4  7#f7  
,m9utes ( negotiation meet+s  7,a7      
,public availability ,be=e pres5t+ !    
recomm5dations develop$ "u p>agraphs    
7#a7 ?r\gh 7#e7 to ,congress1 !         
,secret>y %all make publicly available1 
on ! ,int]net ,web site ( ! ,food &     
,drug ,adm9i/ration1 m9utes ( all       
negotiation meet+s conduct$ "u ?is      
subsection betwe5 ! ,food & ,drug       
,adm9i/ration & ! regulat$ indu/ry4     
7,b7 ,cont5t ,! m9utes describ$ "u      
subp>agraph 7,a7 %all summ>ize any      
sub/antive proposal made by any p>ty to 
! negotiations z well z significant     
controv]sies or diff]5ces ( op9ion dur+ 
! negotiations & _! resolution4  4      
#bjd4 ,sav+s clause ,not)/&+ ! am5dm5ts 
made by ?is title1 "p #e ( sub*apt] ,c (
 *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act1 z 9 effect on ! day be=e
 ! date ( enactm5t ( ?is title1 %all    
cont9ue to be 9 effect ) respect to     
abbreviat$ applications = a g5]ic new   
animal drug & supplem5tal abbreviat$    

applications = a g5]ic new animal drug  
7z def9$ 9 su* "p z ( su* day7 t on or  
aft] ,octob] #a1 #bjjh1 b be=e ,octob]  
#a1 #bjac1 7 accept$ by ! ,food & ,drug 
,adm9i/ration = fil+ ) respect to       
assess+ & collect+ any fee requir$ by   
su* "p = a fiscal ye> prior to fiscal   
ye> #bjad4  #bje4 ,effective date ,!    
am5dm5ts made by ?is title %all take    
effect on ,octob] #a1 #bjac1 or ! date (
 enactm5t ( ?is ,act1 :i*ev] is lat]1   
except t fees "u "p #e ( sub*apt] ,c (  
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act1 z am5d$ by ?is title1   
%all be assess$ = all abbreviat$        
applications = a g5]ic new animal drug &
 supplem5tal abbreviat$ applications = a
 g5]ic new animal drug receiv$ on or    
aft] ,octob] #a1 #bjac1 reg>dless ( !   
date ( enactm5t ( ?is ,act4  #bjf4      
,sunset dates  7a7 ,au?orization        
,section #gda ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cgi;j-#ba7 %all cease to be effective  
,octob] #a1 #bjah4  7b7 ,report+        

requirem5ts ,section #gdb ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#bb7 %all cease to be  
effective ,janu>y #ca1 #bjai4  7c7      
,previ\s sunset provision  7#a7 ,9 g5]al
 ,section #bjd ( ! ,animal ,g5]ic ,drug 
,us] ,fee ,act ( #bjjh 7,public ,law    
#aaj-caf7 is repeal$4  7#b7 ,con=m+     
am5dm5t ,! ,animal ,g5]ic ,drug ,us]    
,fee ,act ( #bjjh 7,public ,law         
#aaj-caf7 is am5d$ 9 ! table ( cont5ts 9
 section #a1 by /rik+ ! item relat+ to  
section #bjd4  ,pass$ ! ,s5ate ,may #h1 
#bjac4  ,secret>y