,,ii ,cal5d> ,no4 #cda #aae? ,,congress 
#b;d ,session  ,s4 #bdcd  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates         
,febru>y #ae1 #bjah,mr4 ,alex&]         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,m>* #g1 #bjah,report$ by ,mr4 ,alex&]1 
) an amendment,strike out all aft] !    
enact+ clause & ins]t ! "p pr9t$ 9      
italic  ,a ,,bill  ,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 ,am5dm5ts ( #bjah4  #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,title             
,,iii--,miscellane\s provisions,sec4    
#cja4 ,electronic submissions4,sec4     
#cjb4 ,index ( legally m>ket$ unapprov$ 
new animal drugs = m9or species4,sec4   
#cjc4 ,misbr&$ drugs & devices4  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 ( #bjah4  7b7 ,f9d+     
,congress f9ds t ! fees au?oriz$ by !   
am5dm5ts made 9 ?is title w be d$icat$  
t[>d exp$it+ ! animal drug developm5t   
process & ! review ( new & supplem5tal  
animal drug applications &              
inve/igational animal drug submissions z
 set =? 9 ! goals id5tifi$ = purposes ( 
"p #d ( sub*apt] ,c ( *apt] ,,vii ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9
 ! lett]s f ! ,secret>y ( ,heal? &      
,human ,s]vices to ! ,*airman ( !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,*airman ( !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate z set =? 9
 ! ,congressional ,record4  #ajb4       
,def9itions ,section #gci 7#ba ,u4,s4,c4
 #cgi;j-#aa7 is am5d$-- 7#a7 by am5d+   
p>agraph 7#a7 to read z foll[s3  7#a7   
7,a7 ,! t]m animal drug application     
means-- 7i7 an application = approval ( 
any new animal drug submitt$ "u section 
#eab7;b77#a72 or  7ii7 an application = 
conditional approval ( a new animal drug

 submitt$ "u section #ega4  7,b7 ,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  2 &  7#b7 9 p>agraph 
7#h71 by add+ at ! end ! foll[+3  7,i7  
,! activities necess>y = implem5tation (
 ! ,unit$ ,/ates & ,european ,union     
,good ,manufactur+ ,practice ,mutual    
,inspection ,agreem5t ) respect to      
animal drug products subject to review1 
includ+ implem5tation activities prior  
to & foll[+ product approval4  4  #ajc4 
,au?ority to assess & use animal drug   
fees  7a7 ,fee rev5ue am\nts ,section   
#gdj7;b7 7#ba ,u4,s4,c4 #cgi;j-#ab7;b77 
is am5d$-- 7#a7 9 p>agraph 7#a7--  7,a7 
9 subp>agraph 7,a7-- 7i7 by /rik+ #bjad 
& ins]t+ #bjai2 &  7ii7 by /rik+        
#bc1fjj1jjj & ins]t+ #cj1cca1bdj2 &     
7,b7 9 subp>agraph 7,b7--  7i7 by /rik+ 
#bjae ?r\gh #bjah & ins]t+ #bjbj ?r\gh  
#bjbc2 &  7ii7 by /rik+ #ba1fjj1jjj &   
ins]t+ #bi1ica1bdj2 &  7#b7 9 p>agraph  
7#b71 9 ! matt] prec$+ subp>agraph 7,a71

 by /rik+ det]m9$ & ins]t+ e/abli%$4    
7b7 ,annual fee sett+2 adju/m5ts  7#a7  
,inflation adju/m5t ,section            
#gdj7;c77#b7 7#ba ,u4,s4,c4             
#cgi;j-#ab7;c77#b77 is am5d$--  7,a7 9 !
 matt] prec$+ subp>agraph 7,a7-- 7i7 by 
/rik+ ,= fiscal ye> #bjae & ins]t+ 7,a7 
,= fiscal ye> #bjbj2 &  7ii7 by ins]t+  
multiply+ su* rev5ue am\nts by be=e an  
am\nt2  7,b7 by r$esignat+ subp>agraphs 
7,a71 7,b71 & 7,c7 z clauses 7i71 7ii71 
& 7iii71 respectively2  7,c7 by /rik+ ! 
flu% text at ! end2 &  7,d7 by add+ at !
 end ! foll[+ new subp>agraph3  7,b7    
,comp\nd$ basis ,! adju/m5t made ea*    
fiscal ye> aft] fiscal ye> #bjbj "u ?is 
p>agraph %all be appli$ on a comp\nd$   
basis to ! rev5ue am\nt calculat$ "u ?is
 p>agraph = ! mo/ rec5t previ\s fiscal  
ye>4  4  7#b7 ,workload adju/m5ts       
,p>agraph 7#c7 ( section #gdj7;c7 7#ba  
,u4,s4,c4 #cgi;j-#ab7;c77 is am5d$ to   
read z foll[s3  7#c7 ,workload adju/m5ts
  7,a7 ,9 g5]al ,= fiscal ye> #bjbj &   
subsequ5t fiscal ye>s1 aft] ! fee rev5ue

 am\nts e/abli%$ "u subsection 7b7 are  
adju/$ = inflation 9 accordance )       
p>agraph 7#b71 ! fee rev5ue am\nts %all 
be fur!r adju/$ = su* fiscal ye> to     
reflect *anges 9 ! workload ( !         
,secret>y = ! process = ! review (      
animal drug applications1 subject to    
subp>agraphs 7,b7 & 7,c74 ,) respect to 
su* adju/m5t--  7i7 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 &  7ii7 !      
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 ! fees result+ f su* adju/m5t & !      
support+ me?odologies4  7,b7 ,r$uction (
 workload-bas$ increase by am\nt ( c]ta9
 excess collections ,= ea* ( fiscal ye>s
 #bjba ?r\gh #bjbc1 if application ( !  

workload adju/m5t "u subp>agraph 7,a7   
increases ! fee rev5ue am\nts o!rwise   
e/abli%$ = ! fiscal ye> "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b71 su* fee rev5ue increase %all be   
r$uc$ by ! am\nt ( any excess           
collections1 z describ$ 9 subsection    
7g77#d71 = ! second prec$+ fiscal ye>1  
up to ! am\nt ( su* fee rev5ue increase4
  7,c7 ,rule ( application ,"u no       
circum/ances %all ! workload adju/m5ts  
"u ?is p>agraph result 9 fee rev5ues = a
 fiscal ye> t are less ?an ! fee rev5ues
 = t fiscal ye> e/abli%$ "u subsection  
7b71 z adju/$ = inflation "u p>agraph   
7#b74  4  7#c7 ,f9al ye> adju/m5t       
,section #gdj7;c77#d7 7#ba ,u4,s4,c4    
#cgi;j-#ab7;c77#d77 is am5d$-- 7,a7 by  
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc2 &  7,b7 by /rik+ #bjai & ins]t+  
#bjbd4  7c7 ,exemptions f fees ,section 
#gdj7;d7 7#ba ,u4,s4,c4 #cgi;j-#ab7;d77 
is am5d$--  7#a7 9 ! subsection head+1  
by ins]t+ 2 exemptions f fees aft]      
r$uction2  7#b7 by /rik+ ! head+ (      

p>agraph 7#a7 & ins]t+ ,waiv] or        
r$uction2 &  7#c7 by add+ at ! end !    
foll[+3  7#d7 ,exemptions f fees  7,a7  
,c]ta9 label+ supplem5ts ,to add numb] (
 approv$ application ,fees "u ?is       
section %all n apply ) respect to any   
p]son :o--  7i7 n lat] ?an ,septemb]    
#cj1 #bjbc1 submits a supplem5tal animal
 drug application relat+ to a new animal
 drug application approv$ "u section    
#eab1 solely to add ! new animal drug   
application numb] to ! label+ ( ! drug 9
 ! mann] specifi$ 9 section #ejb7w77#c72
 &  7ii7 o!rwise w\ld be subject to fees
 "u ?is section solely on ! basis ( su* 
supplem5tal application4  7,b7 ,c]ta9   
animal drug applications ,fees "u       
p>agraphs 7#b71 7#c71 & 7#d7 (          
subsection 7a7 %all n apply ) respect to
 any p]son :o is ! nam$ applicant or    
sponsor ( an animal drug application1   
supplem5tal animal drug application1 or 
inve/igational animal drug submission if
 su* application or submission involves 
! int5tional g5omic alt]ation ( an      

animal t is int5d$ to produce a drug1   
device1 or biological product subject to
 fees "u section #gcf1 #gch1 #gdd;,b1 or
 #gdd;,h4  4  7d7 ,cr$it+ & availability
 ( fees  7#a7 ,au?orization (           
appropriations ,section #gdj7;g77#c7    
7#ba ,u4,s4,c4 #cgi;j-#ab7;g77#c77 is   
am5d$-- 7,a7 by /rik+ #bjad ?r\gh #bjah 
& ins]t+ #bjai ?r\gh #bjbc2  7,b7 by    
/rik+ det]m9$ & ins]t+ e/abli%$2 &  7,c7
 by /rik+ p>agraph 7#d7 & ins]t+        
p>agraph 7#e74  7#b7 ,excess collections
 ,section #gdj7;g7 7#ba ,u4,s4,c4       
#cgi;j-#ab7;g77 is am5d$ by /rik+       
p>agraph 7#d7 & ins]t+ ! foll[+3  7#d7  
,excess collections ,if ! sum total (   
fees collect$ "u ?is section = a fiscal 
ye> exce$s ! am\nt ( fees au?oriz$ to be
 appropriat$ = su* ye> "u p>agraph 7#c71
 ! excess collections %all be cr$it$ to 
! appropriations acc\nt ( ! ,food &     
,drug ,adm9i/ration z describ$ 9        
p>agraph 7#a74  7#e7 ,recov]y (         
collection %ortfalls  7,a7 ,9 g5]al     
,subject to subp>agraph 7,b7-- 7i7 =    

fiscal ye> #bjba1 ! 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> #bjai falls    
bel[ ! am\nt ( fees au?oriz$ = fiscal   
ye> #bjai "u p>agraph 7#c72  7ii7 =     
fiscal ye> #bjbb1 ! 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> #bjbj falls    
bel[ ! am\nt ( fees au?oriz$ = fiscal   
ye> #bjbj "u p>agraph 7#c72 &  7iii7 =  
fiscal ye> #bjbc1 ! am\nt ( fees o!rwise
 au?oriz$ to be collect$ "u ?is section 
%all be increas$ by ! cumulative am\nt1 
if any1 by :i* ! am\nt collect$ "u ?is  
section & appropriat$ = fiscal ye>s     
#bjba & #bjbb 7includ+ e/imat$          
collections = fiscal ye> #bjbb7 falls   
bel[ ! cumulative am\nt ( fees au?oriz$ 
= su* fiscal ye>s "u p>agraph 7#c74     
7,b7 ,r$uction ( %ortfall-bas$ fee      
increase by prior ye> excess collections

  7i7 ,9 g5]al ,subject to clause 7ii71 
! ,secret>y %all1 9 su* mann] z !       
,secret>y det]m9es appropriate1 r$uce   
any fee increase o!rwise applicable = a 
fiscal ye> "u subp>agraph 7,a7 by !     
am\nt ( any excess collections "u ?is   
section = prec$+ fiscal ye>s 7aft]      
fiscal ye> #bjah74  7ii7 ,workload-bas$ 
fee acc\nt+ ,9 apply+ clause 7i71 !     
,secret>y %all acc\nt = ! r$uction (    
workload-bas$ fee rev5ue increases by   
excess collections "u subsection        
7c77#c77;,b71 9 su* mann] z ne$$ to     
provide t no portion ( any excess       
collections describ$ 9 clause 7i7 is    
appli$ = purposes ( r$uc+ fee increases 
"u bo? su* subsection 7c77#c77;,b7 & ?is
 p>agraph4  7,c7 ,rule ( application ,"u
 no circum/ances %all adju/m5ts "u ?is  
p>agraph result 9 fee rev5ues = a fiscal
 ye> t are less ?an ! fee rev5ues = t   
fiscal ye> e/abli%$ 9 subsection 7b71 z 
adju/$ or o!rwise affect$ "u subsection 
7c74  4  #ajd4 ,reau?orization2 report+ 
requirem5ts ,section #gdj;,a 7#ba       

,u4,s4,c4 #cgi;j-#ac7 is am5d$-- 7#a7 9 
subsection 7a71 by /rik+ #bjac & ins]t+ 
#bjah2  7#b7 by /rik+ #bjad ea* place x 
appe>s 9 subsections 7a7 & 7b7 & ins]t+ 
#bjai2 &  7#c7 9 subsection 7d71 by     
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc4  #aje4 ,sav+s clause ,not)/&+ !  
am5dm5ts made by ?is title1 "p #d (     
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]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 #bjac1 b be=e ,octob] #a1  
#bjah1 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> #bjai4  #ajf4 ,effective date ,!    
am5dm5ts made by ?is title %all take    
effect on ,octob] #a1 #bjah1 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$ = animal drug           
applications & supplem5tal animal drug  
applications receiv$ on or aft] ,octob] 
#a1 #bjah1 reg>dless ( ! date ( !       
enactm5t ( ?is ,act4  #ajg4 ,sunset     
dates  7a7 ,au?orization ,section #gdj (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgi;j-#ab7 %all cease  
to be effective ,octob] #a1 #bjbc4  7b7 
,report+ requirem5ts ,section #gdj;,a ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgi;j-#ac7 %all cease to
 be effective ,janu>y #ca1 #bjbd4  7c7  
,previ\s sunset provision ,effective    
,octob] #a1 #bjah1 subsections 7a7 & 7b7
 ( section #ajg ( ! ,animal ,drug ,us]  
,fee ,am5dm5ts ( #bjac 7,public ,law    
#aac-ad7 are 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 ( #bjah4  7b7 ,f9d+ 

,congress f9ds t ! fees au?oriz$ by !   
am5dm5ts made 9 ?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$
 = purposes ( "p #e ( sub*apt] ,c (     
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act1 9 ! lett]s f ! ,secret>y
 ( ,heal? & ,human ,s]vices to !        
,*airman ( ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,*airman ( ! ,committee on ,heal?1     
,education1 ,labor1 & ,p5sions ( !      
,s5ate z set =? 9 ! ,congressional      
,record4  #bjb4 ,au?ority to assess &   
use g5]ic new animal drug fees  7a7 ,fee
 rev5ue am\nts ,subsection 7b7 ( section
 #gda 7#ba ,u4,s4,c4 #cgi;j-#ba7 is     
am5d$ to read z foll[s3  7b7 ,fee rev5ue
 am\nts  7#a7 ,9 g5]al ,subject to      
subsections 7c71 7d71 7f71 & 7g71 = ea* 

( fiscal ye>s #bjai ?r\gh #bjbc1 ! fees 
requir$ "u subsection 7a7 %all be       
e/abli%$ to g5]ate a total rev5ue am\nt 
( #ah1ccf1cdj4  7#b7 ,types ( fees ,( ! 
total rev5ue am\nt e/abli%$ = a fiscal  
ye> "u p>agraph 7#a7-- 7,a7 #be p]c5t   
%all be d]iv$ f fees "u subsection      
7a77#a7 7relat+ to abbreviat$           
applications = a g5]ic new animal drug72
  7,b7 #cg4e p]c5t %all be d]iv$ f fees 
"u subsection 7a77#b7 7relat+ to g5]ic  
new animal drug products72 &  7,c7 #cg4e
 p]c5t %all be d]iv$ f fees "u          
subsection 7a77#c7 7relat+ to g5]ic new 
animal drug sponsors74  4  7b7 ,annual  
fee sett+2 adju/m5ts  7#a7 ,inflation   
adju/m5t ,section #gda7;c7 7#ba         
,u4,s4,c4 #cgi;j-#ba7;c77 is am5d$--    
7,a7 by r$esignat+ p>agraphs 7#b7 ?r\gh 
7#d7 z p>agraphs 7#c7 ?r\gh 7#e71       
respectively2 &  7,b7 by ins]t+ aft]    
p>agraph 7#a7 ! foll[+3  7#b7 ,inflation
 adju/m5t  7,a7 ,9 g5]al ,= fiscal ye>  
#bjbj & subsequ5t fiscal ye>s1 ! rev5ue 
am\nts e/abli%$ "u subsection 7b7 %all  

be adju/$ by ! ,secret>y by notice1     
publi%$ 9 ! ,f$]al ,regi/]1 = a fiscal  
ye>1 by multiply+ su* rev5ue am\nts by  
an am\nt equal to ! sum (--  7i7 "o2    
7ii7 ! av]age annual p]c5t *ange 9 !    
co/1 p] full-"t equival5t position ( !  
,food & ,drug ,adm9i/ration1 ( all      
p]sonnel comp5sation & b5efits paid )   
respect to su* positions = ! fir/ #c ( !
 prec$+ #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 ( !      
prec$+ #d fiscal ye>s = :i* data are    
available2 &  7iii7 ! av]age annual     
p]c5t *ange t occurr$ 9 ! ,consum]      
,price ,index = urban consum]s          
7,wa%+ton-,baltimore1                   
,,dc-,,md-,,va-,,wv2 n seasonally       
adju/$2 all items less food & en]gy2    
annual index7 = ! fir/ #c ( ! prec$+ #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 ( ! prec$+ #d fiscal   
ye>s = :i* data are available4  7,b7    
,comp\nd$ basis ,! adju/m5t made ea*    
fiscal ye> aft] fiscal ye> #bjbj "u ?is 
p>agraph %all be appli$ on a comp\nd$   
basis to ! rev5ue am\nt calculat$ "u ?is
 p>agraph = ! mo/ rec5t previ\s fiscal  
ye>4  4  7#b7 ,workload adju/m5ts       
,p>agraph 7#c7 ( section #gda7;c7 7#ba  
,u4,s4,c4 #cgi;j-#ba7;c771 z r$esignat$1
 is am5d$ to read z foll[s3  7#c7       
,workload adju/m5ts  7,a7 ,9 g5]al ,=   
fiscal ye> #bjbj & subsequ5t fiscal     
ye>s1 aft] ! fee rev5ue am\nts e/abli%$ 
"u subsection 7b7 are adju/$ = inflation
 9 accordance ) p>agraph 7#b71 ! fee    
rev5ue am\nts %all be fur!r adju/$ = ea*
 su* fiscal ye> to reflect *anges 9 !   
workload ( ! ,secret>y = ! process = !  
review ( abbreviat$ applications = g5]ic
 new animal drugs1 subject to           
subp>agraphs 7,b7 & 7,c74 ,) respect to 
su* adju/m5t--  7i7 ?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>y2 &  7ii7 ! ,secret>y %all     
publi% 9 ! ,f$]al ,regi/] ! fees result+
 f ?is adju/m5t & ! support+            
me?odologies4  7,b7 ,r$uction (         
workload-bas$ increase by am\nt ( c]ta9 
excess collections ,= ea* ( fiscal ye>s 
#bjba ?r\gh #bjbc1 if application ( !   
workload adju/m5t "u subp>agraph 7,a7   
increases ! fee rev5ue am\nts o!rwise   
e/abli%$ = ! fiscal ye> "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b71 su* fee rev5ue increase %all be   
r$uc$ by ! am\nt ( any excess           
collections1 z describ$ 9 subsection    
7g77#d71 = ! second prec$+ fiscal ye>1  
up to ! am\nt ( su* fee rev5ue increase4
  7,c7 ,rule ( application ,"u no       

circum/ances %all workload adju/m5ts "u 
?is p>agraph result 9 fee rev5ues = a   
fiscal ye> t are less ?an ! fee rev5ues 
= t fiscal ye> e/abli%$ "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b74  4  7#c7 ,f9al ye> adju/m5t       
,p>agraph 7#d7 ( section #gda7;c7 7#ba  
,u4,s4,c4 #cgi;j-#ba7;c771 z r$esignat$1
 is am5d$ by-- 7,a7 /rik+ #bjah ea*     
place x appe>s & ins]t+ #bjbc2 &  7,b7  
/rik+ #bjai & ins]t+ #bjbd4  7c7 ,fee   
waiv] or r$uction2 exemption f fees     
,subsection 7d7 ( section #gda 7#ba     
,u4,s4,c4 #cgi;j-#ba7 is am5d$ to read z
 foll[s3  7d7 ,fee waiv] or r$uction2   
exemption f fees  7#a7 ,fee waiv] or    
r$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  7#b7 ,exemption f  
fees ,fees "u ?is section %all n apply )
 respect to any p]son :o-- 7,a7 n lat]  
?an ,septemb] #cj1 #bjbc1 submits a     

supplem5tal abbreviat$ application = a  
g5]ic new animal drug approv$ "u section
 #eab1 solely to add ! application numb]
 to ! label+ ( ! drug 9 ! mann] specifi$
 9 section #ejb7w77#c72 &  7,b7 o!rwise 
w\ld be subject to fees "u ?is section  
solely on ! basis ( su* supplem5tal     
abbreviat$ application4  4  7d7 ,cr$it+ 
& availability ( fees ,section #gda7;g7 
7#ba ,u4,s4,c4 #cgi;j-#ba7 is am5d$ by  
/rik+ p>agraph 7#c7 & ins]t+ ! foll[+   
p>agraphs3  7#c7 ,au?orization (        
appropriations ,= ea* ( ! fiscal ye>s   
#bjai ?r\gh #bjbc1 !re is au?oriz$ to be
 appropriat$ = fees "u ?is section an   
am\nt equal to ! total rev5ue am\nt     
e/abli%$ "u subsection 7b7 = ! fiscal   
ye>1 z adju/$ or o!rwise affect$ "u     
subsection 7c74  7#d7 ,excess           
collections ,if ! sum total ( fees      
collect$ "u ?is section = a fiscal ye>  
exce$s ! am\nt ( fees au?oriz$ to be    
appropriat$ = su* ye> "u p>agraph 7#c71 
! excess collections %all be cr$it$ to !
 appropriations acc\nt ( ! ,food & ,drug

 ,adm9i/ration z describ$ 9 p>agraph    
7#a74  4  #bjc4 ,reau?orization2 report+
 requirem5ts ,section #gdb 7#ba         
,u4,s4,c4 #cgi;j-#bb7 is am5d$-- 7#a7 9 
subsection 7a71 by /rik+ #bjac & ins]t+ 
#bjah2  7#b7 by /rik+ #bjad ea* place x 
appe>s 9 subsections 7a7 & 7b7 & ins]t+ 
#bjai2 &  7#c7 9 subsection 7d71 by     
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc4  #bjd4 ,sav+s clause ,not)/&+ !  
am5dm5ts made by ?is title1 "p #e (     
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ba et seq471 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 #bjac1 b  
be=e ,octob] #a1 #bjah1 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> #bjai4  #bje4 ,effective  
date ,! am5dm5ts made by ?is title %all 
take effect on ,octob] #a1 #bjah1 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$ = abbreviat$     
applications = a g5]ic new animal drug &
 supplem5tal abbreviat$ applications = a
 g5]ic new animal drug receiv$ on or    
aft] ,octob] #a1 #bjah1 reg>dless ( !   
date ( enactm5t ( ?is ,act4  #bjf4      
,sunset dates  7a7 ,au?orization        
,section #gda ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cgi;j-#ba7 %all cease to be effective  
,octob] #a1 #bjbc4  7b7 ,report+        
requirem5ts ,section #gdb ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#bb7 %all cease to be  
effective ,janu>y #ca1 #bjbd4  7c7      
,previ\s sunset provision ,effective    
,octob] #a1 #bjah1 subsections 7a7 & 7b7
 ( section #bjf ( ! ,animal ,g5]ic ,drug

 ,us] ,fee ,am5dm5ts ( #bjac 7,public   
,law #aac-ad7 are repeal$4  ,,iii       
,miscellane\s provisions  #cja4         
,electronic submissions  7a7 ,new animal
 drug applications & abbreviat$         
applications = a g5]ic new animal drug  
,section #eab7;b7 7#ba ,u4,s4,c4        
#cfj;b7b77 is am5d$ by add+ at ! end !  
foll[+3  7#d7 ,beg9n+ on ,octob] #a1    
#bjah1 all applications or submissions  
pursuant to ?is subsection %all be      
submitt$ by electronic means 9 su* =mat 
z ! ,secret>y may require4  4  7b7      
,conditional approval ( new animal drugs
 = m9or use & m9or species ,section     
#ega7;a7 7#ba ,u4,s4,c4 #cfj;ccc7a77 is 
am5d$ by add+ at ! end ! foll[+3  7#d7  
,beg9n+ on ,octob] #a1 #bjah1 all       
applications or submissions pursuant to 
?is subsection %all be submitt$ by      
electronic means 9 su* =mat z !         
,secret>y may require4  4  #cjb4 ,index 
( legally m>ket$ unapprov$ new animal   
drugs = m9or species ,effective on      
,octob] #a1 #bjah1 section #egb7;h7 7#ba

 ,u4,s4,c4 #cfj;ccc-#a7;h77 is am5d$--  
7#a7 by am5d+ p>agraph 7#a7 to read z   
foll[s3  7#a7 ,,legal ,,/atus--,9 ord]  
to be legally m>ket$1 a new animal drug 
int5d$ = a m9or species mu/ be ,approv$1
 ,conditionally ,approv$1 or ,index$ by 
! ,food & ,drug ,adm9i/ration4 ,,?is    
,,product ,,is ,,index$--,,mif4 7foll[$ 
by ! applicable m9or species index file 
numb] & a p]iod7 ,extra-label use is    
prohibit$42  2 &  7#b7 9 p>agraph 7#b71 
by /rik+ o!r animals & ins]t+           
food-produc+ animals4  #cjc4 ,misbr&$   
drugs & devices  7a7 ,9 g5]al ,section  
#ejb7w7 7#ba ,u4,s4,c4 #ceb7w77 is      
am5d$--  7#a7 9 p>agraph 7#a71 by /rik+ 
2 or & ins]t+ 22  7#b7 9 p>agraph 7#b71 
by /rik+ ! p]iod & ins]t+ 2 or2 &  7#c7 
by add+ at ! end ! foll[+3  7#c7 = :i*  
an application has be5 approv$ "u       
section #eab & ! label+ ( su* drug does 
n include ! application numb] 9 ! =mat3 
,approv$ by ,,fda "u 7,a7,,nada         
xxx-xxx1 except t ?is subp>agraph %all n
 apply to repres5tative label+ requir$  

"u section #ead4a7;b77#c77v77b7 ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulation7 = animal fe$ be>+
 or conta9+ a new animal drug4  4  7b7  
,applicability ,section #ejb7w77#c7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7a71 %all apply     
beg9n+ on ,septemb] #cj1 #bjbc4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,animal ,drug & ,animal ,g5]ic ,drug    
,us] ,fee ,am5dm5ts ( #bjah4  #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,,title            
,,iii--,miscellane\s provisions,sec4    
#cja4 ,electronic submissions4,sec4     
#cjb4 ,index ( legally m>ket$ unapprov$ 
new animal drugs = m9or species4,sec4   
#cjc4 ,misbr&$ drugs & devices4,sec4    
#cjd4 ,issuance ( recomm5dations4,sec4  
#cje4 ,guidance address+ inve/igation   
designs4,sec4 #cjf4 ,food additives     
int5d$ = use 9 animal food4  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 ( #bjah4  7b7 ,f9d+     
,congress f9ds t ! fees au?oriz$ by !   

am5dm5ts made 9 ?is title w be d$icat$  
t[>d exp$it+ ! animal drug developm5t   
process & ! review ( new & supplem5tal  
animal drug applications &              
inve/igational animal drug submissions z
 set =? 9 ! goals id5tifi$ = purposes ( 
"p #d ( sub*apt] ,c ( *apt] ,,vii ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9
 ! lett]s f ! ,secret>y ( ,heal? &      
,human ,s]vices to ! ,*airman ( !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,*airman ( !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate z set =? 9
 ! ,congressional ,record4  #ajb4       
,def9itions ,section #gci 7#ba ,u4,s4,c4
 #cgi;j-#aa7 is am5d$-- 7#a7 by am5d+   
p>agraph 7#a7 to read z foll[s3  7#a7   
7,a7 ,! t]m animal drug application     
means-- 7i7 an application = approval ( 
any new animal drug submitt$ "u section 
#eab7;b77#a72 or  7ii7 an application = 
conditional approval ( a new animal drug
 submitt$ "u section #ega4  7,b7 ,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  2 &  7#b7 9 p>agraph 
7#h71 by add+ at ! end ! foll[+3  7,i7  
,! activities necess>y = implem5tation (
 ! ,unit$ ,/ates & ,european ,union     
,good ,manufactur+ ,practice ,mutual    
,inspection ,agreem5t ) respect to      
animal drug products subject to review1 
includ+ implem5tation activities prior  
to & foll[+ product approval4  4  #ajc4 
,au?ority to assess & use animal drug   
fees  7a7 ,fee rev5ue am\nts ,section   
#gdj7;b7 7#ba ,u4,s4,c4 #cgi;j-#ab7;b77 
is am5d$-- 7#a7 9 p>agraph 7#a7--  7,a7 
9 subp>agraph 7,a7-- 7i7 by /rik+ #bjad 
& ins]t+ #bjai2 &  7ii7 by /rik+        
#bc1fjj1jjj & ins]t+ #cj1cca1bdj2 &     
7,b7 9 subp>agraph 7,b7--  7i7 by /rik+ 
#bjae ?r\gh #bjah & ins]t+ #bjbj ?r\gh  
#bjbc2 &  7ii7 by /rik+ #ba1fjj1jjj &   
ins]t+ #bi1ica1bdj2 &  7#b7 9 p>agraph  
7#b71 9 ! matt] prec$+ subp>agraph 7,a71
 by /rik+ det]m9$ & ins]t+ e/abli%$4    
7b7 ,annual fee sett+2 adju/m5ts  7#a7  

,inflation adju/m5t ,section            
#gdj7;c77#b7 7#ba ,u4,s4,c4             
#cgi;j-#ab7;c77#b77 is am5d$--  7,a7 9 !
 matt] prec$+ subp>agraph 7,a7-- 7i7 by 
/rik+ ,= fiscal ye> #bjae & ins]t+ 7,a7 
,= fiscal ye> #bjbj2 &  7ii7 by ins]t+  
multiply+ su* rev5ue am\nts by be=e an  
am\nt2  7,b7 by r$esignat+ subp>agraphs 
7,a71 7,b71 & 7,c7 z clauses 7i71 7ii71 
& 7iii71 respectively2  7,c7 by /rik+ ! 
flu% text at ! end2 &  7,d7 by add+ at !
 end ! foll[+ new subp>agraph3  7,b7    
,comp\nd$ basis ,! adju/m5t made ea*    
fiscal ye> aft] fiscal ye> #bjbj "u ?is 
p>agraph %all be appli$ on a comp\nd$   
basis to ! rev5ue am\nt calculat$ "u ?is
 p>agraph = ! mo/ rec5t previ\s fiscal  
ye>4  4  7#b7 ,workload adju/m5ts       
,p>agraph 7#c7 ( section #gdj7;c7 7#ba  
,u4,s4,c4 #cgi;j-#ab7;c77 is am5d$ to   
read z foll[s3  7#c7 ,workload adju/m5ts
  7,a7 ,9 g5]al ,= fiscal ye> #bjbj &   
subsequ5t fiscal ye>s1 aft] ! fee rev5ue
 am\nts e/abli%$ "u subsection 7b7 are  
adju/$ = inflation 9 accordance )       

p>agraph 7#b71 ! fee rev5ue am\nts %all 
be fur!r adju/$ = su* fiscal ye> to     
reflect *anges 9 ! workload ( !         
,secret>y = ! process = ! review (      
animal drug applications1 subject to    
subp>agraphs 7,b7 & 7,c74 ,) respect to 
su* adju/m5t--  7i7 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 &  7ii7 !      
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 ! fees result+ f su* adju/m5t & !      
support+ me?odologies4  7,b7 ,r$uction (
 workload-bas$ increase by am\nt ( c]ta9
 excess collections ,= ea* ( fiscal ye>s
 #bjba ?r\gh #bjbc1 if application ( !  
workload adju/m5t "u subp>agraph 7,a7   
increases ! fee rev5ue am\nts o!rwise   

e/abli%$ = ! fiscal ye> "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b71 su* fee rev5ue increase %all be   
r$uc$ by ! am\nt ( any excess           
collections1 z describ$ 9 subsection    
7g77#d71 = ! second prec$+ fiscal ye>1  
up to ! am\nt ( su* fee rev5ue increase4
  7,c7 ,rule ( application ,"u no       
circum/ances %all ! workload adju/m5ts  
"u ?is p>agraph result 9 fee rev5ues = a
 fiscal ye> t are less ?an ! fee rev5ues
 = t fiscal ye> e/abli%$ "u subsection  
7b71 z adju/$ = inflation "u p>agraph   
7#b74  4  7#c7 ,f9al ye> adju/m5t       
,section #gdj7;c77#d7 7#ba ,u4,s4,c4    
#cgi;j-#ab7;c77#d77 is am5d$-- 7,a7 by  
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc2 &  7,b7 by /rik+ #bjai & ins]t+  
#bjbd4  7c7 ,exemptions f fees ,section 
#gdj7;d7 7#ba ,u4,s4,c4 #cgi;j-#ab7;d77 
is am5d$--  7#a7 9 ! subsection head+1  
by ins]t+ 2 exemptions f fees aft]      
r$uction2  7#b7 by /rik+ ! head+ (      
p>agraph 7#a7 & ins]t+ ,waiv] or        
r$uction2 &  7#c7 by add+ at ! end !    

foll[+3  7#d7 ,exemptions f fees  7,a7  
,c]ta9 label+ supplem5ts ,to add numb] (
 approv$ application ,fees "u ?is       
section %all n apply ) respect to any   
p]son :o--  7i7 n lat] ?an ,septemb]    
#cj1 #bjbc1 submits a supplem5tal animal
 drug application relat+ to a new animal
 drug application approv$ "u section    
#eab1 solely to add ! new animal drug   
application numb] to ! label+ ( ! drug 9
 ! mann] specifi$ 9 section #ejb7w77#c72
 &  7ii7 o!rwise w\ld be subject to fees
 "u ?is section solely on ! basis ( su* 
supplem5tal application4  7,b7 ,c]ta9   
animal drug applications ,fees "u       
p>agraphs 7#b71 7#c71 & 7#d7 (          
subsection 7a7 %all n apply ) respect to
 any p]son :o is ! nam$ applicant or    
sponsor ( an animal drug application1   
supplem5tal animal drug application1 or 
inve/igational animal drug submission if
 su* application or submission involves 
! int5tional g5omic alt]ation ( an      
animal t is int5d$ to produce a drug1   
device1 or biological product subject to

 fees "u section #gcf1 #gch1 #gdd;,b1 or
 #gdd;,h4  4  7d7 ,cr$it+ & availability
 ( fees  7#a7 ,au?orization (           
appropriations ,section #gdj7;g77#c7    
7#ba ,u4,s4,c4 #cgi;j-#ab7;g77#c77 is   
am5d$-- 7,a7 by /rik+ #bjad ?r\gh #bjah 
& ins]t+ #bjai ?r\gh #bjbc2  7,b7 by    
/rik+ det]m9$ & ins]t+ e/abli%$2 &  7,c7
 by /rik+ p>agraph 7#d7 & ins]t+        
p>agraph 7#e74  7#b7 ,excess collections
 ,section #gdj7;g7 7#ba ,u4,s4,c4       
#cgi;j-#ab7;g77 is am5d$ by /rik+       
p>agraph 7#d7 & ins]t+ ! foll[+3  7#d7  
,excess collections ,if ! sum total (   
fees collect$ "u ?is section = a fiscal 
ye> exce$s ! am\nt ( fees au?oriz$ to be
 appropriat$ = su* ye> "u p>agraph 7#c71
 ! excess collections %all be cr$it$ to 
! appropriations acc\nt ( ! ,food &     
,drug ,adm9i/ration z provid$ 9 p>agraph
 7#a74  7#e7 ,recov]y ( collection      
%ortfalls  7,a7 ,9 g5]al ,subject to    
subp>agraph 7,b7-- 7i7 = fiscal ye>     
#bjba1 ! 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> #bjai falls    
bel[ ! am\nt ( fees au?oriz$ = fiscal   
ye> #bjai "u p>agraph 7#c72  7ii7 =     
fiscal ye> #bjbb1 ! 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> #bjbj falls    
bel[ ! am\nt ( fees au?oriz$ = fiscal   
ye> #bjbj "u p>agraph 7#c72 &  7iii7 =  
fiscal ye> #bjbc1 ! am\nt ( fees o!rwise
 au?oriz$ to be collect$ "u ?is section 
%all be increas$ by ! cumulative am\nt1 
if any1 by :i* ! am\nt collect$ "u ?is  
section & appropriat$ = fiscal ye>s     
#bjba & #bjbb 7includ+ e/imat$          
collections = fiscal ye> #bjbb7 falls   
bel[ ! cumulative am\nt ( fees au?oriz$ 
= su* fiscal ye>s "u p>agraph 7#c74     
7,b7 ,r$uction ( %ortfall-bas$ fee      
increase by prior ye> excess collections
  7i7 ,9 g5]al ,subject to clause 7ii71 
! ,secret>y %all1 9 su* mann] z !       

,secret>y det]m9es appropriate1 r$uce   
any fee increase o!rwise applicable = a 
fiscal ye> "u subp>agraph 7,a7 by !     
am\nt ( any excess collections "u ?is   
section = prec$+ fiscal ye>s 7aft]      
fiscal ye> #bjah74  7ii7 ,workload-bas$ 
fee acc\nt+ ,9 apply+ clause 7i71 !     
,secret>y %all acc\nt = ! r$uction (    
workload-bas$ fee rev5ue increases by   
excess collections "u subsection        
7c77#c77;,b71 9 su* mann] z ne$$ to     
provide t no portion ( any excess       
collections describ$ 9 clause 7i7 is    
appli$ = purposes ( r$uc+ fee increases 
"u bo? su* subsection 7c77#c77;,b7 & ?is
 p>agraph4  7,c7 ,rule ( application ,"u
 no circum/ances %all adju/m5ts "u ?is  
p>agraph result 9 fee rev5ues = a fiscal
 ye> t are less ?an ! fee rev5ues = t   
fiscal ye> e/abli%$ 9 subsection 7b71 z 
adju/$ or o!rwise affect$ "u subsection 
7c74  4  #ajd4 ,reau?orization2 report+ 
requirem5ts ,section #gdj;,a 7#ba       
,u4,s4,c4 #cgi;j-#ac7 is am5d$-- 7#a7 9 
subsection 7a71 by /rik+ #bjac & ins]t+ 

#bjah2  7#b7 by /rik+ #bjad ea* place x 
appe>s 9 subsections 7a7 & 7b7 & ins]t+ 
#bjai2 &  7#c7 9 subsection 7d71 by     
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc4  #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 #bjac1 b be=e ,octob] #a1  
#bjah1 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> #bjai4  #ajf4 ,effective date ,!    
am5dm5ts made by ?is title %all take    
effect on ,octob] #a1 #bjah1 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$ = animal drug           
applications & supplem5tal animal drug  
applications receiv$ on or aft] ,octob] 
#a1 #bjah1 reg>dless ( ! date ( !       
enactm5t ( ?is ,act4  #ajg4 ,sunset     
dates  7a7 ,au?orization ,section #gdj (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgi;j-#ab7 %all cease  
to be effective ,octob] #a1 #bjbc4  7b7 
,report+ requirem5ts ,section #gdj;,a ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgi;j-#ac7 %all cease to
 be effective ,janu>y #ca1 #bjbd4  7c7  
,previ\s sunset provision ,effective    
,octob] #a1 #bjah1 subsections 7a7 & 7b7
 ( section #ajg ( ! ,animal ,drug ,us]  
,fee ,am5dm5ts ( #bjac 7,public ,law    
#aac-ad7 are 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 ( #bjah4  7b7 ,f9d+ 
,congress f9ds t ! fees au?oriz$ by !   
am5dm5ts made 9 ?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$
 = purposes ( "p #e ( sub*apt] ,c (     
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act1 9 ! lett]s f ! ,secret>y
 ( ,heal? & ,human ,s]vices to !        
,*airman ( ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,*airman ( ! ,committee on ,heal?1     
,education1 ,labor1 & ,p5sions ( !      
,s5ate z set =? 9 ! ,congressional      
,record4  #bjb4 ,au?ority to assess &   
use g5]ic new animal drug fees  7a7 ,fee
 rev5ue am\nts ,subsection 7b7 ( section
 #gda 7#ba ,u4,s4,c4 #cgi;j-#ba7 is     
am5d$ to read z foll[s3  7b7 ,fee rev5ue
 am\nts  7#a7 ,9 g5]al ,subject to      
subsections 7c71 7d71 7f71 & 7g71 = ea* 
( fiscal ye>s #bjai ?r\gh #bjbc1 ! fees 
requir$ "u subsection 7a7 %all be       

e/abli%$ to g5]ate a total rev5ue am\nt 
( #ah1ccf1cdj4  7#b7 ,types ( fees ,( ! 
total rev5ue am\nt e/abli%$ = a fiscal  
ye> "u p>agraph 7#a7-- 7,a7 #be p]c5t   
%all be d]iv$ f fees "u subsection      
7a77#a7 7relat+ to abbreviat$           
applications = a g5]ic new animal drug72
  7,b7 #cg4e p]c5t %all be d]iv$ f fees 
"u subsection 7a77#b7 7relat+ to g5]ic  
new animal drug products72 &  7,c7 #cg4e
 p]c5t %all be d]iv$ f fees "u          
subsection 7a77#c7 7relat+ to g5]ic new 
animal drug sponsors74  4  7b7 ,annual  
fee sett+2 adju/m5ts  7#a7 ,inflation   
adju/m5t ,section #gda7;c7 7#ba         
,u4,s4,c4 #cgi;j-#ba7;c77 is am5d$--    
7,a7 by r$esignat+ p>agraphs 7#b7 ?r\gh 
7#d7 z p>agraphs 7#c7 ?r\gh 7#e71       
respectively2 &  7,b7 by ins]t+ aft]    
p>agraph 7#a7 ! foll[+3  7#b7 ,inflation
 adju/m5t  7,a7 ,9 g5]al ,= fiscal ye>  
#bjbj & subsequ5t fiscal ye>s1 ! rev5ue 
am\nts e/abli%$ "u subsection 7b7 %all  
be adju/$ by ! ,secret>y by notice1     
publi%$ 9 ! ,f$]al ,regi/]1 = a fiscal  

ye>1 by multiply+ su* rev5ue am\nts by  
an am\nt equal to ! sum (--  7i7 "o2    
7ii7 ! 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 ( !      
prec$+ #d fiscal ye>s = :i* data are    
available2 &  7iii7 ! av]age annual     
p]c5t *ange t occurr$ 9 ! ,consum]      
,price ,index = urban consum]s          
7,wa%+ton-,baltimore1                   
,,dc-,,md-,,va-,,wv2 n seasonally       
adju/$2 all items less food & en]gy2    
annual index7 = ! fir/ #c ( ! prec$+ #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   
7,b7 ,comp\nd$ basis ,! adju/m5t made   
ea* fiscal ye> aft] fiscal ye> #bjbj "u 
?is p>agraph %all be appli$ on a        
comp\nd$ basis to ! rev5ue am\nt        
calculat$ "u ?is p>agraph = ! mo/ rec5t 
previ\s fiscal ye>4  4  7#b7 ,workload  
adju/m5ts ,p>agraph 7#c7 ( section      
#gda7;c7 7#ba ,u4,s4,c4 #cgi;j-#ba7;c771
 z r$esignat$1 is am5d$ to read z       
foll[s3  7#c7 ,workload adju/m5ts  7,a7 
,9 g5]al ,= fiscal ye> #bjbj & subsequ5t
 fiscal ye>s1 aft] ! fee rev5ue am\nts  
e/abli%$ "u subsection 7b7 are adju/$ = 
inflation 9 accordance ) p>agraph 7#b71 
! fee rev5ue am\nts %all be fur!r adju/$
 = ea* su* fiscal ye> to reflect *anges 
9 ! workload ( ! ,secret>y = ! process =
 ! review ( abbreviat$ applications =   
g5]ic new animal drugs1 subject to      
subp>agraphs 7,b7 & 7,c74 ,) respect to 
su* adju/m5t--  7i7 ?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>y2 &  7ii7 ! ,secret>y %all     
publi% 9 ! ,f$]al ,regi/] ! fees result+
 f ?is adju/m5t & ! support+            
me?odologies4  7,b7 ,r$uction (         
workload-bas$ increase by am\nt ( c]ta9 
excess collections ,= ea* ( fiscal ye>s 
#bjba ?r\gh #bjbc1 if application ( !   
workload adju/m5t "u subp>agraph 7,a7   
increases ! fee rev5ue am\nts o!rwise   
e/abli%$ = ! fiscal ye> "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b71 su* fee rev5ue increase %all be   
r$uc$ by ! am\nt ( any excess           
collections1 z describ$ 9 subsection    
7g77#d71 = ! second prec$+ fiscal ye>1  
up to ! am\nt ( su* fee rev5ue increase4
  7,c7 ,rule ( application ,"u no       
circum/ances %all workload adju/m5ts "u 
?is p>agraph result 9 fee rev5ues = a   

fiscal ye> t are less ?an ! fee rev5ues 
= t fiscal ye> e/abli%$ "u subsection   
7b71 z adju/$ = inflation "u p>agraph   
7#b74  4  7#c7 ,f9al ye> adju/m5t       
,p>agraph 7#d7 ( section #gda7;c7 7#ba  
,u4,s4,c4 #cgi;j-#ba7;c771 z r$esignat$1
 is am5d$ by-- 7,a7 /rik+ #bjah ea*     
place x appe>s & ins]t+ #bjbc2 &  7,b7  
/rik+ #bjai & ins]t+ #bjbd4  7c7 ,fee   
waiv] or r$uction2 exemption f fees     
,subsection 7d7 ( section #gda 7#ba     
,u4,s4,c4 #cgi;j-#ba7 is am5d$ to read z
 foll[s3  7d7 ,fee waiv] or r$uction2   
exemption f fees  7#a7 ,fee waiv] or    
r$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  7#b7 ,exemption f  
fees ,fees "u ?is section %all n apply )
 respect to any p]son :o-- 7,a7 n lat]  
?an ,septemb] #cj1 #bjbc1 submits a     
supplem5tal abbreviat$ application = a  
g5]ic new animal drug approv$ "u section

 #eab1 solely to add ! application numb]
 to ! label+ ( ! drug 9 ! mann] specifi$
 9 section #ejb7w77#c72 &  7,b7 o!rwise 
w\ld be subject to fees "u ?is section  
solely on ! basis ( su* supplem5tal     
abbreviat$ application4  4  7d7 ,cr$it+ 
& availability ( fees ,section #gda7;g7 
7#ba ,u4,s4,c4 #cgi;j-#ba7 is am5d$ by  
/rik+ p>agraph 7#c7 & ins]t+ ! foll[+   
p>agraphs3  7#c7 ,au?orization (        
appropriations ,= ea* ( ! fiscal ye>s   
#bjai ?r\gh #bjbc1 !re is au?oriz$ to be
 appropriat$ = fees "u ?is section an   
am\nt equal to ! total rev5ue am\nt     
e/abli%$ "u subsection 7b7 = ! fiscal   
ye>1 z adju/$ or o!rwise affect$ "u     
subsection 7c74  7#d7 ,excess           
collections ,if ! sum total ( fees      
collect$ "u ?is section = a fiscal ye>  
exce$s ! am\nt ( fees au?oriz$ to be    
appropriat$ = su* ye> "u p>agraph 7#c71 
! excess collections %all be cr$it$ to !
 appropriations acc\nt ( ! ,food & ,drug
 ,adm9i/ration z provid$ 9 p>agraph     
7#a74  4  #bjc4 ,reau?orization2 report+

 requirem5ts ,section #gdb 7#ba         
,u4,s4,c4 #cgi;j-#bb7 is am5d$-- 7#a7 9 
subsection 7a71 by /rik+ #bjac & ins]t+ 
#bjah2  7#b7 by /rik+ #bjad ea* place x 
appe>s 9 subsections 7a7 & 7b7 & ins]t+ 
#bjai2 &  7#c7 9 subsection 7d71 by     
/rik+ #bjah ea* place x appe>s & ins]t+ 
#bjbc4  #bjd4 ,sav+s clause ,not)/&+ !  
am5dm5ts made by ?is title1 "p #e (     
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ba et seq471 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 #bjac1 b  
be=e ,octob] #a1 #bjah1 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> #bjai4  #bje4 ,effective  
date ,! am5dm5ts made by ?is title %all 

take effect on ,octob] #a1 #bjah1 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$ = abbreviat$     
applications = a g5]ic new animal drug &
 supplem5tal abbreviat$ applications = a
 g5]ic new animal drug receiv$ on or    
aft] ,octob] #a1 #bjah1 reg>dless ( !   
date ( enactm5t ( ?is ,act4  #bjf4      
,sunset dates  7a7 ,au?orization        
,section #gda ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cgi;j-#ba7 %all cease to be effective  
,octob] #a1 #bjbc4  7b7 ,report+        
requirem5ts ,section #gdb ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#bb7 %all cease to be  
effective ,janu>y #ca1 #bjbd4  7c7      
,previ\s sunset provision ,effective    
,octob] #a1 #bjah1 subsections 7a7 & 7b7
 ( section #bjf ( ! ,animal ,g5]ic ,drug
 ,us] ,fee ,am5dm5ts ( #bjac 7,public   
,law #aac-ad7 are repeal$4  ,,iii       

,miscellane\s provisions  #cja4         
,electronic submissions  7a7 ,new animal
 drug applications & abbreviat$         
applications = a g5]ic new animal drug  
,section #eab7;b7 7#ba ,u4,s4,c4        
#cfj;b7b77 is am5d$ by add+ at ! end !  
foll[+3  7#d7 ,beg9n+ on ,octob] #a1    
#bjah1 all applications or submissions  
pursuant to ?is subsection %all be      
submitt$ by electronic means 9 su* =mat 
z ! ,secret>y may require4  4  7b7      
,conditional approval ( new animal drugs
 = m9or use & m9or species ,section     
#ega7;a7 7#ba ,u4,s4,c4 #cfj;ccc7a77 is 
am5d$ by add+ at ! end ! foll[+3  7#d7  
,beg9n+ on ,octob] #a1 #bjah1 all       
applications or submissions pursuant to 
?is subsection %all be submitt$ by      
electronic means 9 su* =mat z !         
,secret>y may require4  4  #cjb4 ,index 
( legally m>ket$ unapprov$ new animal   
drugs = m9or species ,effective on      
,octob] #a1 #bjah1 section #egb7;h7 7#ba
 ,u4,s4,c4 #cfj;ccc-#a7;h77 is am5d$--  
7#a7 by am5d+ p>agraph 7#a7 to read z   

foll[s3  7#a7 ,,legal ,,/atus--,9 ord]  
to be legally m>ket$1 a new animal drug 
int5d$ = a m9or species mu/ be ,approv$1
 ,conditionally ,approv$1 or ,index$ by 
! ,food & ,drug ,adm9i/ration4 ,,?is    
,,product ,,is ,,index$--,,mif4 7foll[$ 
by ! applicable m9or species index file 
numb] & a p]iod7 ,extra-label use is    
prohibit$42  2 &  7#b7 9 p>agraph 7#b71 
by /rik+ o!r animals & ins]t+           
food-produc+ animals4  #cjc4 ,misbr&$   
drugs & devices  7a7 ,9 g5]al ,section  
#ejb7w7 7#ba ,u4,s4,c4 #ceb7w77 is      
am5d$--  7#a7 9 p>agraph 7#a71 by /rik+ 
2 or & ins]t+ 22  7#b7 9 p>agraph 7#b71 
by /rik+ ! p]iod & ins]t+ 2 or2 &  7#c7 
by add+ at ! end ! foll[+3  7#c7 = :i*  
an application has be5 approv$ "u       
section #eab & ! label+ ( su* drug does 
n include ! application numb] 9 ! =mat3 
,approv$ by ,,fda "u 7,a7,,nada         
xxx-xxx1 except t ?is subp>agraph %all n
 apply to repres5tative label+ requir$  
"u section #ead4a7;b77#c77v77b7 ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any

 successor regulation7 = animal fe$ be>+
 or conta9+ a new animal drug4  4  7b7  
,applicability ,section #ejb7w77#c7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7a71 %all apply     
beg9n+ on ,septemb] #cj1 #bjbc4  #cjd4  
,issuance ( recomm5dations ,n lat] ?an  
,septemb] #cj1 #bjai1 ! ,secret>y (     
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y7 %all issue   
recomm5dations t ! ,secret>y1 9 ! lett]s
 describ$ 9 section #aja7;b7 ( ! ,animal
 ,drug ,us] ,fee ,am5dm5ts ( #bjac      
7,public ,law #aac-ad71 agre$ to develop
 reg>d+ ! feasibility ( pursu+ /atutory 
revisions t may exp& ! use ( conditional
 approval ( new animal drugs "u section 
#ega ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc7 
to appropriate categories ( new animal  
drugs4  #cje4 ,guidance address+        
inve/igation designs  7a7 ,9 g5]al ,=   
purposes ( assi/+ sponsors 9 incorporat+
 complex adaptive & o!r novel           
inve/igation designs1 data f =eign      

c\ntries1 real _w evid5ce 7includ+ ongo+
 surveillance activities1 obs]vational  
/udies1 & regi/ry data71 biom>k]s1 &    
surrogate endpo9ts 7ref]r$ to 9 ?is     
section z elem5ts ( inve/igations7 into 
propos$ cl9ical inve/igation protocols &
 applications = new animal drugs "u     
sections #eab & #ega ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;b2 #cfj;ccc71 ! ,secret>y ( ,heal? 
& ,human ,s]vices 7ref]r$ to 9 ?is      
section z ! ,secret>y7 %all issue       
guidance address+ ! use ( su* elem5ts ( 
inve/igations 9 ! developm5t &          
regulatory review ( su* new animal      
drugs4  7b7 ,cont5ts ,! guidance "u     
subsection 7a7 %all address h[ !        
,secret>y w evaluate ! elem5ts (        
inve/igations propos$ or submitt$       
pursuant to section #eab7;b77#a77;,a7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
or to meet ! commitm5t "u section       
#ega7;a77#b77;,f7 ( su* ,act1 & h[      
sponsors ( su* applications may obta9   
fe$back f ! ,secret>y on te*nical issues

 relat$ to su* inve/igations prior to ! 
submission ( an application to !        
,secret>y4  7c7 ,meet+ ,prior to issu+ !
 guidance "u subsection 7a71 ! ,secret>y
 %all consult ) /akehold]s1 includ+     
repres5tatives ( regulat$ indu/ry1      
consum] gr\ps1 academia1 vet]9>ians1 &  
food produc]s1 ?r\gh a public meet+ to  
be held n lat] ?an #a ye> aft] ! date ( 
enactm5t ( ?is ,act4  7d7 ,tim+ ,!      
,secret>y %all issue a draft guidance "u
 subsection 7a7 n lat] ?an #a ye> aft] !
 date ( ! public meet+ "u subsection    
7c71 & %all f9alize su* guidance n lat] 
?an #a ye> aft] ! date on :i* ! public  
comm5t p]iod on su* draft guidance ends4
  #cjf4 ,food additives int5d$ = use 9  
animal food  7a7 ,food additive         
petitions = animal food ,section #dji ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cdh7 is am5d$ by add+ at
 ! end ! foll[+3  7k7 ,food additives   
int5d$ = use 9 animal food  7#a7 ,9 tak+
 action on a petition "u subsection 7c7 
=1 or = recognition (1 a food additive  

int5d$ = use 9 animal food1 ! ,secret>y 
%all review reports ( inve/igations     
conduct$ 9 =eign c\ntries1 provid$ by ! 
petition]4  7#b7 ,! ,secret>y %all po/  
on ! int]net website ( ! ,food & ,drug  
,adm9i/ration1 no lat] ?an ,m>* #a ( ea*
 ye>1 on--  7,a7 ! numb] ( petitions =  
food additives int5d$ = use 9 animal    
food fil$ "u subsection 7b7 t are p5d+2 
7,b7 h[ long ea* su* petition submitt$  
"u subsection 7b7 has be5 p5d+1 includ+ 
su* petitions ! ,secret>y has ext5d$ "u 
subsection 7c77#b72 &  7,c7 ! numb] (   
/udy protocols t h be5 p5d+ review = ov]
 #ej days1 & ! numb] t h receiv$ an     
ext5sion4  7#c7 ,9 ! case ( a food      
additive petition int5d$ = use 9 animal 
food1 ! ,secret>y %all provide in=mation
 to ! petition] on ! requir$ cont5ts (  
su* petition4 ,if ! ,secret>y requires  
additional /udies beyond :at ! petition]
 propos$1 ! ,secret>y %all provide !    
sci5tific rationale = su* requirem5t4  4
  7b7 ,ensur+ ! safety ( pet food       
,section #ajjb7;a7 ( ! ,food & ,drug    

,adm9i/ration ,am5dm5ts ,act ( #bjjg    
7#ba ,u4,s4,c4 #bajb7;a77 is am5d$--    
7#a7 by /rik+ p>agraph 7#a72 &  7#b7 by 
r$esignat+ p>agraphs 7#b7 & 7#c7 z      
p>agraphs 7#a7 & 7#b71 respectively4    
7c7 ,guidance on pre-petition           
consultation process = animal food      
additives  7#a7 ,9 g5]al ,n lat] ?an #ah
 mon?s aft] ! date ( enactm5t ( ?is     
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices 7ref]r$ to 9 ?is subsection z !
 ,secret>y7 %all publi% draft guidance  
relat+ to ! volunt>y pre-petition       
consultation process = food additives   
int5d$ = use 9 animal food4  7#b7       
,cont5ts ,! guidance "u p>agraph 7#a7   
%all include-- 7,a7 ! recomm5d$ =mat to 
submit to ! ,food & ,drug ,adm9i/ration 
exi/+ data1 includ+ any applicable =eign
 data1 = assessm5t prior to submission (
 a food additive petition = animal food 
"u section #dji7;b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act2  7,b7 ! mann] &
 ! numb] ( days by :i* ! ,food & ,drug  
,adm9i/ration int5ds to review & respond

 to su* exi/+ data1 includ+ ) respect to
 provid+ a sci5tific rationale = any    
additional data reque/2  7,c7           
circum/ances "u :i* ! submission ( /udy 
protocols is recomm5d$ prior to         
submission ( a food additive petition "u
 su* section #dji7;b72  7,d7 ! mann] 9  
:i* ! ,secret>y int5ds to in=m ! p]son  
submitt+ a /udy protocol = a food       
additive if ! review ( su* /udy protocol
 w take long] ?an #ej days2 &  7,e7 be/ 
practices = communication betwe5 ! ,food
 & ,drug ,adm9i/ration & indu/ry on !   
developm5t ( pre-petition submissions ( 
/udy protocols & exi/+ data = food      
additives4  7#c7 ,f9al guidance ,!      
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