,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #adjh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #i1 #bjac ,mr4 
,g>dn] 7= himself1 ,mr4 ,%imkus1 ,mr4   
,upton1 ,mr4 ,pitts1 ,mr4 ,waxman1 ,mr4 
,pallone1 ,mr4 ,burgess1 ,mr4 ,gu?rie1 &
 ,mr4 ,k9z+] ( ,ill9ois7 introduc$ !    
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to reau?orize us] fee  
programs relat+ to g5]ic new animal     
drugs4  #a4 ,%ort title2 f9d+  7a7 ,%ort
 title ,?is ,act may be cit$ z ! ,animal
 ,g5]ic ,drug ,us] ,fee ,am5dm5ts (     
#bjac4  7b7 ,f9d+ ,! fees au?oriz$ by   
?is ,act 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  #b4 ,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 = an animal drug describ$ 9 
section #eab7;d77#d7 & submitt$ on or   
aft] ,octob] #a1 #bjac1 %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  #c4 
,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 #a7;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  #d4 
,sav+s clause ,not)/&+ ! am5dm5ts made  
by ?is ,act1 "p #e ( sub*apt] ,c ( *apt]
 ,,vii ( ! ,f$]al ,food1 ,drug1 &       
,cosmetic ,act1 z 9 effect on ! day be=e
 ! date ( enactm5t ( ?is ,act1 %all     
cont9ue to be 9 effect ) respect to     
abbreviat$ 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  #e4 ,effective date ,!      
am5dm5ts made by ?is ,act %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 ,act1    
%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  #f4 ,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