,,ii  #aae? ,,congress  #a/ ,session    
,s4 #icd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,april #be1 #bjag ,mr4 
,alex&] 7= himself & ,mrs4 ,murray7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to revise &     
ext5d ! us]-fee programs = prescription 
drugs1 m$ical devices1 g5]ic drugs1 &   
biosimil> biological products1 & = o!r  
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,,fda ,reau?orization ,act 
( #bjag4  #b4 ,table ( cont5ts ,! table 
( cont5ts = ?is ,act is z foll[s3  ,sec4
 #a4 ,%ort title4 ,sec4 #b4 ,table (    
cont5ts4 ,,title ,i--,fees relat+ to    
drugs ,sec4 #aja4 ,%ort title2 f9d+4    
,sec4 #ajb4 ,au?ority to assess & use   
drug fees4 ,sec4 #ajc4 ,reau?orization2 
report+ requirem5ts4 ,sec4 #ajd4 ,sunset
 dates4 ,sec4 #aje4 ,effective date4    
,sec4 #ajf4 ,sav+s clause4 ,,title      
,,ii--,fees relat+ to devices ,sec4     

#bja4 ,%ort title2 f9d+s4 ,sec4 #bjb4   
,def9itions4 ,sec4 #bjc4 ,au?ority to   
assess & use device fees4 ,sec4 #bjd4   
,reau?orization2 report+ requirem5ts4   
,sec4 #bje4 ,con=mity assessm5t pilot   
program4 ,sec4 #bjf4 ,reau?orization (  
review4 ,sec4 #bjg4 ,electronic =mat =  
submissions4 ,sec4 #bjh4 ,sav+s clause4 
,sec4 #bji4 ,effective date4 ,sec4 #baj4
 ,sunset clause4 ,,title ,,iii--,fees   
relat+ to g5]ic drugs ,sec4 #cja4 ,%ort 
title2 f9d+4 ,sec4 #cjb4 ,def9itions4   
,sec4 #cjc4 ,au?ority to assess & use   
human g5]ic drug fees4 ,sec4 #cjd4      
,reau?orization2 report+ requirem5ts4   
,sec4 #cje4 ,sunset dates4 ,sec4 #cjf4  
,effective date4 ,sec4 #cjg4 ,sav+s     
clause4 ,,title ,,iv--,fees relat+ to   
biosimil> biological products ,sec4     
#dja4 ,%ort title2 f9d+4 ,sec4 #djb4    
,def9itions4 ,sec4 #djc4 ,au?ority to   
assess & use biosimil> fees4 ,sec4 #djd4
 ,reau?orization2 report+ requirem5ts4  
,sec4 #dje4 ,sunset dates4 ,sec4 #djf4  
,effective date4 ,sec4 #djg4 ,sav+s     

clause4 ,,title ,v--,reau?orization (   
o!r programs ,sec4 #eja4 ,reau?orization
 ( provision relat+ to exclusivity (    
c]ta9 drugs conta9+ s+le enantiom]s4    
,sec4 #ejb4 ,reau?orization ( p$iatric  
humanit>ian device exceptions4 ,sec4    
#ejc4 ,reau?orization ( ! critical pa?  
public-private p>tn]%ips4 ,sec4 #ejd4   
,reau?orization ( p$iatric device       
consortia4 ,sec4 #eje4 ,reau?orization (
 orphan grants program4  ,i ,fees relat+
 to drugs  #aja4 ,%ort title2 f9d+  7a7 
,%ort ,title ,?is title may be cit$ z ! 
,prescription ,drug ,us] ,fee ,am5dm5ts 
( #bjag4  7b7 ,f9d+ ,! ,congress f9ds t 
! fees au?oriz$ by ! am5dm5ts made 9 ?is
 title w be d$icat$ t[>d exp$it+ ! drug 
developm5t process & ! process = !      
review ( human drug applications1       
includ+ po/m>ket drug safety activities1
 z set =? 9 ! goals id5tifi$ = purposes 
( "p #b ( 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 ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,*airman ( ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives1 z 
set =? 9 ! ,congressional ,record4      
#ajb4 ,au?ority to assess & use drug    
fees  7a7 ,types ( fees  7#a7 ,9 g5]al  
,section #gcf7;a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;h7a77 is am5d$-- 7,a7 9 ! matt]    
prec$+ p>agraph 7#a71 by /rik+ fiscal   
ye> #bjac & ins]t+ fiscal ye> #bjah2    
7,b7 9 ! head+ ( p>agraph 7#a71 by /rik+
 & supplem5t2  7,c7 9 p>agraph 7#a71 by 
/rik+ or a supplem5t & or supplem5t ea* 
place ei!r appe>s2  7,d7 9 p>agraph     
7#a77;,a7-- 7i7 9 clause 7i71 by /rik+  
7c77#d7 & ins]t+ 7c77#e72 &  7ii7 9     
clause 7ii71 by /rik+ ,a fee e/abli%$ & 
all t foll[s ?r\gh are requir$4 & ins]t+
 ! foll[+3 ,a fee e/abli%$ "u subsection
 7c77#e7 = a human drug application =   
:i* cl9ical data 7o!r ?an               
bioavailability or bioequival5ce /udies7
 ) respect to safety or effectiv5ess are

 n requir$ = approval42  7,e7 9 ! head+ 
( p>agraph 7#a77;,c71 by /rik+ or       
supplem5t2  7,f7 9 p>agraph 7#a77;,f7-- 
7i7 9 ! head+1 by /rik+ or indication2 &
  7ii7 by /rik+ ! second s5t5ce2  7,g7  
by /rik+ p>agraph 7#b7 7relat+ to a     
prescription drug e/abli%m5t fee72  7,h7
 by r$esignat+ p>agraph 7#c7 z p>agraph 
7#b72  7,i7 9 ! head+ ( p>agraph 7#b71 z
 s r$esignat$1 by /rik+ ,prescription   
drug product fee & ins]t+ ,prescription 
drug program fee2  7,j7 9 subp>agraph   
7,a7 ( su* p>agraph 7#b71 by am5d+ !    
fir/ s5t5ce to read z foll[s3 ,except z 
provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* 
p]son :o is nam$ z ! applicant 9 a human
 drug application1 & :o1 aft] ,septemb] 
#a1 #aiib1 _h p5d+ be=e ! ,secret>y a   
human drug application or supplem5t1    
%all pay ! annual prescription drug     
program fee e/abli%$ = a fiscal ye> "u  
subsection 7c77#e7 = ea* prescription   
drug product t is id5tifi$ 9 su* a human
 drug application approv$ z ( ,octob] #a
 ( su* fiscal ye>4 2  7,k7 9 subp>agraph

 7,b7 ( su* p>agraph 7#b7-- 7i7 9 !     
head+ ( subp>agraph 7,b71 by ins]t+ aft]
 ,exception ! foll[+3 = c]ta9           
prescription drug products2 &  7ii7 by  
/rik+ ,a prescription drug product %all 
n be assess$ a fee & ins]t+ ,a          
prescription drug program fee %all n be 
assess$ = a prescription drug product2 &
  7,l7 by add+ at ! end ( su* p>agraph  
7#b7 ! foll[+3  7,c7 ,limitation ,a     
p]son :o is nam$ z ! applicant 9 an     
approv$ human drug application %all n be
 assess$ m ?an #e prescription drug     
program fees = a fiscal ye> =           
prescription drug products id5tifi$ 9   
su* approv$ human drug application4  4  
7#b7 ,con=m+ am5dm5t ,subp>agraph 7,c7 (
 section #gdj7;a77#c7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#ab7;a77#c77 is am5d$ to read z  
foll[s3  7,c7 ,limitation ,an e/abli%m5t
 %all be assess$ only "o fee p] fiscal  
ye> "u ?is section4  4  7b7 ,fee rev5ue 
am\nts ,subsection 7b7 ( section #gcf ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 

7#ba ,u4,s4,c4 #cgi;h7 is am5d$ to read 
z foll[s3  7b7 ,fee rev5ue am\nts  7#a7 
,9 g5]al ,= ea* ( ! fiscal ye>s #bjah   
?r\gh #bjbb1 fees "u subsection 7a7     
%all1 except z provid$ 9 subsections    
7c71 7d71 7f71 & 7g71 be e/abli%$ to    
g5]ate a total rev5ue am\nt "u su*      
subsection t is equal to ! sum (--  7,a7
 ! annual base rev5ue = ! fiscal ye> 7z 
det]m9$ "u p>agraph 7#c772  7,b7 ! doll>
 am\nt equal to ! inflation adju/m5t = !
 fiscal ye> 7z det]m9$ "u subsection    
7c77#a772  7,c7 ! doll> am\nt equal to !
 capacity plann+ adju/m5t = ! fiscal ye>
 7z det]m9$ "u subsection 7c77#b772     
7,d7 ! doll> am\nt equal to ! op]at+    
res]ve adju/m5t = ! fiscal ye>1 if      
applicable 7z det]m9$ "u subsection     
7c77#c772  7,e7 ! doll> am\nt equal to !
 additional direct co/ adju/m5t = !     
fiscal ye> 7z det]m9$ "u subsection     
7c77#d772 &  7,f7 additional doll>      
am\nts = ea* fiscal ye> z foll[s3 7i7   
#bj1jgg1gic = fiscal ye> #bjah2  7ii7   
#ba1cag1dgb = fiscal ye> #bjai2  7iii7  

#af1iec1cbi = fiscal ye> #bjbj2  7iv7   
#e1dbf1hif = fiscal ye> #bjba2 &  7v7   
#b1gfi1fji = fiscal ye> #bjbb4  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   
human drug application fees "u          
subsection 7a77#a72 &  7,b7 #hj p]c5t   
%all be d]iv$ f prescription drug       
program fees "u subsection 7a77#b74     
7#c7 ,annual base rev5ue ,= purposes (  
p>agraph 7#a71 ! doll> am\nt ( ! annual 
base rev5ue = a fiscal ye> %all be--    
7,a7 = fiscal ye> #bjah1 #hgh1eij1jjj2 &
  7,b7 = fiscal ye>s #bjai ?r\gh #bjbb1 
! doll> am\nt ( ! total rev5ue am\nt    
e/abli%$ "u p>agraph 7#a7 = ! previ\s   
fiscal ye>1 n includ+ any adju/m5ts made
 "u subsection 7c77#c7 or 7c77#d74  4   
7c7 ,adju/m5ts2 annual fee sett+        
,subsection 7c7 ( section #gcf ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;h7 is am5d$ to read 
z foll[s3  7c7 ,adju/m5ts2 annual fee   
sett+  7#a7 ,inflation adju/m5t  7,a7 ,9

 g5]al ,= purposes ( subsection         
7b77#a77;,b71 ! doll> am\nt ( !         
inflation adju/m5t to ! annual base     
rev5ue = ea* fiscal ye> %all be equal to
 ! product (--  7i7 su* annual base     
rev5ue = ! fiscal ye> "u subsection     
7b77#a77;,a72 &  7ii7 ! inflation       
adju/m5t p]c5tage "u subp>agraph 7,b74  
7,b7 ,inflation adju/m5t p]c5tage ,!    
inflation adju/m5t p]c5tage "u ?is      
subp>agraph = a fiscal ye> is equal to !
 sum (--  7i7 ! 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 ye>s ( !      
prec$+ #d fiscal ye>s1 multipli$ by !   
proportion ( p]sonnel comp5sation &     
b5efits co/s to total co/s ( ! process =
 ! review ( human drug applications 7z  
def9$ 9 section #gce7f77 = ! fir/ #c    
ye>s ( ! prec$+ #d fiscal ye>s2 &  7ii7 
! av]age annual p]c5t *ange t occurr$ 9 
! ,consum] ,price ,index = urban        

consum]s 7,wa%+ton-,baltimore1          
,,dc-,,md-,,va-,,wv2 ,n ,seasonally     
,adju/$2 ,all items2 ,annual ,index7 = !
 fir/ #c ye>s ( ! prec$+ #d ye>s (      
available data multipli$ by ! proportion
 ( all co/s o!r ?an p]sonnel comp5sation
 & b5efits co/s to total co/s ( !       
process = ! review ( human drug         
applications 7z def9$ 9 section #gce7f77
 = ! fir/ #c ye>s ( ! prec$+ #d fiscal  
ye>s4  7#b7 ,capacity plann+ adju/m5t   
7,a7 ,9 g5]al ,= ea* fiscal ye>1 aft] ! 
annual base rev5ue e/abli%$ 9 subsection
 7b77#a77;,a7 is adju/$ = inflation 9   
accordance ) p>agraph 7#a71 su* rev5ue  
%all be adju/$ fur!r = su* fiscal ye>1 9
 accordance ) ?is p>agraph1 to reflect  
*anges 9 ! res\rce capacity ne$s ( !    
,secret>y = ! process = ! review ( human
 drug applications4  7,b7 ,int]im       
me?odology  7i7 ,9 g5]al ,until !       
capacity plann+ me?odology describ$ 9   
subp>agraph 7,c7 is effective1 !        
adju/m5t "u ?is p>agraph = a fiscal ye> 
%all be bas$ on ! product (--  7,i7 !   

annual base rev5ue = su* ye>1 z adju/$ =
 inflation "u p>agraph 7#a72 &  7,,ii7 !
 adju/m5t p]c5tage "u clause 7ii74  7ii7
 ,adju/m5t p]c5tage ,! adju/m5t p]c5tage
 "u ?is clause = a fiscal ye> is !      
weight$ *ange 9 ! #c-ye> av]age end+ 9 !
 mo/ rec5t ye> = :i* data are available1
 ov] ! #c-ye> av]age end+ 9 ! previ\s   
ye>1 =--  7,i7 ! total numb] ( human    
drug applications1 efficacy supplem5ts1 
& manufactur+ supplem5ts submitt$ to !  
,secret>y2  7,,ii7 ! total numb] (      
active comm]cial inve/igational new drug
 applications2 &  7,,iii7 ! total numb] 
( =mal meet+s s*$ul$ by ! ,secret>y1 &  
writt5 responses issu$ by ! ,secret>y 9 
lieu ( su* =mal meet+s1 z id5tifi$ 9    
section ,i4,h ( ! lett]s describ$ 9     
section #aja7;b7 ( ! ,prescription ,drug
 ,us] ,fee ,am5dm5ts ( #bjag4  7,c7     
,capacity plann+ me?odology  7i7        
,developm5t2 evaluation & report ,!     
,secret>y %all obta91 ?r\gh a contract )
 an indep5d5t acc\nt+ or consult+ firm1 
a report evaluat+ options &             

recomm5dations = a new me?odology to    
accurately assess *anges 9 ! res\rce &  
capacity ne$s ( ! process = ! review (  
human drug applications4 ,! capacity    
plann+ me?odological options &          
recomm5dations pres5t$ 9 su* report %all
 utilize & be in=m$ by p]sonnel "t      
report+ data z an input4 ,! report %all 
be publi%$ = public comm5t no lat] ?an !
 end ( fiscal ye> #bjbj4  7ii7          
,e/abli%m5t & implem5tation ,aft] review
 ( ! report describ$ 9 clause 7i7 & any 
public comm5ts !reon1 ! ,secret>y %all  
e/abli% a capacity plann+ me?odology =  
purposes ( ?is p>agraph1 :i* %all--     
7,i7 replace ! int]im me?odology "u     
subp>agraph 7,b72  7,,ii7 incorporate   
su* approa*es & attributes z ! ,secret>y
 det]m9es appropriate2 &  7,,iii7 be    
effective beg9n+ ) ! fir/ fiscal ye> =  
:i* fees are set aft] su* capacity      
plann+ me?odology is e/abli%$4  7,d7    
,limitation ,"u no circum/ances %all an 
adju/m5t "u ?is p>agraph result 9 fee   
rev5ue = a fiscal ye> t is less ?an !   

sum ( ! am\nts "u subsections           
7b77#a77;,a7 7! annual base rev5ue = !  
fiscal ye>7 & 7b77#a77;,b7 7! doll>     
am\nt ( ! inflation adju/m5t = ! fiscal 
ye>74  7,e7 ,publication 9 f$]al regi/] 
,! ,secret>y %all publi% 9 ! ,f$]al     
,regi/] notice "u p>agraph 7#e7 ! fee   
rev5ue & fees result+ f ! adju/m5t & !  
me?odologies "u ?is p>agraph4  7#c7     
,op]at+ res]ve adju/m5t  7,a7 ,increase 
,= fiscal ye> #bjah & subsequ5t fiscal  
ye>s1 ! ,secret>y may1 9 addition to    
adju/m5ts "u p>agraphs 7#a7 & 7#b71     
fur!r increase ! fee rev5ue & fees if   
su* an adju/m5t is necess>y to provide =
 n m ?an #ad weeks ( op]at+ res]ves (   
c>ryov] us] fees = ! process = ! review 
( human drug applications4  7,b7        
,decrease ,if ! ,secret>y has c>ryov]   
balances = su* process 9 excess ( #ad   
weeks ( su* op]at+ res]ves1 ! ,secret>y 
%all decrease su* fee rev5ue & fees to  
provide = n m ?an #ad weeks ( su* op]at+
 res]ves4  7,c7 ,notice ( rationale ,if 
an adju/m5t "u subp>agraph 7,a7 or 7,b7 

is made1 ! rationale = ! am\nt ( !      
increase or decrease 7z applicable7 9   
fee rev5ue & fees %all be conta9$ 9 !   
annual ,f$]al ,regi/] notice "u p>agraph
 7#e7 e/abli%+ fee rev5ue & fees = !    
fiscal ye> involv$4  7#d7 ,additional   
direct co/ adju/m5t  7,a7 ,9 g5]al ,!   
,secret>y %all1 9 addition to adju/m5ts 
"u p>agraphs 7#a71 7#b71 & 7#c71 fur!r  
increase ! fee rev5ue & fees--  7i7 =   
fiscal ye> #bjah1 by #h1gcj1jjj2 &  7ii7
 = fiscal ye> #bjai & subsequ5t fiscal  
ye>s1 by ! am\nt det]m9$ "u subp>agraph 
7,b74  7,b7 ,am\nt ,! am\nt det]m9$ "u  
?is subp>agraph is-- 7i7 #h1gcj1jjj1    
multipli$ by  7ii7 ! ,consum] ,price    
,index = urban consum]s                 
7,wa%+ton-,baltimore1                   
,,dc-,,md-,,va-,,wv2 ,n ,seasonally     
,adju/$2 ,all ,items2 ,annual ,index7 = 
! mo/ rec5t ye> ( available data1 divid$
 by su* ,index = #bjaf4  7#e7 ,annual   
fee sett+ ,! ,secret>y %all1 n lat] ?an 
#fj days be=e ! />t ( ea* fiscal ye> t  
beg9s aft] ,septemb] #cj1 #bjag--  7,a7 

e/abli%1 = ! next fiscal ye>1 human drug
 application fees & prescription drug   
program fees "u subsection 7a71 bas$ on 
! rev5ue am\nts e/abli%$ "u subsection  
7b7 & ! adju/m5ts provid$ "u ?is        
subsection2 &  7,b7 publi% su* fee      
rev5ue & fees 9 ! ,f$]al ,regi/]4  7#f7 
,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 ( human drug applications4  4  
7d7 ,fee waiv] or r$uction ,section     
#gcf7;d7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7d77
 is am5d$-- 7#a7 9 p>agraph 7#a7--  7,a7
 by ins]t+ or at ! end ( subp>agraph    
7,b72  7,b7 by /rik+ subp>agraph 7,c72 &
  7,c7 by r$esignat+ subp>agraph 7,d7 z 
subp>agraph 7,c72  7#b7 by /rik+        
p>agraph 7#c7 7relat+ to use ( /&>d     
co/s72  7#c7 by r$esignat+ p>agraph 7#d7
 z p>agraph 7#c72 &  7#d7 9 p>agraph    
7#c71 z s r$esignat$--  7,a7 9          
subp>agraphs 7,a7 & 7,b71 by /rik+      

p>agraph 7#a77;,d7 & ins]t+ p>agraph    
7#a77;,c72 &  7,b7 9 subp>agraph 7,b7-- 
7i7 by /rik+ clause 7ii72  7ii7 by /rik+
 %all pay ?r\gh 7i7 application fees &  
ins]t+ %all pay application fees2 &     
7iii7 by /rik+ 2 & at ! end & ins]t+ a  
p]iod4  7e7 ,effect ( failure ,to pay   
fees ,section #gcf7;e7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cgi;h7e77 is am5d$ by /rik+ all fees & 
ins]t+ all su* fees4  7f7 ,limitations  
,section #gcf7;f77#b7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;h7f77#b77 is am5d$ by /rik+        
supplem5ts1 prescription drug           
e/abli%m5ts1 & prescription drug        
products & ins]t+ prescription drug     
program fees4  7g7 ,cr$it+ &            
availability ( fees ,section #gcf7;g7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgi;h7g77 is am5d$--    
7#a7 9 p>agraph 7#c7--  7,a7 by /rik+   
#bjac ?r\gh #bjag & ins]t+ #bjah ?r\gh  
#bjbb2 &  7,b7 by /rik+ & p>agraph 7#d7 
( ?is subsection2 &  7#b7 by /rik+      

p>agraph 7#d74  7h7 ,orphan drugs       
,section #gcf7k7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;h7k77 is am5d$ by /rik+ product &  
e/abli%m5t fees ea* place x appe>s &    
ins]t+ prescription drug program fees4  
#ajc4 ,reau?orization2 report+          
requirem5ts ,section #gcf;,b ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 9  
subsection 7a77#a7--  7,a7 9 ! matt]    
be=e subp>agraph 7,a71 by /rik+ #bjac & 
ins]t+ #bjah2 &  7,b7 9 subp>agraph     
7,a71 by /rik+ ,prescription ,drug ,us] 
,fee ,am5dm5ts ( #bjab & ins]t+         
,prescription ,drug ,us] ,fee ,am5dm5ts 
( #bjag2  7#b7 9 subsection 7b71 by     
/rik+ #bjac & ins]t+ #bjah2 &  7#c7 9   
subsection 7d71 by /rik+ #bjag ea* place
 x appe>s & ins]t+ #bjbb4  #ajd4 ,sunset
 dates  7a7 ,au?orization ,sections #gce
 & #gcf ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2   
#cgi;h7 %all cease to be effective      
,octob] #a1 #bjbb4  7b7 ,report+        

,requirem5ts ,section #gcf;,b ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cgi;h-#b7 %all cease to be   
effective ,janu>y #ca1 #bjbc4  7c7      
,previ\s ,sunset ,provision ,effective  
,octob] #a1 #bjag1 subsections 7a7 & 7b7
 ( section #aje ( ! ,food & ,drug       
,adm9i/ration ,safety & ,innovation ,act
 7,public ,law #aab-add7 are repeal$4   
#aje4 ,effective date ,! am5dm5ts made  
by ?is title %all take effect on ,octob]
 #a1 #bjag1 or ! date ( ! enactm5t ( ?is
 ,act1 :i*ev] is lat]1 except t fees "u 
"p #b ( sub*apt] ,c ( *apt] ,,vii ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
%all be assess$ = all human drug        
applications receiv$ on or aft] ,octob] 
#a1 #bjag1 reg>dless ( ! date ( !       
enactm5t ( ?is ,act4  #ajf4 ,sav+s      
clause ,not)/&+ ! am5dm5ts made by ?is  
title1 "p #b ( 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 human drug     

applications & supplem5ts 7z def9$ 9 su*
 "p z ( su* day7 t on or aft] ,octob]   
#a1 #bjab1 b be=e ,octob] #a1 #bjag1 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> #bjah4  ,,ii ,fees 
relat+ to devices  #bja4 ,%ort title2   
f9d+s  7a7 ,%ort ,title ,?is title may  
be cit$ z ! ,m$ical ,device ,us] ,fee   
,am5dm5ts ( #bjag4  7b7 ,f9d+s ,!       
,congress f9ds t ! fees au?oriz$ "u !   
am5dm5ts made by ?is title w be d$icat$ 
t[>d exp$it+ ! process = ! review (     
device applications & = assur+ ! safety 
& effectiv5ess ( devices1 z set =? 9 !  
goals id5tifi$ = purposes ( "p #c (     
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 9 !      
lett]s f ! ,secret>y ( ,heal? & ,human  
,s]vices to ! ,*airman ( ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
( ! ,s5ate & ! ,*airman ( ! ,committee  
on ,en]gy & ,comm]ce ( ! ,h\se (        
,repres5tatives1 z set =? 9 !           

,congressional ,record4  #bjb4          
,def9itions ,section #gcg ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 by    
r$esignat+ p>agraphs 7#h7 ?r\gh 7#ac7 z 
p>agraphs 7#i7 ?r\gh 7#ad71             
respectively2  7#b7 by ins]t+ aft]      
p>agraph 7#g7 ! foll[+ new p>agraph3    
7#h7 ,! t]m de novo classification      
reque/ means a reque/ made "u section   
#eac7;f77#b77;,a7 ) respect to !        
classification ( a device4  2  7#c7 9   
subp>agraph 7,d7 ( p>agraph 7#aj7 7z    
r$esignat$ by p>agraph 7#a771 by /rik+ &
 submissions & ins]t+ submissions1 & de 
novo classification reque/s2 &  7#d7 9  
p>agraph 7#aa7 7z r$esignat$ by p>agraph
 7#a771 by /rik+ #bjaa & ins]t+ #bjaf4  
#bjc4 ,au?ority to assess & use device  
fees  7a7 ,types ( ,fees ,section       
#gch7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77
 is am5d$-- 7#a7 9 p>agraph 7#a71 by    
/rik+ fiscal ye> #bjac & ins]t+ fiscal  
ye> #bjah2 &  7#b7 9 p>agraph 7#b7--    

7,a7 9 subp>agraph 7,a7--  7i7 9 ! matt]
 prec$+ clause 7i71 by /rik+ ,octob] #a1
 #bjab & ins]t+ ,octob] #a1 #bjag2  7ii7
 9 clause 7viii71 by /rik+ #b & ins]t+  
#c4d2 &  7iii7 by add+ at ! end ! foll[+
 new clause3  7xi7 ,= a de novo         
classification reque/1 a fee equal to   
#cj p]c5t ( ! fee t applies "u clause   
7i74  2 &  7,b7 9 subp>agraph           
7,b77v77,i71 by /rik+ or prem>ket       
notification submission & ins]t+        
prem>ket notification submission1 or de 
novo classification reque/4  7b7 ,fee   
,am\nts ,section #gch7;b7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j7b77 is am5d$ to read z 
foll[s3  7b7 ,fee ,am\nts  7#a7 ,9      
,g5]al ,subject to subsections 7c71 7d71
 7e71 & 7h71 = ea* ( fiscal ye>s #bjah  
?r\gh #bjbb1 fees "u subsection 7a7 %all
 be d]iv$ f ! base fee am\nts specifi$ 9
 p>agraph 7#b71 to g5]ate ! total rev5ue
 am\nts specifi$ 9 p>agraph 7#c74  7#b7 
,base fee am\nts specifi$ ,= purposes ( 
p>agraph 7#a71 ! base fee am\nts        

specifi$ 9 ?is p>agraph are z foll[s3   
,fee ,type,fiscal ,ye> #bjah;,fiscal    
,ye> #bjai;,fiscal ,ye> #bjbj;,fiscal   
,ye> #bjba;,fiscal ,ye> #bjbb ,prem>ket 
,application#bid1jjjcjj1jjjcaj1jjjcbh1jj
jcbi1jjj ,e/abli%m5t                    
,regi/ration#d1cged1edhd1gfjd1iged1igh  
7#c7 ,total rev5ue am\nts specifi$ ,=   
purposes ( p>agraph 7#a71 ! total rev5ue
 am\nts specifi$ 9 ?is p>agraph are z   
foll[s3  7,a7 #ahc1bhj1gef = fiscal ye> 
#bjah4  7,b7 #aij1fed1hge = fiscal ye>  
#bjai4  7,c7 #bjj1acb1jad = fiscal ye>  
#bjbj4  7,d7 #baa1gdh1ghi = fiscal ye>  
#bjba4  7,e7 #bac1fhg1ffj = fiscal ye>  
#bjbb4  4  7c7 ,annual ,fee ,sett+2     
,adju/m5ts ,section #gch7;c7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j7c77 is am5d$--  7#a7 9 
p>agraph 7#a71 by /rik+ #bjab & ins]t+  
#bjag2  7#b7 9 p>agraph 7#b7--  7,a7 9  
subp>agraph 7,a71 by /rik+ #bjad &      
ins]t+ #bjah2  7,b7 by /rik+ subp>agraph
 7,b7 & ins]t+ ! foll[+ new subp>agraph3
  7,b7 ,applicable inflation adju/m5t ,!

 applicable inflation adju/m5t = fiscal 
ye> #bjah & ea* subsequ5t fiscal ye> is 
! product (--  7i7 ! base inflation     
adju/m5t "u subp>agraph 7,c7 = su*      
fiscal ye>2 &  7ii7 ! product ( ! base  
inflation adju/m5t "u subp>agraph 7,c7 =
 ea* ( ! fiscal ye>s prec$+ su* fiscal  
ye>1 beg9n+ ) fiscal ye> #bjaf4  2  7,c7
 9 subp>agraph 7,c71 9 ! head+1 by /rik+
 to total rev5ue am\nts2 &  7,d7 by     
am5d+ subp>agraph 7,d7 to read z foll[s3
  7,d7 ,adju/m5t to base fee am\nts ,=  
ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 !  
,secret>y %all-- 7i7 adju/ ! base fee   
am\nts specifi$ 9 subsection 7b77#b7 =  
su* fiscal ye> by multiply+ su* am\nts  
by ! applicable inflation adju/m5t "u   
subp>agraph 7,b7 = su* ye>2 &  7ii7 if !
 ,secret>y det]m9es necess>y1 increase  
79 addition to ! adju/m5t "u clause 7i77
 su* base fee am\nts1 on a uni=m        
proportionate basis1 to g5]ate ! total  
rev5ue am\nts "u subsection 7b77#c71 z  
adju/$ = inflation "u subp>agraph 7,a74 
2 &  7#c7 9 p>agraph 7#c7-- 7,a7 by     

/rik+ #bjad ?r\gh #bjag & ins]t+ #bjah  
?r\gh #bjbb2 &  7,b7 by /rik+ fur!r     
adju/$ & ins]t+ increas$4  7d7 ,small   
bus9esses2 ,fee ,waiv] & ,fee ,r$uction 
,reg>d+ ,prem>ket ,approval ,fees       
,section #gch7;d7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j7d77 is am5d$--  7#a7 9 p>agraph  
7#a71 by /rik+ specifi$ 9 clauses 7i7   
?r\gh 7v7 & clauses 7vii71 7ix71 & 7x7 &
 ins]t+ specifi$ 9 clauses 7i7 ?r\gh    
7vii7 & clauses 7ix71 7x71 & 7xi72 &    
7#b7 9 p>agraph 7#b77;,c7--  7,a7 by    
/rik+ supplem5t1 or & ins]t+ supplem5t12
 &  7,b7 by ins]t+ 1 or a de novo       
classification reque/ aft] class ,,iii  
device4  7e7 ,small ,bus9esses2 ,fee    
,r$uction ,reg>d+ ,prem>ket             
,notification ,submissions ,section     
#gch7;e77#b77;,c7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j7e77#b77;,c77 is am5d$ by /rik+   
#ej & ins]t+ #be4  7f7 ,fee ,waiv] or   
,r$uction  7#a7 ,repeal ,section #gch ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 

7#ba ,u4,s4,c4 #cgi;j7 is am5d$ by /rik+
 subsection 7f74  7#b7 ,con=m+ *anges   
7,a7 ,section #eae7;c77#d77;,a7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;e7c77#d77;,a77 is   
am5d$ by /rik+ #gch7;h7 & ins]t+        
#gch7;g74  7,b7 ,section #gch ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cgi;j71 z am5d$ by p>agraph  
7#a71 is fur!r am5d$--  7i7 by          
r$esignat+ subsections 7g7 ?r\gh 7l7 z  
subsections 7f7 ?r\gh 7k72  7ii7 9      
subsection 7a77#b77;,a71 by /rik+ 7d71  
7e71 & 7f7 & ins]t+ 7d7 & 7e72 &  7iii7 
9 subsection 7a77#c77;,a71 by /rik+ &   
subsection 7f74  7g7 ,effect ( failure  
,to pay fees ,subsection 7f77#a71 z     
r$esignat$1 ( section #gch ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j7 is am5d$--  7#a7 by   
/rik+ or p]iodic report+ conc]n+ a class
 ,,iii device & ins]t+ p]iodic report+  
conc]n+ a class ,,iii device1 or de novo
 classification reque/2 &  7#b7 by /rik+
 all fees & ins]t+ all su* fees4  7h7   

,conditions ,subsection 7g77#a77;,a71 z 
r$esignat$1 ( section #gch ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j7 is am5d$ by /rik+     
#bhj1ehg1jjj & ins]t+ #cbj1hbe1jjj4  7i7
 ,cr$it+ & ,availability ( ,fees        
,subsection 7h71 z r$esignat$1 ( section
 #gch ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is
 am5d$--  7#a7 9 p>agraph 7#c7-- 7,a7 by
 /rik+ #bjac ?r\gh #bjag & ins]t+ #bjah 
?r\gh #bjbb2 &  7,b7 by /rik+ subsection
 7c7 & all t foll[s ?r\gh ! p]iod at !  
end & ins]t+ subsection 7c742 &  7#b7 by
 /rik+ p>agraph 7#d74  #bjd4            
,reau?orization2 report+ requirem5ts    
7a7 ,p]=mance ,reports ,section         
#gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#a7;a77 is am5d$-- 7#a7 9        
p>agraph 7#a7--  7,a7 9 subp>agraph     
7,a7-- 7i7 by /rik+ #bjac & ins]t+      
#bjah2 &  7ii7 by /rik+ ! ,m$ical       
,device ,us] ,fee ,am5dm5ts ( #bjab &   
ins]t+ ,m$ical ,device ,us] ,fee        

,am5dm5ts ( #bjag2 &  7,b7 9 subp>agraph
 7,b71 by /rik+ ! ,m$ical ,device ,us]  
,fee ,am5dm5ts ( #bjab & ins]t+ ,m$ical 
,device ,us] ,fee ,am5dm5ts ( #bjag2 &  
7#b7 9 p>agraph 7#b71 by /rik+ #bjac    
?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4 
7b7 ,reau?orization ,section #gch;,a7b7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is   
am5d$--  7#a7 9 p>agraph 7#a71 by /rik+ 
#bjag & ins]t+ #bjbb2 &  7#b7 9 p>agraph
 7#e71 by /rik+ #bjag & ins]t+ #bjbb4   
#bje4 ,con=mity assessm5t pilot program 
7a7 ,9 g5]al ,section #ead ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;d7 is am5d$ by add+ at ! 
end ! foll[+3  7d7 ,pilot accr$itation  
s*eme = con=mity assessm5t  7#a7 ,9     
g5]al ,! ,secret>y %all e/abli% a pilot 
program "u :i*-- 7,a7 te/+ laboratories 
may be accr$it$1 by accr$itation bodies 
meet+ crit]ia specifi$ by ! ,secret>y1  
to assess ! con=mance ( a device ) c]ta9
 /&>ds recogniz$ "u ?is section2 &  7,b7
 subject to p>agraph 7#b71 det]m9ations 

by te/+ laboratories s accr$it$ t a     
device con=ms ) su* /&>d or /&>ds %all  
be accept$ by ! ,secret>y = purposes (  
demon/rat+ su* con=mity "u ?is section  
unless ! ,secret>y f9ds t a p>ticul> su*
 det]m9ation %all n be s accept$4  7#b7 
,secret>ial review ( accr$it$ laboratory
 det]m9ations ,! ,secret>y may-- 7,a7   
review det]m9ations by te/+ laboratories
 accr$it$ pursuant to ?is subsection1   
includ+ by conduct+ p]iodic audits ( su*
 det]m9ations or processes ( accr$it$   
bodies or te/+ laboratories &1 foll[+   
su* review1 tak+ additional measures "u 
?is ,act1 su* z susp5sion or )drawal (  
accr$itation ( su* te/+ laboratory "u   
p>agraph 7#a77;,a7 or reque/+ additional
 in=mation ) respect to su* device1 z ! 
,secret>y det]m9es appropriate2 &  7,b7 
if ! ,secret>y becomes aw>e ( in=mation 
mat]ially be>+ on safety or effectiv5ess
 ( a device assess$ = con=mity by a te/+
 laboratory s accr$it$1 take su*        
additional measures "u ?is ,act z !     
,secret>y det]m9es appropriate1 su* z   

susp5sion or )drawal ( accr$itation (   
su* te/+ laboratory "u p>agraph         
7#a77;,a71 or reque/+ additional        
in=mation ) reg>d to su* device4  7#c7  
,implem5tation & report+  7,a7 ,public  
meet+ ,! ,secret>y %all publi% 9 !      
,f$]al ,regi/] a notice ( a public meet+
 to be held no lat] ?an ,septemb] #cj1  
#bjah1 to discuss & obta9 input &       
recomm5dations f /akehold]s reg>d+ !    
goals & scope (1 & a suitable framework 
& proc$ures & requirem5ts =1 ! pilot    
program "u ?is subsection4  7,b7 ,pilot 
program guidance ,! ,secret>y %all-- 7i7
 n lat] ?an ,septemb] #cj1 #bjai1 issue 
draft guidance reg>d+ ! goals &         
implem5tation ( ! pilot program "u ?is  
subsection2 &  7ii7 n lat] ?an ,septemb]
 #cj1 #bjba1 issue f9al guidance )      
respect to ! implem5tation ( su*        
program4  7,c7 ,pilot program initiation
 ,n lat] ?an ,septemb] #cj1 #bjbj1 !    
,secret>y %all initiate ! pilot program 
"u ?is subsection4  7,d7 ,report ,!     
,secret>y %all make available on !      

website ( ! ,food & ,drug ,adm9i/ration 
an annual report on ! progress ( ! pilot
 program "u ?is subsection4  7#d7       
,sunset ,z ( ,octob] #a1 #bjbb-- 7,a7 ! 
au?ority = accr$itation bodies to       
accr$it te/+ laboratories pursuant to   
p>agraph 7#a77;,a7 %all cease to h =ce  
or effect2  7,b7 ! ,secret>y-- 7i7 may n
 accept a det]m9ation pursuant to       
p>agraph 7#a77;,b7 made by a te/+       
laboratory aft] su* date2 &  7ii7 may   
accept su* a det]m9ation made prior to  
su* date2  7,c7 except = purposes (     
accept+ a det]m9ation describ$ 9        
subp>agraph 7,b77ii71 ! ,secret>y %all n
 cont9ue to recognize ! accr$itation (  
te/+ laboratories accr$it$ "u p>agraph  
7#a77;,a72 &  7,d7 ! ,secret>y may take 
actions 9 accordance ) p>agraph 7#b7 )  
respect to ! det]m9ations made prior to 
su* date & recognition ( ! accr$itation 
( te/+ laboratories pursuant to         
det]m9ations made prior to su* date4  4 
#bjf4 ,reau?orization ( review ,section 
#ebc ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7 is 
am5d$-- 7#a7 9 subsection 7a77#c7--     
7,a7 9 subp>agraph 7,a71 by /rik+       
clauses 7ii7 & 7iii7 & ins]t+ ! foll[+3 
7ii7 a device classifi$ "u section      
#eac7;f77#b7 or designat$ "u section    
#eae;,c7d72 or  7iii7 a device t is ( a 
type1 or subset ( a type1 li/$ z n      
eligible = review "u subp>agraph        
7,b77iii74  2  7,b7 by /rik+ subp>agraph
 7,b7 & ins]t+ ! foll[+3  7,b7          
,designation = review ,! ,secret>y      
%all--  7i7 issue draft guidance on !   
factors ! ,secret>y w use 9 det]m9+ :e!r
 a class ,i or class ,,ii device type1  
or subset ( su* device types1 is        
eligible = review by an accr$it$ p]son1 
includ+--  7,i7 ! risk ( ! device type1 
or subset ( su* device type2 &  7,,ii7  
:e!r ! device type1 or subset ( su*     
device type1 is p]man5tly implantable1  
life su/a9+1 or life support+2  7ii7 n  
lat] ?an #bd mon?s aft] ! date on :i* ! 
,secret>y issues su* draft guidance1    
f9alize su* guidance2 &  7iii7 beg9n+ on

 ! date su* guidance is f9aliz$1        
designate & po/ on ! ,int]net website ( 
! ,food & ,drug ,adm9i/ration1 an updat$
 li/ ( class ,i & class ,,ii device     
types1 or subsets ( su* device types1 & 
! ,secret>y's det]m9ation ) respect to  
:e!r ea* su* device type1 or subset ( a 
device type1 is eligible or n eligible =
 review by an accr$it$ p]son "u ?is     
section bas$ on ! factors describ$ 9    
clause 7i74  2 &  7,c7 by add+ at ! end 
! foll[+3  7,c7 ,int]im rule ,until !   
date on :i* ! updat$ li/ is designat$ & 
po/$ 9 accordance ) subp>agraph         
7,b77iii71 ! li/ 9 effect on ! date (   
enactm5t ! ,m$ical ,device ,us] ,fee    
,am5dm5ts ( #bjag %all be 9 effect4  2  
7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 
7#b7--  7i7 by /rik+ subp>agraph 7,d72 &
  7ii7 by r$esignat+ subp>agraph 7,e7 z 
subp>agraph 7,d72 &  7,b7 9 p>agraph    
7#c7-- 7i7 by r$esignat+ subp>agraph    
7,e7 z subp>agraph 7,f72  7ii7 9        
subp>agraph 7,f7 7z s r$esignat$71 by   
/rik+ ,! op]ations ( & all t foll[s     

?r\gh x w-- & ins]t+ ,su* p]son %all    
agree1 at a m9imum1 to include 9 its    
reque/ = accr$itation a commitm5t to1 at
 ! "t ( accr$itation1 & at any "t x is  
p]=m+ any review pursuant to ?is        
section--2 &  7iii7 by ins]t+ aft]      
subp>agraph 7,d7 ! foll[+ new           
subp>agraph3  7,e7 ,! op]ations ( su*   
p]son %all be 9 accordance ) g5]ally    
accept$ pr(essional & e?ical bus9ess    
practices4  2 &  7#c7 9 subsection 7c71 
by /rik+ #bjag & ins]t+ #bjbb4  #bjg4   
,electronic =mat = submissions ,section 
#gde;,a7b7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgik-#a7;b77 is am5d$ by add+ at ! end 
! foll[+ new p>agraph3  7#c7            
,presubmissions & submissions solely 9  
electronic =mat  7,a7 ,9 g5]al ,beg9n+  
on ,octob] #a1 #bjba 7or su* lat] date z
 may be specifi$ by ! ,secret>y "u      
subp>agraph 7,b771 presubmissions &     
submissions = devices describ$ 9        
p>agraph 7#a7 7& any appeals ( action   
tak5 by ! ,secret>y ) respect to su*    

presubmissions or submissions7 %all be  
submitt$ solely 9 su* electronic =mat z 
specifi$ by ! ,secret>y 9 guidance issu$
 "u subp>agraph 7,c74  7,b7 ,ext5sion ,!
 ,secret>y may1 if ! ,secret>y det]m9es 
an ext5sion ( ! date specifi$ 9         
subp>agraph 7,a7 is necess>y = !        
developm5t & adoption ( ! electronic    
=mat ref]r$ to 9 su* p>agraph1 ext5d su*
 date until su* lat] date z ! ,secret>y 
may specify1 b 9 no ev5t lat] ?an ,april
 #a1 #bjbc4  7,c7 ,guidance ,! ,secret>y
 %all1 n lat] ?an ,janu>y #a1 #bjba1 or 
su* lat] date z may be specifi$ by !    
,secret>y "u subp>agraph 7,b71 issue    
guidance provid+ =--  7i7 any fur!r     
/&>ds = ! submission by electronic =mat 
requir$ "u subp>agraph 7,a72  7ii7 a    
timetable = ! e/abli%m5t by ! ,secret>y 
( su* fur!r /&>ds2 &  7iii7 set =?      
crit]ia = waiv]s ( & exemptions f !     
requirem5ts ( ?is subsection4  4  #bjh4 
,sav+s clause ,not)/&+ ! am5dm5ts made  
by ?is title1 "p #c ( sub*apt] ,c (     
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  

,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et 
seq471 z 9 effect on ! day be=e ! date (
 ! enactm5t ( ?is title1 %all cont9ue to
 be 9 effect ) respect to ! submissions 
li/$ 9 section #gch7;a77#b77;,a7 ( su*  
,act 7z def9$ 9 su* "p z ( su* day7 t on
 or aft] ,octob] #a1 #bjab1 b be=e      
,octob] #a1 #bjag1 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> #bjah4  #bji4 ,effective date ,!    
am5dm5ts made by ?is title %all take    
effect on ,octob] #a1 #bjag1 or ! date (
 ! enactm5t ( ?is ,act1 :i*ev] is lat]1 
except t fees "u "p #c ( sub*apt] ,c (  
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act %all be assess$ = all    
submissions li/$ 9 section              
#gch7;a77#b77;,a7 ( su* ,act receiv$ on 
or aft] ,octob] #a1 #bjag1 reg>dless ( !
 date ( ! enactm5t ( ?is ,act4  #baj4   
,sunset clause  7a7 ,au?orization       
,sections #gcg & #gch ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#gci;i2 #gci;j7 %all cease to be        
effective ,octob] #a1 #bjbb4  7b7       
,report+ requirem5ts ,section #gch;,a   
7#ba ,u4,s4,c4 #gci;j-#a7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7reg>d+  
reau?orization & report+ requirem5ts7   
%all cease to be effective ,janu>y #ca1 
#bjbc4  7c7 ,previ\s ,sunset ,provision 
7#a7 ,9 g5]al ,effective ,octob] #a1    
#bjag1 section #bjg7;a7 ( ! ,m$ical     
,device ,us] ,fee ,am5dm5ts ( #bjab     
7,public ,law #aab-add7 is repeal$4     
7#b7 ,con=m+ am5dm5t ,! ,food & ,drug   
,adm9i/ration ,safety & ,innovation ,act
 7,public ,law #aab-add7 is am5d$ 9 !   
table ( cont5ts 9 section #b by /rik+ ! 
item relat+ to section #bjg4  ,,iii     
,fees relat+ to g5]ic drugs  #cja4 ,%ort
 title2 f9d+  7a7 ,%ort title ,?is title
 may be cit$ z ! ,g5]ic ,drug ,us] ,fee 
,am5dm5ts ( #bjag4  7b7 ,f9d+ ,!        
,congress f9ds t ! fees au?oriz$ by !   
am5dm5ts made 9 ?is title w be d$icat$  
to human g5]ic drug activities1 z set =?
 9 ! goals id5tifi$ = purposes ( "p #g (

 sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act1 9 !     
lett]s f ! ,secret>y ( ,heal? & ,human  
,s]vices to ! ,*airman ( ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
( ! ,s5ate & ! ,*airman ( ! ,committee  
on ,en]gy & ,comm]ce ( ! ,h\se (        
,repres5tatives1 z set =? 9 !           
,congressional ,record4  #cjb4          
,def9itions ,section #gdd;,a ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#da7 is am5d$-- 7#a7 9 
p>agraph 7#a77;,b71 by /rik+ application
 = a positron emission tomography drug4 
& ins]t+ 8application--  7i7 = a        
positron emission tomography drug2 or   
7ii7 submitt$ by a ,/ate or ,f$]al      
gov]nm5tal entity = a drug t is n       
di/ribut$ comm]cially4  2  7#b7 by      
r$esignat+ p>agraphs 7#e7 ?r\gh 7#ab7 z 
p>agraphs 7#f7 ?r\gh 7#ac71             
respectively2 &  7#c7 by ins]t+ aft]    
p>agraph 7#d7 ! foll[+3  7#e7 ,! t]m    
contract manufactur+ organization       
facility means a manufactur+ facility ( 

a f9i%$ dosage =m ( a drug approv$      
pursuant to an abbreviat$ new drug      
application1 :]e su* manufactur+        
facility is n id5tifi$ 9 an approv$     
abbreviat$ new drug application held by 
! own] ( su* facility or an affiliate ( 
su* own] or facility4  4  #cjc4         
,au?ority to assess & use human g5]ic   
drug fees  7a7 ,types ( fees ,section   
#gdd;,b7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#db7;a77 is am5d$-- 7#a7 9 !     
matt] prec$+ p>agraph 7#a71 by /rik+    
fiscal ye> #bjac & ins]t+ fiscal ye>    
#bjah2  7#b7 9 p>agraph 7#a71 by add+ at
 ! end ! foll[+3  7,e7 ,sunset ,?is     
p>agraph %all cease to be effective     
,octob] #a1 #bjbb4  2  7#c7 9 p>agraph  
7#b7-- 7,a7 by am5d+ subp>agraph 7,c7 to
 read z foll[s3  7,c7 ,notice ,n lat]   
?an #fj days be=e ! />t ( ea* ( fiscal  
ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all
 publi% 9 ! ,f$]al ,regi/] ! am\nt ( !  
drug ma/] file fee e/abli%$ by ?is      
p>agraph = su* fiscal ye>4  2 &  7,b7 9 

subp>agraph 7,e7-- 7i7 9 clause 7i7--   
7,i7 by /rik+ no lat] ?an ! date &      
ins]t+ 8on ! e>li] (--  7,i7 ! date  2  
7,,ii7 by /rik+ ! p]iod & ins]t+ 2 or2 &
  7,,iii7 by add+ at ! end ! foll[+3    
7,,ii7 ! date on :i* ! drug ma/] file   
hold] reque/s ! initial complet5ess     
assessm5t4  2 &  7ii7 9 clause 7ii71 by 
/rik+ notice provid$ = 9 clause 7i7 or  
7ii7 ( subp>agraph 7,c71 z applicable & 
ins]t+ notice provid$ = 9 subp>agraph   
7,c72  7#d7 9 p>agraph 7#c7-- 7,a7 9 !  
head+1 by /rik+ & prior approval        
supplem5t2  7,b7 9 subp>agraph 7,a71 by 
/rik+ or a prior approval supplem5t to  
an abbreviat$ new drug application2     
7,c7 by am5d+ subp>agraphs 7,b7 & 7,c7  
to read z foll[s3  7,b7 ,notice ,n lat] 
?an #fj days be=e ! />t ( ea* ( fiscal  
ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all
 publi% 9 ! ,f$]al ,regi/] ! am\nt ( !  
fees "u subp>agraph 7,a7 = su* fiscal   
ye>4  7,c7 ,fee due date ,! fees requir$
 by subp>agraphs 7,a7 & 7,f7 %all be due
 no lat] ?an ! date ( submission ( !    

abbreviat$ new drug application or prior
 approval supplem5t = :i* su* fee       
applies4  2  7,d7 9 subp>agraph 7,d7--  
7i7 9 ! head+1 by ins]t+ 1 is )drawn    
prior to be+ receiv$1 or is no long]    
receiv$ aft] receiv$2 &  7ii7 by /rik+  
,! ,secret>y %all & all t foll[s ?r\gh !
 p]iod & ins]t+ ! foll[+3  7i7          
,applications n consid]$ to h be5       
receiv$ & applications )drawn prior to  
be+ receiv$ ,! ,secret>y %all refund #ge
 p]c5t ( ! fee paid "u subp>agraph 7,a7 
= any abbreviat$ new drug application t 
! ,secret>y consid]s n to h be5 receiv$ 
)9 ! mean+ ( section #eje7;j77#e77;,a7 =
 a cause o!r ?an failure to pay fees1 or
 t has be5 )drawn prior to be+ receiv$  
)9 ! mean+ ( section #eje7;j77#e77;,a74 
7ii7 ,applications no long] receiv$ ,!  
,secret>y %all refund #ajj p]c5t ( ! fee
 paid "u subp>agraph 7,a7 = any         
abbreviat$ new drug application if !    
,secret>y initially receives !          
application "u section #eje7;j77#e77;,a7
 & subsequ5tly det]m9es t an exclusivity

 p]iod = a li/$ drug %\ld h prev5t$ !   
,secret>y f receiv+ su* application1 su*
 t ! abbreviat$ new drug application is 
no long] receiv$ )9 ! mean+ ( section   
#eje7;j77#e77;,a74  2  7,e7 9           
subp>agraph 7,e71 by /rik+ or prior     
approval supplem5t2 &  7,f7 9 ! matt]   
prec$+ clause 7i7 ( subp>agraph 7,f7--  
7i7 by /rik+ #bjab & ins]t+ #bjag2 &    
7ii7 by /rik+ subsection 7d77#c7 &      
ins]t+ subsection 7d77#b72  7#e7 9      
p>agraph 7#d7-- 7,a7 9 subp>agraph      
7,a7--  7i7 9 ! matt] prec$+ clause 7i7 
& 9 clause 7iii71 by /rik+ 1 or int5d$  
to be id5tifi$1 9 at lea/ "o g5]ic drug 
submission t is p5d+ or & ins]t+ 9 at   
lea/ "o g5]ic drug submission t is2     
7ii7 9 clause 7i71 by /rik+ or int5d$ to
 be id5tifi$ 9 at lea/ "o g5]ic drug    
submission t is p5d+ or & ins]t+ 9 at   
lea/ "o g5]ic drug submission t is2     
7iii7 9 clause 7ii71 by /rik+ produces1 
& all t foll[s ?r\gh su* a & ins]t+ is  
id5tifi$ 9 at lea/ "o g5]ic drug        
submission 9 :i* ! facility is approv$  

to produce "o or m active ph>maceutical 
+r$i5ts or 9 a ,type ,,ii active        
ph>maceutical +r$i5t drug ma/] file     
ref]5c$ 9 at lea/ "o su*2 &  7iv7 9     
clause 7iii71 by /rik+ to fees "u bo?   
su* clauses & ins]t+ only to ! fee      
attributable to ! manufacture ( ! f9i%$ 
dosage =ms2 &  7,b7 by am5d+            
subp>agraphs 7,c7 & 7,d7 to read z      
foll[s3  7,c7 ,notice ,)9 ! timeframe   
specifi$ 9 subsection 7d77#a71 !        
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 ! am\nt ( ! fees "u subp>agraph 7,a7 = 
su* fiscal ye>4  4  7,d7 ,fee due date  
,= ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 
! fees "u subp>agraph 7,a7 = su* fiscal 
ye> %all be due on ! lat] (--  7i7 !    
fir/ bus9ess day on or aft] ,octob] #a (
 ea* su* ye>2 or  7ii7 ! fir/ bus9ess   
day aft] ! enactm5t ( an appropriations 
,act provid+ = ! collection & obligation
 ( fees = su* ye> "u ?is section = su*  
ye>4  2  7#f7 by r$esignat+ p>agraph    
7#e7 z p>agraph 7#f72 &  7#g7 by ins]t+ 
aft] p>agraph 7#d7 ! foll[+3  7#e7      

,g5]ic drug applicant program fee  7,a7 
,9 g5]al ,a g5]ic drug applicant program
 fee %all be assess$ annually z describ$
 9 subsection 7b77#b77;,e74  7,b7 ,am\nt
 ,! am\nt ( fees e/abli%$ "u subp>agraph
 7,a7 %all be e/abli%$ "u subsection    
7d74  7,c7 ,notice ,)9 ! timeframe      
specifi$ 9 subsection 7d77#a71 !        
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 ! am\nt ( ! fees "u subp>agraph 7,a7 = 
su* fiscal ye>4  7,d7 ,fee due date ,=  
ea* ( fiscal ye>s #bjah ?r\gh #bjbb1 !  
fees "u subp>agraph 7,a7 = su* fiscal   
ye> %all be due on ! lat] (--  7i7 !    
fir/ bus9ess day on or aft] ,octob] #a (
 ea* su* fiscal ye>2 or  7ii7 ! fir/    
bus9ess day aft] ! date ( enactm5t ( an 
appropriations ,act provid+ = !         
collection & obligation ( fees = su*    
fiscal ye> "u ?is section = su* fiscal  
ye>4  4  7b7 ,fee rev5ue am\nts ,section
 #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#db7;b77 is am5d$-- 7#a7 9       
p>agraph 7#a7--  7,a7 9 subp>agraph     

7,a7-- 7i7 9 ! head+1 by /rik+ #bjac &  
ins]t+ #bjah2  7ii7 by /rik+ #bjac &    
ins]t+ #bjah2  7iii7 by /rik+           
#bii1jjj1jjj & ins]t+ #dic1fjj1jjj2 &   
7iv7 by /rik+ ,( t am\nt & all t foll[s 
?r\gh ! end ( clause 7ii72 &  7,b7 9    
subp>agraph 7,b7--  7i7 9 ! head+1 by   
/rik+ #bjad ?r\gh #bjag & ins]t+ #bjai  
?r\gh #bjbb2  7ii7 by /rik+ #bjad ?r\gh 
#bjag & ins]t+ #bjai ?r\gh #bjbb2  7iii7
 by /rik+ p>agraphs 7#b7 ?r\gh 7#d7 &   
ins]t+ p>agraphs 7#b7 ?r\gh 7#e72 &     
7iv7 by /rik+ #bii1jjj1jjj & ins]t+     
#dic1fjj1jjj2 &  7#b7 9 p>agraph 7#b7-- 
7,a7 9 ! matt] prec$+ subp>agraph 7,a7--
  7i7 by /rik+ p>agraph 7#a77;,a77ii7 = 
fiscal ye> #bjac & p>agraph 7#a77;,b7 = 
ea* ( fiscal ye>s #bjad ?r\gh #bjag &   
ins]t+ su* p>agraph = a fiscal ye>2 &   
7ii7 by /rik+ ?r\gh 7#d7 & ins]t+ ?r\gh 
7#e72  7,b7 9 subp>agraph 7,a71 by /rik+
 ,six p]c5t & ins]t+ ,five p]c5t2  7,c7 
by am5d+ subp>agraphs 7,b7 & 7,c7 to    
read z foll[s3  7,b7 ,?irty-?ree p]c5t  
%all be d]iv$ f fees "u subsection      

7a77#c7 7relat+ to abbreviat$ new drug  
applications74  7,c7 ,tw5ty p]c5t %all  
be d]iv$ f fees "u subsection           
7a77#d77;,a77i7 7relat+ to g5]ic drug   
facilities74 ,! am\nt ( ! fee = a       
contract manufactur+ organization       
facility %all be equal to "o-?ird !     
am\nt ( ! fee = a facility t is n a     
contract manufactur+ organization       
facility4 ,! am\nt ( ! fee = a facility 
locat$ outside ! ,unit$ ,/ates & its    
t]ritories & possessions %all be #ae1jjj
 high] ?an ! am\nt ( ! fee = a facility 
locat$ 9 ! ,unit$ ,/ates & its          
t]ritories & possessions4  2  7,d7 9    
subp>agraph 7,d7-- 7i7 by /rik+ ,f\rte5 
p]c5t & ins]t+ ,sev5 p]c5t2  7ii7 by    
/rik+ n less ?an #ae1jjj & n m ?an      
#cj1jjj & ins]t+ #ae1jjj2 &  7iii7 by   
/rik+ 1 z det]m9$ & all t foll[s ?r\gh !
 p]iod at ! end & ins]t+ a p]iod2 &     
7,e7 by add+ at ! end ! foll[+3  7,e7   
7i7 ,?irty-five p]c5t %all be d]iv$ f   
fees "u subsection 7a77#e7 7relat+ to   
g5]ic drug applicant program fees74 ,=  

purposes ( ?is subp>agraph1 if a p]son  
has affiliates1 a s+le program fee %all 
be assess$ ) respect to t p]son1 includ+
 its affiliates1 & may be paid by t     
p]son or any "o ( its affiliates4 ,!    
,secret>y %all det]m9e ! fees z foll[s3 
7,i7 ,if a p]son 7includ+ its           
affiliates7 owns at lea/ "o b n m ?an #e
 approv$ abbreviat$ new drug            
applications on ! due date = ! fee "u   
?is subsection1 ! p]son 7includ+ its    
affiliates7 %all be assess$ a small     
bus9ess g5]ic drug applicant program fee
 equal to "o-t5? ( ! l>ge size op]ation 
g5]ic drug applicant program fee4       
7,,ii7 ,if a p]son 7includ+ its         
affiliates7 owns at lea/ #f b n m ?an   
#ai approv$ abbreviat$ new drug         
applications on ! due date = ! fee "u   
?is subsection1 ! p]son 7includ+ its    
affiliates7 %all be assess$ a m$ium size
 op]ation g5]ic drug applicant program  
fee equal to two-fif?s ( ! l>ge size    
op]ation g5]ic drug applicant program   
fee4  7,,iii7 ,if a p]son 7includ+ its  

affiliates7 owns #bj or m approv$       
abbreviat$ new drug applications on !   
due date = ! fee "u ?is subsection1 !   
p]son 7includ+ its affiliates7 %all be  
assess$ a l>ge size op]ation g5]ic drug 
applicant program fee4  7ii7 ,= purposes
 ( ?is subp>agraph1 an abbreviat$ new   
drug application %all be deem$ n to be  
approv$ if ! applicant has submitt$ a   
writt5 reque/ = )drawal ( approval ( su*
 abbreviat$ new drug application by     
,april #a ( ! previ\s fiscal ye>4  4    
7c7 ,adju/m5ts ,section #gdd;,b7c7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is       
am5d$-- 7#a7 9 p>agraph 7#a7--  7,a7 by 
/rik+ #bjad & ins]t+ #bjai2  7,b7 by    
ins]t+ to equal ! product ( ! total     
rev5ues e/abli%$ 9 su* notice = ! prior 
fiscal ye> multipli$ aft] a fiscal ye>12
 &  7,c7 by /rik+ ! flu% text foll[+    
subp>agraph 7,c72 &  7#b7 9 p>agraph    
7#b7--  7,a7 by /rik+ #bjag ea* place x 
appe>s & ins]t+ #bjbb2 &  7,b7 by /rik+ 
#bjah & ins]t+ #bjbc4  7d7 ,annual fee  

sett+ ,section #gdd;,b ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cgi;j-#db7 is am5d$-- 7#a7 9 subsection
 7c77#b71 by /rik+ ,su* fees may only be
 us$ 9 fiscal ye> #bjah42 &  7#b7 9     
subsection 7d7-- 7,a7 by /rik+ p>agraphs
 7#a7 & 7#b7 & ins]t+ ! foll[+3  7#a7   
,fiscal ye>s #bjah ?r\gh #bjbb ,n m ?an 
#fj days be=e ! fir/ day ( ea* ( fiscal 
ye>s #bjah ?r\gh #bjbb1 ! ,secret>y %all
 e/abli% ! fees describ$ 9 p>agraphs    
7#b7 ?r\gh 7#e7 ( subsection 7a71 bas$  
on ! rev5ue am\nts e/abli%$ "u          
subsection 7b7 & ! adju/m5ts provid$ "u 
subsection 7c74  2  7,b7 by r$esignat+  
p>agraph 7#c7 z p>agraph 7#b72 &  7,c7 9
 p>agraph 7#b7 7z s r$esignat$71 9 !    
matt] prec$+ subp>agraph 7,a71 by /rik+ 
fees "u p>agraphs 7#a7 & 7#b7 & ins]t+  
fee "u p>agraph 7#a74  7e7              
,id5tification ( facilities ,section    
#gdd;,b7f7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#db7;f77 is am5d$-- 7#a7 by /rik+
 p>agraph 7#a72  7#b7 by r$esignat+     

p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs   
7#a7 ?r\gh 7#c71 respectively2  7#c7 9  
p>agraph 7#a7 7z s r$esignat$7--  7,a7  
by /rik+ p>agraph 7#d7 & ins]t+ p>agraph
 7#c72 &  7,b7 by /rik+ ,su* in=mation  
%all & all t foll[s ?r\gh ! end (       
subp>agraph 7,b7 & ins]t+ ,su* in=mation
 %all1 = ea* fiscal ye>1 be submitt$1   
updat$1 or reconfirm$ on or be=e ,june  
#a ( ! previ\s fiscal ye>42 &  7#d7 9   
p>agraph 7#b71 z s r$esignat$-- 7,a7 9 !
 head+1 by /rik+ ,cont5ts ( notice &    
ins]t+ ,in=mation requir$ to be         
submitt$2  7,b7 9 ! matt] prec$+        
subp>agraph 7,a71 by /rik+ p>agraph 7#b7
 & ins]t+ p>agraph 7#a72  7,c7 9        
subp>agraph 7,a71 by /rik+ or int5d$ to 
be id5tifi$2  7,d7 9 subp>agraph 7,d71  
by /rik+ & at ! end2  7,e7 9 subp>agraph
 7,e71 by /rik+ ! p]iod & ins]t+ 2 &2 & 
7,f7 by add+ at ! end ! foll[+3  7,f7   
:e!r ! facility is a contract           
manufactur+ organization facility4  4   
7f7 ,effect ( failure ,to pay fees      
,section #gdd;,b7g7 ( ! ,f$]al ,food1   

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi-db7;g77 is am5d$-- 7#a7 9 p>agraph 
7#a71 by add+ at ! end ! foll[+3 ,?is   
p>agraph %all cease to be effective on  
,octob] #a1 #bjbb42  7#b7 9 p>agraph    
7#b77;,c77ii71 by /rik+ (               
#eje7;j77#e77;,a7 & ins]t+ ( section    
#eje7;j77#e77;,a72 &  7#c7 by add+ at ! 
end ! foll[+3  7#e7 ,g5]ic drug         
applicant program fee  7,a7 ,9 g5]al ,a 
p]son :o fails to pay a fee z requir$ "u
 subsection 7a77#e7 by ! date t is #bj  
cal5d> days aft] ! due date1 z specifi$ 
9 subp>agraph 7,d7 ( su* subsection1    
%all be subject to ! foll[+3  7i7 ,!    
,secret>y %all place ! p]son on a       
publicly available arre>s li/4  7ii7    
,any abbreviat$ new drug application    
submitt$ by ! g5]ic drug applicant or an
 affiliate ( su* applicant %all n be    
receiv$1 )9 ! mean+ ( section           
#eje7;j77#e77;,a74  7iii7 ,all drugs    
m>ket$ pursuant to any abbreviat$ new   
drug application held by su* applicant  
or an affiliate ( su* applicant %all be 

deem$ misbr&$ "u section #ejb7;aa74     
7,b7 ,application ( p5alties ,! p5alties
 "u subp>agraph 7,a7 %all apply until ! 
fee requir$ "u subsection 7a77#e7 is    
paid4  4  7g7 ,limitations ,section     
#gdd;,b7h77#b7 ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cgi-db7;h77#b77 is am5d$ by /rik+ =    
,type ,,ii active ph>maceutical +r$i5t  
drug ma/] files1 abbreviat$ new drug    
applications & prior approval           
supplem5ts1 & g5]ic drug facilities &   
active ph>maceutical +r$i5t facilities4 
7h7 ,cr$it+ & availability ( fees       
,section #gdd;,b7i7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi-db7;i77 is am5d$-- 7#a7 9 p>agraph 
7#b7--  7,a7 by /rik+ subp>agraph 7,c7  
7relat+ to fee collection dur+ fir/     
program ye>72  7,b7 9 subp>agraph 7,d7--
  7i7 9 ! head+1 by /rik+ 9 subsequ5t   
ye>s2 &  7ii7 by /rik+ 7aft] fiscal ye> 
#bjac72 &  7,c7 by r$esignat+           
subp>agraph 7,d7 z subp>agraph 7,c72 &  
7#b7 9 p>agraph 7#c71 by /rik+ fiscal   

ye>s #bjac ?r\gh #bjag & ins]t+ fiscal  
ye>s #bjah ?r\gh #bjbb4  7i7 ,in=mation 
on abbreviat$ new drug applications held
 by applicants & _! affiliates ,section 
#gdd;,b ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7  
is am5d$ by add+ at ! end ! foll[+3  7o7
 ,in=mation on abbreviat$ new drug      
applications own$ by applicants & _!    
affiliates  7#a7 ,9 g5]al ,by ,april #a 
( ea* ye>1 ea* p]son t owns an          
abbreviat$ new drug application1 or any 
affiliate ( su* p]son1 %all submit to ! 
,secret>y a li/ (--  7,a7 all approv$   
abbreviat$ new drug applications own$ by
 su* p]son2 &  7,b7 if any affiliate (  
su* p]son also owns an abbreviat$ new   
drug application1 all approv$ abbreviat$
 new drug applications own$ by any su*  
affiliate4  7#b7 ,=mat & me?od ,!       
,secret>y %all specify 9 guidance ! =mat
 & me?od = submission ( li/s "u ?is     
subsection4  4  #cjd4 ,reau?orization2  
report+ requirem5ts ,section #gdd;,c ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  

7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$--   
7#a7 9 subsection 7a7--  7,a7 by /rik+  
#bjac & ins]t+ #bjah2 &  7,b7 by /rik+  
,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjab
 & ins]t+ ,g5]ic ,drug ,us] ,fee        
,am5dm5ts ( #bjag2  7#b7 9 subsection   
7b71 by /rik+ #bjac & ins]t+ #bjah2 &   
7#c7 9 subsection 7d71 by /rik+ #bjag   
ea* place x appe>s & ins]t+ #bjbb4      
#cje4 ,sunset dates  7a7 ,au?orization  
,sections #gdd;,a & #gdd;,b ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all  
cease to be effective ,octob] #a1 #bjbb4
  7b7 ,report+ requirem5ts ,section     
#gdd;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#dc7 %all cease to be effective  
,janu>y #ca1 #bjbc4  7c7 ,previ\s sunset
 provision ,effective ,octob] #a1 #bjag1
 subsections 7a7 & 7b7 ( section #cjd ( 
! ,food & ,drug ,adm9i/ration ,safety & 
,innovation ,act 7,public ,law #aab-add7
 are repeal$4  #cjf4 ,effective date ,! 
am5dm5ts made by ?is title %all take    

effect on ,octob] #a1 #bjag1 or ! date (
 ! enactm5t ( ?is ,act1 :i*ev] is lat]1 
except t fees "u "p #g ( sub*apt] ,c (  
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act %all be assess$ = all    
abbreviat$ new drug applications receiv$
 on or aft] ,octob] #a1 #bjag1 reg>dless
 ( ! date ( ! enactm5t ( ?is ,act4      
#cjg4 ,sav+s clause ,not)/&+ ! am5dm5ts 
made by ?is title1 "p #g ( sub*apt] ,c (
 *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act1 z 9 effect on ! day be=e
 ! date ( ! enactm5t ( ?is title1 %all  
cont9ue to be 9 effect ) respect to     
abbreviat$ new drug applications 7z     
def9$ 9 su* "p z ( su* day7 t on or aft]
 ,octob] #a1 #bjab1 b be=e ,octob] #a1  
#bjag1 7 receiv$ by ! ,food & ,drug     
,adm9i/ration )9 ! mean+ (              
#eje7;j77#e77;,a7 ( su* ,act 7#ba       
,u4,s4,c4 #cee7;j77#e77;,a771 prior     
approval supplem5ts t 7 submitt$1 & drug
 ma/] files = ,type ,,ii active         
ph>maceutical +r$i5ts t 7 fir/ ref]5c$ )
 respect to assess+ & collect+ any fee  

requir$ by su* "p = a fiscal ye> prior  
to fiscal ye> #bjah4  ,,iv ,fees relat+ 
to biosimil> biological products  #dja4 
,%ort title2 f9d+  7a7 ,%ort ,title ,?is
 title may be cit$ z ! ,biosimil> ,us]  
,fee ,am5dm5ts ( #bjag4  7b7 ,f9d+ ,!   
,congress f9ds t ! fees au?oriz$ by !   
am5dm5ts made 9 ?is title w be d$icat$  
to exp$it+ ! process = ! review (       
biosimil> biological product            
applications1 includ+ po/m>ket safety   
activities1 z set =? 9 ! goals id5tifi$ 
= purposes ( "p #h ( sub*apt] ,c ( *apt]
 ,,vii ( ! ,f$]al ,food1 ,drug1 &       
,cosmetic ,act1 9 ! lett]s f ! ,secret>y
 ( ,heal? & ,human ,s]vices to !        
,*airman ( ! ,committee on ,heal?1      
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,*airman ( ! ,committee on   
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives1 z set =? 9 !           
,congressional ,record4  #djb4          
,def9itions  7a7 ,adju/m5t factor       
,section #gdd;,g7#a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#cgi;j-#ea7a77 is am5d$ to read z       
foll[s3  7#a7 ,! 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 
su* ,index = ,octob] #bjaa4  4  7b7     
,biosimil> biological product ,section  
#gdd;,g7#c7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#ea7c77 is am5d$ by /rik+ means a
 product & ins]t+ means a specific /r5g?
 ( a biological product 9 f9al dosage   
=m4  #djc4 ,au?ority to assess & use    
biosimil> fees  7a7 ,types ( fees       
,section #gdd;,h7a7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#eb7;a77 is am5d$-- 7#a7 9 !     
matt] prec$+ p>agraph 7#a71 by /rik+    
fiscal ye> #bjac & ins]t+ fiscal ye>    
#bjah2  7#b7 9 ! head+ ( p>agraph 7#a71 
by /rik+ ,biosimil> & ins]t+ ,biosimil> 
biological product2  7#c7 9 p>agraph    
7#a77;,a77i71 by /rik+ 7b77#a77;,a7 &   
ins]t+ 7c77#e72  7#d7 9 p>agraph        

7#a77;,b77i71 by /rik+ 7b77#a77;,b7 =   
biosimil> biological product developm5t 
& ins]t+ 7c77#e7 = ! biosimil>          
biological product developm5t program2  
7#e7 9 p>agraph 7#a77;,b77ii71 by /rik+ 
annual biosimil> biological product     
developm5t program fee & ins]t+ annual  
biosimil> biological product developm5t 
fee2  7#f7 9 p>agraph 7#a77;,b77iii71 by
 /rik+ annual biosimil> developm5t      
program fee & ins]t+ annual biosimil>   
biological product developm5t fee2  7#g7
 9 p>agraph 7#a77;,b71 by add+ at ! end 
! foll[+3  7iv7 ,refund ,if a p]son     
submits a m>ket+ application = a        
biosimil> biological product be=e       
,octob] #a ( a fiscal ye> & su*         
application is accept$ = fil+ on or aft]
 ,octob] #a ( su* fiscal ye>1 ! p]son   
may reque/ a refund equal to ! annual   
biosimil> developm5t fee paid by ! p]son
 = ! product = su* fiscal ye>4 ,to      
qualify = consid]ation = a refund "u ?is
 clause1 a p]son %all submit to !       
,secret>y a writt5 reque/ = su* refund n

 lat] ?an #ahj days aft] ! m>ket+       
application is accept$ = fil+4  2  7#h7 
9 p>agraph 7#a77;,c71 by /rik+ = a      
product effective ,octob] #a ( a fiscal 
ye> by1 & ins]t+ = a product1 effective 
,octob] #a ( a fiscal ye>1 by12  7#i7 9 
p>agraph 7#a77;,d7--  7,a7 9 clause 7i7 
9 ! matt] prec$+ subclause 7,i71 by     
ins]t+ 1 if ! p]son seeks to resume     
p>ticipation 9 su* program1 be=e pay a  
fee2  7,b7 9 clause 7i77,i71 by ins]t+  
aft] grants a reque/ ! foll[+3 by su*   
p]son2 &  7,c7 9 clause 7i77,,ii71 by   
ins]t+ aft] discont9u$7 ! foll[+3 by su*
 p]son2  7#aj7 9 ! head+ ( p>agraph     
7#a77;,e71 by /rik+ biosimil> developm5t
 program2  7#aa7 9 ! head+ ( subp>agraph
 7,f7 ( p>agraph 7#a71 by /rik+         
biosimil> developm5t program fees &     
ins]t+ biosimil> biological product     
developm5t fees2  7#ab7 9 p>agraph      
7#a77;,f7--  7,a7 9 ! head+ (           
subp>agraph 7,f71 by /rik+ biosimil>    
developm5t program be=e fees2 &  7,b7 by
 am5d+ clause 7i7 to read z foll[s3  7i7

 ,refunds ,except z provid$ 9           
subp>agraph 7,b77iv71 ! ,secret>y %all n
 refund any initial or annual biosimil> 
biological product developm5t fee paid  
"u subp>agraph 7,a7 or 7,b71 or any     
reactivation fee paid "u subp>agraph    
7,d74  2  7#ac7 9 p>agraph 7#b7-- 7,a7 9
 ! head+ ( p>agraph 7#b71 by /rik+ &    
supplem5t2  7,b7 by am5d+ subp>agraphs  
7,a7 & 7,b7 to read z foll[s3  7,a7 ,9  
g5]al ,ea* p]son t submits1 on or aft]  
,octob] #a1 #bjag1 a biosimil>          
biological product application %all be  
subject to ! foll[+ fees3  7i7 ,a fee   
e/abli%$ "u subsection 7c77#e7 = a      
biosimil> biological product application
 = :i* cl9ical data 7o!r ?an comp>ative 
bioavailability /udies7 ) respect to    
safety or effectiv5ess are requir$ =    
approval4  7ii7 ,a fee e/abli%$ "u      
subsection 7c77#e7 = a biosimil>        
biological product application = :i*    
cl9ical data 7o!r ?an comp>ative        
bioavailability /udies7 ) respect to    
safety or effectiv5ess are n requir$ =  

approval4 ,su* fee %all be equal to half
 ( ! am\nt ( ! fee describ$ 9 clause    
7i74  7,b7 ,rule ( applicability2       
treatm5t ( c]ta9 previ\sly paid fees    
,any p]son :o pays a fee "u subp>agraph 
7,a71 7,b71 or 7,d7 ( p>agraph 7#a7 = a 
product be=e ,octob] #a1 #bjag1 b       
submits a biosimil> biological product  
application = t product aft] su* date1  
%all--  7i7 be subject to any biosimil> 
biological product application fees t   
may be assess$ at ! "t :5 su* biosimil> 
biological product application is       
submitt$2 &  7ii7 be entitl$ to no      
r$uction ( su* application fees bas$ on 
! am\nt ( fees paid = t product be=e    
,octob] #a1 #bjag1 "u su* subp>agraph   
7,a71 7,b71 or 7,d74  2  7,c7 9 ! head+ 
( subp>agraph 7,d71 by /rik+ or         
supplem5t2 &  7,d7 9 subp>agraphs 7,c7  
?r\gh 7,f7--  7i7 by /rik+ or supplem5t 
ea* place x appe>s2 &  7ii7 9           
subp>agraph 7,d71 by /rik+ or a         
supplem5t2 &  7#ad7 by am5d+ p>agraph   
7#c7 to read z foll[s3  7#c7 ,biosimil> 

biological product program fee  7,a7 ,9 
g5]al ,ea* p]son :o is nam$ z !         
applicant 9 a biosimil> biological      
product application %all pay ! annual   
biosimil> biological product program fee
 e/abli%$ = a fiscal ye> "u subsection  
7c77#e7 = ea* biosimil> biological      
product t--  7i7 is id5tifi$ 9 su* a    
biosimil> biological product application
 approv$ z ( ,octob] #a ( su* fiscal    
ye>2 &  7ii7 z ( ,octob] #a ( su* fiscal
 ye>1 does n appe> on a li/1 develop$ & 
ma9ta9$ by ! ,secret>y1 ( discont9u$    
biosimil> biological products4  7,b7    
,due date ,! biosimil> biological       
product program fee = a fiscal ye> %all 
be due on ! lat] (-- 7i7 ! fir/ bus9ess 
day on or aft] ,octob] #a ( ea* su* ye>2
 or  7ii7 ! fir/ bus9ess day aft] !     
enactm5t ( an appropriations ,act       
provid+ = ! collection & obligation (   
fees = su* ye> "u ?is section4  7,c7 ,"o
 fee p] product p] ye> ,! biosimil>     
biological product program fee %all be  
paid only once = ea* product = ea*      

fiscal ye>4  7,d7 ,limitation ,a p]son  
:o is nam$ z ! applicant 9 a biosimil>  
biological product application %all n be
 assess$ m ?an #e biosimil> biological  
product program fees = a fiscal ye> =   
biosimil> biological products id5tifi$ 9
 su* biosimil> biological product       
application4  4  7b7 ,fee rev5ue am\nts 
,subsection 7b7 ( section #gdd;,h ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$ to  
read z foll[s3  7b7 ,fee rev5ue am\nts  
7#a7 ,fiscal ye> #bjah ,= fiscal ye>    
#bjah1 fees "u subsection 7a7 %all be   
e/abli%$ to g5]ate a total rev5ue am\nt 
equal to ! sum (--  7,a7 #de1jjj1jjj2 & 
7,b7 ! doll> am\nt equal to ! fiscal ye>
 #bjah adju/m5t 7z det]m9$ "u subsection
 7c77#d774  7#b7 ,subsequ5t fiscal ye>s 
,= ea* ( ! fiscal ye>s #bjai ?r\gh      
#bjbb1 fees "u subsection 7a7 %all1     
except z provid$ 9 subsection 7c71 be   
e/abli%$ to g5]ate a total rev5ue am\nt 
equal to ! sum (--  7,a7 ! annual base  
rev5ue = ! fiscal ye> 7z det]m9$ "u     

p>agraph 7#d772  7,b7 ! doll> am\nt     
equal to ! inflation adju/m5t = ! fiscal
 ye> 7z det]m9$ "u subsection 7c77#a772 
7,c7 ! doll> am\nt equal to ! capacity  
plann+ adju/m5t = ! fiscal ye> 7z       
det]m9$ "u subsection 7c77#b772 &  7,d7 
! doll> am\nt equal to ! op]at+ res]ve  
adju/m5t = ! fiscal ye>1 if applicable  
7z det]m9$ "u subsection 7c77#c774  7#c7
 ,allocation ( rev5ue am\nt among fees2 
limitations on fee am\nts  7,a7         
,allocation ,! ,secret>y %all det]m9e ! 
p]c5tage ( ! total rev5ue am\nt = a     
fiscal ye> to be d]iv$ f1 respectively--
  7i7 initial & annual biosimil>        
developm5t fees & reactivation fees "u  
subsection 7a77#a72  7ii7 biosimil>     
biological product application fees "u  
subsection 7a77#b72 &  7iii7 biosimil>  
biological product program fees "u      
subsection 7a77#c74  7,b7 ,limitations  
on fee am\nts ,until ! fir/ fiscal ye> =
 :i* ! capacity plann+ adju/m5t "u      
subsection 7c77#b7 is effective1 ! am\nt
 ( any fee "u subsection 7a7 = a fiscal 

ye> aft] fiscal ye> #bjah %all n exce$  
#abe p]c5t ( ! am\nt ( su* fee = fiscal 
ye> #bjah4  7,c7 ,biosimil> biological  
product developm5t fees ,! initial      
biosimil> biological product developm5t 
fee "u subsection 7a77#a77;,a7 = a      
fiscal ye> %all be equal to ! annual    
biosimil> biological product developm5t 
fee "u subsection 7a77#a77;,b7 = t      
fiscal ye>4  7,d7 ,reactivation fee ,!  
reactivation fee "u subsection          
7a77#a77;,d7 = a fiscal ye> %all be     
equal to twice ! am\nt ( ! annual       
biosimil> biological product developm5t 
fee "u subsection 7a77#a77;,b7 = t      
fiscal ye>4  7#d7 ,annual base rev5ue ,=
 purposes ( p>agraph 7#b71 ! doll> am\nt
 ( ! annual base rev5ue = a fiscal ye>  
%all be ! doll> am\nt ( ! total rev5ue  
am\nt = ! previ\s fiscal ye>1 exclud+   
any adju/m5ts to su* rev5ue am\nt "u    
subsection 7c77#c74  4  7c7 ,adju/m5ts2 
annual fee sett+ ,section #gdd;,h ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$--   

7#a7 by r$esignat+ subsections 7c7 ?r\gh
 7h7 z subsections 7d7 ?r\gh 7i71       
respectively2  7#b7 9 subsections       
7a77#b77;,f7 & 7g71 by /rik+ subsection 
7c7 & ins]t+ subsection 7d72  7#c7 9    
subsection 7a77#d77;,a71 by /rik+       
subsection 7b77#a77;,f7 & ins]t+        
subsection 7c77#e72 &  7#d7 by ins]t+   
aft] subsection 7b7 ! foll[+3  7c7      
,adju/m5ts2 annual fee sett+  7#a7      
,inflation adju/m5t  7,a7 ,9 g5]al ,=   
purposes ( subsection 7b77#b77;,b71 !   
doll> am\nt ( ! inflation adju/m5t to ! 
annual base rev5ue = ea* fiscal ye> %all
 be equal to ! product (--  7i7 su*     
annual base rev5ue = ! fiscal ye> "u    
subsection 7b72 &  7ii7 ! inflation     
adju/m5t p]c5tage "u subp>agraph 7,b74  
7,b7 ,inflation adju/m5t p]c5tage ,!    
inflation adju/m5t p]c5tage "u ?is      
subp>agraph = a fiscal ye> is equal to !
 sum (--  7i7 ! 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 ye>s ( !      
prec$+ #d fiscal ye>s1 multipli$ by !   
proportion ( p]sonnel comp5sation &     
b5efits co/s to total co/s ( ! process =
 ! review ( biosimil> biological product
 applications 7z def9$ 9 section        
#gdd;,g7#ac77 = ! fir/ #c ye>s ( !      
prec$+ #d fiscal ye>s2 &  7ii7 ! av]age 
annual p]c5t *ange t occurr$ 9 !        
,consum] ,price ,index = urban consum]s 
7,wa%+ton-,baltimore1                   
,,dc-,,md-,,va-,,wv2 ,n ,seasonally     
,adju/$2 ,all items2 ,annual ,index7 = !
 fir/ #c ye>s ( ! prec$+ #d ye>s (      
available data multipli$ by ! proportion
 ( all co/s o!r ?an p]sonnel comp5sation
 & b5efits co/s to total co/s ( !       
process = ! review ( biosimil>          
biological product applications 7z def9$
 9 section #gdd;,g7#ac77 = ! fir/ #c    
ye>s ( ! prec$+ #d fiscal ye>s4  7#b7   
,capacity plann+ adju/m5t  7,a7 ,9 g5]al
 ,beg9n+ ) ! fiscal ye> describ$ 9      
subp>agraph 7,b77ii77,,ii71 ! ,secret>y 

%all1 9 addition to ! adju/m5t "u       
p>agraph 7#a71 fur!r increase ! fee     
rev5ue & fees "u ?is section = a fiscal 
ye> to reflect *anges 9 ! res\rce       
capacity ne$s ( ! ,secret>y = ! process 
= ! review ( biosimil> biological       
product applications4  7,b7 ,capacity   
plann+ me?odology  7i7 ,developm5t2     
evaluation & report ,! ,secret>y %all   
obta91 ?r\gh a contract ) an indep5d5t  
acc\nt+ or consult+ firm1 a report      
evaluat+ options & recomm5dations = a   
new me?odology to accurately assess     
*anges 9 ! res\rce & capacity ne$s ( !  
process = ! review ( biosimil>          
biological product applications4 ,!     
capacity plann+ me?odological options & 
recomm5dations pres5t$ 9 su* report %all
 utilize & be in=m$ by p]sonnel "t      
report+ data z an input4 ,! report %all 
be publi%$ = public comm5t n lat] ?an   
,septemb] #cj1 #bjbj4  7ii7 ,e/abli%m5t 
& implem5tation ,aft] review ( ! report 
describ$ 9 clause 7i7 & receipt & review
 ( public comm5ts !reon1 ! ,secret>y    

%all e/abli% a capacity plann+          
me?odology = purposes ( ?is p>agraph1   
:i* %all--  7,i7 incorporate su*        
approa*es & attributes z ! ,secret>y    
det]m9es appropriate2 &  7,,ii7 be      
effective beg9n+ ) ! fir/ fiscal ye> =  
:i* fees are set aft] su* capacity      
plann+ me?odology is e/abli%$4  7,c7    
,limitation ,"u no circum/ances %all an 
adju/m5t "u ?is p>agraph result 9 fee   
rev5ue = a fiscal ye> t is less ?an !   
sum ( ! am\nts "u subsections           
7b77#b77;,a7 7! annual base rev5ue = !  
fiscal ye>7 & 7b77#b77;,b7 7! doll>     
am\nt ( ! inflation adju/m5t = ! fiscal 
ye>74  7,d7 ,publication 9 f$]al regi/] 
,! ,secret>y %all publi% 9 ! ,f$]al     
,regi/] notice "u p>agraph 7#e7 ! fee   
rev5ue & fees result+ f ! adju/m5t & !  
me?odologies "u ?is p>agraph4  7#c7     
,op]at+ res]ve adju/m5t  7,a7 ,int]im   
application2 fee r$uction ,until ! fir/ 
fiscal ye> = :i* ! capacity plann+      
adju/m5t "u p>agraph 7#b7 is effective1 
! ,secret>y may1 9 addition to !        

adju/m5t "u p>agraph 7#a71 r$uce ! fee  
rev5ue & fees "u ?is section = a fiscal 
ye> z ! ,secret>y det]m9es appropriate =
 long-t]m f9ancial plann+ purposes4     
7,b7 ,g5]al application & me?odology    
,beg9n+ ) ! fir/ fiscal ye> = :i* !     
capacity plann+ adju/m5t "u p>agraph    
7#b7 is effective1 ! ,secret>y may1 9   
addition to ! adju/m5ts "u p>agraphs    
7#a7 & 7#b7--  7i7 r$uce ! fee rev5ue & 
fees "u ?is section z ! ,secret>y       
det]m9es appropriate = long-t]m f9ancial
 plann+ purposes2 or  7ii7 increase !   
fee rev5ue & fees "u ?is section if su* 
an adju/m5t is necess>y to provide = n m
 ?an #ba weeks ( op]at+ res]ves (       
c>ryov] us] fees = ! process = ! review 
( biosimil> biological product          
applications4  7,c7 ,f$]al regi/] notice
 ,if an adju/m5t "u subp>agraph 7,a7 or 
7,b7 is made1 ! rationale = ! am\nt ( ! 
increase or decrease 7z applicable7 9   
fee rev5ue & fees %all be conta9$ 9 !   
annual ,f$]al ,regi/] notice "u p>agraph
 7#e7 e/abli%+ fee rev5ue & fees = !    

fiscal ye> involv$4  7#d7 ,fiscal ye>   
#bjah adju/m5t  7,a7 ,9 g5]al ,= fiscal 
ye> #bjah1 ! ,secret>y %all adju/ ! fee 
rev5ue & fees "u ?is section 9 su* am\nt
 7if any7 z ne$$ to reflect an updat$   
assessm5t ( ! workload = ! process = !  
review ( biosimil> biological product   
applications4  7,b7 ,me?odology ,!      
,secret>y %all publi% "u p>agraph 7#e7 a
 description ( ! me?odology us$ to      
calculate ! fiscal ye> #bjah adju/m5t "u
 ?is p>agraph 9 ! ,f$]al ,regi/] notice 
e/abli%+ fee rev5ue & fees = fiscal ye> 
#bjah4  7,c7 ,limitation ,no adju/m5t "u
 ?is p>agraph %all result 9 an increase 
9 fee rev5ue & fees "u ?is section 9    
excess ( #i1jjj1jjj4  7#e7 ,annual fee  
sett+ ,= fiscal ye> #bjah & ea*         
subsequ5t fiscal ye>1 ! ,secret>y %all1 
n lat] ?an #fj days be=e ! />t ( ea* su*
 fiscal ye>--  7,a7 e/abli%1 = ! fiscal 
ye>1 initial & annual biosimil>         
biological product developm5t fees &    
reactivation fees "u subsection 7a77#a71
 biosimil> biological product           

application fees "u subsection 7a77#b71 
& biosimil> biological product program  
fees "u subsection 7a77#c71 bas$ on !   
rev5ue am\nts e/abli%$ "u subsection 7b7
 & ! adju/m5ts provid$ "u ?is           
subsection2 &  7,b7 publi% su* fee      
rev5ue & fees 9 ! ,f$]al ,regi/]4  7#f7 
,limit ,! total am\nt ( fees assess$ = a
 fiscal ye> "u ?is section may n exce$ !
 total co/s = su* fiscal ye> = !        
res\rces allocat$ = ! process = ! review
 ( biosimil> biological product         
applications4  4  7d7 ,application fee  
waiv] = small bus9ess ,subsection       
7d77#a7 ( section #gdd;,h ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#eb71 z r$esignat$ by  
subsection 7c77#a71 is am5d$--  7#a7 by 
/rik+ subp>agraph 7,b72  7#b7 by /rik+  
%all pay-- & all t foll[s ?r\gh         
application fees & ins]t+ %all pay      
application fees2 &  7#c7 by /rik+ 2 &  
at ! end & ins]t+ a p]iod4  7e7 ,effect 
( failure ,to pay fees ,subsection 7e7 (
 section #gdd;,h ( ! ,f$]al ,food1      

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#eb71 z r$esignat$ by subsection 
7c77#a71 is am5d$ by /rik+ all fees &   
ins]t+ all su* fees4  7f7 ,cr$it+ &     
availability ( fees ,subsection 7f7 (   
section #gdd;,h ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cgi;j-#eb71 z r$esignat$ by subsection 
7c77#a71 is am5d$--  7#a7 9 p>agraph    
7#b7-- 7,a7 by /rik+ subp>agraph 7,c7   
7relat+ to fee collection dur+ fir/     
program ye>7 & ins]t+ ! foll[+3  7,c7   
,compliance ,! ,secret>y %all be        
consid]$ to h met ! requirem5ts (       
subp>agraph 7,b7 9 any fiscal ye> if !  
co/s describ$ 9 su* subp>agraph are n m 
?an #ae p]c5t bel[ ! level specifi$ 9   
su* subp>agraph4  2 &  7,b7 9           
subp>agraph 7,d7-- 7i7 9 ! head+1 by    
/rik+ 9 subsequ5t ye>s2 &  7ii7 by /rik+
 7aft] fiscal ye> #bjac72 &  7#b7 9     
p>agraph 7#c71 by /rik+ #bjac ?r\gh     
#bjag & ins]t+ #bjah ?r\gh #bjbb4  #djd4
 ,reau?orization2 report+ requirem5ts   
,section #gdd;,i ( ! ,f$]al ,food1      

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#ec7 is am5d$-- 7#a7 9 subsection
 7a7--  7,a7 by /rik+ #bjac & ins]t+    
#bjah2 &  7,b7 by /rik+ ,biosimil> ,us] 
,fee ,act ( #bjab & ins]t+ ,biosimil>   
,us] ,fee ,am5dm5ts ( #bjag2  7#b7 9    
subsection 7b71 by /rik+ #bjac & ins]t+ 
#bjah2  7#c7 by /rik+ subsection 7d72   
7#d7 by r$esignat+ subsection 7e7 z     
subsection 7d72 &  7#e7 9 subsection    
7d71 z s r$esignat$1 by /rik+ #bjag ea* 
place x appe>s & ins]t+ #bjbb4  #dje4   
,sunset dates  7a7 ,au?orization        
,sections #gdd;,g & #gdd;,h ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act1 z am5d$ 
by section #djc ( ?is ,act1 %all cease  
to be effective ,octob] #a1 #bjbb4  7b7 
,report+ ,requirem5ts ,section #gdd;,i (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     
,act1 z am5d$ by section #djd ( ?is     
,act1 %all cease to be effective ,janu>y
 #ca1 #bjbc4  7c7 ,previ\s ,sunset      
,provision  7#a7 ,9 g5]al ,effective    
,octob] #a1 #bjag1 section #djd ( !     
,food & ,drug ,adm9i/ration ,safety &   

,innovation ,act 7,public ,law #aab-add7
 is repeal$4  7#b7 ,con=m+ am5dm5t ,!   
,food & ,drug ,adm9i/ration ,safety &   
,innovation ,act 7,public ,law #aab-add7
 is am5d$ 9 ! table ( cont5ts 9 section 
#b by /rik+ ! item relat+ to section    
#djd4  #djf4 ,effective date ,! am5dm5ts
 made by ?is title %all take effect on  
,octob] #a1 #bjag1 or ! date ( !        
enactm5t ( ?is ,act1 :i*ev] is lat]1    
except t fees "u "p #h ( sub*apt] ,c (  
*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act %all be assess$ = all    
biosimil> biological product            
applications receiv$ on or aft] ,octob] 
#a1 #bjag1 reg>dless ( ! date ( !       
enactm5t ( ?is ,act4  #djg4 ,sav+s      
clause ,not)/&+ ! am5dm5ts made by ?is  
title1 "p #h ( sub*apt] ,c ( *apt] ,,vii
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act1 z 9 effect on ! day be=e ! date ( 
! enactm5t ( ?is title1 %all cont9ue to 
be 9 effect ) respect to biosimil>      
biological product applications &       
supplem5ts 7z def9$ 9 su* "p z ( su*    

day7 t 7 accept$ by ! ,food & ,drug     
,adm9i/ration = fil+ on or aft] ,octob] 
#a1 #bjab1 b be=e ,octob] #a1 #bjag1 )  
respect to assess+ & collect+ any fee   
requir$ by su* "p = a fiscal ye> prior  
to fiscal ye> #bjah4  ,v ,reau?orization
 ( o!r programs  #eja4 ,reau?orization (
 provision relat+ to exclusivity ( c]ta9
 drugs conta9+ s+le enantiom]s ,section 
#eje7u77#d7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7u77#d77 is am5d$ by /rik+ #bjag &  
ins]t+ #bjbb4  #ejb4 ,reau?orization (  
p$iatric humanit>ian device exceptions  
,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is    
am5d$ by /rik+ #bjag & ins]t+ #bjbb4    
#ejc4 ,reau?orization ( ! critical pa?  
public-private p>tn]%ips ,section       
#eff7;f7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#e7;f77 is am5d$ by /rik+ #bjac
 ?r\gh #bjag & ins]t+ #bjah ?r\gh #bjbb4
  #ejd4 ,reau?orization ( p$iatric      

device consortia ,section #cje7;e7 (    
,p$iatric ,m$ical ,device ,safety &     
,improvem5t ,act ( #bjjg 7,public ,law  
#aaj-he2 #db ,u4,s4,c4 #bhb note7 is    
am5d$ by /rik+ #bjac ?r\gh #bjag &      
ins]t+ #bjah ?r\gh #bjbb4  #eje4        
,reau?orization ( orphan grants program 
,section #e7;c7 ( ! ,orphan ,drug ,act  
7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by  
/rik+ #bjac ?r\gh #bjag & ins]t+ #bjah  
?r\gh #bjbb4