,,ib ,union ,cal5d> ,no4 #bed #aai?     
,,congress  #a/ ,session  ,h4 ,r4 #dbgc 
,report ,no4 #aai-cjj ,,9 ,,! ,,h\se ,,(
 ,,repres5tatives  ,july #b1 #bjbe,mr4  
,latta 7= himself1 ,ms4 ,de,gette1 ,mr4 
,cr5%aw1 & ,mrs4 ,d+ell7 introduc$ !    
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce         
,septemb] #ag1 #bjbe,report$ ) an       
am5dm5t1 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union1 &    
ord]$ to be printed,strike out all aft] 
! enact+ clause & ins]t ! "p pr9t$ 9    
italic,for text ( introduc$ bill1 see   
copy ( bill z introduc$ on ,july #b1    
#bjbe  ,a ,,bill  ,to am5d ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act to revise
 & ext5d ! us] fee program = ov]-!-c\nt]
 monograph drugs1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,ov]-!-,c\nt] ,monograph ,drug ,us] ,fee
 ,am5dm5ts4  #b4 ,f9d+ ,congress f9ds t 
! fees au?oriz$ by ! am5dm5ts made 9 ?is
 ,act w be d$icat$ to ,,otc monograph   
drug activities1 z set =? 9 ! goals     

id5tifi$ = purposes ( "p #aj ( sub*apt] 
,c ( *apt] ,,vii ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#ga et seq471 9 ! lett]s f !     
,secret>y ( ,heal? & ,human ,s]vices to 
! ,*airman ( ! ,committee on ,en]gy &   
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,*airman ( ! ,committee on ,heal?1     
,education1 ,labor1 & ,p5sions ( !      
,s5ate1 z set =? 9 ! ,congressional     
,record4  #c4 ,def9itions ,section      
#gdd,l7#i77;,a7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cgi;j-#ga7i77;,a77 is am5d$-- 7#a7 9   
clause 7v71 by /rik+ 2 or & ins]t+ a    
semicolon2  7#b7 9 clause 7vi7-- 7,a7 by
 /rik+ addition & ins]t+ ! addition2 &  
7,b7 by /rik+ ! p]iod & ins]t+ 2 or2 &  
7#c7 by add+ at ! end ! foll[+3  7vii7 !
 addition or modification ( a te/+      
proc$ure applicable to "o or m ,,otc    
monograph drugs1 provid$ t su*          
additional or modifi$ te/+ proc$ure     
reflects a volunt>y cons5sus /&>d )     
respect to ph>maceutical quality t is-- 

7,i7 e/abli%$ by a national or          
int]national /&>ds developm5t           
organization2 &  7,,ii7 recogniz$ by !  
,secret>y ?r\gh a process describ$ 9    
guidance = indu/ry1 initially publi%$ 9 
,july #bjbc1 or any successor guidance1 
publicly available on ! website ( !     
,food & ,drug ,adm9i/ration1 :i*        
addresses volunt>y cons5sus /&>ds =     
ph>maceutical quality4  4  #d4 ,au?ority
 to assess & use ,,otc monograph fees   
7a7 ,types ( fees ,section #gdd,m7a77#a7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;a77#a77 
is am5d$-- 7#a7 9 subp>agraph 7,a7--    
7,a7 by /rik+ on ,decemb] #ca ( ! fiscal
 ye> or at any "t dur+ ! prec$+ #ab-mon?
 p]iod & ins]t+ at any "t dur+ !        
applicable p]iod specifi$ 9 clause 7ii7 
= a fiscal ye>2  7,b7 by /rik+ ,ea*     
p]son & ins]t+ ! foll[+3  7i7 ,assessm5t
 ( fees ,ea* p]son  2 &  7,c7 by add+ at
 ! end ! foll[+3  7ii7 ,applicable p]iod
 ,= purposes ( clause 7i71 ! applicable 
p]iod is-- 7,i7 = fiscal ye> #bjbf1 !   

#ab-mon? p]iod end+ on ,decemb] #ca1    
#bjbe2  7,,ii7 = fiscal ye> #bjbg1 !    
#i-mon? p]iod end+ on ,septemb] #cj1    
#bjbf2 &  7,,iii7 = fiscal ye> #bjbh &  
ea* subsequ5t fiscal ye>1 ! #ab-mon?    
p]iod end+ on ,septemb] #cj ( ! prec$+  
fiscal ye>4  2  7#b7 9 subp>agraph      
7,b77i71 by am5d+ subclause 7,i7 to read
 z foll[s3  7,i7 has ceas$ all          
activities relat$ to ,,otc monograph    
drugs prior to-- 7aa7 = purposes (      
fiscal ye> #bjbf1 ,janu>y #a1 #bjbe2    
7bb7 = purposes ( fiscal ye> #bjbg1     
,janu>y #a1 #bjbf2 &  7cc7 = purposes ( 
fiscal ye> #bjbh & ea* subsequ5t fiscal 
ye>1 ,octob] #a ( ! prec$+ fiscal ye>2 &
  2 &  7#c7 by am5d+ subp>agraph 7,d7 to
 read z foll[s3  7,d7 ,due date  7i7    
,fiscal ye> #bjbf ,= fiscal ye> #bjbf1 !
 facility fees requir$ "u subp>agraph   
7,a7 %all be due on ! lat] (-- 7,i7 !   
fir/ bus9ess day ( ,june ( su* ye>2 or  
7,,ii7 ! fir/ bus9ess day aft] !        
enactm5t ( an appropriations ,act       
provid+ = ! collection & obligation (   

fees "u ?is section = su* ye>4  7ii7    
,fiscal ye> #bjbg ,= fiscal ye> #bjbg1 !
 facility fees requir$ "u subp>agraph   
7,a7 %all be due-- 7,i7 9 a fir/        
in/allm5t repres5t+ #ej p]c5t ( su* fee1
 on ! lat] (-- 7aa7 ,octob] #a1 #bjbf2  
or  7bb7 ! fir/ bus9ess day aft] !      
enactm5t ( an appropriations ,act       
provid+ = ! collection & obligation (   
fees "u ?is section = su* ye>2 &  7,,ii7
 9 a second in/allm5t repres5t+ ! rema9+
 #ej p]c5t ( su* fee1 on-- 7aa7 ,febru>y
 #a1 #bjbg2 or  7bb7 if an              
appropriations ,act describ$ 9 subclause
 7,i77bb7 is n 9 effect on ,febru>y #a1 
#bjbg1 ! fir/ bus9ess day aft] enactm5t 
( su* an appropriations ,act4  7iii7    
,subsequ5t fiscal ye>s ,= fiscal ye>    
#bjbh & ea* subsequ5t fiscal ye>1 !     
facility fees requir$ "u subp>agraph    
7,a7 %all be due on ! lat] (-- 7,i7 !   
fir/ bus9ess day on or aft] ,octob] #a (
 ! fiscal ye>2 or  7,,ii7 ! fir/ bus9ess
 day aft] ! date ( enactm5t ( an        
appropriations ,act provid+ = !         

collection & obligation ( fees "u ?is   
section = ! fiscal ye>4  4  7b7 ,fee    
rev5ue am\nts ,section #gdd,m7b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#gb7;b77 is am5d$ 
to read z foll[s3  7b7 ,fee rev5ue      
am\nts  7#a7 ,9 g5]al ,= ea* ( ! fiscal 
ye>s #bjbf ?r\gh #bjcj1 fees "u         
subsection 7a77#a7 %all be e/abli%$ to  
g5]ate a total facility fee rev5ue am\nt
 equal to ! sum (-- 7,a7 ! annual base  
rev5ue = ! fiscal ye> 7z det]m9$ "u     
p>agraph 7#b772  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 ! op]at+    
res]ve adju/m5t = ! fiscal ye>1 if      
applicable 7z det]m9$ "u subsection     
7c77#b772  7,d7 additional direct co/   
adju/m5ts 7z det]m9$ "u subsection      
7c77#c772  7,e7 an additional doll>     
am\nt equal to-- 7i7 #b1cgc1jjj = fiscal
 ye> #bjbf2  7ii7 #a1bcc1jjj = fiscal   
ye> #bjbg2 &  7iii7 #hed1jjj = fiscal   
ye> #bjbh2 &  7,f7 9 ! case ( a fiscal  

ye> = :i* ! ,secret>y applies ! "o-"t   
facility fee workload adju/m5t "u       
subsection 7c77#d71 ! doll> am\nt equal 
to su* adju/m5t4  7#b7 ,annual base     
rev5ue ,= purposes ( p>agraph 7#a71 !   
doll> am\nt ( ! annual base rev5ue = a  
fiscal ye> %all be-- 7,a7 = fiscal ye>  
#bjbf1 ! doll> am\nt ( ! total rev5ue   
am\nt e/abli%$ = fiscal ye> #bjbe "u ?is
 subsection z 9 effect on ! day be=e !  
date ( enactm5t ( ! ,ov]-!-,c\nt]       
,monograph ,drug ,us] ,fee ,am5dm5ts1 n 
includ+ any adju/m5ts made = su* fiscal 
ye> #bjbe "u subsection 7c77#b71 z s 9  
effect2 &  7,b7 = fiscal ye>s #bjbg     
?r\gh #bjcj1 ! doll> am\nt ( ! total    
rev5ue am\nt e/abli%$ "u ?is subsection 
= ! previ\s fiscal ye>1 n includ+ any   
adju/m5ts made = su* previ\s fiscal ye> 
"u subsection 7c77#b7 or 7c77#c74  4    
7c7 ,adju/m5ts2 annual fee sett+        
,section #gdd,m7c7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgi;j-#gb7 is am5d$-- 7#a7 9 p>agraph  
7#a7-- 7,a7 9 subp>agraph 7,a71 9 !     

matt] prec$+ clause 7i7-- 7i7 by /rik+  
subsection 7b77#b77;,b7 & ins]t+        
subsection 7b77#a77;,b72 &  7ii7 by     
/rik+ fiscal ye> #bjbb & ea* subsequ5t  
fiscal ye> & ins]t+ ea* fiscal ye>2     
7,b7 9 subp>agraph 7,b71 by /rik+ fiscal
 ye> #bjbb & all t foll[s ?r\gh ! p]iod 
at ! end & ins]t+ ! foll[+3 a fiscal ye>
 %all be equal to ! product (-- 7i7 =   
fiscal ye> #bjbf-- 7,i7 ! fee = fiscal  
ye> #bjbe "u subsection 7a77#b72 &      
7,,ii7 ! inflation adju/m5t p]c5tage "u 
subp>agraph 7,c72 &  7ii7 = ea* ( fiscal
 ye>s #bjbg ?r\gh #bjcj-- 7,i7 !        
applicable fee "u subsection 7a77#b7 = !
 prec$+ fiscal ye>2 &  7,,ii7 !         
inflation adju/m5t p]c5tage "u          
subp>agraph 7,c74  2 &  7,c7 9          
subp>agraph 7,c7-- 7i7 9 ! matt] prec$+ 
clause 7i71 by ins]t+ ! sum ( aft] is   
equal to2  7ii7 by /rik+ clause 7i72    
7iii7 by r$esignat+ subclauses 7,i7 &   
7,,ii7 ( clause 7ii7 z clauses 7i7 &    
7ii71 respectively1 & adju/+ ! m>g9s    
accord+ly2  7iv7 by /rik+ 7ii7 = ea* (  

fiscal ye>s #bjbd & #bjbe1 ! sum (--2 & 
7v7 9 clause 7ii71 z s r$esignat$1 by   
/rik+ ,wa%+ton-,baltimore1              
,,dc-,,md-,,va-,,wv & ins]t+            
,wa%+ton-,arl+ton-,alex&ria-,,dc-,,va-,,
md-,,wv2  7#b7 9 p>agraph 7#b7-- 7,a7 9 
subp>agraph 7,a7-- 7i7 by /rik+ fiscal  
ye> #bjba & subsequ5t fiscal ye>s &     
ins]t+ ea* fiscal ye>2  7ii7 by /rik+   
subsections 7b77#a77;,b7 & 7b77#b77;,c7 
& ins]t+ subsection 7b77#a77;,c72 &     
7iii7 by /rik+ ! numb] ( weeks specifi$ 
9 subp>agraph 7,b7 & ins]t+ #aj weeks2  
7,b7 by /rik+ subp>agraph 7,b72  7,c7 by
 r$esignat+ subp>agraphs 7,c7 & 7,d7 z  
subp>agraphs 7,b7 & 7,c71 respectively2 
&  7,d7 9 subp>agraph 7,c71 z s         
r$esignat$1 by /rik+ p>agraph 7#d7      
e/abli%+ & ins]t+ p>agraph 7#e7 publi%+2
  7#c7 9 p>agraph 7#c7-- 7,a7 9 ! matt] 
prec$+ subp>agraph 7,a71 by /rik+       
subsection 7b77#b77;,d7 & ins]t+        
subsection 7b77#a77;,d72 &  7,b7 by     
/rik+ subp>agraphs 7,a7 ?r\gh 7,e7 &    
ins]t+ ! foll[+3  7,a7 #ace1jjj = fiscal

 ye> #bjbf2  7,b7 #cjj1jjj = fiscal ye> 
#bjbg2  7,c7 #ee1jjj = fiscal ye> #bjbh2
  7,d7 #cj1jjj = fiscal ye> #bjbi2 &    
7,e7 #j = fiscal ye> #bjcj4  2 &  7#d7  
by /rik+ p>agraph 7#d7 & ins]t+ !       
foll[+3  7#d7 ,"o-"t facility fee       
workload adju/m5t  7,a7 ,9 g5]al ,9     
addition to ! adju/m5ts "u p>agraphs    
7#a71 7#b71 & 7#c71 ! ,secret>y may     
fur!r increase ! fee rev5ues & fees     
?r\gh a "o-"t adju/m5t made = fiscal ye>
 #bjbh1 #bjbi1 or #bjcj1 9 accordance ) 
?is p>agraph4  7,b7 ,adju/m5t describ$  
7i7 ,conditions = adju/m5t ,an adju/m5t 
"u ?is p>agraph may be made = a fiscal  
ye> only if-- 7,i7 an adju/m5t "u ?is   
p>agraph _h n be5 made = any prior      
fiscal ye>2  7,,ii7 ! av]age numb] (    
,,otc monograph drug facilities subject 
to a facility fee "u subsection 7a77#a7 
ov] ! p]iod ( ! prec$+ #c fiscal ye>s   
exce$s #a1fbe2 &  7,,iii7 ) respect to  
facilities describ$ 9 subclause 7,,ii71 
! av]age numb] ( su* facilities         
7express$ z a p]c5tage7 t appe>$ on !   

arre>s li/s pursuant to subsection      
7e77#a77;,a77i7 ov] ! p]iod ( ! prec$+  
#c fiscal ye>s is less ?an #cj p]c5t4   
7ii7 ,am\nt ( adju/m5t ,an adju/m5t "u  
?is p>agraph = a fiscal ye> %all equal !
 product (-- 7,i7 ! total facility      
rev5ue am\nt det]m9$ "u subsection 7b7 =
 ! fiscal ye>1 exclusive ( ! adju/m5t "u
 ?is p>agraph = su* fiscal ye>2 &       
7,,ii7 ! excess facility p]c5tage       
describ$ 9 clause 7iii74  7iii7 ,excess 
facility p]c5tage ,! excess facility    
p]c5tage describ$ 9 ?is clause is-- 7,i7
 ! am\nt by :i* ! av]age numb] ( ,,otc  
monograph drug facilities subject to a  
facility fee "u subsection 7a77#a7 ov] !
 prec$+ #c fiscal ye>s exce$s #a1fbe2   
divid$ by  7,,ii7 #a1fbe4  7#e7 ,annual 
fee sett+ ,! ,secret>y %all1 n lat] ?an 
#fj days be=e ! fir/ day ( ea* fiscal   
ye>-- 7,a7 e/abli% = su* fiscal ye>1    
bas$ on ! rev5ue am\nts "u subsection   
7b7 & ! adju/m5ts provid$ "u ?is        
subsection-- 7i7 ,,otc monograph drug   
facility fees "u subsection 7a77#a72 &  

7ii7 ,,otc monograph ord] reque/ fees "u
 subsection 7a77#b72 &  7,b7 publi% su* 
fee rev5ue am\nts1 facility fees1 &     
,,otc monograph ord] reque/ fees 9 !    
,f$]al ,regi/]4  4  7d7 ,cr$it+ &       
availability ( fees ,section #gdd,m7f7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgi;j-#gb7;f77 is      
am5d$-- 7#a7 9 p>agraph 7#b77;,d7-- 7,a7
 9 ! subp>agraph head+1 by /rik+ 9      
subsequ5t ye>s2 &  7,b7 by /rik+ 7aft]  
fiscal ye> #bjba72 &  7#b7 9 p>agraph   
7#c71 by /rik+ #bjba ?r\gh #bjbe &      
ins]t+ #bjbf ?r\gh #bjcj4  #e4          
,reau?orization2 report+ requirem5ts    
,section #gdd,n ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cgi;j-#gc7 is am5d$-- 7#a7 9 subsection
 7a7-- 7,a7 by /rik+ ,beg9n+ ) fiscal   
ye> #bjba1 & n lat] ?an #abj cal5d> days
 aft] ! end ( ea* fiscal ye> !reaft] &  
ins]t+ ,n lat] ?an #abj cal5d> days aft]
 ! end ( ea* fiscal ye>2 &  7,b7 by     
/rik+ section #chfa7;b7 ( ! ,,c>es ,act 
& ins]t+ section #b ( ! ,ov]-!-,c\nt]   

,monograph ,drug ,us] ,fee ,am5dm5ts2   
7#b7 9 subsection 7b71 by /rik+ fiscal  
ye> #bjba & ea* subsequ5t fiscal ye> &  
ins]t+ ea* fiscal ye>2 &  7#c7 9        
subsection 7d71 by /rik+ #bjbe ea* place
 x appe>s & ins]t+ #bjcj4  #f4          
,regulation ( c]ta9 nonprescription     
drugs t are m>ket$ )\t an approv$ drug  
application  7a7 ,developm5t advice to  
sponsors or reque/ors ,section          
#eje;,g7h7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7h77
 is am5d$ by /rik+ sponsors or reque/ors
 & ins]t+ sponsors1 reque/ors1 or       
organizations nom9at$ by sponsors or    
reque/ors to repres5t _! int]e/s 9 a    
proce$+4  7b7 ,te*nical correction      
,section #eje;,g7b77#b77;,a77iv77,,iii7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4                     
#cee;h7b77#b77;,a77iv77,,iii77 is am5d$ 
by /rik+ reque/ors & ins]t+ sponsors or 
reque/ors4  #g4 ,sunset dates  7a7      
,au?orization ,sections #gdd,l & #gdd,m 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    

,act 7#ba ,u4,s4,c4 #cgi;j-#ga2         
#cgi;j-#gb7 %all cease to be effective  
,octob] #a1 #bjcj4  7b7 ,report+        
requirem5ts ,section #gdd,n ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#gc7 %all cease to be  
effective ,janu>y #ca1 #bjca4  #h4      
,effective date ,! am5dm5ts made by ?is 
,act %all take effect on ,octob] #a1    
#bjbe1 or ! date ( ! enactm5t ( ?is     
,act1 :i*ev] is lat]1 except t fees "u  
"p #aj ( sub*apt] ,c ( *apt] ,,vii ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#ga et seq47 %all 
be assess$ beg9n+ ,octob] #a1 #bjbe1    
reg>dless ( ! date ( ! enactm5t ( ?is   
,act4  #i4 ,sav+s clause ,not)/&+ !     
am5dm5ts made by ?is ,act1 "p #aj (     
sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ga et seq471 z 9      
effect on ! day be=e ! date ( enactm5t (
 ?is ,act1 %all cont9ue to be 9 effect )
 respect to assess+ & collect+ any fee  
requir$ by su* "p = a fiscal ye> prior  

to fiscal ye> #bjbf4  ,septemb] #ag1    
#bjbe,report$ ) an am5dm5t1 committ$ to 
! ,committee ( ! ,:ole ,h\se on ! ,/ate 
( ! ,union1 & ord]$ to be pr9t$