,,ii ,cal5d> ,no4 #aeb #aai? ,,congress 
#a/ ,session  ,s4 #bbib  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,july #ae1    
#bjbe,mr4 ,banks 7= himself1 ,mr4 ,ka9e1
 ,mr4 ,kim1 & ,mr4 ,hu/$7 introduc$ !   
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,septemb] #h1       
#bjbe,report$ by ,mr4 ,cassidy1 ) an    
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to revise & ext5d ! us]
 fee program = ov]-!-c\nt] monograph    
drugs1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ 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 ,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  #g4  
,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  #h4 ,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  #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$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga
 et seq47 9 ! lett]s f ! ,secret>y (    
,heal? & ,human ,s]vices to ! ,*airman (
 ! ,committee on ,en]gy & ,comm]ce ( !  
,h\se ( ,repres5tatives & ! ,*airman ( !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate1 z set =? 
9 ! ,congressional ,record4  #c4        
,def9itions ,section #gdd,l7#i77;,a7 ( !
 ,f$]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    
7a7 ,p]=mance report ,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+ ! foll[+3   
7#a7 ,9 g5]al ,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,c7 by add+ at ! end !  
foll[+3  7#b7 ,additional in=mation     
,beg9n+ ) fiscal ye> #bjbf1 ! annual    
report "u ?is subsection %all include-- 
7,a7 ! progress ( ! ,food & ,drug       
,adm9i/ration 9 a*iev+ ! goals1 & future
 plans = meet+ ! goals1 includ+-- 7i7 ! 
numb] ( ,ti] #a ,,otc monograph ord]    
reque/s = :i* a propos$ ord] 0 issu$1 & 
! numb] ( su* reque/s = :i* a f9al ord] 
0 issu$1 9 ! previ\s fiscal ye>2  7ii7 !
 numb] ( ,ti] #b ,,otc monograph ord]   

reque/s = :i* a propos$ ord] 0 issu$1 & 
! numb] ( su* reque/s = :i* a f9al ord] 
0 issu$1 9 ! previ\s fiscal ye>2  7iii7 
! numb] ( specifi$ safety ,,otc         
monograph ord] reque/s = :i* a propos$  
ord] 0 issu$1 & ! numb] ( su* reque/s = 
:i* a f9al ord] 0 issu$1 9 ! previ\s    
fiscal ye>2  7iv7 ! numb] ( g5]ally     
recogniz$ z safe & effective f9alization
 ,,otc monograph ord] reque/s = :i* a   
propos$ ord] 0 issu$1 & ! numb] ( su*   
reque/s = :i* a f9al ord] 0 issu$1 9 !  
previ\s fiscal ye>2  7v7 ! av]age       
timel9e = process+ ,,otc monograph ord] 
reque/s1 9 ! aggregate & by submission  
type1 9 ! previ\s fiscal ye>2 &  7vi7   
po/m>ket safety activities ) respect to 
,,otc monograph drugs1 includ+-- 7,i7   
collect+1 develop+1 & review+ safety    
in=mation on ,,otc monograph drugs1     
includ+ adv]se ev5t reports2  7,,ii7    
develop+ & us+ improv$ analytical tools1
 adv]se ev5t data-collection sy/ems1    
includ+ in=mation te*nology sy/ems1 to  
assess pot5tial safety problems1 includ+

 access to ext]nal databases2 &  7,,iii7
 activities "u section #gfj2  7,b7      
in=mation reg>d+ regi/ration ( ,,otc    
monograph drug facilities & contract    
manufactur+ organization facilities &   
paym5t ( regi/ration fees by su*        
facilities1 includ+-- 7i7 ! ,,otc       
monograph drug facilities & contract    
manufactur+ organization facilities t 7 
fir/ regi/]$ "u section #eaj7;c7 or     
#eaj7;i7 9 ! fiscal ye>2 &  7ii7 = ea*  
,,otc monograph drug facility & contract
 manufactur+ organization facility t 0  
assess$ a facility fee "u section       
#gdd,m7a7 9 ! fiscal ye>1 :e!r !        
facility paid su* fee2  7,c7 ! /atus (  
implem5tation ( evid5ce & te/+ /&>ds =  
nonprescription drugs int5d$ = topical  
adm9i/ration1 includ+-- 7i7 !           
application ( evid5ce or te/+ /&>ds2 &  
7ii7 ! numb] ( active +r$i5t reque/s =  
nonprescription drugs int5d$ = topical  
adm9i/ration review$ us+ ! /&>ds "u     
section #eje;,g7b72 &  7,d7 ! progress (
 ! ,food & ,drug ,adm9i/ration 9 all[+  

noncl9ical te/+ alt]natives to animal   
te/+ = ! consid]ation ( sunscre5 active 
+r$i5ts4  7#c7 ,confid5tiality ,no?+ 9  
p>agraph 7#b7 %all be con/ru$ to        
au?orize ! disclosure ( in=mation t is  
prohibit$ f disclosure "u section       
#cja7;j7 ( ?is ,act or section #aije (  
title #ah1 ,unit$ ,/ates ,code1 or t is 
subject to )hold+ "u section            
#eeb7;b77#d7 ( title #e1 ,unit$ ,/ates  
,code4  2  7#b7 9 subsection 7b71 by    
/rik+ fiscal ye> #bjba & ea* subsequ5t  
fiscal ye> & ins]t+ ea* fiscal ye>2 &   
7#c7 9 subsection 7d7-- 7,a7 by /rik+   
#bjbe ea* place x appe>s & ins]t+ #bjcj2
 &  7,b7 by add+ at ! end ! foll[+3     
7#d7 ,m9utes ( negotiation meet+s  7,a7 
,public availability ,! ,secret>y %all  
make publicly available1 on ! public    
website ( ! ,food & ,drug ,adm9i/ration1
 robu/ writt5 m9utes ( all negotiation  
meet+s conduct$ "u ?is subsection betwe5
 ! ,food & ,drug ,adm9i/ration & !      
regulat$ indu/ry1 n lat] ?an #cj days   
aft] ea* su* negotiation meet+4  7,b7   

,cont5t ,! robu/ writt5 m9utes describ$ 
"u subp>agraph 7,a7 %all conta91 9      
detail1 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  7b7 ,,gao report  7#a7  
,9 g5]al ,n lat] ?an ,septemb] #cj1     
#bjbg1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all submit to ! ,committee on   
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report assess+ ! supply *a9 (           
ov]-!-c\nt] monograph drugs4  7#b7      
,cont5ts ,! report requir$ "u p>agraph  
7#a7 %all include an assessm5t (-- 7,a7 
! ov]all /ability ( ! supply *a9 (      
ov]-!-c\nt] monograph drugs2  7,b7 :at  
in=mation is collect$ by ! ,food & ,drug
 ,adm9i/ration ) respect to ! supply *a9
 ( ov]-!-c\nt] monograph drugs2  7,c7 h[
 ! ,food & ,drug ,adm9i/ration uses     
in=mation collect$ on ! supply *a9 (    
ov]-!-c\nt] monograph drugs to in=m     

regulatory decisions2  7,d7 h[ ! ,food &
 ,drug ,adm9i/ration coord9ates ) o!r   
,f$]al ag5cies to monitor & mitigate    
disruptions to ! supply *a9 (           
ov]-!-c\nt] monograph drugs2 &  7,e7 !  
unique *>act]i/ics ( ! ov]-!-c\nt]      
monograph drug m>ketplace & :at         
additional au?orities or in=mation !    
,food & ,drug ,adm9i/ration may ne$ to  
ensure ! /ability ( ! supply *a9 (      
ov]-!-c\nt] monograph drugs4  #f4       
,treatm5t ( active +r$i5ts = topical    
adm9i/ration  7a7 ,9 g5]al ,section     
#eje;,g ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 is
 am5d$ by add+ at ! end ! foll[+3  7r7  
,evid5ce & te/+ /&>ds = active +r$i5ts =
 topical adm9i/ration  7#a7 ,evid5ce &  
te/+ /&>ds = active +r$i5ts = topical   
adm9i/ration ,! ,secret>y %all-- 7,a7 9 
evaluat+ ! g5]ally recogniz$ z safe &   
effective /atus ( active +r$i5ts us$ 9  
nonprescription drugs int5d$ = topical  
adm9i/ration = purposes ( subsection    
7a71 utilize /&>ds t all[ = ! use ( real

 _w evid5ce 7z def9$ 9 section          
#eje;,f7b771 z appropriate1 z "p ( a    
compreh5sive evaluation ( sci5tific     
evid5ce to demon/rate ! safety &        
effectiv5ess ( su* active +r$i5ts1 to   
supplem5t evid5ce f traditional cl9ical 
trials1 provid$ t su* /&>ds all[ !      
,secret>y to evaluate :e!r ! b5efits (  
su* active +r$i5ts outweigh ! risks2 &  
7,b7 apply subsection 7b77#f77;,c7 to ! 
regulation ( active +r$i5ts us$ 9 drugs 
int5d$ = topical adm9i/ration4  7#b7    
,non-animal te/+ me?ods = topical active
 +r$i5ts  7,a7 ,9 g5]al ,! ,secret>y    
%all consid] ! types ( noncl9ical te/s  
describ$ 9 p>agraphs 7#a7 ?r\gh 7#d7 ( !
 fir/ subsection 7z7 ( section #eje 7z  
ins]t$ by section #cbji7;a77#b7 ( !     
,heal? ,ext5d]s1 ,improv+ ,access to    
,m$ic>e1 ,m$icaid1 & ,,*ip1 & ,/r5g!n+  
,public ,heal? ,act ( #bjbb 7division   
,,ff ( ,public ,law #aag-cbh771 or any  
o!r alt]native to animal te/+ t !       
,secret>y det]m9es appropriate1 9 !     
consid]ation ( drugs int5d$ = topical   

adm9i/ration "u ?is section4  7,b7      
,guidance ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is subsection1 !         
,secret>y %all issue new draft guidance 
on h[ sponsors c use noncl9ical te/+    
alt]natives to animal te/+1 z           
appropriate1 to meet safety & efficacy  
/&>ds "u ?is section = drugs int5d$ =   
topical adm9i/ration4  7#c7             
,cl>ification ,no?+ 9 ?is subsection    
%all be con/ru$ to alt]1 sup]s$e1 or    
limit ! /&>ds = mak+ det]m9ations ( :e!r
 a drug is g5]ally recogniz$ z safe &   
effective "u section #bja7p7 or ! /&>ds 
set =? "u section #eje = det]m9+ !      
safety & effectiv5ess ( drugs4  4  7b7  
,sunscre5 f9al adm9i/rative ord] ,a f9al
 adm9i/rative ord] on nonprescription   
sunscre5 active +r$i5ts issu$ "u section
 #ched ( ! ,coronavirus ,aid1 ,relief1 &
 ,economic ,security ,act 7,public ,law 
#aaf-acf2 #ba ,u4,s4,c4 #cfj;fff-#c     
note7 %all-- 7#a7 acc\nt = hi/orical    
data reg>d+ ! safety ( sunscre5 active  
+r$i5ts t h previ\sly be5 accept$ =     

m>ket+ 9 ! ,unit$ ,/ates2  7#b7 acc\nt =
 ! role ( broad spectrum sunscre5s ) a  
,sun ,protection ,factor ( #ae or high] 
9 effective sk9 canc] prev5tion2 &  7#c7
 incorporate ! evid5ce & te/+ /&>ds =   
sunscre5 active +r$i5ts detail$ 9       
section #eje;,g7r7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;h7 7z add$ by subsection 7a774  #g4
 ,increas+ ! cl>ity & pr$ictability ( ! 
process = develop+ applications =       
,rx-to-nonprescription swit*es  7a7 ,9  
g5]al ,section #eje7;b7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77 is am5d$ by add+ at 
! end ! foll[+3  7#g7                   
,rx-to-nonprescription swit*es  7,a7    
,meet+s ,any p]son plann+ to submit an  
application = an ,rx-to-nonprescription 
swit* may submit to ! ,secret>y a writt5
 reque/ = a meet+1 = purposes ( develop+
 a plan = su* application t addresses ! 
pot5tial risks to public heal? ( su*    
swit* & ! evid5ce necess>y to support   
su* application1 includ+ ! design ( any 

necess>y /udies1 & ! =mat & cont5t ( !  
plann$ application4 ,! ,secret>y may    
grant su* a meet+1 z appropriate1       
consi/5t ) e/abli%$ proc$ures = grant+  
meet+s )1 & provid+ writt5 responses to1
 sponsors ( applications "u ?is section4
 ,ea* su* meet+ %all be docum5t$ 9 meet+
 m9utes4  7,b7 ,guidance  7i7 ,9 g5]al  
,n lat] ?an #ah mon?s aft] ! date (     
enactm5t ( ?is p>agraph1 ! ,secret>y    
%all issue guidance to increase ! cl>ity
 & pr$ictability ( ! process & /&>ds =  
approval ( applications =               
nonprescription drugs "u ?is section1   
includ+ 9 ! case ( applications = an    
,rx-to-nonprescription swit*1 especially
 ) respect to prescription drugs )      
well-e/abli%$ safety pr(iles = :i* an   
applicant may seek approval =           
nonprescription use4  7ii7 ,cont5ts ,!  
guidance "u clause 7i7 %all-- 7,i7      
describe h[ publi%$ reports 9 m$ical    
lit]ature1 any previ\s f9d+ ( safety or 
effectiv5ess = ! drug "u ?is section1 ! 
results ( significant human exp]i5ce ) !

 drug1 unpubli%$ /udies & o!r data1 &   
o!r s\rces ( in=mation may be us$ to    
support an application = a              
nonprescription drug1 includ+ 9 !       
context ( an application = an           
,rx-to-nonprescription swit*2  7,,ii7   
set =? proc$ures = sponsors to reque/   
meet+s describ$ 9 subp>agraph 7,a7 &    
docum5t ! recomm5dations made 9 su*     
meet+s2  7,,iii7 describe evid5ti>y     
expectations to support approval ( an   
application = a nonprescription drug1   
includ+ 9 ! context ( an application =  
an ,rx-to-nonprescription swit*1 includ+
 h[ sponsors c demon/rate t consum]s c  
appropriately self-select & use ! drug &
 compreh5d ! nonprescription drug label2
 &  7,,iv7 provide recomm5dations = h[  
me*anisms1 9 addition to ! requir$ ,drug
 ,facts ,label1 su* z mobile            
applications & decision aids1 c be      
incorporat$ into ! in=mation submitt$ 9 
support ( an application = an           
,rx-to-nonprescription swit*4  7,c7     
,plan to engage ) /akehold]s ,n lat] ?an

 #a ye> aft] ! date ( enactm5t ( ?is    
p>agraph1 ! ,secret>y %all develop &    
make publicly available on ! website ( !
 ,food & ,drug ,adm9i/ration a plan to  
engage /akehold]s on /eps & factors =   
application hold]s & o!r /akehold]s to  
consid] 9 id5tify+ approv$ prescription 
drugs t may be promis+ c&idates =       
applications = an ,rx-to-nonprescription
 swit*4  7,d7 ,def9ition ,! t]m         
,rx-to-nonprescription swit* means !    
approval ( an application1 or           
supplem5tal application1 z applicable1  
submitt$ "u ?is section by ! hold] ( an 
approv$ application = a prescription    
drug seek+ approval to m>ket su* drug z 
a nonprescription drug1 includ+ =-- 7i7 
a full ,rx-to-nonprescription swit*1 "u 
:i* a drug previ\sly approv$ =          
prescription use only is-- 7,i7 approv$ 
= nonprescription use "u ! same         
conditions ( use z appli$ to ! drug :5  
approv$ = prescription use2 or  7,,ii7  
approv$ = nonprescription use subject to
 "o or m additional conditions =        

nonprescription use2 &  7ii7 a p>tial   
,rx-to-nonprescription swit*1 "u :i* !  
drug is approv$ = nonprescription use   
only "u c]ta9 conditions ( use describ$ 
9 ! approv$ label+1 :ile ! drug o!rwise 
rema9s approv$ = prescription use only4 
7,e7 ,rule ( con/ruction ,no?+ 9 ?is    
p>agraph %all be con/ru$ to-- 7i7       
sup]s$e or modify ! au?ority ( !        
,secret>y "u section #eje;,g ) respect  
to ! regulation ( ,,otc monograph drugs2
 or  7ii7 au?orize ! disclosure by !    
,secret>y ( confid5tial comm]cial       
in=mation or trade secrets4  4  7b7     
,,gao ,report  7#a7 ,9 g5]al ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all submit to ! ,committee on   
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report t evaluates-- 7,a7 ! numb] (     
applications = an ,rx-to-nonprescription
 swit* approv$ dur+ ! p]iod beg9n+ on   
,octob] #a1 #bjbb1 & end+ on ! date ( ! 

report2  7,b7 ! numb] ( drugs = :i* an  
application = an ,rx-to-nonprescription 
swit* 0 approv$ dur+ su* p]iod subject  
to an additional condition =            
nonprescription use2  7,c7 among ! drugs
 = :i* an application = a full or p>tial
 ,rx-to-nonprescription swit* 0 approv$ 
dur+ su* p]iod1 ! av]age l5g? ( "t f    
receipt by ! ,food & ,drug ,adm9i/ration
 ( ! application to ! approval ( su*    
application2  7,d7 ! numb] ( p>tial     
,rx-to-nonprescription swit*            
applications approv$ dur+ su* p]iod1 & !
 numb] ( applications = su* a p>tial    
swit* 0 n approv$2  7,e7 any b>ri]s to  
timely & pr$ictable review (            
applications = an ,rx-to-nonprescription
 swit*2  7,f7 engagem5t by ! ,food &    
,drug ,adm9i/ration ) public /akehold]s1
 includ+ public meet+s or additional    
activities1 to support review (         
applications = an ,rx-to-nonprescription
 swit*2 &  7,g7 opportunities =         
collaboration betwe5 ! ,c5t] = ,drug    
,evaluation & ,rese>* & ! ,c5t]s =      

,m$ic>e  ,m$icaid ,s]vices = ! purpose (
 analyz+ heal? insurance claims data =  
commonly prescrib$ drugs t appe> to be  
suitable = an ,rx-to-nonprescription    
swit*4  7#b7 ,def9ition ,9 ?is          
subsection1 ! t]m ,rx-to-nonprescription
 swit* has ! mean+ giv5 su* t]m 9       
p>agraph 7#g7 ( section #eje7;b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #bdd7;b771 z add$ by     
subsection 7a74  #h4 ,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  #i4      
,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  #aj4 ,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] #h1     
#bjbe,report$ ) an am5dm5t