,,ii ,cal5d> ,no4 #efh #aac? ,,congress 
#b;d ,session  ,s4 #bada  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,m>*   
#ac1 #bjad,mr4 ,re$ 7= himself1 ,mr4    
,isakson1 ,mr4 ,coons1 ,mr4 ,br[n1 ,mr4 
,c>p]1 ,mr4 ,portman1 ,ms4 ,ayotte1 ,mr4
 ,rob]ts1 ,mr4 ,kirk1 ,ms4 ,w>r51 ,mr4  
,mc,connell1 ,ms4 ,l&rieu1 ,mr4 ,paul1  
,mr4 ,scott1 ,mr4 ,s*um]1 ,mrs4 ,hagan1 
,mr4 ,h>k91 ,mr4 ,alex&]1 ,mr4 ,burr1 & 
,mr4 ,book]7 introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,septemb] #ag       
7legislative day1 ,septemb] #af71       
#bjad,report$ by ,mr4 ,h>k91 ) an       
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide an          
alt]native process = review ( safety &  
effectiv5ess ( nonprescription sunscre5 
active +r$i5ts & = o!r purposes4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,sunscre5 ,innovation ,act4  #b4        

,regulation ( nonprescription sunscre5  
active +r$i5ts ,sub*apt] ,a ( *apt] ,v  
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ebd;,b4      
,proc$ures = classify+ sunscre5 active  
+r$i5ts  7a7 ,9 g5]al ,! ,secret>y %all 
review & det]m9e :e!r nonprescription   
sunscre5 conditions are g5]ally         
recogniz$ z safe & effective & %all     
ensure t any su* conditions t are m>ket$
 9 ! ,unit$ ,/ates are appropriately    
label$4  7b7 ,def9itions  7#a7 ,active  
+r$i5t ,! t]m active +r$i5t means any   
compon5t t is int5d$ to furni%          
ph>macological activity or o!r direct   
effect 9 ! diagnosis1 cure1 mitigation1 
treatm5t1 or prev5tion ( disease1 or to 
affect ! /ructure or function ( ! body (
 humans or animals4 ,! t]m includes     
compon5ts t may und]go *emical *ange 9 !
 manufacture ( a drug & may be pres5t 9 
a drug 9 a modifi$ =m int5d$ to furni% !
 specifi$ activity or effect4  7#b7     
,sunscre5 active +r$i5t ,! t]m sunscre5 
active +r$i5t means an active +r$i5t t  

absorbs1 reflects1 or scatt]s radiation 
9 ! ultraviolet range at wavel5g?s f    
#bij to #djj nanomet]s4  7#c7 ,sunscre5 
condition ,! t]m sunscre5 condition     
means a sunscre5 active +r$i5t 7or a    
comb9ation ( sunscre5 active +r$i5ts71  
dosage =m1 dosage /r5g?1 or r\te (      
adm9i/ration1 m>ket$ = a specific       
nonprescription use4  7c7 ,crit]ia =    
eligibility ,to be eligible = review "u 
?is section1 a sunscre5 condition %all--
 7#a7 n be includ$ 9 ! /ay$ sunscre5    
monograph2 &  7#b7 h be5 m>ket$ z a     
nonprescription sunscre5 condition 9 !  
,unit$ ,/ates or at lea/ #a o!r c\ntry1 
or m>ket$ z a cosmetic or diet>y        
supplem5t 9 #a or m c\nties o!r ?an !   
,unit$ ,/ates-- 7,a7 = a m9imum ( #e    
cont9u\s ye>s2 &  7,b7 9 suffici5t      
quantity1 z det]m9$ by ! ,secret>y bas$ 
^u ! in=mation submitt$ "u subp>agraphs 
7,d7 & 7,e7 ( subsection 7d77#a7 &1 if  
applicable1 subsection 7d77#b77;,a77ii74
  7d7 ,application = eligibility  7#a7  
,9 g5]al ,a sponsor ( a nonprescription 

sunscre5 condition describ$ 9 subsection
 7c7 desir+ to m>ket su* condition 9 !  
,unit$ ,/ates may submit an application 
to ! ,secret>y1 9 su* mann] & conta9+   
su* in=mation z requir$ by ! ,secret>y1 
includ+ ! foll[+3 7,a7 ,basic in=mation 
ab\t ! sunscre5 condition 7includ+ a    
description ( ea* active +r$i5t1        
ph>macologic class1 int5d$              
nonprescription use1 nonprescription    
/r5g? & dosage =m1 r\te ( adm9i/ration1 
& directions = use74  7,b7 ,a detail$   
*emical description ( ! sunscre5 active 
+r$i5t t includes a full description ( !
 drug sub/ance1 includ+ its physical &  
*emical *>act]i/ics1 ! me?od ( syn!sis  
7or isolation7 & purification ( ! drug  
sub/ance1 & any specifications &        
analytical me?ods necess>y to ensure !  
id5tity1 /r5g?1 quality1 & purity ( !   
drug sub/ance1 includ+ ref]5ce to !     
curr5t edition ( ! (ficial ,national    
,=mul>y1 ! ,unit$ ,/ates ,ph>macopeia1  
or =eign comp5diums1 :]e applicable4    
7,c7 ,a li/ ( ea* c\ntry 9 :i* !        

sunscre5 condition has be5 m>ket$4  7,d7
 ,! cumulative total numb] ( dosage     
units sold = ea* dosage =m ( ! sunscre5 
condition1 includ+ total weight ( !     
active +r$i5t1 package size = ea* dosage
 =m 9 :i* ! condition is m>ket$ z       
nonprescription1 & an e/imate ( ! m9imum
 numb] ( pot5tial consum] exposures to !
 condition4  7,e7 ,! use patt]n 7accord+
 to ! label7 = ea* c\ntry 9 :i* !       
sunscre5 condition is m>ket$ & any      
*anges 9 use patt]n t h occurr$ ov] "t4 
7,f7 ,a li/ ( all c\ntries 9 :i* !      
sunscre5 condition has be5 )drawn f     
m>ket+ or 9 :i* an application =        
nonprescription m>ket+ approval has be5 
d5i$ & an explanation = su* )drawal or  
application d5ial4  7#b7 ,sunscre5      
conditions t h n be5 m>ket$ 9 ! ,unit$  
,/ates = #e cont9u\s ye>s  7,a7 ,9 g5]al
 ,9 ! case ( an application ) respect to
 a nonprescription sunscre5 condition t 
has n be5 m>ket$ 9 ! ,unit$ ,/ates = #e 
cont9u\s ye>s1 9 addition to ! in=mation
 requir$ "u p>agraph 7#a71 ! sponsor    

%all submit ! foll[+ in=mation = ea*    
c\ntry 9 :i* ! sunscre5 condition has   
be5 m>ket$3 7i7 ,! mann] 9 :i* !        
sunscre5 condition has be5 m>ket$ to    
consum]s4 ,if ! sunscre5 condition is   
m>ket$ to consum]s z a nonprescription  
ph>macy only condition1 ! ,secret>y may 
require supplem5tal in=mation4  7ii7 ,a 
description ( ! population demographics 
& ! s\rce f :i* ?is in=mation has be5   
compil$1 to ensure t ! sunscre5         
condition's use c be reasonably         
extrapolat$ to ! population ( ! ,unit$  
,/ates4  7iii7 ,a description ( !       
c\ntry's sy/em = id5tify+ adv]se drug   
exp]i5ces1 especially ^? f\nd 9         
nonprescription m>ket+ exp]i5ce1 includ+
 me?od ( collection if applicable4  7iv7
 ,a /atem5t ( h[ long ! sunscre5        
condition has be5 m>ket$ 9 ea* c\ntry & 
h[ long ! curr5t product label+ has be5 
9 use1 accompani$ by a copy ( ! curr5t  
product label+1 includ+ a translation   
into ,engli% ( any label+ t is n 9      
,engli%1 & a /atem5t ( :e!r ! curr5t    

product label+ has be5 au?oriz$1        
accept$1 or approv$ by a regulatory body
 9 ea* c\ntry :]e ! condition is m>ket$4
  7v7 ,a li/ ( all c\ntries :]e !       
sunscre5 condition is m>ket$ z a        
prescription drug only & an explanation 
= su* re/riction4  7,b7 ,sunscre5       
conditions t h be5 m>ket$ 9 m ?an #e    
c\ntries  7i7 ,9 g5]al ,9 ! case ( a    
sunscre5 condition t has be5 m>ket$ z a 
nonprescription sunscre5 9 m ?an #e     
c\ntries1 ) a m9imum ( #e cont9u\s ye>s 
( m>ket+ 9 at lea/ "o su* c\ntry1 !     
sponsor-- 7,i7 may submit in=mation 9   
accordance ) clauses 7i7 ?r\gh 7iv7 (   
subp>agraph 7,a7 ) respect to only #e   
su* c\ntries1 includ+-- 7aa7 ! c\ntry ) 
a m9imum ( #e cont9u\s ye>s (           
nonprescription m>ket+2  7bb7 ! c\ntry )
 ! longe/ duration ( m>ket+2 &  7cc7 !  
c\ntry ) ! mo/ support = m>ket+1 su* z a
 l>ge volume ( sales ) cultural div]sity
 among us]s ( ! product2 &  7,,ii7 %all 
expla9 ! basis = ! c\ntries select$ "u  
subclause 7,i72 &  7,,iii7 %all provide 

in=mation f m ?an #e c\ntries if su*    
in=mation is ne$$ to support !          
application4  7ii7 ,requirem5t ,if !    
sunscre5 condition meets ! crit]ia "u   
items 7aa7 ?r\gh 7cc7 ( clause 7i77,i7 9
 #a or m c\ntries li/$ 9 section        
#hjb7;b77#a77;,a71 at lea/ #a su* c\ntry
 %all be includ$ among ! #e c\ntries    
select$ "u su* clause 7i77,i74  7#c7    
,p5d+ applications ,! requirem5ts ( ?is 
subsection %all n apply to a sunscre5   
condition deem$ eligible = review (     
safety & effectiv5ess by publication ( a
 notice ( eligibility 9 ! ,f$]al ,regi/]
 prior to ! date ( enactm5t ( !         
,sunscre5 ,innovation ,act4             
,applications = su* sunscre5 conditions 
%all be consid]$ 9 accordance )         
subsection 7g74  7e7 ,public            
availability ,if a condition is f\nd    
eligible "u subsection 7d71 ! ,secret>y 
%all make ! application publicly        
available1 ) r$actions = confid5tial    
comm]cial in=mation or trade secret     
in=mation1 & any o!r in=mation exempt f 

disclosure pursuant to section #aije (  
title #ah1 ,unit$ ,/ates ,code1 section 
#eeb7;b7 ( title #e1 ,unit$ ,/ates      
,code1 or section #cja7;j7 ( ?is ,act4  
,applications %all rema9 confid5tial    
dur+ ! ,secret>y's consid]ation (       
eligibility4  7f7 ,new sunscre5         
condition application  7#a7 ,eligibility
 det]m9ation ,n lat] ?an #fj days aft] !
 submission ( an eligibility application
 "u subsection 7d71 ! ,secret>y %all    
det]m9e if ! sunscre5 condition is      
eligible = fur!r review = safety &      
effectiv5ess4 ,9 ! case ( a sunscre5    
condition det]m9$ to be eligible1 !     
,secret>y %all publi% a notice (        
eligibility 9 ! ,f$]al ,regi/]1 &       
provide int]e/$ p]sons an opportunity to
 submit publi%$ & unpubli%$ data relat$ 
to ! safety & effectiv5ess ( ! sunscre5 
condition = its int5d$ nonprescription  
uses1 9 accordance ) p>agraph 7#b74 ,9 !
 case ( a sunscre5 condition det]m9$ n  
eligible1 ! ,secret>y %all issue a lett]
 to ! sponsor1 :i* %all be made publicly

 available4  7#b7 ,safety & effectiv5ess
 data submissions  7,a7 ,9 g5]al ,)9 #fj
 days ( ! publication 9 ! ,f$]al ,regi/]
 ( an application deem$ eligible1 z     
describ$ 9 p>agraph 7#a71 ! sponsor &   
o!r int]e/$ p>ties %all submit safety & 
effectiv5ess data to ! ,secret>y = fur!r
 review1 z describ$ 9 subp>agraph 7,b74 
7,b7 ,requir$ submissions reg>d+ data   
,submissions "u ?is p>agraph %all       
include ! foll[+3 7i7 ,human safety data
  7,i7 ,individual active compon5ts ,)  
respect to individual active compon5ts1 
controll$ /udies1 p>tially controll$ or 
uncontroll$ /udies1 docum5t$ case       
reports1 p]t95t m>ket+ exp]i5ces t may  
influ5ce a det]m9ation z to ! safety (  
ea* individual active compon5t1 & p]t95t
 m$ical & sci5tific lit]ature4  7,,ii7  
,comb9ations ( individual active        
compon5ts ,) respect to comb9ations ( ! 
individual active compon5ts1 controll$  
/udies1 p>tially controll$ or           
uncontroll$ /udies1 docum5t$ case       
reports1 p]t95t m>ket+ exp]i5ces t may  

influ5ce a det]m9ation z to ! safety (  
comb9ations ( ! individual active       
compon5t1 & p]t95t m$ical & sci5tific   
lit]ature4  7ii7 ,efficacy data  7,i7   
,individual active compon5ts ,) respect 
to individual active compon5ts1         
controll$ /udies1 p>tially controll$ or 
uncontroll$ /udies1 docum5t$ case       
reports1 p]t95t m>ket+ exp]i5ces t may  
influ5ce a det]m9ation on ! efficacy (  
ea* individual active compon5t1 p]t95t  
m$ical & sci5tific lit]ature4  7,,ii7   
,comb9ations ( individual active        
compon5ts ,) respect to comb9ations ( ! 
individual active compon5ts1 controll$  
/udies1 p>tially controll$ or           
uncontroll$ /udies1 docum5t$ case       
reports1 p]t95t m>ket+ exp]i5ces t may  
influ5ce a det]m9ation on ! efficacy (  
comb9ations ( ! individual active       
compon5ts1 & p]t95t m$ical & sci5tific  
lit]ature4  7iii7 ,data sett+ =? m$ical 
rationale & purpose ,a summ>y ( ! data &
 views sett+ =? ! m$ical rationale &    
purpose 7or lack !re(7 = ! sunscre5     

condition & ! sci5tific basis 7or lack  
!re(7 = ! conclusion t ! condition has  
be5 prov5 safe & effective = ! int5d$   
use4 ,if !re is an abs5ce ( controll$   
/udies 9 ! mat]ial submitt$1 an         
explanation z to :y su* /udies are n    
consid]$ necess>y mu/ be includ$4  7iv7 
,(ficial drug monograph ,an applicable  
,unit$ ,/ates ,ph>macopoeia or ,national
 ,=mul>y = ! sunscre5 active +r$i5t or a
 propos$ /&>d = inclusion 9 an article  
to be recogniz$ 9 an (ficial drug       
monograph = ! active +r$i5t1 includ+    
in=mation %[+ t ! (ficial or propos$    
comp5dial monograph = ! active +r$i5t is
 consi/5t ) ! active +r$i5t us$ 9 !     
/udies e/abli%+ safety & effectiv5ess & 
) ! active +r$i5t m>ket$ 9 !            
nonprescription product to a mat]ial    
ext5t & = a mat]ial "t4 ,if diff]5ces   
exi/ betwe5 ! (ficial or propos$        
comp5dial monograph = ! active +r$i5t & 
! active +r$i5t t is ! subject ( !      
application1 sponsor %all expla9 su*    
diff]5ces4  7v7 ,adv]se drug exp]i5ces  

,a li/ ( all s]i\s adv]se drug          
exp]i5ces1 z def9$ by ! ,secret>y1 f ea*
 c\ntry :]e ! condition has be5 or is   
curr5tly m>ket$ z a prescription drug or
 z a nonprescription drug or product4   
7,c7 ,optional animal safety data ,9    
addition to ! in=mation requir$ "u      
subp>agraph 7,b71 ! sponsor may submit  
in=mation ) respect to animal safety    
data1 includ+ controll$ /udies &        
p>tially controll$ or uncontroll$       
/udies1 9 ! case ( an application =     
individual active compon5ts1 & controll$
 /udies & p>tially controll$ or         
uncontroll$ /udies 9 ! case ( an        
application = comb9ations ( individual  
active compon5ts4  7,d7 ,confid5tiality 
( submissions ,! ,secret>y %all make    
data & in=mation submitt$ by ! sponsor1 
or pursuant to a notice reque/+ safety &
 effectiv5ess data publi%$ 9 ! ,f$]al   
,regi/]1 publicly available1 ) r$actions
 = confid5tial comm]cial in=mation or   
trade secret in=mation1 & any o!r       
in=mation exempt f disclosure pursuant  

to section #aije ( title #ah1 ,unit$    
,/ates ,code1 section #eeb7;b7 ( title  
#e1 ,unit$ ,/ates ,code1 or section     
#cja7;j7 ( ?is ,act4  7#c7 ,new sunscre5
 condition application submission to !  
advisory committee ,n lat] ?an #cj days 
aft] ! end ( ! public comm5t p]iod      
describ$ 9 p>agraph 7#b71 ! ,secret>y   
%all submit ! application & ! safety &  
effectiv5ess data submitt$ "u p>agraph  
7#b7 to ! ,nonprescription ,drugs       
,advisory ,committee 7ref]r$ to 9 ?is   
section z ! advisory committee7 =       
review4  7g7 ,p5d+ sunscre5 condition   
applications ,n lat] ?an #cj days aft] !
 date ( enactm5t ( ! ,sunscre5          
,innovation ,act1 ! ,secret>y %all      
submit to ! advisory committee all      
safety & effectiv5ess data submitt$ )   
respect to ea* application = review (   
sunscre5 conditions t ! ,secret>y _h    
det]m9$1 prior to ! date ( enactm5t ( ! 
,sunscre5 ,innovation ,act1 to be       
eligible = review ( safety &            
effectiv5ess & = :i* ! in=mation requir$

 "u subsection 7f77#b7 has be5 submitt$ 
to ! ,secret>y prior to su* date (      
enactm5t4  7h7 ,review & recomm5dation =
 nonprescription sunscre5 condition     
7#a7 ,9 g5]al ,! ,secret>y %all require 
! advisory committee to evaluate !      
safety & effectiv5ess data submitt$ 9   
accordance ) subsection 7f77#b7 or 7g74 
7#b7 ,/&>ds ,9 evaluat+ a               
nonprescription sunscre5 condition "u   
p>agraph 7#a71 ! advisory committee %all
 use ! regulations 9 effect at ! "t ( ! 
application1 includ+ regulations )      
respect to-- 7,a7 ! safety ( !          
nonprescription sunscre5 condition2     
7,b7 ! effectiv5ess ( ! nonprescription 
sunscre5 condition2  7,c7 !             
b5efit-to-risk ratio ( ! nonprescription
 sunscre5 condition2 &  7,d7 ! label+ ( 
! nonprescription sunscre5 condition4   
7#c7 ,communications betwe5 advisory    
committee & o!r individuals :o submit   
data ,! advisory committee %all h !     
au?ority to communicate ) ! sponsor &   
o!r individuals :o submit data dur+ !   

advisory committee's review1 includ+    
reque/+ cl>ification or additional      
in=mation4  7#d7 ,recomm5dations  7,a7  
,9 g5]al ,= ea* su* submission "u       
subsection 7f77#c7 or 7g71 ! advisory   
committee %all make "o ( ! foll[+       
recomm5dations to ! ,secret>y3 7i7 ,!   
sunscre5 condition is g5]ally recogniz$ 
z safe & effective 7includ+ any or all  
indications71 includ+ nonprescription   
sunscre5 conditions = :i* a new drug    
application has be5 approv$ by !        
,secret>y4  7ii7 ,insuffici5t in=mation 
has be5 provid$ to support a            
recomm5dation t ! sunscre5 condition is 
g5]ally recogniz$ z safe & effective    
7includ+ any or all indications74  7iii7
 ,! sunscre5 condition is n g5]ally     
recogniz$ z safe & effective to be      
m>ket$ or sold1 unless an application ) 
respect to su* condition is approv$ "u  
section #eje7;b74  7,b7 ,tim+ ,!        
advisory committee %all make a          
recomm5dation "u subp>agraph 7,a7 n lat]
 ?an #ahj days aft] ! advisory committee

 receives ! application & data submitt$ 
"u subsection 7f77#c7 or subsection 7g74
  7,c7 ,resubmission ( data ,if !       
advisory committee recomm5ds t          
insuffici5t in=mation has be5 provid$1 9
 accordance ) subp>agraph 7,a77ii71 !   
advisory committee %all make su*        
recomm5dation n lat] ?an #ahj days aft] 
! date on :i* su* additional in=mation  
is submitt$4  7i7 ,det]m9ation by !     
,c5t] = ,drug ,evaluation & ,rese>*     
7#a7 ,9 g5]al ,! ,c5t] = ,drug          
,evaluation & ,rese>* %all respond to ! 
recomm5dations ( ! advisory committee "u
 subsection 7h77#d7 z foll[s3 7,a7 ,9 ! 
case ( a recomm5dation by ! advisory    
committee describ$ 9 clause 7i7 (       
subsection 7h77#d71 n lat] ?an #de days 
aft] ! advisory committee issues !      
recomm5dation1 ! ,c5t] = ,drug          
,evaluation & ,rese>* %all issue a      
det]m9ation affirm+ or d5y+ !           
recomm5dation ( ! advisory committee4   
,if ! ,c5t] = ,drug ,evaluation &       
,rese>* affirms ! recomm5dation ( !     

advisory committee1 or if ! ,c5t] =     
,drug ,evaluation & ,rese>* takes no    
action reg>d+ ! recomm5dation )9 #de    
days ( receiv+ su* recomm5dation1 !     
nonprescription sunscre5 condition %all 
be g5]ally recogniz$ z safe & effective1
 n misbr&$1 & p]mitt$ to be m>ket$ &    
sold 9 accordance ) all applicable rules
 & regulations = ov]-!-c\nt] drugs4     
7,b7 ,9 ! case ( a recomm5dation        
describ$ 9 clause 7ii7 ( su* subsection1
 ! ,c5t] = ,drug ,evaluation & ,rese>*  
%all issue a det]m9ation affirm+ or d5y+
 ! recomm5dation ( ! advisory committee1
 to be made publicly available1 )9 #de  
days ( receiv+ ! recomm5dation1 & in=m !
 sponsor t ! sponsor mu/ submit         
additional in=mation to ! advisory      
committee 9 ord] to cont9ue ! review by 
! advisory committee4  7,c7 ,9 ! case ( 
a recomm5dation describ$ 9 clause 7iii7 
( su* subsection1 ! ,c5t] = ,drug       
,evaluation & ,rese>* %all issue a      
det]m9ation affirm+ or d5y+ !           
recomm5dation ( ! advisory committee1 to

 be made publicly available1 )9 #de days
 ( receiv+ su* recomm5dation1 & indicate
 :e!r su* sunscre5 condition det]m9$ to 
be n g5]ally recogniz$ z safe &         
effective to be m>ket$ & sold1 unless an
 application ) respect to su* condition 
is approv$ "u section #eje7;b71 or :e!r 
additional data mu/ be submitt$ to !    
advisory committee4  7#b7 ,sup]visory   
review ( det]m9ation  7,a7 ,9 g5]al ,any
 p]son may reque/ a sup]visory review ( 
a det]m9ation ( ! ,c5t] = ,drug         
,evaluation & ,rese>* to n accept a     
recomm5dation ( an advisory committee4  
,su* review may be conduct$ at ! next   
sup]visory or high] level above !       
individual :o made ! det]m9ation4  7,b7 
,reque/ = sup]visory review ,a reque/   
describ$ 9 subp>agraph 7,a7 %all be made
 to ! ,secret>y n lat] ?an #cj days aft]
 su* decision & %all indicate 9 ! reque/
 :e!r su* p]son seeks an 9-p]son meet+  
or a teleconf]5ce4 ,! ,secret>y %all    
s*$ule an 9-p]son or teleconf]5ce       
review1 if s reque/$1 n lat] ?an #cj    

days aft] su* reque/ is made4 ,!        
,secret>y %all issue a decision to !    
p]son reque/+ a review "u ?is p>agraph n
 lat] ?an #de days aft] ! meet+4  7,c7  
,/&>d ( sup]visory review ,! ,secret>y  
%all be au?oriz$ to ov]turn a           
det]m9ation ( ! ,c5t] = ,drug           
,evaluation & ,rese>* n to accept a     
recomm5dation ( ! advisory committee if 
! sup]visory review results 9 a decision
 by ! review] t ! individual :o made !  
det]m9ation did n provide reasonable &  
suffici5t sub/antive support = !        
decision to disreg>d ! advisory         
committee's recomm5dation4  7,d7        
,sup]visory review decision ,if !       
,secret>y ov]turns a det]m9ation by !   
,c5t] = ,drug ,evaluation & ,rese>* n to
 accept a favorable recomm5dation ( an  
advisory committee1 ! nonprescription   
sunscre5 condition %all be g5]ally      
recogniz$ z safe & effective1 n misbr&$1
 & p]mitt$ to be m>ket$ & sold 9        
accordance ) all applicable rules &     
regulations = ov]-!-c\nt] drugs4  7,e7  

,f9al ag5cy action ,a decision made     
?r\gh sup]visory review %all con/itute  
f9al ag5cy action subject to judicial   
review4  7j7 ,reports  7#a7 ,9 g5]al ,n 
lat] ?an #a ye> aft] ! date ( enactm5t (
 ! ,sunscre5 ,innovation ,act1 on ,m>*  
#a1 #bjae1 & e #b ye>s !reaft]1 !       
,secret>y %all issue a report to        
,congress describ+ actions tak5 "u ?is  
section4  7#b7 ,cont5ts ,! reports "u   
p>agraph 7#a7 %all include-- 7,a7 a     
review ( ! progress made 9 issu+ 9 a    
timely mann] decisions on ! safety &    
effectiv5ess = sunscre5 conditions =    
applications p5d+ z ( ! date ( enactm5t 
( ! ,sunscre5 ,innovation ,act1 includ+ 
! numb] ( p5d+ applications-- 7i7       
review$ & ! decision times = ea*        
application1 measur$ f ! date ( orig9al 
eligibility application submission by ! 
sponsor2  7ii7 result+ 9 a det]m9ation (
 g5]ally recogniz$ z safe & effective & 
n misbr&$2  7iii7 result+ 9 a           
det]m9ation ( n g5]ally recogniz$ z safe
 & effective & n misbr&$ & ! reasons =  

su* det]m9ations2 &  7iv7 = :i* a       
det]m9ation has n be5 made1 an          
explanation = ! delay1 a description ( !
 curr5t /atus ( ea* su* application1 & !
 l5g? ( "t su* applications h be5 p5d+1 
measur$ f ! date ( orig9al eligibility  
application submission by ! sponsor2    
7,b7 a review ( ! progress made 9 issu+ 
9 a timely mann] a decision on safety & 
effectiv5ess = sunscre5 condition       
applications submitt$ aft] ! date (     
enactm5t ( ! ,sunscre5 ,innovation ,act1
 includ+ ! numb] ( su* applications--   
7i7 review$ & ! decision times = ea*    
application2  7ii7 result+ 9 a          
det]m9ation ( g5]ally recogniz$ z safe &
 effective & n misbr&$2 &  7iii7 result+
 9 a det]m9ation ( n g5]ally recogniz$ z
 safe & effective & n misbr&$ & !       
reasons = su* det]m9ations2  7,c7 a     
description ( ! /aff+ & res\rces relat+ 
to ! co/s associat$ ) ! review &        
decisionmak+ p]ta9+ to applications2    
7,d7 a review ( ! progress 9 meet+ !    
deadl9es ) respect to process+          

applications "u ?is section2  7,e7 to ! 
ext5t ! ,secret>y det]m9es appropriate1 
recomm5dations = process improvem5ts 9 !
 h&l+ ( p5d+ & new applications2 &  7,f7
 recomm5dations = exp&+ ! applicability 
( ?is section to nonprescription active 
+r$i5ts or conditions t are n relat$ to 
! sunscre5 category ( ov]-!-c\nt] drugs4
  7#c7 ,me?od ,! ,secret>y %all publi% !
 reports requir$ "u ?is subsection 9 !  
mann] ! ,secret>y det]m9es to be ! mo/  
effective = effici5tly dissem9at+ !     
report1 includ+ publication ( ! report  
on ! ,int]net website ( ! ,food & ,drug 
,adm9i/ration4  7k7 ,rules ( con/ruction
  7#a7 ,au?ority to )draw or susp5d     
,no?+ 9 ?is section %all be con/ru$ to  
alt] ! ,secret>y's au?ority to )draw or 
susp5d f ! m>ket a drug t ! ,secret>y   
det]m9es to be unsafe or ineffective4   
7#b7 ,o!r conditions ,no?+ 9 ! section  
%all affect ! ,secret>y's au?ority to   
review nonprescription conditions o!r   
?an sunscre5 conditions4  4  #c4        
,sunscre5 te/+ & label+ ,n lat] ?an #ahj

 days aft] ! date ( enactm5t ( ?is ,act1
 ! ,secret>y %all issue det]m9ations )  
respect to-- 7#a7 ! appropriate te/+ &  
label+ requirem5ts = sunscre5s sold z an
 a]osol2 &  7#b7 :e!r sunscre5 may      
conta9 a label indicat+ a sun protection
 factor great] ?an #ej4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,sunscre5    
,innovation ,act4  #b4 ,regulation (    
nonprescription sunscre5 active +r$i5ts 
7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cea et seq47 is am5d$ by add+ at ! end 
! foll[+3  ,i ,nonprescription sunscre5 
& o!r active +r$i5ts  #ehf4 ,def9itions 
,9 ?is sub*apt]-- 7#a7 ! t]m ,advisory  
,committee means ! ,nonprescription     
,drug ,advisory ,committee ( ! ,food &  
,drug ,adm9i/ration or any successor to 
su* ,committee2  7#b7 ! t]m f9al        
sunscre5 ord] means an ord] publi%$ by !
 ,secret>y 9 ! ,f$]al ,regi/] conta9+   
in=mation /at+ t a nonprescription      
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active         

+r$i5ts-- 7,a7 is ,,grase & is n misbr&$
 if m>ket$ 9 accordance ) su* ord]2 or  
7,b7 is n ,,grase & is misbr&$2  7#c7 ! 
t]m ,,grase means g5]ally recogniz$1    
among exp]ts qualifi$ by sci5tific tra9+
 & exp]i5ce to evaluate ! safety &      
effectiv5ess ( drugs1 z safe & effective
 = use "u ! conditions prescrib$1       
recomm5d$1 or sugge/$ 9 ! label+ ( a    
drug z describ$ 9 section #bja7p72  7#d7
 ! t]m ,,grase det]m9ation means1 )     
respect to a nonprescription active     
+r$i5t or a comb9ation ( nonprescription
 active +r$i5ts1 a det]m9ation ( :e!r   
su* +r$i5t or comb9ation ( +r$i5ts is   
,,grase2  7#e7 ! t]m nonprescription    
means n subject to section #ejc7;b77#a72
  7#f7 ! t]m p5d+ reque/ means ea*      
reque/ ) respect to a nonprescription   
sunscre5 active +r$i5t submitt$ "u      
section #ccj4ad ( title #ba1 ,code (    
,f$]al ,regulations 7z 9 effect on !    
date ( enactm5t ( ! ,sunscre5           
,innovation ,act7 = consid]ation =      
inclusion 9 ! ov]-!-c\nt] drug monograph

 sy/em-- 7,a7 t 0 det]m9$ to be eligible
 = su* review by publication ( a notice 
( eligibility 9 ! ,f$]al ,regi/] prior  
to ! date ( enactm5t ( su* ,act2 &  7,b7
 = :i* safety & effectiv5ess data h be5 
submitt$ to ! ,secret>y prior to su*    
date ( enactm5t2  7#g7 ! t]m propos$    
sunscre5 ord] means an ord] conta9+ a   
t5tative det]m9ation publi%$ by !       
,secret>y 9 ! ,f$]al ,regi/] conta9+    
in=mation propos+ t a nonprescription   
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active         
+r$i5ts-- 7,a7 is ,,grase & is n misbr&$
 if m>ket$ 9 accordance ) su* ord]2     
7,b7 is n ,,grase & is misbr&$2 or  7,c7
 is n ,,grase & is misbr&$ because !    
data are insuffici5t to classify su*    
+r$i5t or comb9ation ( +r$i5ts z ,,grase
 & n misbr&$ & additional in=mation is  
necess>y to all[ ! ,secret>y to det]m9e 
o!rwise2  7#h7 ! t]m sponsor means !    
p]son t submitt$-- 7,a7 a reque/ "u     
section #ehf;,a2  7,b7 a p5d+ reque/2 or
  7,c7 any o!r application subject to   

?is sub*apt]2  7#i7 ! t]m sunscre5 means
 a drug conta9+ "o or m sunscre5 active 
+r$i5ts2 &  7#aj7 ! t]m sunscre5 active 
+r$i5t means an active +r$i5t t is      
int5d$ = application to ! sk9 ( humans =
 purposes ( absorb+1 reflect+1 or       
scatt]+ ultraviolet radiation4  #ehf;,a4
 ,submission ( reque/s ,any p]son may   
submit a reque/ to ! ,secret>y = a      
det]m9ation ( :e!r a nonprescription    
sunscre5 active +r$i5t or a comb9ation (
 nonprescription sunscre5 active        
+r$i5ts1 = use "u specifi$ conditions1  
to be prescrib$1 recomm5d$1 or sugge/$ 9
 ! label+ !re( 7includ+ dosage =m1      
dosage /r5g?1 & r\te ( adm9i/ration7 is 
,,grase & %\ld be includ$ 9 "p #ceb (   
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations7 conc]n+  
nonprescription sunscre54  #ehf;,b4     
,eligibility det]m9ations2 data         
submission2 fil+  7a7 ,eligibility      
det]m9ations  7#a7 ,9 g5]al ,n lat] ?an 
#fj cal5d> days aft] ! date ( receipt ( 
a reque/ "u section #ehf;,a1 ! ,secret>y

 %all-- 7,a7 det]m9e1 9 accordance )    
p>agraph 7#b71 :e!r ! reque/ is eligible
 = fur!r review "u subsection 7b7 &     
section #ehf;,c2  7,b7 notify ! sponsor 
( ! det]m9ation ( ! ,secret>y2 &  7,c7  
make su* det]m9ation publicly available 
9 accordance ) p>agraph 7#c7 &          
subsection 7b77#a74  7#b7 ,crit]ia =    
eligibility  7,a7 ,9 g5]al ,to be       
eligible = review "u subsection 7b7 &   
section #ehf;,c1 a reque/ %all be = a   
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts1 = use "u specifi$      
conditions1 to be prescrib$1 recomm5d$1 
or sugge/$ 9 ! label+ !re(1 t-- 7i7 is n
 includ$ 9 "p #ceb ( title #ba1 ,code ( 
,f$]al ,regulations 7or any successor   
regulations7 conc]n+ nonprescription    
sunscre52 &  7ii7 has be5 us$ to a      
mat]ial ext5t & = a mat]ial "t "u su*   
conditions1 z describ$ 9 section        
#bja7p77#b74  7,b7 ,e/abli%m5t ( "t &   
ext5t ,a sponsor %all include 9 a reque/
 "u section #ehf;,a ! in=mation requir$ 

"u section #ccj4ad ( title #ba1 ,code ( 
,f$]al ,regulations 7or any successor   
regulations7 to meet ! /&>d describ$ 9  
subp>agraph 7,a77ii74  7#c7 ,public     
availability  7,a7 ,r$actions =         
confid5tial in=mation ,if a             
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts is det]m9$ "u p>agraph  
7#a77;,a7 to be eligible = fur!r review1
 ! ,secret>y %all make ! reque/ publicly
 available1 ) r$actions = in=mation t is
 treat$ z confid5tial "u section        
#eeb7;b7 ( title #e1 ,unit$ ,/ates      
,code1 section #aije ( title #ah1 ,unit$
 ,/ates ,code1 or section #cja7;j7 ( ?is
 ,act4  7,b7 ,id5tification (           
confid5tial in=mation by sponsor ,at !  
"t t a reque/ is made "u section        
#ehf;,a1 ! sponsor ( su* reque/ %all    
id5tify any in=mation t su* sponsor     
consid]s to be confid5tial in=mation    
describ$ 9 subp>agraph 7,a74  7,c7      
,confid5tiality dur+ eligibility review 
,! in=mation conta9$ 9 a reque/ "u      

section #ehf;,a %all rema9 confid5tial  
dur+ ! ,secret>y's consid]ation "u ?is  
section ( :e!r ! reque/ is eligible =   
fur!r review consi/5t ) section #ccj4ad 
( title #ba1 ,code ( ,f$]al ,regulations
 7or any successor regulations74  7b7   
,data submission & fil+ ( reque/s  7#a7 
,9 g5]al ,9 ! case ( a reque/ "u section
 #ehf;,a t is det]m9$ to be eligible "u 
subsection 7a7 = fur!r review "u ?is    
section & section #ehf;,c1 ! ,secret>y  
%all1 9 notify+ ! public "u subsection  
7a77#a77;,c7 ( su* eligibility          
det]m9ation1 po/ ! eligibility          
det]m9ation on ! ,int]net website ( !   
,food & ,drug ,adm9i/ration1 invite !   
sponsor ( su* reque/ & any o!r int]e/$  
p>ty to submit comm5ts1 & provide a     
p]iod ( n less ?an #de cal5d> days =    
comm5ts 9 support ( or o!rwise relat+ to
 a ,,grase det]m9ation1 includ+ publi%$ 
& unpubli%$ data & o!r in=mation relat$ 
to ! safety & efficacy ( su* reque/4    
7#b7 ,fil+ det]m9ation ,n lat] ?an #fj  
cal5d> days aft] ! submission ( data &  

o!r in=mation describ$ 9 p>agraph 7#a7  
by ! sponsor1 ! ,secret>y %all det]m9e  
:e!r ! data & o!r in=mation submitt$ by 
! sponsor "u ?is section are suffici5tly
 complete1 includ+ be+ =matt$ 9 a mann] 
t enables ! ,secret>y to det]m9e !      
complet5ess ( su* data & in=mation1 to  
enable ! ,secret>y to conduct a         
sub/antive review "u section #ehf;,c )  
respect to su* reque/4 ,n lat] ?an #fj  
cal5d> days aft] ! submission ( data &  
o!r in=mation describ$ 9 p>agraph 7#a7  
by ! sponsor1 if ! ,secret>y det]m9es-- 
7,a7 t su* data & o!r in=mation are     
suffici5tly complete1 ! ,secret>y %all--
 7i7 issue a writt5 notification to !   
sponsor ( ! det]m9ation to file su*     
reque/1 & make su* notification publicly
 available2 &  7ii7 file su* reque/ made
 "u section #ehf;,a2 or  7,b7 t su* data
 & o!r in=mation are n suffici5tly      
complete1 ! ,secret>y %all issue a      
writt5 notification to ! sponsor ( !    
det]m9ation to refuse to file ! reque/1 
:i* %all include ! reasons = ! refusal1 

includ+ :y su* data & o!r in=mation are 
n suffici5tly complete1 & make su*      
notification publicly available4  7#c7  
,refusal to file a reque/  7,a7 ,reque/ 
= meet+s2 submission ( additional data  
or o!r in=mation ,if ! ,secret>y refuses
 to file a reque/ made "u section       
#ehf;,a1 ! sponsor may-- 7i7 )9 #cj     
cal5d> days ( receipt ( writt5          
notification ( su* refusal1 reque/1 9   
writ+1 a meet+ ) ! ,secret>y reg>d+ !   
fil+ det]m9ation2 &  7ii7 submit        
additional data or o!r in=mation4  7,b7 
,meet+s  7i7 ,9 g5]al ,if a sponsor     
seeks a meet+ "u subp>agraph 7,a77i71 ! 
,secret>y %all conv5e ! meet+ )9 #cj    
cal5d> days ( ! reque/ = su* meet+4     
7ii7 ,actions aft] meet+ ,foll[+ any    
meet+ held "u clause 7i7-- 7,i7 !       
,secret>y may file ! reque/ )9 #fj      
cal5d> days2  7,,ii7 ! sponsor may      
submit additional data or o!r in=mation2
 or  7,,iii7 if ! sponsor elects1 )9    
#abj cal5d> days1 to h ! ,secret>y file 
! reque/ 7) or )\t am5dm5ts to correct  

any purport$ defici5cies to ! reque/7-- 
7aa7 ! ,secret>y %all file ! reque/ ov] 
prote/1 n lat] ?an #cj cal5d> days aft] 
! sponsor makes su* election2  7bb7 at !
 "t ( fil+1 ! ,secret>y %all provide    
writt5 notification ( su* fil+ to !     
sponsor2 &  7cc7 ! ,secret>y %all make  
su* notification publicly available4    
7iii7 ,reque/s fil$ ov] prote/ ,!       
,secret>y %all n require ! sponsor to   
resubmit a copy ( ! reque/ = purposes ( 
fil+ a reque/ fil$ ov] prote/1 z        
describ$ 9 clause 7ii77,,iii74  7,c7    
,submissions ( additional data or o!r   
in=mation ,)9 #fj cal5d> days ( any     
submission ( additional data or o!r     
in=mation "u subp>agraph 7,a77ii7 or    
7,b77ii77,,ii71 ! ,secret>y %all        
reconsid] ! previ\s det]m9ation made "u 
p>agraph 7#b7 ) respect to ! applicable 
reque/ & make a new det]m9ation 9       
accordance ) p>agraph 7#b74  7#d7       
,public availability  7,a7 ,r$actions = 
confid5tial in=mation ,aft] ! p]iod (   
confid5tiality describ$ 9 subsection    

7a77#c77;,c71 ! ,secret>y %all make data
 & o!r in=mation submitt$ 9 connection )
 a reque/ "u section #ehf;,a publicly   
available1 ) r$actions = in=mation t is 
treat$ z confid5tial "u section #eeb7;b7
 ( title #e1 ,unit$ ,/ates ,code1       
section #aije ( title #ah1 ,unit$ ,/ates
 ,code1 or section #cja7;j7 ( ?is ,act4 
7,b7 ,id5tification ( confid5tial       
in=mation by sponsor ,a p]son submitt+  
in=mation "u ?is section %all id5tify at
 ! "t ( su* submission ! portions ( su* 
in=mation t ! p]son consid]s to be      
confid5tial in=mation describ$ 9        
subp>agraph 7,a74  #ehf;,c4 ,,grase     
det]m9ation  7a7 ,review ( new reque/   
7#a7 ,propos$ sunscre5 ord] ,9 ! case ( 
a reque/ "u section #ehf;,a1 n lat] ?an 
#cjj cal5d> days aft] ! date on :i* su* 
reque/ is fil$ "u subsection            
7b77#b77;,a7 or 7b77#c77;,b77ii77,,iii7 
( section #ehf;,b1 ! ,secret>y-- 7,a7   
may conv5e a meet+ ( ! ,advisory        
,committee to review su* reque/2 &  7,b7
 %all complete ! review ( su* reque/ &  

issue a propos$ sunscre5 ord] ) respect 
to su* reque/4  7#b7 ,propos$ sunscre5  
ord] by ,commission] ,if ! ,secret>y    
does n issue a propos$ sunscre5 ord] "u 
p>agraph 7#a77;,b7 )9 su* #cjj-;day     
p]iod1 ! sponsor ( su* reque/ may notify
 ! ,(fice ( ! ,commission] ( su* reque/ 
& reque/ review by ! ,(fice ( !         
,commission]4 ,if su* sponsor s notifies
 ! ,(fice ( ! ,commission]1 !           
,commission] %all1 n lat] ?an #fj cal5d>
 days aft] ! date ( notification "u ?is 
p>agraph1 issue a propos$ sunscre5 ord] 
) respect to su* reque/4  7#c7 ,public  
comm5t p]iod ,a propos$ sunscre5 ord]   
issu$ "u p>agraph 7#a77;,b7 or 7#b7 )   
respect to a reque/ %all provide = a    
p]iod ( #de cal5d> days = public comm5t4
  7#d7 ,meet+ ,a sponsor may reque/1 9  
writ+1 a meet+ ) respect to a propos$   
sunscre5 ord] issu$ "u ?is subsection & 
describ$ 9 subp>agraph 7,b7 or 7,c7 (   
section #ehf7g71 n lat] ?an #cj cal5d>  
days aft] ! ,secret>y issues su* ord]4  
,! ,secret>y %all conv5e a meet+ ) su*  

sponsor n lat] ?an #de cal5d> days aft] 
su* reque/ = a meet+4  7#e7 ,f9al       
sunscre5 ord] ,) respect to a propos$   
sunscre5 ord] "u p>agraph 7#a77;,b7 or  
7#b7-- 7,a7 ! ,secret>y %all issue a    
f9al sunscre5 ord]-- 7i7 9 ! case ( a   
propos$ sunscre5 ord] describ$ 9        
subp>agraph 7,a7 or 7,b7 ( section      
#ehf7g71 n lat] ?an #ij cal5d> days aft]
 ! end ( ! public comm5t p]iod "u       
p>agraph 7#c72 or  7ii7 9 ! case ( a    
propos$ sunscre5 ord] describ$ 9        
subp>agraph 7,c7 ( section #ehf7g71 n   
lat] ?an #baj cal5d> days aft] ! date on
 :i* ! sponsor submits ! additional     
in=mation reque/$ pursuant to su*       
propos$ sunscre5 ord]2 or  7,b7 if !    
,secret>y does n issue su* f9al sunscre5
 ord] )9 su* #ij- or #baj-;cal5d>-day   
p]iod1 z applicable1 ! sponsor ( su*    
reque/ may notify ! ,(fice ( !          
,commission] ( su* reque/ & reque/      
review by ! ,(fice ( ! ,commission]4    
7#f7 ,f9al sunscre5 ord] by ,commission]
 ,! ,commission] %all issue a f9al      

sunscre5 ord] ) respect to a propos$    
sunscre5 ord] subject to p>agraph       
7#e77;,b7 n lat] ?an #fj cal5d> days    
aft] ! date ( notification "u su*       
p>agraph4  7b7 ,review ( p5d+ reque/s   
7#a7 ,9 g5]al ,! review ( a p5d+ reque/ 
%all be c>ri$ out by ! ,secret>y 9      
accordance ) ?is subsection4  7#b7      
,inapplicability ( sections #ehf;,a &   
#ehf;,b ,sections #ehf;,a & #ehf;,b %all
 n apply ) respect to any p5d+ reque/4  
7#c7 ,fe$back lett]s z propos$ sunscre5 
ord] ,not)/&+ ! requirem5ts ( section   
#ehf7g71 a lett] issu$ pursuant to      
section #ccj4ad7;g7 ( title #ba1 ,code (
 ,f$]al ,regulations be=e ! date (      
enactm5t ( ! ,sunscre5 ,innovation ,act1
 ) respect to a p5d+ reque/1 %all be    
deem$ to be a propos$ sunscre5 ord] &   
display$ on ! ,int]net website ( ! ,food
 & ,drug ,adm9i/ration4 ,notification ( 
! availability ( su* lett] %all be      
publi%$ 9 ! ,f$]al ,regi/] n lat] ?an   
#de cal5d> days aft] ! date ( enactm5t (
 su* ,act4  7#d7 ,propos$ sunscre5 ord] 

,9 ! case ( a p5d+ reque/ = :i* !       
,secret>y has n issu$ a lett] pursuant  
to section #ccj4ad7;g7 ( title #ba1     
,code ( ,f$]al ,regulations be=e ! date 
( enactm5t ( ! ,sunscre5 ,innovation    
,act1 ! ,secret>y %all complete review (
 su* reque/ &1 n lat] ?an #ij cal5d>    
days aft] ! date ( enactm5t ( su* ,act1 
issue a propos$ sunscre5 ord] ) respect 
to su* reque/4  7#e7 ,propos$ sunscre5  
ord] by ,commission] ,if ! ,secret>y    
does n issue a propos$ sunscre5 ord] "u 
p>agraph 7#d71 or ! ,secret>y does n    
publi% a notification ( ! availability (
 a lett] "u p>agraph 7#c71 z applicable1
 ! sponsor ( su* reque/ may notify !    
,(fice ( ! ,commission] ( su* reque/ &  
reque/ review by ! ,(fice ( !           
,commission]4 ,! ,commission] %all1 n   
lat] ?an #fj cal5d> days aft] ! date (  
notification "u ?is p>agraph1 issue a   
propos$ ord] ) respect to su* reque/4   
7#f7 ,public comm5t p]iod ,a propos$    
sunscre5 ord] issu$ "u p>agraph 7#d7 or 
7#e71 or a notification ( ! availability

 ( a lett] "u p>agraph 7#c71 ) respect  
to a p5d+ reque/ %all provide = a p]iod 
( #de cal5d> days = public comm5t4  7#g7
 ,meet+ ,a sponsor may reque/1 9 writ+1 
a meet+ ) respect to a propos$ sunscre5 
ord] issu$ "u ?is subsection1 includ+ a 
lett] deem$ to be a propos$ sunscre5    
ord] "u p>agraph 7#c71 n lat] ?an #cj   
cal5d> days aft] ! ,secret>y issues su* 
ord] or ! date ^u :i* su* fe$back lett] 
is deem$ to be a propos$ sunscre5 ord]1 
z applicable4 ,! ,secret>y %all conv5e a
 meet+ ) su* sponsor n lat] ?an #de     
cal5d> days aft] ! date ( su* reque/ = a
 meet+4  7#h7 ,advisory committee ,9 !  
case ( a propos$ sunscre5 ord] "u       
p>agraph 7#c71 7#d71 or 7#e71 an        
,advisory ,committee meet+ may be conv5$
 = ! purpose ( review+ & provid+        
recomm5dations reg>d+ ! p5d+ reque/4    
7#i7 ,f9al sunscre5 ord] ,9 ! case ( a  
propos$ sunscre5 ord] "u p>agraph 7#c71 
7#d71 or 7#e7-- 7,a7 ! ,secret>y %all   
issue a f9al sunscre5 ord] ) respect to 
! reque/-- 7i7 9 ! case ( a propos$     

sunscre5 ord] describ$ 9 subp>agraph    
7,a7 or 7,b7 ( section #ehf7g71 n lat]  
?an #ij cal5d> days aft] ! end ( !      
public comm5t p]iod "u p>agraph 7#f72 or
  7ii7 9 ! case ( a propos$ sunscre5    
ord] describ$ 9 subp>agraph 7,c7 (      
section #ehf7g7-- 7,i7 if ! ,advisory   
,committee is n conv5$ "u p>agraph 7#h71
 n lat] ?an #baj cal5d> days aft] ! date
 on :i* ! sponsor submits ! additional  
in=mation reque/$ pursuant to su*       
propos$ sunscre5 ord]1 :i* %all include 
a rationale = n conv5+ su* ,advisory    
,committee2 or  7,,ii7 if ! ,advisory   
,committee is conv5$ "u p>agraph 7#h71 n
 lat] ?an #bgj cal5d> days aft] ! date  
on :i* ! sponsor submits su* additional 
in=mation2 or  7,b7 if ! ,secret>y does 
n issue su* f9al sunscre5 ord] )9 su*   
#ij-1 #baj-1 or #bgj-;cal5d>-day p]iod1 
z applicable1 ! sponsor ( su* reque/ may
 notify ! ,(fice ( ! ,commission] ab\t  
su* reque/ & reque/ review by ! ,(fice (
 ! ,commission]4  7#aj7 ,f9al sunscre5  
ord] by ,commission] ,! ,commission]    

%all issue a f9al sunscre5 ord] )       
respect to a propos$ sunscre5 ord]      
subject to p>agraph 7#i77;,b7 n lat] ?an
 #fj cal5d> days aft] ! date (          
notification "u su* p>agraph4  7c7      
,advisory committee ,! ,secret>y %all n 
be requir$ to-- 7#a7 conv5e ! ,advisory 
,committee-- 7,a7 m ?an once ) respect  
to any reque/ "u section #ehf;,a or any 
p5d+ reque/2 or  7,b7 m ?an twice 9 any 
cal5d> ye> ) respect to ! review "u ?is 
section2 or  7#b7 submit m ?an a total (
 #c reque/s "u section #ehf;,a or p5d+  
reque/s to ! ,advisory ,committee p]    
meet+4  7d7 ,no delegation ,any         
responsibility ve/$ 9 ! ,commission] by 
subsection 7a77#b71 7a77#f71 7b77#e71 or
 7b77#aj7 %all n be delegat$4  7e7      
,effect ( f9al sunscre5 ord]  7#a7 ,9   
g5]al  7,a7 ,sunscre5 active +r$i5ts    
det]m9$ to be ,,grase ,^u issuance ( a  
f9al sunscre5 ord] det]m9+ t a          
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts is ,,grase & is n       

misbr&$1 a sunscre5 conta9+ su* +r$i5t  
or comb9ation ( +r$i5ts %all be p]mitt$ 
to be introduc$ or deliv]$ into int]/ate
 comm]ce = use "u ! conditions describ$ 
9 su* f9al sunscre5 ord]1 9 accordance )
 all requirem5ts applicable to drugs n  
subject to section #ejc7;b77#a71 = s    
long z su* f9al sunscre5 ord] rema9s 9  
effect4  7,b7 ,sunscre5 active +r$i5ts  
det]m9$ n to be ,,grase ,^u issuance ( a
 f9al sunscre5 ord] det]m9+ t a         
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts is n ,,grase & is       
misbr&$1 a sunscre5 conta9+ su* +r$i5t  
or comb9ation ( +r$i5ts %all n be       
introduc$ or deliv]$ into int]/ate      
comm]ce1 = use "u ! conditions describ$ 
9 su* f9al sunscre5 ord]1 unless an     
application is approv$ pursuant to      
section #eje ) respect to a sunscre5    
conta9+ su* +r$i5t or comb9ation (      
+r$i5ts1 or unless conditions are lat]  
e/abli%$ "u :i* su* +r$i5t or comb9ation
 ( +r$i5ts is lat] det]m9$ to be ,,grase

 & n misbr&$ "u ! ov]-!-c\nt] drug      
monograph sy/em4  7#b7 ,am5dm5ts to f9al
 sunscre5 ord]s  7,a7 ,am5dm5ts at      
initiative ( ,secret>y ,9 ! ev5t t      
in=mation relevant to a nonprescription 
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active +r$i5ts 
becomes available to ! ,secret>y aft]   
issuance ( a f9al sunscre5 ord]1 !      
,secret>y may am5d su* f9al sunscre5    
ord] by issu+ a new propos$ sunscre5    
ord] "u subsection 7a77#a7 & foll[+ !   
proc$ures set =? 9 ?is section4  7,b7   
,petition to am5d f9al ord] ,any int]e/$
 p]son may petition ! ,secret>y to am5d 
a f9al sunscre5 ord] "u section #aj4cj1 
title #ba ,code ( ,f$]al ,regulations   
7or any successor regulations74 ,if !   
,secret>y grants any petition "u su*    
section1 ! ,secret>y %all initiate !    
process = am5d+ a f9al sunscre5 ord] by 
issu+ a new propos$ sunscre5 ord] "u    
subsection 7a77#a7 & foll[+ ! proc$ures 
set =? 9 ?is section4  7,c7             
,applicability ( f9al ord]s ,once !     

,secret>y issues a new propos$ sunscre5 
ord] to am5d a f9al sunscre5 ord] "u    
subp>agraph 7,a7 or 7,b71 su* f9al      
sunscre5 ord] %all rema9 9 effect &     
p>agraph 7#c7 %all n apply to su* f9al  
sunscre5 ord] until ! ,secret>y has     
issu$ a new f9al sunscre5 ord] or has   
det]m9$ n to am5d ! f9al sunscre5 ord]4 
7#c7 ,inclusion ( ,+r$i5ts t are        
subjects ( ,f9al ,ord]s 9 ! ,sunscre5   
,monograph  7,a7 ,am5d+ regulations  7i7
 ,requirem5t ,at any "t t ! ,secret>y   
proposes to am5d "p #ceb ( title #ba1   
,code ( ,f$]al ,regulations 7or any     
successor regulations7 conc]n+          
nonprescription sunscre51 includ+       
pursuant to section #ehf;,e1 except z   
provid$ 9 clause 7iv71 ! ,secret>y %all 
include 9 su* "p #ceb 7or any successor 
regulations7 any nonprescription        
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active +r$i5ts 
t is ! subject ( an effective f9al      
sunscre5 ord] ( ! type describ$ 9       
section #ehf7b77;,a7 & issu$ s9ce ! "t t

 ! ,secret>y la/ am5d$ su* regulations4 
,su* regulation %all set =? conditions (
 use "u :i* ea* su* +r$i5t or comb9ation
 ( +r$i5ts is ,,grase & n misbr&$4 ,if  
^! conditions diff] f1 or are 9 addition
 to1 ^? previ\sly set =? 9 ! applicable 
f9al sunscre5 ord]1 ! ,secret>y %all    
provide notice & opportunity = comm5t on
 su* conditions 9 ! rulemak+1 & !       
applicable f9al sunscre5 ord] %all      
cont9ue 9 effect until ! effective date 
( a f9al regulation1 z set =? 9 clause  
7iii74  7ii7 ,inclusion ( ord]s ,9      
propos+ to am5d ! regulations z describ$
 9 clause 7i71 ! ,secret>y %all include 
9 ! propos$ regulations a li/ ( f9al    
sunscre5 ord]s t %all cease to be       
effective on ! effective date ( a       
result+ f9al regulation4 ,su* li/ %all  
include all f9al sunscre5 ord]s ( ! type
 describ$ 9 section #ehf7b77;,a7 t are 9
 effect on ! date t su* regulations are 
propos$1 ) ! exception t su* li/ %all n 
include any f9al sunscre5 ord]s t1 on ! 
date t ! regulations are propos$1 !     

,secret>y is 9 ! process ( am5d+ "u     
p>agraph 7#b74  7iii7 ,ord]s no long]   
effective ,any f9al sunscre5 ord]       
includ$ by ! ,secret>y 9 a li/ describ$ 
9 clause 7ii7 & 9 a li/ includ$ 9       
result+ f9al regulations %all cease to  
be effective on ! date t su* f9al       
regulations includ+ su* ord] 9 su* li/  
become effective4  7iv7 ,+r$i5ts n      
,,grase ,if1 not)/&+ a f9al sunscre5    
ord] /at+ t a nonprescription sunscre5  
active +r$i5t or comb9ation (           
nonprescription sunscre5 active +r$i5ts 
is ,,grase & is n misbr&$ if m>ket$ 9   
accordance ) su* ord]1 :ile am5d+ !     
regulations z describ$ 9 clause 7i71 !  
,secret>y concludes t su* +r$i5t or     
comb9ation ( +r$i5ts is no long] ,,grase
 = use 9 nonprescription sunscre51 !    
,secret>y %all1 at ! discretion ( !     
,secret>y1 ei!r initiate ! process =    
am5d+ ! f9al sunscre5 ord] set =? 9     
p>agraph 7#b7 ( ?is subsection or       
include 9 a propos$ regulation an       
explanation & in=mation support+ !      

det]m9ation ( ! ,secret>y t su* +r$i5t  
or comb9ation ( +r$i5ts is no long]     
,,grase = use 9 nonprescription         
sunscre54  7,b7 ,proc$ure = updat+      
regulations ,aft] ! ,secret>y am5ds &   
f9alizes ! regulations "u "p #ceb (     
title #ba1 ,code ( ,f$]al ,regulations  
"u section #ehf;,e & su* regulations    
become effective1 ! ,secret>y may use   
direct f9al rulemak+ to include 9 su*   
regulations any nonprescription sunscre5
 active +r$i5ts t are ! subject (       
effective f9al sunscre5 ord]s4  #ehf;,d4
 ,guidance2 o!r provisions  7a7         
,guidance  7#a7 ,9 g5]al  7,a7 ,draft   
guidance ,n lat] ?an #a ye> aft] ! date 
( enactm5t ( ! ,sunscre5 ,innovation    
,act1 ! ,secret>y %all issue draft      
guidance on ! implem5tation (1 &        
compliance )1 ! requirem5ts ) respect to
 sunscre5 "u ?is sub*apt]1 includ+      
guidance on-- 7i7 ! =mat & cont5t (     
in=mation submitt$ by a sponsor 9       
support ( a reque/ "u section #ehf;,a or
 a p5d+ reque/2  7ii7 ! data requir$ to 

meet ! safety & efficacy /&>d = det]m9+ 
:e!r a nonprescription sunscre5 active  
+r$i5t or comb9ation ( nonprescription  
sunscre5 active +r$i5ts is ,,grase & is 
n misbr&$2  7iii7 ! process by :i* a    
reque/ "u section #ehf;,a or a p5d+     
reque/ is )drawn2 &  7iv7 ! process by  
:i* ! ,secret>y w c>ry out section      
#ehf;,c7c71 includ+ ) respect to h[ !   
,secret>y w address ! total numb] (     
reque/s receiv$ "u section #ehf;,a &    
p5d+ reque/s4  7,b7 ,f9al guidance ,!   
,secret>y %all f9alize ! guidance       
describ$ 9 subp>agraph 7,a7 n lat] ?an  
#b ye>s aft] ! date ( enactm5t ( !      
,sunscre5 ,innovation ,act4  7,c7       
,inapplicability ( ,pap]work ,r$uction  
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code %all n apply to collections
 ( in=mation made = purposes ( guidance 
"u ?is subsection4  7#b7 ,submissions   
p5d+ issuance ( f9al guidance           
,irrespective ( :e!r f9al guidance "u   
p>agraph 7#a7 has be5 issu$-- 7,a7      
p]sons may1 beg9n+ on ! date ( enactm5t 

( ! ,sunscre5 ,innovation ,act1 make    
submissions "u ?is sub*apt]2 &  7,b7 !  
,secret>y %all review & act ^u su*      
submissions 9 accordance ) ?is sub*apt]4
  7b7 ,rules ( con/ruction  7#a7        
,curr5tly m>ket$ sunscre5s ,no?+ 9 ?is  
sub*apt] %all be con/ru$ to affect !    
m>ket+ ( sunscre5s t are m>ket$ 9       
int]/ate comm]ce on or be=e ! date (    
enactm5t ( ?is sub*apt]1 except z       
o!rwise provid$ 9 ?is sub*apt]4  7#b7   
,ensur+ safety & effectiv5ess ,no?+ 9   
?is sub*apt] %all be con/ru$ to alt] !  
au?ority ( ! ,secret>y ) respect to     
prohibit+ ! m>ket+ ( a sunscre5 t is n  
safe & effective or is misbr&$1 or )    
respect to impos+ re/rictions on !      
m>ket+ ( a sunscre5 to ensure safety &  
effectiv5ess1 except z o!rwise provid$ 9
 ?is sub*apt]1 includ+ section          
#ehf;,c7e74  7#c7 ,o!r drugs ,except z  
o!rwise provid$ 9 section #ehf;,f1 no?+ 
9 ?is sub*apt] %all be con/ru$ to affect
 ! au?ority ( ! ,secret>y "u ?is ,act or
 ! ,public ,heal? ,s]vice ,act 7#db     

,u4,s4,c4 #bja et seq47 ) respect to a  
drug o!r ?an a nonprescription sunscre54
  7#d7 ,effect on drugs o!rwise approv$ 
,no?+ 9 ?is sub*apt] %all affect !      
m>ket+ ( a drug approv$ "u section #eje 
( ?is ,act or section #cea ( ! ,public  
,heal? ,s]vice ,act4  7c7 ,timel9es ,!  
timel9es = ! processes & proc$ures "u   
p>agraphs 7#a71 7#b71 7#e71 & 7#f7 (    
section #ehf;,c7a7 %all n apply to any  
reque/s submitt$ to ! ,secret>y "u      
section #ehf;,a aft] ! date t is #f ye>s
 aft] ! date ( enactm5t ( ! ,sunscre5   
,innovation ,act4  #ehf;,e4 ,sunscre5   
monograph  7a7 ,9 g5]al ,n lat] ?an #e  
ye>s aft] ! date ( enactm5t ( !         
,sunscre5 ,innovation ,act1 ! ,secret>y 
%all am5d & f9alize regulations "u "p   
#ceb ( title #ba1 ,code ( ,f$]al        
,regulations conc]n+ nonprescription    
sunscre5 t are effective n lat] ?an #e  
ye>s aft] su* date ( enactm5t4 ,!       
,secret>y %all publi% su* regulations n 
less ?an #cj cal5d> days be=e !         
effective date ( su* regulations4  7b7  

,reports ,if ! regulations promulgat$ "u
 subsection 7a7 d n include provisions  
relat$ to ! effectiv5ess ( v>i\s sun    
protection factor levels1 & d n address 
all dosage =ms kn[n to ! ,secret>y to be
 us$ 9 sunscre5s m>ket$ 9 ! ,unit$      
,/ates )\t a new drug approval "u       
section #eje1 ! ,secret>y %all submit a 
report to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives on 
! rationale = su* provisions n be+      
includ$ 9 su* regulations1 & a plan &   
timel9e to compile any in=mation        
necess>y to address su* provisions ?r\gh
 f9al regulations4  4  7b7 ,rules (     
con/ruction ,no?+ 9 ! am5dm5t made by   
?is section %all be con/ru$ to-- 7#a7   
limit ! "r ( a sponsor 7z def9$ 9       
section #ehf7h7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act1 z add$ by subsection 
7a77 to reque/ t ! ,secret>y ( ,heal? & 
,human ,s]vices conv5e an advisory      
committee2 or  7#b7 limit ! au?ority ( !

 ,secret>y ( ,heal? & ,human ,s]vices to
 meet ) a sponsor 7z def9$ 9 section    
#ehf7h7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act1 z add$ by subsection    
7a774  #c4 ,non-sunscre5 "t & ext5t     
applications ,sub*apt] ,i ( *apt] ,v ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 
z add$ by section #b1 is am5d$ by add+  
at ! end ! foll[+3  #ehf;,f4            
,non-sunscre5 "t & ext5t applications   
7a7 ,p5d+ "t & ext5t applications  7#a7 
,9 g5]al  7,a7 ,reque/ = framework =    
review ,if1 prior to ! date ( enactm5t (
 ! ,sunscre5 ,innovation ,act1 an       
application 0 submitt$ pursuant to      
section #ccj4ad ( title #ba1 ,code (    
,f$]al ,regulations = a ,,grase         
det]m9ation = a drug o!r ?an a          
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts & su* drug 0 f\nd to be 
eligible to be consid]$ = inclusion 9 ! 
ov]-!-c\nt] drug monograph sy/em        
pursuant to section #ccj4ad ( title #ba1
 ,code ( ,f$]al ,regulations1 ! sponsor 

( su* application may reque/ t !        
,secret>y provide a framework "u        
p>agraph 7#b7 = ! review ( su*          
application4  7,b7 ,reque/ requirem5ts  
,a reque/ = a framework = review ( an   
application made "u subp>agraph 7,a7    
%all be made )9 #ahj cal5d> days ( !    
date ( enactm5t ( ! ,sunscre5           
,innovation ,act & %all include !       
pref]5ce ( su* sponsor z to :e!r su*    
application is review$ by ! ,secret>y 9 
accordance )-- 7i7 ! processes &        
proc$ures set =? = p5d+ reque/s "u      
section #ehf;,c7b71 except t specific   
timel9es %all be det]m9$ 9 accordance ) 
o!r applicable requirem5ts "u ?is       
section2  7ii7 ! processes & proc$ures  
set =? "u "p #ccj ( title #ba1 ,code (  
,f$]al ,regulations 7or any successor   
regulations72  7iii7 an initial fil+    
det]m9ation "u ! processes & proc$ures  
describ$ 9 section #ehf;,b7b7 & !       
processes & proc$ures set =? = p5d+     
reque/s "u section #ehf;,c7b71 except t 
specific timel9es %all be det]m9$ 9     

accordance ) o!r applicable requirem5ts 
"u ?is section2 or  7iv7 an initial fil+
 det]m9ation "u ! processes & proc$ures 
describ$ 9 section #ehf;,b7b7 & !       
processes & proc$ures set =? "u "p #ccj 
( title #ba1 ,code ( ,f$]al ,regulations
 7or any successor regulations74  7,c7  
,no reque/ ,if a sponsor describ$ 9     
subp>agraph 7,a7 does n make su* reque/ 
)9 #ahj cal5d> days ( ! date ( enactm5t 
( ! ,sunscre5 ,innovation ,act1 su*     
application %all be review$ by !        
,secret>y 9 accordance ) ! timel9es ( ! 
applicable regulations :5 su*           
regulations are f9aliz$ "u subsection   
7b74  7#b7 ,framework ,n lat] ?an #a ye>
 aft] ! date ( enactm5t ( ! ,sunscre5   
,innovation ,act1 ! ,secret>y %all      
provide1 9 writ+1 a framework to ea*    
sponsor t submitt$ a reque/ "u p>agraph 
7#a74 ,su* framework %all set =? ! v>i\s
 timel9es1 9 cal5d> days1 ) respect to !
 processes & proc$ures = review "u      
clauses 7i71 7ii71 7iii71 & 7iv7 (      
p>agraph 7#a77;,b7 &-- 7,a7 su* timel9es

 %all acc\nt = ! consid]ations "u       
p>agraph 7#e72 &  7,b7 ! timel9es = !   
v>i\s processes & proc$ures %all n be   
%ort] ?an ! timel9es set =? = p5d+      
reque/s "u sections #ehf;,b7b7 &        
#ehf;,c7b71 z applicable4  7#c7 ,gov]n+ 
processes & proc$ures = review  7,a7    
,election ,n lat] ?an #fj cal5d> days   
aft] ! ,secret>y provides a framework to
 a sponsor "u p>agraph 7#b71 su* sponsor
 may provide an election to ! ,secret>y 
reg>d+ ! processes & proc$ures = review 
"u clause 7i71 7ii71 7iii71 or 7iv7 (   
p>agraph 7#a77;,b74 ,if su* sponsor     
makes su* election1 ! ,secret>y %all    
review ! application t is ! subject (   
su* election pursuant to ! processes &  
proc$ures elect$ by su* sponsor & !     
applicable timel9es 9 cal5d> days set =?
 "u su* framework1 :i* ! ,secret>y %all 
confirm 9 writ+ to ! sponsor n lat] ?an 
! date ^u :i* ! ,secret>y provides a    
report "u p>agraph 7#d74 ,if su* sponsor
 does n make su* election1 su*          
application %all be review$ by !        

,secret>y 9 accordance ) ! timel9es ( ! 
applicable regulations :5 su*           
regulations are f9aliz$ "u subsection   
7b74  7,b7 ,diff]5t processes &         
proc$ures ,at any "t dur+ review ( an   
application1 ! ,secret>y may review su* 
application "u diff]5t processes &      
proc$ures "u clause 7i71 7ii71 7iii71 or
 7iv7 ( p>agraph 7#a77;,b7 ?an !        
processes & proc$ures ! sponsor elect$ 9
 accordance ) subp>agraph 7,a71 s long z
 ! ,secret>y proposes1 9 writ+1 ! *ange 
& ! sponsor agrees1 9 writ+1 to su*     
*ange4  7,c7 ,inclusion ( +r$i5ts 9     
monographs ,if ! sponsor elects to use !
 processes & proc$ures = review 9       
accordance ) clause 7i7 or 7iii7 (      
p>agraph 7#a77;,b71 ! ,secret>y may     
incorporate any result+ f9al ord] into a
 regulation address+ ! conditions "u :i*
 o!r drugs 9 ! same !rapeutic category  
are ,,grase & n misbr&$1 includ+ ?r\gh  
direct f9al rulemak+1 & ! f9al ord] s   
incorporat$ %all cease to be effective  
on ! effective date ( ! f9al regulation 

t addresses su* drug4  7#d7 ,lett]      
reg>d+ p5d+ applications ,n lat] ?an #ah
 mon?s aft] ! date ( enactm5t ( !       
,sunscre5 ,innovation ,act1 ! ,secret>y 
%all report to ! ,committee on ,heal?1  
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 9 
writ+1 reg>d+ all p5d+ applications     
subject to p>agraph 7#a74 ,9 su* lett]1 
! ,secret>y %all provide a report on !  
review ( su* applications1 includ+ !    
timel9es1 9 cal5d> days1 = ! review &   
,,grase det]m9ation = ea* application4  
,su* timel9es %all acc\nt = !           
consid]ations "u p>agraph 7#e74  7#e7   
,timel9es ,! timel9es 9 cal5d> days     
e/abli%$ by ! ,secret>y pursuant to ?is 
subsection-- 7,a7 may v>y bas$ on !     
cont5t1 complexity1 & =mat ( !          
application submitt$ to ! ,secret>y2 &  
7,b7 %all-- 7i7 reflect ! public heal?  
priorities ( ! ,food & ,drug            
,adm9i/ration1 includ+ ! pot5tial public
 heal? b5efits pos$ by ! inclusion (    

additional drugs 9 ! ov]-!-c\nt] drug   
monograph sy/em2  7ii7 take into        
consid]ation ! res\rces available to !  
,secret>y = c>ry+ out su* priorities & !
 processes & proc$ures describ$ 9       
p>agraphs 7#a77;,b7 & 7#b72 &  7iii7 be 
reasonable1 tak+ into consid]ation !    
requirem5ts describ$ 9 clauses 7i7 &    
7ii74  7b7 ,new "t & ext5t applications 
7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft]
 ! date ( enactm5t ( ! ,sunscre5        
,innovation ,act1 ! ,secret>y %all issue
 propos$ regulations e/abli%+ timel9es =
 ! review ( applications = ,,grase      
det]m9ations = drugs o!r ?an            
nonprescription sunscre5 active +r$i5ts 
or comb9ations ( nonprescription        
sunscre5 active +r$i5ts t are submitt$  
to ! ,secret>y aft] ! date ( enactm5t ( 
! ,sunscre5 ,innovation ,act1 "u section
 #ccj4ad ( title #ba1 ,code ( ,f$]al    
,regulations 7or any successor          
regulations71 & t are f\nd to be        
eligible to be consid]$ = inclusion 9 ! 
ov]-!-c\nt] drug monograph sy/em        

pursuant to section #ccj4ad ( title #ba1
 ,code ( ,f$]al ,regulations 7or any    
successor regulations71 or t are subject
 to ?is subsection pursuant to p>agraph 
7#a7 or 7#c7 ( subsection 7a71 z        
applicable1 provid+-- 7,a7 timely &     
effici5t completion ( evaluations (     
applications "u section #ccj4ad ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations7 = drugs o!r ?an 
sunscre5s2 &  7,b7 timely & effici5t    
completion ( ! review ( ! safety &      
effectiv5ess submissions pursuant to su*
 applications1 includ+ e/abli%+-- 7i7   
reasonable timel9es1 9 cal5d> days1 = ! 
applicable propos$ & f9al regulations = 
applications ( v>i\s cont5t1 complexity1
 & =mat1 & timel9es = int]nal proc$ures 
relat$ to su* processes2 &  7ii7        
measurable metrics = track+ ! ext5t to  
:i* ! timel9es set =? 9 ! regulations   
are met4  7#b7 ,timel9es ,! timel9es 9  
cal5d> days e/abli%$ 9 ! regulations "u 
p>agraph 7#a7-- 7,a7 may v>y bas$ on !  
cont5t1 complexity1 & =mat ( !          

application submitt$ to ! ,secret>y2 &  
7,b7 %all-- 7i7 reflect ! public heal?  
priorities ( ! ,food & ,drug            
,adm9i/ration1 includ+ ! pot5tial public
 heal? b5efits pos$ by ! inclusion (    
additional drugs 9 ! ov]-!-c\nt] drug   
monograph sy/em2  7ii7 take into        
consid]ation ! res\rces available to !  
,secret>y = c>ry+ out su* priorities & !
 processes & proc$ures describ$ 9       
p>agraph 7#a72 &  7iii7 be reasonable1  
tak+ into consid]ation ! requirem5ts    
describ$ 9 clauses 7i7 & 7ii74  7#c7    
,proc$ure ,9 promulgat+ regulations "u  
?is subsection1 ! ,secret>y %all issue a
 notice ( propos$ rulemak+ t includes a 
copy ( ! propos$ regulation1 provide a  
p]iod ( n less ?an #fj cal5d> days =    
comm5ts on ! propos$ regulation1 &      
publi% ! f9al regulation n less ?an #cj 
cal5d> days be=e ! effective date ( !   
regulation4  7#d7 ,re/rictions ,not)/&+ 
any o!r provision ( law1 ! ,secret>y    
%all promulgate regulations implem5t+   
?is section only z describ$ 9 p>agraphs 

7#a71 7#b71 & 7#c74  7#e7 ,f9al         
regulations ,! ,secret>y %all f9alize ! 
regulations "u ?is section n lat] ?an   
#bg mon?s aft] ! date ( enactm5t ( !    
,sunscre5 ,innovation ,act4  4  #d4     
,reports  7a7 ,initial ,,gao report ,n  
lat] ?an #c ye>s 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 review+
 ! ov]all progress ( ! ,secret>y (      
,heal? & ,human ,s]vices 9 c>ry+ out    
sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7z add$ by     
section #b & am5d$ by section #c &      
subsection 7c771 includ+ f9d+s on &     
recomm5dations ) respect to-- 7#a7 !    
progress made 9 complet+ ! review (     
reque/s "u sub*apt] ,i ( *apt] ,v ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
includ+ p5d+ reque/s1 & ! feasibility ( 
! timel9es associat$ ) su* sub*apt]2    

7#b7 ! role ( ! ,(fice ( ! ,commission] 
( ,food & ,drugs 9 issu+ det]m9ations ) 
respect to reque/s review$ "u su*       
sub*apt]1 includ+ ! numb] ( reque/s     
transf]r$ to ! ,(fice ( ! ,commission]  
"u section #ehf;,c ( su* ,act2  7#c7 !  
ext5t to :i* advisory committees 7      
conv5$ by ! ,secret>y reg>d+ reque/s "u 
sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act1 includ+ p5d+  
reque/s2 &  7#d7 ! types ( metrics t h  
be51 or %\ld be1 e/abli%$ = ! review (  
"t & ext5t applications4  7b7 ,subsequ5t
 ,,gao report ,n lat] ?an #ea_/b ye>s   
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 review+ ! ov]all progress ( !    
,secret>y ( ,heal? & ,human ,s]vices 9  
c>ry+ out sub*apt] ,i ( *apt] ,v ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z
 add$ by section #b & am5d$ by section  

#c & subsection 7c77 & ! regulation (   
ov]-!-c\nt] drug products1 includ+ f9d+s
 on & recomm5dations ) respect to-- 7#a7
 updates on ! matt]s report$ on by !    
,comptroll] ,g5]al "u subsection 7a72   
7#b7 significant factors impact+ !      
ability ( ! ,food & ,drug ,adm9i/ration 
to fulfill ! mission ( ! ag5cy ) reg>d  
to ! regulation ( ov]-!-c\nt] drug      
products1 includ+ f9aliz+ out/&+        
monographs & respond+ to em]g+ & novel  
safety issues2  7#c7 ! p]=mance ( !     
,secret>y 9 c>ry+ out section #ehf;,e ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2
  7#d7 ! types ( metrics t h be51 or    
%\ld be1 e/abli%$ = ! review &          
regulation ( ov]-!-c\nt] drug products2 
&  7#e7 timel9ess1 effici5cy1 &         
acc\ntability 9 review+ "t & ext5t      
applications & safety & effectiv5ess    
reviews = ov]-!-c\nt] drug products4    
7c7 ,,fda report ,sub*apt] ,i ( *apt] ,v
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act1 z am5d$ by section #c1 is fur!r   
am5d$ by add+ at ! end ! foll[+3        

#ehf;,g4 ,report  7a7 ,9 g5]al  7#a7 ,9 
g5]al ,n lat] ?an #ah mon?s aft] ! date 
( enactm5t ( ! ,sunscre5 ,innovation    
,act1 & on ! dates t are #b & #d ye>s   
!reaft]1 ! ,secret>y %all issue a report
 to ! ,committee on ,heal?1 ,education1 
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives describ+ actions
 tak5 "u ?is sub*apt]4  7#b7 ,cont5ts ,!
 reports "u ?is subsection %all         
include-- 7,a7 a review ( ! progress    
made 9 issu+ ,,grase det]m9ations = p5d+
 reque/s1 includ+ ! numb] ( p5d+        
reque/s-- 7i7 review$ & ! decision times
 = ea* reque/1 measur$ f ! date ( !     
orig9al reque/ = an eligibility         
det]m9ation submitt$ by ! sponsor2  7ii7
 result+ 9 a det]m9ation t !            
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts is ,,grase & is n       
misbr&$2  7iii7 result+ 9 a det]m9ation 
t ! nonprescription sunscre5 active     
+r$i5t or comb9ation ( nonprescription  

sunscre5 active +r$i5ts is n ,,grase &  
is misbr&$ & ! reasons = su*            
det]m9ations2 &  7iv7 = :i* a           
det]m9ation has n be5 made1 & an        
explanation = ! delay1 a description ( !
 curr5t /atus ( ea* su* reque/1 & ! l5g?
 ( "t ea* su* reque/ has be5 p5d+1      
measur$ f ! date ( orig9al reque/ = an  
eligibility det]m9ation by ! sponsor2   
7,b7 a review ( ! progress made 9 issu+ 
,,grase det]m9ations = reque/s n includ$
 9 ! report+ "u subp>agraph 7,a71       
includ+ ! numb] ( su* reque/s-- 7i7     
review$ & ! decision times = ea* reque/2
  7ii7 result+ 9 a det]m9ation t !      
nonprescription sunscre5 active +r$i5t1 
comb9ation ( nonprescription sunscre5   
active +r$i5ts1 or o!r +r$i5t is ,,grase
 & is n misbr&$2  7iii7 result+ 9 a     
det]m9ation t ! nonprescription sunscre5
 active +r$i5t1 comb9ation (            
nonprescription sunscre5 active +r$i5ts1
 or o!r +r$i5t is n ,,grase & is misbr&$
 & ! reasons = su* det]m9ations2 &  7iv7
 = :i* a det]m9ation has n be5 made1 &  

an explanation = ! delay1 a description 
( ! curr5t /atus ( ea* su* reque/1 & !  
l5g? ( "t ea* su* reque/ has be5 p5d+1  
measur$ f ! date ( orig9al reque/ = an  
eligibility det]m9ation by ! sponsor2   
7,c7 an annual acc\nt+ 7includ+         
in=mation f ye>s prior to ! date (      
enactm5t ( ! ,sunscre5 ,innovation ,act 
:]e su* in=mation is available7 ( !     
total numb] ( reque/s submitt$1 p5d+1 or
 complet$ "u ?is sub*apt]1 includ+ :e!r 
su* reque/s 7 ! subject ( an advisory   
committee conv5$ by ! ,secret>y2  7,d7 a
 description ( ! /aff+ & res\rces relat+
 to ! co/s associat$ ) ! review &       
decisionmak+ p]ta9+ to reque/s "u ?is   
sub*apt]2  7,e7 a review ( ! progress   
made 9 meet+ ! deadl9es ) respect to    
process+ reque/s "u ?is sub*apt]2 &     
7,f7 to ! ext5t ! ,secret>y det]m9es    
appropriate1 recomm5dations = process   
improvem5ts 9 ! h&l+ ( reque/s "u ?is   
sub*apt]1 includ+ ! advisory committee  
review process4  7b7 ,me?od ,! ,secret>y
 %all publi% ! reports "u subsection 7a7

 9 ! mann] ! ,secret>y det]m9es to be ! 
mo/ effective = effici5tly dissem9at+ ! 
report1 includ+ publication ( ! report  
on ! ,int]net website ( ! ,food & ,drug 
,adm9i/ration4  4  ,septemb] #ag        
7legislative day1 ,septemb] #af71       
#bjad,report$ ) an am5dm5t