,,ii  #aac? ,,congress  #b;d ,session   
,s4 #bada  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #ac1 #bjad,mr4    
,re$ 7= himself & ,mr4 ,isakson7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to provide an   
alt]native process = review ( safety &  
effectiv5ess ( nonprescription sunscre5 
active +r$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