#aac? ,,congress  #b;d ,session  ,s4    
#bada  ,,an ,,act  ,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$i5ts  7a7 ,9 g5]al   
,*apt] ,v ( ! ,f$]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  ,pass$ ! ,s5ate      
,septemb] #ag 7legislative day1         
,septemb] #af71 #bjad4,secret>y