,,ib  ,union ,cal5d> ,no4 #dah  #aac?   
,,congress  #b;d ,session  ,h4 ,r4 #dbej
  ,report ,no4 #aac-eeh  ,,9 ,,! ,,h\se 
,,( ,,repres5tatives  ,m>* #ac1 #bjad   
,mr4 ,:itfield 7= himself & ,mr4 ,d+ell7
 introduc$ ! foll[+ bill2 :i* 0 ref]r$  
to ! ,committee on ,en]gy & ,comm]ce    
,july #bd1 #bjad ,additional sponsors3  
,mr4 ,f>r1 ,mr4 ,gu?rie1 ,mr4 ,tib]i1   
,mr4 ,/iv]s1 ,mr4 ,rog]s ( ,k5tucky1    
,mr4 ,b>r1 ,mr4 ,=bes1 ,mr4 ,c>ney1 ,mr4
 ,lance1 ,mrs4 ,ellm]s1 ,mrs4           
,blackburn1 ,mrs4 ,c>olyn ,b4 ,maloney (
 ,new ,york1 ,mr4 ,griff9 ( ,arkansas1  
,mr4 ,cr5%aw1 ,mr4 ,lank=d1 ,mr4 ,d5t1  
,mr4 ,rooney1 ,mr4 ,b>r[ ( ,georgia1    
,mr4 ,k+/on1 ,mrs4 ,noem1 ,mr4 ,latta1  
,mr4 ,graves ( ,georgia1 ,mr4 ,ross1    
,mr4 ,bi%op ( ,new ,york1 ,mr4          
,p]lmutt]1 ,mr4 ,murphy ( ,p5nsylvania1 
,mr4 ,diaz-,bal>t1 ,mr4 ,johnson (      
,ohio1 ,mr4 ,ma!son1 ,mr4 ,roskam1 ,mr4 
,fleis*mann1 ,mr4 ,*abot1 & ,mr4 ,r5acci
  ,july #bd1 #bjad ,report$ ) an        
am5dm5t1 committ$ to ! ,committee ( !   

,:ole ,h\se on ! ,/ate ( ! ,union1 &    
ord]$ to be pr9t$ ,/rike out all aft] ! 
enact+ clause & ins]t ! "p pr9t$ 9      
italic ,= text ( introduc$ bill1 see    
copy ( bill z introduc$ on ,m>* #ac1    
#bjad  ,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$i5ts ,*apt] ,v ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  ,i            
,nonprescription sunscre5 active +r$i5ts
  #ehf4 ,def9itions ,9 ?is sub*apt]3    
7#a7 ,! t]m ,advisory ,committee means !
 ,nonprescription ,drug ,advisory       
,committee or any successor to su*      
,committee4  7#b7 ,! t]ms g5]ally       
recogniz$ z safe & effective & ,,grase  
mean 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 ! product's label+1 z describ$
 9 section #bja7p74  7#c7 ,! t]m ,,grase
 det]m9ation means1 ) respect to a      
nonprescription sunscre5 active +r$i5t  
or a comb9ation ( nonprescription       
sunscre5 active +r$i5ts1 a det]m9ation (
 :e!r su* +r$i5ts or comb9ation (       
+r$i5ts is g5]ally recogniz$ z safe &   
effective & n misbr&$ = use "u !        
conditions prescrib$1 recomm5d$1 or     
sugge/$ 9 ! product's label+1 z describ$
 9 section #bja7p74  7#d7 ,! t]m        
nonprescription means n subject to      
section #ejc7;b77#a74  7#e7 ,! t]m p5d+ 
reque/ means ea* reque/ submitt$ to !   
,secret>y--  7,a7 = consid]ation =      
inclusion 9 ! ov]-!-c\nt] drug monograph
 sy/em2  7,b7 t 0 deem$ eligible = su*  
review by publication ( a notice (      
eligibility 9 ! ,f$]al ,regi/] prior to 
! date ( enactm5t ( ! ,sunscre5         

,innovation ,act2 &  7,c7 = :i* safety &
 effectiv5ess data has be5 submitt$ to !
 ,secret>y prior to su* date ( enactm5t4
  7#f7 ,! t]m sponsor means ! p]son     
submitt+ ! reque/ "u section #ehf;,a7a71
 includ+ a "t & ext5t application "u    
section #ehf;,b1 or ! p]son t submitt$ !
 p5d+ reque/4  7#g7 ,! 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]+ radiation4  7#h7 ,! t]m      
sunscre5 means a product conta9+ "o or m
 sunscre5 active +r$i5ts4  #ehf;,a4     
,g5]al provisions  7a7 ,reque/s ,any    
p]son may submit a reque/ to ! ,secret>y
 = a det]m9ation ( :e!r a               
nonprescription sunscre5 active +r$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 g5]ally recogniz$ z 
safe & effective & n misbr&$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 lawfully m>ket$ 9 !     
,unit$ ,/ates on or be=e ! date (       
enactm5t ( ?is sub*apt]4  7#b7 ,ensur+  
safety & effectiv5ess ,no?+ 9 ?is       
sub*apt] %all be con/ru$ to alt] !      
,secret>y's au?ority to prohibit !      
m>ket+ ( a sunscre5 t is n safe &       
effective or to impose re/rictions on ! 
m>ket+ ( a sunscre5 to ensure safety &  
effectiv5ess4  7#c7 ,o!r products ,no?+ 
9 ?is sub*apt] %all be con/ru$ to affect
 ! ,secret>y's regulation ( products o!r
 ?an sunscre5s4  7c7 ,sunset ,?is       
sub*apt] %all cease to be effective at !
 end ( ! #e-ye> p]iod beg9n+ on ! date (
 enactm5t ( ?is sub*apt]4  #ehf;,b4     
,eligibility det]m9ation  7a7 ,9 g5]al  
,^u receipt ( a reque/ "u section       
#ehf;,a7a71 n lat] ?an #fj days aft] !  
date ( receipt ( su* reque/1 ! ,secret>y
 %all--  7#a7 det]m9e :e!r ! reque/ is  
eligible = fur!r review "u sections     

#ehf;,c & #ehf;,d1 z describ$ 9         
subsection 7b72  7#b7 notify ! sponsor (
 ! ,secret>y's det]m9ation2 &  7#c7 make
 su* det]m9ation publicly available 9   
accordance ) subsection 7c74  7b7       
,crit]ia = eligibility  7#a7 ,9 g5]al   
,to be eligible = review "u sections    
#ehf;,c & #ehf;,d1 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--  7,a7 is
 n includ$ 9 ! /ay$ sunscre5 monograph 9
 "p #ceb ( title #ba1 ,code ( ,f$]al    
,regulations2 &  7,b7 has be5 us$ to a  
mat]ial ext5t & = a mat]ial "t1 z       
describ$ 9 section #bja7p77#b74  7#b7   
,"t & ext5t application ,a sponsor %all 
include 9 a reque/ "u section #ehf;,a7a7
 a "t & ext5t application includ+ all ! 
in=mation requir$ to meet ! /&>d        
describ$ 9 p>agraph 7#a77;,b74  7c7     
,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$ to be        
eligible = fur!r review "u subsection   
7a77#a71 ! ,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 ,sponsors %all id5tify any   
in=mation :i* ! sponsor consid]s to be  
confid5tial in=mation describ$ 9        
p>agraph 7#a74  7#c7 ,confid5tiality    
dur+ eligibility review ,! in=mation    
conta9$ 9 a reque/ "u section #ehf;,a7a7
 %all rema9 confid5tial dur+ !          
,secret>y's consid]ation "u ?is section 
( :e!r ! reque/ is eligible = fur!r     
review4  #ehf;,c4 ,data submission2 fil+
 det]m9ation  7a7 ,9 g5]al ,9 ! case ( a
 reque/ "u section #ehf;,a7a7 t is      
det]m9$ to be eligible "u section       

#ehf;,b = fur!r review "u ?is section & 
section #ehf;,d--  7#a7 ! ,secret>y     
%all1 9 notify+ ! public "u section     
#ehf;,b7a77#c7 ( su* eligibility        
det]m9ation1 invite ! sponsor ( ! reque/
 & any o!r int]e/$ p>ty to submit1 9    
support ( or o!rwise relat+ to a ,,grase
 det]m9ation--  7,a7 publi%$ & unpubli%$
 data & o!r in=mation relat$ to ! safety
 & effectiv5ess ( ! nonprescription     
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active +r$i5ts 
= its int5d$ nonprescription uses2 or   
7,b7 any o!r comm5ts2 &  7#b7 n lat] ?an
 #fj days aft] ! submission ( su* data &
 o!r in=mation by ! sponsor1 includ+ any
 revis$ submission ( su* data & o!r     
in=mation foll[+ a refusal to file "u   
subp>agraph 7,b71 ! ,secret>y %all--    
7,a7  7i7 issue a writt5 notification to
 ! sponsor det]m9+ t ! reque/ "u section
 #ehf;,a7a71 toge!r ) su* data & o!r    
in=mation1 is suffici5tly complete to   
conduct a sub/antive review & make su*  
notification publicly available2 &  7ii7

 file su* reque/2 or  7,b7 issue a      
writt5 notification to ! sponsor refus+ 
to file ! reque/ & /at+ ! reasons = !   
refusal & :y ! data & o!r in=mation     
submitt$ is n suffici5tly complete to   
conduct a sub/antive review & make su*  
notification publicly available2  7#c7 !
 ,secret>y %all1 9 fil+ a reque/ "u     
p>agraph 7#b7--  7,a7 invite ! public to
 submit fur!r comm5ts ) respect to su*  
fil+2 &  7,b7 limit su* public comm5t1 &
 ! comm5t p]iod "u p>agraph 7#a71 to !  
p]iod end+ on ! date t is #fj days aft] 
su* fil+2  7#d7 if ! ,secret>y refuses  
to file ! reque/--  7,a7 ! sponsor may1 
)9 #cj days ( receipt ( writt5          
notification ( su* refusal1 seek a meet+
 ) ! ,secret>y reg>d+ :e!r ! ,secret>y  
%\ld file ! reque/2 &  7,b7 ! ,secret>y 
%all conv5e ! meet+2 &  7#e7 foll[+ any 
su* meet+--  7,a7 if ! sponsor asks t ! 
,secret>y file ! reque/ 7) or )\t       
am5dm5ts to correct any purport$        
defici5cies to ! reque/7 ! ,secret>y    
%all file ! reque/ ov] prote/1 issue a  

writt5 notification ( ! fil+ to !       
sponsor1 & make su* notification        
publicly available2 &  7,b7 if ! reque/ 
is s fil$ ov] prote/1 ! ,secret>y %all n
 require ! sponsor to resubmit a copy ( 
! reque/ = purposes ( su* fil+4  7b7    
,reasons = refusal to file reque/ ,!    
,secret>y may refuse to file a reque/   
submitt$ "u section #ehf;,a7a7 if !     
,secret>y det]m9es ! data or o!r        
in=mation submitt$ by ! sponsor "u ?is  
section are n suffici5tly complete to   
conduct a sub/antive review ) respect to
 su* reque/4  7c7 ,public availability  
7#a7 ,r$actions = confid5tial in=mation 
,! ,secret>y %all make data & o!r       
in=mation submitt$ 9 connection ) a     
reque/ "u section #ehf;,a7a7 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 ,sponsors or any   

o!r individual submitt+ data or o!r     
in=mation "u ?is section %all id5tify   
any in=mation :i* ! sponsor or          
individual consid]s to be confid5tial   
in=mation describ$ 9 p>agraph 7#a74     
#ehf;,d4 ,,grase det]m9ation  7a7       
,review ( new reque/  7#a7 ,propos$ ord]
 by ,,cd] ,9 ! case ( a reque/ "u       
section #ehf;,a7a71 ! ,director ( !     
,c5t] = ,drug ,evaluation & ,rese>*     
%all--  7,a7 n lat] ?an #cjj days aft] !
 date on :i* ! reque/ is fil$ "u section
 #ehf;,c7a71 complete ! review ( !      
reque/ & issue a propos$ ord] det]m9+   
t--  7i7 ! nonprescription sunscre5     
active +r$i5t or comb9ation (           
nonprescription sunscre5 active +r$i5ts 
t is ! subject ( ! reque/--  7,i7 is    
,,grase2 &  7,,ii7 is n misbr&$2  7ii7 !
 nonprescription sunscre5 active +r$i5t 
or comb9ation ( nonprescription sunscre5
 active +r$i5ts t is ! subject ( !      
reque/--  7,i7 is n ,,grase2 or  7,,ii7 
is misbr&$2 or  7iii7 additional        
in=mation is necess>y to all[ !         

,director ( ! ,c5t] = ,drug ,evaluation 
& ,rese>* to complete ! review ( su*    
reque/2  7,b7 )9 su* #cjj-;day p]iod1   
conv5e a meet+ ( ! ,advisory ,committee 
to review ! reque/ "u section           
#ehf;,a7a73 &  7,c7 if ! ,director fails
 to issue su* propos$ ord] )9 !         
#cjj-;day p]iod ref]r$ to 9 subp>agraph 
7,a71 transmit ! reque/ to !            
,commission] ( ,food & ,drugs = review4 
7#b7 ,propos$ ord] by ,commission] ,)   
respect to a reque/ transmitt$ to !     
,commission] ( ,food & ,drugs "u        
p>agraph 7#a77;,c71 ! ,commission] %all1
 n lat] ?an #fj days aft] ! date ( su*  
transmission1 issue--  7,a7 a propos$   
ord] describ$ 9 p>agraph 7#a77;,a77i72  
7,b7 a propos$ ord] describ$ 9 p>agraph 
7#a77;,a77ii72 or  7,c7 a propos$ ord]  
describ$ 9 p>agraph 7#a77;,a77iii74     
7#c7 ,publication 9 ,f$]al ,regi/]2     
public comm5t p]iod ,a propos$ ord]     
issu$ "u p>agraph 7#a7 or 7#b7 ) respect
 to a reque/ %all--  7,a7 be publi%$ 9 !
 ,f$]al ,regi/]2 &  7,b7 solicit public 

comm5ts = a p]iod ( n m ?an #de days4   
7#d7 ,f9al ord] by ,,cd] ,9 ! case ( a  
propos$ ord] "u p>agraph 7#a77;,a7 or   
7#b7 ) respect to a reque/1 ! ,director 
( ! ,c5t] = ,drug ,evaluation & ,rese>* 
%all--  7,a7 issue a f9al ord] ) respect
 to ! reque/--  7i7 9 ! case ( a propos$
 ord] "u clause 7i7 or 7ii7 ( p>agraph  
7#a77;,a7 or subp>agraph 7,a7 or 7,b7 ( 
p>agraph 7#b71 n lat] ?an #ij days aft] 
! end ( ! public comm5t p]iod "u        
p>agraph 7#c77;,b72 or  7ii7 9 ! case ( 
a propos$ ord] "u p>agraph              
7#a77;,a77iii7 or p>agraph 7#b77;,c71 n 
lat] ?an #baj days aft] ! date on :i* ! 
sponsor submits ! additional in=mation  
reque/$ pursuant to su* propos$ ord]2 or
  7,b7 if ! ,director fails to issue su*
 f9al ord] )9 su* #ij- or #baj-;day     
p]iod1 z applicable1 transmit su*       
propos$ ord] to ! ,commission] ( ,food &
 ,drugs = review4  7#e7 ,f9al ord] by   
,commission] ,) respect to a propos$    
ord] transmitt$ to ! ,commission] (     
,food & ,drugs "u p>agraph 7#d77;,b71 ! 

,commission] %all issue a f9al ord] )   
respect to su* propos$ ord] n lat] ?an  
#fj days aft] ! date ( su* transmission4
  7b7 ,review ( p5d+ reque/s  7#a7 ,9   
g5]al ,! review ( a p5d+ reque/ %all be 
c>ri$ out by ! ,director ( ! ,c5t] =    
,drug ,evaluation & ,rese>* 9 accordance
 ) p>agraph 7#c74  7#b7 ,inapplicability
 ( c]ta9 provisions ,sections #ehf;,b & 
#ehf;,c %all n apply ) respect to any   
p5d+ reque/4  7#c7 ,propos$ ord] by     
,,cd] ,! ,director ( ! ,c5t] = ,drug    
,evaluation & ,rese>* %all--  7,a7 )9 ! 
timeframe applicable "u p>agraph 7#d71  
complete ! review ( ! reque/ & issue a  
propos$ ord] det]m9+ t--  7i7 !         
nonprescription sunscre5 active +r$i5t  
or comb9ation ( nonprescription sunscre5
 active +r$i5ts t is ! subject ( ! p5d+ 
reque/--  7,i7 is ,,grase2 &  7,,ii7 is 
n misbr&$2  7ii7 ! nonprescription      
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active +r$i5ts 
t is ! subject ( ! p5d+ reque/--  7,i7  
is n ,,grase2 or  7,,ii7 is misbr&$2 or 

7iii7 additional in=mation is necess>y  
to all[ ! ,director ( ! ,c5t] = ,drug   
,evaluation & ,rese>* to complete !     
review ( ! p5d+ reque/2 &  7,b7 if !    
,director fails to issue su* propos$    
ord] )9 ! timeframe applicable "u       
p>agraph 7#d71 transmit ! p5d+ reque/ to
 ! ,commission] ( ,food & ,drugs =      
review4  7#d7 ,timeframe = issuance (   
propos$ ord] by ,,cd] ,! ,director ( !  
,c5t] = ,drug ,evaluation & ,rese>* %all
 issue a propos$ ord]1 z requir$ by     
p>agraph 7#c77;,a7--  7,a7 9 ! case ( a 
p5d+ reque/ = :i* ! ,food & ,drug       
,adm9i/ration has issu$ a fe$back lett] 
be=e ! date ( enactm5t ( ! ,sunscre5    
,innovation ,act1 n lat] ?an #de days   
aft] su* date ( enactm5t2 &  7,b7 9 !   
case ( a p5d+ reque/ = :i* ! ,food &    
,drug ,adm9i/ration has n issu$ a       
fe$back lett] be=e ! date ( enactm5t ( !
 ,sunscre5 ,innovation ,act1 n lat] ?an 
#ij days aft] su* date ( enactm5t4  7#e7
 ,propos$ ord] by ,commission] ,)       
respect to a p5d+ reque/ transmitt$ to !

 ,commission] ( ,food & ,drugs "u       
p>agraph 7#c77;,b71 ! ,commission] %all1
 n lat] ?an #fj days aft] ! date ( su*  
transmission1 issue--  7,a7 a propos$   
ord] describ$ 9 p>agraph 7#c77;,a77i72  
7,b7 a propos$ ord] describ$ 9 p>agraph 
7#c77;,a77ii72 or  7,c7 a propos$ ord]  
describ$ 9 p>agraph 7#c77;,a77iii74     
7#f7 ,publication 9 ,f$]al ,regi/]2     
public comm5t p]iod ,a propos$ ord]     
issu$ "u p>agraph 7#c7 or 7#e7 ) respect
 to a p5d+ reque/ %all--  7,a7 be       
publi%$ 9 ! ,f$]al ,regi/]2 &  7,b7     
solicit public comm5ts = a p]iod ( n m  
?an #de days4  7#g7 ,advisory committee 
,= a propos$ ord] issu$ "u p>agraph     
7#c77;,a77iii7 or 7#e77;,c7 reque/+     
additional in=mation1 an ,advisory      
,committee meet+ %all be conv5$ if !    
sponsor reque/s1 or ! ,director ( !     
,c5t] = ,drug ,evaluation & ,rese>* or !
 ,commission] ( ,food & ,drugs decides1 
to conv5e su* a meet+ = ! purpose (     
review+ ! p5d+ reque/4  7#h7 ,f9al ord] 
by ,,cd] ,9 ! case ( a propos$ ord] "u  

p>agraph 7#c77;,a7 or 7#e7 ) respect to 
a reque/1 ! ,director ( ! ,c5t] = ,drug 
,evaluation & ,rese>* %all--  7,a7 issue
 a f9al ord] ) respect to ! reque/--    
7i7 9 ! case ( a propos$ ord] "u clause 
7i7 or 7ii7 ( p>agraph 7#c77;,a7 or     
subp>agraph 7,a7 or 7,b7 ( p>agraph     
7#e71 n lat] ?an #ij days aft] ! end ( !
 public comm5t p]iod "u p>agraph        
7#c77;,b72 or  7ii7 9 ! case ( a propos$
 ord] "u p>agraph 7#c77;,a77iii7 or     
p>agraph 7#e77;,c7--  7,i7 if !         
,advisory ,committee is n conv5$        
pursuant to p>agraph 7#g71 n lat] ?an   
#baj days aft] ! date on :i* ! sponsor  
submits ! additional in=mation reque/$  
pursuant to su* propos$ ord]2 or  7,,ii7
 if ! ,advisory ,committee is conv5$    
pursuant to p>agraph 7#g71 n lat] ?an   
#bgj days aft] date on :i* ! sponsor    
submits su* additional in=mation2 or    
7,b7 if ! ,director fails to issue su*  
f9al ord] )9 su* #ij-1 #baj-1 &         
#bgj-;day p]iod1 z applicable1 transmit 
su* propos$ ord] to ! ,commission] (    

,food & ,drugs = review4  7#i7 ,f9al    
ord] by ,commission] ,) respect to a    
propos$ ord] transmitt$ to !            
,commission] ( ,food & ,drugs "u        
p>agraph 7#h77;,b71 ! ,commission] %all 
issue a f9al ord] ) respect to su*      
propos$ ord] n lat] ?an #fj days aft] ! 
date ( su* transmission4  7c7 ,advisory 
committee  7#a7 ,limitations ,! ,food & 
,drug ,adm9i/ration--  7,a7 %all n be   
requir$ to conv5e ! ,advisory           
,committee--  7i7 m ?an once ) respect  
to any reque/ "u section #ehf;,a7a7 or  
any p5d+ reque/2 or  7ii7 m ?an twice 9 
any twelve mon? p]iod ) respect to !    
review ( submissions "u ?is section2 &  
7,b7 %all n be requir$ to submit m ?an  
#c submissions to ! ,advisory ,committee
 p] meet+4  7#b7 ,memb]%ip ,9 appo9t+ ! 
memb]s ( ! ,advisory ,committee1 !      
,secret>y may select to s]ve tempor>ily 
z vot+ memb]s on ! ,advisory            
,committee--  7,a7 memb]s ( o!r ,f$]al  
advisory committees2 or  7,b7           
consultants f outside ( ! ,dep>tm5t (   

,heal? & ,human ,s]vices :o h sub/antive
 exp]tise reg>d+ sunscre5 active        
+r$i5ts4  7d7 ,no delegation ,any       
responsibility ve/$ by ?is section 9 !  
,commission] ( ,food & ,drugs is n      
delegable4  7e7 ,effect ( f9al ord]     
7#a7 ,cont5t ,a f9al ord] "u subsection 
7a77#d71 7a77#e71 7b77#h71 or 7b77#i7 ) 
respect to a reque/ "u section          
#ehf;,a7a7 or a p5d+ reque/ %all det]m9e
 t ! nonprescription sunscre5 active    
+r$i5t or comb9ation ( nonprescription  
sunscre5 active +r$i5ts t is ! subject (
 ! reque/--  7,a7 is ,,grase & is n     
misbr&$2 or  7,b7 is n ,,grase or is    
misbr&$4  7#b7 ,active +r$i5ts det]m9$  
to be ,,grase ,^u issuance ( a f9al ord]
 det]m9+ t a nonprescription sunscre5   
active +r$i5t or comb9ation (           
nonprescription sunscre5 active +r$i5ts 
is ,,grase & is n misbr&$1 ! active     
+r$i5t or comb9ation ( active +r$i5ts   
%all be p]mitt$ to be introduc$ or      
deliv]$ into int]/ate comm]ce1 = use "u 
! conditions subject to ! f9al ord]1 9  

accordance ) all requirem5ts applicable 
to drugs n subject to section           
#ejc7;b77#a74  7#c7 ,active +r$i5ts     
det]m9$ n to be ,,grase ,^u issuance ( a
 f9al ord] det]m9+ t ! nonprescription  
sunscre5 active +r$i5t or comb9ation (  
nonprescription sunscre5 active +r$i5ts 
is n ,,grase or is misbr&$1 ! active    
+r$i5t or comb9ation ( active +r$i5ts   
%all n be introduc$ or deliv]$ into     
int]/ate comm]ce1 = use "u ! conditions 
subject to ! f9al ord]1 unless an       
application submitt$ pursuant to section
 #eje7;b7 ) respect to su* active +r$i5t
 or comb9ation ( active +r$i5ts is      
approv$4  #ehf;,e4 ,reports  7a7 ,,gao  
report ,n lat] ?an #a ye> aft] ! date ( 
enactm5t ( ! ,sunscre5 ,innovation ,act1
 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 
%all--  7#a7 submit a report review+ !  
ov]all progress ( ! ,secret>y 9 c>ry+   
out ?is sub*apt] to ! ,committee on     
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives2 & 

7#b7 include f9d+s on--  7,a7 ! progress
 made 9 complet+ ! review ( p5d+        
reque/s2 &  7,b7 ! role ( ! ,(fice ( !  
,commission] ( ,food & ,drugs 9 issu+   
det]m9ations ) respect to p5d+ reque/s1 
includ+ ! numb] ( reque/s transf]r$ to !
 ,(fice ( ! ,commission] "u section     
#ehf;,d4  7b7 ,secret>y's report  7#a7  
,9 g5]al ,n lat] ?an #a ye> aft] ! date 
( enactm5t ( ! ,sunscre5 ,innovation    
,act1 & e #b 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 section4   
,ea* report "u ?is subsection %all be   
po/$ on ! ,int]net site ( ! ,food &     
,drug ,adm9i/ration4  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 & 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+ 9 a timely mann] ,,grase   
det]m9ations = reque/s submitt$ "u      
section #ehf;,a7a71 includ+ ! numb] (   
su* reque/s--  7i7 review$ & ! decision 
times = ea* reque/2  7ii7 result+ 9 a   
det]m9ation t ! nonprescription sunscre5
 active +r$i5t or comb9ation (          

nonprescription sunscre5 active +r$i5ts 
is ,,grase & 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,c7 a description ( ! /aff+ & res\rces 
relat+ to ! co/s associat$ ) ! review & 
decisionmak+ p]ta9+ to reque/s "u ?is   
sub*apt]2  7,d7 a review ( ! progress   
made 9 meet+ ! deadl9es ) respect to    
process+ reque/s "u ?is sub*apt]2  7,e7 
to ! ext5t ! ,secret>y det]m9es         
appropriate1 recomm5dations = process   
improvem5ts 9 ! h&l+ ( p5d+ & new       
reque/s1 includ+ ! advisory committee   
review process2 &  7,f7 recomm5dations =
 exp&+ ! applicability ( ?is sub*apt] to

 nonprescription active +r$i5ts t are n 
relat$ to ! sunscre5 category (         
ov]-!-c\nt] drugs4  7c7 ,me?od ,!       
,secret>y %all publi% ! reports requir$ 
"u subsection 7b7 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  #c4 ,guidance  7a7 ,9 g5]al  7#a7  
,issuance ,n lat] ?an "o ye> aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y (   
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
issue guidance1 9 accordance ) good     
guidance practices1 on ! implem5tation  
(1 & compliance )1 sub*apt] ,i ( *apt]  
,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic 
,act1 z add$ by section #b1 includ+     
guidance on--  7,a7 ! crit]ia = det]m9+ 
:e!r a nonprescription sunscre5 active  
+r$i5t or comb9ation ( nonprescription  
sunscre5 active +r$i5ts has be5 us$ to a
 mat]ial ext5t & = a mat]ial "t1 z      
describ$ 9 section #bja7p77#b7 ( !      

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba7p77#b772  7,b7 !    
=mat & cont5t ( a safety & effectiv5ess 
data submission2 &  7,c7 ! safety &     
efficacy /&>ds = det]m9+ :e!r a         
nonprescription sunscre5 active +r$i5ts 
or comb9ation ( nonprescription sunscre5
 active +r$i5ts is g5]ally recogniz$ z  
safe & effective1 z def9$ 9 section #ehf
 ( su* sub*apt] ,i4  7#b7               
,inapplicability ( ,pap]work ,r$uction  
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code1 %all n apply to           
collections ( in=mation made = purposes 
( guidance "u ?is subsection4  7b7      
,submissions p5d+ issuance ( f9al       
guidance ,irrespective ( :e!r f9al      
guidance "u subsection 7a7 has be5      
issu$--  7#a7 p]sons may1 beg9n+ on !   
date ( enactm5t ( ?is ,act1 make        
submissions "u sub*apt] ,i ( *apt] ,v ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1
 z add$ by section #b2 &  7#b7 !        
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     

,drugs1 %all review & act ^u su*        
submissions 9 accordance ) su* sub*apt]4
  ,july #bd1 #bjad ,report$ ) an        
am5dm5t1 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union1 &    
ord]$ to be pr9t$