,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bdia  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #bi1 #bjbe,ms4   
,hassan 7= h]self & ,mr4 ,m>%all7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to improve !    
regulatory review process to det]m9e !  
safety & effectiv5ess ( nonprescription 
drugs int5d$ = topical adm9i/ration1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,support+          
,accessible1 ,flexible1 & ,effective    
,sunscre5 ,/&>ds or ! ,,safe ,sunscre5  
,/&>ds ,act4  #b4 ,treatm5t ( active    
+r$i5ts = topical adm9i/ration ,section 
#eje;,g ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 is
 am5d$ by add+ at ! end ! foll[+3  7r7  
,evid5ce & te/+ /&>ds = active +r$i5ts =
 topical adm9i/ration  7#a7 ,evid5ce &  
te/+ /&>ds = active +r$i5ts = topical   
adm9i/ration ,! ,secret>y %all-- 7,a7 9 

evaluat+ ! g5]ally recogniz$ z safe &   
effective /atus ( active +r$i5ts us$ 9  
nonprescription drugs int5d$ = topical  
adm9i/ration = purposes ( subsection    
7a71 utilize /&>ds t all[ = ! use ( real
 _w evid5ce 7z def9$ 9 section          
#eje;,f7b771 z appropriate1 z "p ( a    
compreh5sive evaluation ( sci5tific     
evid5ce to demon/rate ! safety &        
effectiv5ess ( su* active +r$i5ts1 to   
supplem5t evid5ce f traditional cl9ical 
trials1 provid$ t su* /&>ds all[ !      
,secret>y to evaluate :e!r ! b5efits (  
su* active +r$i5ts outweigh ! risks2 &  
7,b7 apply subsection 7b77#f77;,c7 to ! 
regulation ( active +r$i5ts us$ 9 drugs 
int5d$ = topical adm9i/ration4  7#b7    
,non-animal te/+ me?ods = topical active
 +r$i5ts  7,a7 ,9 g5]al ,! ,secret>y    
%all consid] ! types ( noncl9ical te/s  
describ$ 9 p>agraphs 7#a7 ?r\gh 7#d7 ( !
 fir/ subsection 7z7 ( section #eje 7z  
ins]t$ by section #cbji7;a77#b7 ( !     
,heal? ,ext5d]s1 ,improv+ ,access to    
,m$ic>e1 ,m$icaid1 & ,,*ip1 & ,/r5g!n+  

,public ,heal? ,act ( #bjbb 7division   
,,ff ( ,public ,law #aag-cbh771 or any  
o!r alt]native to animal te/+ t !       
,secret>y det]m9es appropriate1 9 !     
consid]ation ( drugs int5d$ = topical   
adm9i/ration "u ?is section4  7,b7      
,guidance ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is subsection1 !         
,secret>y %all issue new draft guidance 
on h[ sponsors c use noncl9ical te/+    
alt]natives to animal te/+1 z           
appropriate1 to meet safety & efficacy  
/&>ds "u ?is section = drugs int5d$ =   
topical adm9i/ration4  7#c7             
,cl>ification ,no?+ 9 ?is subsection    
%all be con/ru$ to alt]1 sup]s$e1 or    
limit ! /&>ds = mak+ det]m9ations ( :e!r
 a drug is g5]ally recogniz$ z safe &   
effective "u section #bja7p7 or ! /&>ds 
set =? "u section #eje = det]m9+ !      
safety & effectiv5ess ( drugs4  4  #c4  
,sunscre5 f9al adm9i/rative ord] ,a f9al
 adm9i/rative ord] on nonprescription   
sunscre5 active +r$i5ts issu$ "u section
 #ched ( ! ,coronavirus ,aid1 ,relief1 &

 ,economic ,security ,act 7,public ,law 
#aaf-acf2 #ba ,u4,s4,c4 #cfj;fff-#c     
note7 %all-- 7#a7 acc\nt = hi/orical    
data reg>d+ ! safety ( sunscre5 active  
+r$i5ts t h previ\sly be5 accept$ =     
m>ket+ 9 ! ,unit$ ,/ates2  7#b7 acc\nt =
 ! role ( broad spectrum sunscre5s ) a  
,sun ,protection ,factor ( #ae or high] 
9 effective sk9 canc] prev5tion2 &  7#c7
 incorporate ! evid5ce & te/+ /&>ds =   
sunscre5 active +r$i5ts detail$ 9       
section #eje;,g7r7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;h7 7z add$ by section #b74  #d4    
,report+ & transp>5cy  7a7 ,9 g5]al ,!  
,secret>y ( ,heal? & ,human ,s]vices 79 
?is section ref]r$ to z ! ,secret>y7    
%all1 n lat] ?an #ah mon?s aft] ! date (
 enactm5t ( ?is ,act & annually = #e    
ye>s !reaft]1 submit to ! ,committee on 
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate a report describ+1 9          
compliance ) section #eje;,g7d7 ( !     

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee;h7d77-- 7#a7 ! /atus
 ( implem5tation ( evid5ce & te/+ /&>ds 
= nonprescription drugs int5d$ = topical
 adm9i/ration1 includ+-- 7,a7 !         
application ( evid5ce or te/+ /&>ds made
 "u section #eje;,g7r7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee;h7 7z add$ by section #b72 &  7,b7 
! numb] ( sunscre5 active +r$i5t reque/s
 review$ us+ ! /&>ds "u su* section     
#eje;,g7b72 &  7#b7 ! progress ( ! ,food
 & ,drug ,adm9i/ration 9 all[+          
noncl9ical te/+ alt]natives to animal   
te/+ = ! consid]ation ( sunscre5 active 
+r$i5ts4  7b7 ,publication ,n lat] ?an  
#g days aft] ! date on :i* ! ,secret>y  
submits a report "u subsection 7a71 !   
,secret>y %all publi% su* report on !   
website ( ! ,food & ,drug ,adm9i/ration4