,,ii  #aaith ,,congress  #ast ,session  
,s4 #bdia  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #bi1     
#bjbe,ms4 ,hassan 7for herself and ,mr4 
,marshall7 introduced the following     
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to improve the
 regulatory review process to determine 
the safety and effectiveness of         
nonprescription drugs intended for      
topical administration1 and for other   
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,supporting         
,accessible1 ,flexible1 and ,effective  
,sunscreen ,standards or the ,,safe     
,sunscreen ,standards ,act4  #b4        
,treatment of active ingredients for    
topical administration ,section #eje;,g 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 is
 amended by adding at the end the       
following3  7r7 ,evidence and testing   

standards for active ingredients for    
topical administration  7#a7 ,evidence  
and testing standards for active        
ingredients for topical administration  
,the ,secretary shall-- 7,a7 in         
evaluating the generally recognized as  
safe and effective status of active     
ingredients used in nonprescription     
drugs intended for topical              
administration for purposes of          
subsection 7a71 utilize standards that  
allow for the use of real world evidence
 7as defined in section #eje;,f7b771 as 
appropriate1 as part of a comprehensive 
evaluation of scientific evidence to    
demonstrate the safety and effectiveness
 of such active ingredients1 to         
supplement evidence from traditional    
clinical trials1 provided that such     
standards allow the ,secretary to       
evaluate whether the benefits of such   
active ingredients outweigh the risks2  
and  7,b7 apply subsection 7b77#f77;,c7 
to the regulation of active ingredients 
used in drugs intended for topical      

administration4  7#b7 ,non-animal       
testing methods for topical active      
ingredients  7,a7 ,in general ,the      
,secretary shall consider the types of  
nonclinical tests described in          
paragraphs 7#a7 through 7#d7 of the     
first subsection 7z7 of section #eje 7as
 inserted by section #cbji7;a77#b7 of   
the ,health ,extenders1 ,improving      
,access to ,medicare1 ,medicaid1 and    
,,chip1 and ,strengthening ,public      
,health ,act of #bjbb 7division ,,ff of 
,public ,law #aag-cbh771 or any other   
alternative to animal testing that the  
,secretary determines appropriate1 in   
the consideration of drugs intended for 
topical administration under this       
section4  7,b7 ,guidance ,not later than
 #a year after the date of enactment of 
this subsection1 the ,secretary shall   
issue new draft guidance on how sponsors
 can use nonclinical testing            
alternatives to animal testing1 as      
appropriate1 to meet safety and efficacy
 standards under this section for drugs 

intended for topical administration4    
7#c7 ,clarification ,nothing in this    
subsection shall be construed to alter1 
supersede1 or limit the standards for   
making determinations of whether a drug 
is generally recognized as safe and     
effective under section #bja7p7 or the  
standards set forth under section #eje  
for determining the safety and          
effectiveness of drugs4  4  #c4         
,sunscreen final administrative order ,a
 final administrative order on          
nonprescription sunscreen active        
ingredients issued under section #ched  
of the ,coronavirus ,aid1 ,relief1 and  
,economic ,security ,act 7,public ,law  
#aaf-acf2 #ba ,u4,s4,c4 #cfj;fff-#c     
note7 shall-- 7#a7 account for          
historical data regarding the safety of 
sunscreen active ingredients that have  
previously been accepted for marketing  
in the ,united ,states2  7#b7 account   
for the role of broad spectrum          
sunscreens with a ,sun ,protection      
,factor of #ae or higher in effective   

skin cancer prevention2 and  7#c7       
incorporate the evidence and testing    
standards for sunscreen active          
ingredients detailed in section         
#eje;,g7r7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cee;h7 7as added by section #b74  #d4  
,reporting and transparency  7a7 ,in    
general ,the ,secretary of ,health and  
,human ,services 7in this section       
referred to as the ,secretary7 shall1   
not later than #ah months after the date
 of enactment of this ,act and annually 
for #e years thereafter1 submit to the  
,committee on ,energy and ,commerce of  
the ,house of ,representatives and the  
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate a  
report describing1 in compliance with   
section #eje;,g7d7 of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee;h7d77-- 7#a7 the status  
of implementation of evidence and       
testing standards for nonprescription   
drugs intended for topical              

administration1 including-- 7,a7 the    
application of evidence or testing      
standards made under section #eje;,g7r7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7   
7as added by section #b72 and  7,b7 the 
number of sunscreen active ingredient   
requests reviewed using the standards   
under such section #eje;,g7b72 and  7#b7
 the progress of the ,food and ,drug    
,administration in allowing nonclinical 
testing alternatives to animal testing  
for the consideration of sunscreen      
active ingredients4  7b7 ,publication   
,not later than #g days after the date  
on which the ,secretary submits a report
 under subsection 7a71 the ,secretary   
shall publish such report on the website
 of the ,food and ,drug ,administration4