,i #aaith ,,congress #ast ,session ,h4 ,r4 #cfhf ,,in ,,the ,,house ,,of ,,representatives ,june #c1 #bjbe,mr4 ,joyce of ,pennsylvania 7for himself1 ,mrs4 ,dingell1 ,mr4 ,joyce of ,ohio1 and ,ms4 ,ross7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,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 sunscreen active ingredients1 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 ,findings ,congress finds the following3 7#a7 ,skin cancer is the most common cancer in the ,united ,states4 7#b7 ,more people are diagnosed with skin cancer each year in the ,united ,states than all other cancers combined4 7#c7 ,the ,united ,states ,surgeon ,general issued a ,call to ,action to ,prevent ,skin ,cancer in #bjad based on finding that nearly #e1jjj1jjj ,americans are treated for skin cancer each year at a cost that exceeds #h1ajj1jjj1jjj4 7#d7 ,it is estimated that the number of new melanoma cases diagnosed in #bjbd will increase by #g4c percent1 with an estimated #bjj1cdj cases of melanoma diagnosed4 7#e7 ,skin cancer is a deadly disease1 and it is expected that there will be #h1bij deaths from melanoma in #bjbd4 7#f7 ,skin cancer affects individuals of all ages1 and melanoma is one of the most common cancers in young adults4 7#g7 ,in the ,united ,states1 more than #i1ejj people are diagnosed with skin cancer every day and more than #b people die of the disease every hour4 7#h7 ,according to the ,world ,health ,organization 7,,who71 #d out of #e cases of skin cancer can be prevented by adopting sun-safe practices4 7#i7 ,according to the ,environmental ,protection ,agency 7,,epa71 the ,ultraviolet 7,,uv7 ,index in the ,united ,states continues to rise1 increasing the risk of melanoma and other skin cancers for ,americans4 7#aj7 ,the ,,epa recommends ,americans ,use a broad spectrum sunscreen with a ,sun ,protection ,factor 7,,spf7 of at least #cj to protect against the risks of a rising ,,uv ,index4 7#aa7 ,congress unanimously passed the ,sunscreen ,innovation ,act in #bjad to streamline the approval process for sunscreen active ingredients to improve access to new sunscreens1 but no new sunscreen active ingredients have been approved through the ,food and ,drug ,administration's over-the-counter approval process since #aiii4 #c4 ,regulations establishing requirements for sunscreen active ingredients ,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 ,regulations establishing requirements for sunscreen active ingredients 7#a7 ,evidence and testing standards for sunscreen active ingredients ,the ,secretary shall establish1 through guidance or regulation1 standards for evaluating the safety and efficacy of sunscreen active ingredients1 provided that such standards-- 7,a7 ensure the safety of consumers based on a comprehensive evaluation of scientific evidence2 7,b7 allow for the use of real-world evidence 7as defined in section #eje;,f7b771 observational studies1 and other scientifically valid approaches in place of1 or to supplement1 traditional clinical tests to demonstrate safety and effectiveness2 and 7,c7 apply subsection 7b77#f77;,c7 to the regulation of sunscreen active ingredients in demonstrating a prima facie safe nonprescription marketing and use4 7#b7 ,non-animal testing methods for sunscreen 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 deems appropriate1 in the consideration of sunscreen active ingredients4 7,b7 ,guidance ,not later than #ahj days after the date of enactment of this subsection1 the ,secretary shall issue new guidance on how sponsors can use nonclinical testing alternatives to animal testing to meet safety and efficacy standards for sunscreen active ingredients4 4 #d4 ,sunscreen final administrative order ,the final administrative order on pending over-the-counter sunscreen active ingredient submissions 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 demonstrating safe use of sunscreen active ingredients that have previously been accepted for marketing in the ,united ,states2 7#b7 emphasize that sunscreen is an effective skin cancer prevention tool2 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 #c74 #e4 ,reporting and transparency 7a7 ,to ,congress ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall1 beginning not later than #a year after the date of enactment of this ,act1 annually 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 describing-- 7#a7 the status of implementation of evidence and testing standards for sunscreen active ingredients1 including-- 7,a7 any adjustments to 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 #c72 and 7,b7 the number and types of sunscreen active ingredient applications reviewed using the standards under such section #eje;,g7r72 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