,i #aacth ,,congress #b;d ,session ,h4 ,r4 #dbej ,,in ,,the ,,house ,,of ,,representatives ,march #ac1 #bjad ,mr4 ,whitfield 7for himself and ,mr4 ,dingell7 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 provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,sunscreen ,innovation ,act4 #b4 ,regulation of nonprescription sunscreen active ingredients ,subchapter ,a of chapter ,v 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,procedures for classifying sunscreen active ingredients 7a7 ,in general ,the ,secretary shall review and determine whether nonprescription sunscreen conditions are generally recognized as safe and effective and shall ensure that any such conditions that are marketed in the ,united ,states are appropriately labeled4 7b7 ,definitions 7#a7 ,active ingredient ,the term active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis1 cure1 mitigation1 treatment1 or prevention of disease1 or to affect the structure or function of the body of humans or animals4 ,the term includes components that may undergo chemical change in the manufacture of a drug and may be present in a drug in a modified form intended to furnish the specified activity or effect4 7#b7 ,sunscreen active ingredient ,the term sunscreen active ingredient means an active ingredient that absorbs1 reflects1 or scatters radiation in the ultraviolet range at wavelengths from #bij to #djj nanometers4 7#c7 ,sunscreen condition ,the term sunscreen condition means a sunscreen active ingredient 7or a combination of sunscreen active ingredients71 dosage form1 dosage strength1 or route of administration1 marketed for a specific nonprescription use4 7c7 ,criteria for eligibility ,to be eligible for review under this section1 a sunscreen condition shall-- 7#a7 not be included in the stayed sunscreen monograph2 and 7#b7 have been marketed as a nonprescription sunscreen condition in the ,united ,states or at least #a other country1 or marketed as a cosmetic or dietary supplement in #a or more counties other than the ,united ,states-- 7,a7 for a minimum of #e continuous years2 and 7,b7 in sufficient quantity1 as determined by the ,secretary based upon the information submitted under subparagraphs 7,d7 and 7,e7 of subsection 7d77#a7 and1 if applicable1 subsection 7d77#b77;,a77ii74 7d7 ,application for eligibility 7#a7 ,in general ,a sponsor of a nonprescription sunscreen condition described in subsection 7c7 desiring to market such condition in the ,united ,states may submit an application to the ,secretary1 in such manner and containing such information as required by the ,secretary1 including the following3 7,a7 ,basic information about the sunscreen condition 7including a description of each active ingredient1 pharmacologic class1 intended nonprescription use1 nonprescription strength and dosage form1 route of administration1 and directions for use74 7,b7 ,a detailed chemical description of the sunscreen active ingredient that includes a full description of the drug substance1 including its physical and chemical characteristics1 the method of synthesis 7or isolation7 and purification of the drug substance1 and any specifications and analytical methods necessary to ensure the identity1 strength1 quality1 and purity of the drug substance1 including reference to the current edition of the official ,national ,formulary1 the ,united ,states ,pharmacopeia1 or foreign compendiums1 where applicable4 7,c7 ,a list of each country in which the sunscreen condition has been marketed4 7,d7 ,the cumulative total number of dosage units sold for each dosage form of the sunscreen condition1 including total weight of the active ingredient1 package size for each dosage form in which the condition is marketed as nonprescription1 and an estimate of the minimum number of potential consumer exposures to the condition4 7,e7 ,the use pattern 7according to the label7 for each country in which the sunscreen condition is marketed and any changes in use pattern that have occurred over time4 7,f7 ,a list of all countries in which the sunscreen condition has been withdrawn from marketing or in which an application for nonprescription marketing approval has been denied and an explanation for such withdrawal or application denial4 7#b7 ,sunscreen conditions that have not been marketed in the ,united ,states for #e continuous years 7,a7 ,in general ,in the case of an application with respect to a nonprescription sunscreen condition that has not been marketed in the ,united ,states for #e continuous years1 in addition to the information required under paragraph 7#a71 the sponsor shall submit the following information for each country in which the sunscreen condition has been marketed3 7i7 ,the manner in which the sunscreen condition has been marketed to consumers4 ,if the sunscreen condition is marketed to consumers as a nonprescription pharmacy only condition1 the ,secretary may require supplemental information4 7ii7 ,a description of the population demographics and the source from which this information has been compiled1 to ensure that the sunscreen condition's use can be reasonably extrapolated to the population of the ,united ,states4 7iii7 ,a description of the country's system for identifying adverse drug experiences1 especially those found in nonprescription marketing experience1 including method of collection if applicable4 7iv7 ,a statement of how long the sunscreen condition has been marketed in each country and how long the current product labeling has been in use1 accompanied by a copy of the current product labeling1 including a translation into ,english of any labeling that is not in ,english1 and a statement of whether the current product labeling has been authorized1 accepted1 or approved by a regulatory body in each country where the condition is marketed4 7v7 ,a list of all countries where the sunscreen condition is marketed as a prescription drug only and an explanation for such restriction4 7,b7 ,sunscreen conditions that have been marketed in more than #e countries 7i7 ,in general ,in the case of a sunscreen condition that has been marketed as a nonprescription sunscreen in more than #e countries1 with a minimum of #e continuous years of marketing in at least one such country1 the sponsor-- 7,i7 may submit information in accordance with clauses 7i7 through 7iv7 of subparagraph 7,a7 with respect to only #e such countries1 including-- 7aa7 the country with a minimum of #e continuous years of nonprescription marketing2 7bb7 the country with the longest duration of marketing2 and 7cc7 the country with the most support for marketing1 such as a large volume of sales with cultural diversity among users of the product2 and 7,,ii7 shall explain the basis for the countries selected under subclause 7,i72 and 7,,iii7 shall provide information from more than #e countries if such information is needed to support the application4 7ii7 ,requirement ,if the sunscreen condition meets the criteria under items 7aa7 through 7cc7 of clause 7i77,i7 in #a or more countries listed in section #hjb7;b77#a77;,a71 at least #a such country shall be included among the #e countries selected under such clause 7i77,i74 7#c7 ,pending applications ,the requirements of this subsection shall not apply to a sunscreen condition deemed eligible for review of safety and effectiveness by publication of a notice of eligibility in the ,federal ,register prior to the date of enactment of the ,sunscreen ,innovation ,act4 ,applications for such sunscreen conditions shall be considered in accordance with subsection 7g74 7e7 ,public availability ,if a condition is found eligible under subsection 7d71 the ,secretary shall make the application publicly available1 with redactions for confidential commercial information or trade secret information1 and any other information exempt from disclosure pursuant to section #aije of title #ah1 ,united ,states ,code1 section #eeb7;b7 of title #e1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 ,applications shall remain confidential during the ,secretary's consideration of eligibility4 7f7 ,new sunscreen condition application 7#a7 ,eligibility determination ,not later than #fj days after the submission of an eligibility application under subsection 7d71 the ,secretary shall determine if the sunscreen condition is eligible for further review for safety and effectiveness4 ,in the case of a sunscreen condition determined to be eligible1 the ,secretary shall publish a notice of eligibility in the ,federal ,register1 and provide interested persons an opportunity to submit published and unpublished data related to the safety and effectiveness of the sunscreen condition for its intended nonprescription uses1 in accordance with paragraph 7#b74 ,in the case of a sunscreen condition determined not eligible1 the ,secretary shall issue a letter to the sponsor1 which shall be made publicly available4 7#b7 ,safety and effectiveness data submissions 7,a7 ,in general ,within #fj days of the publication in the ,federal ,register of an application deemed eligible1 as described in paragraph 7#a71 the sponsor and other interested parties shall submit safety and effectiveness data to the ,secretary for further review1 as described in subparagraph 7,b74 7,b7 ,required submissions regarding data ,submissions under this paragraph shall include the following3 7i7 ,human safety data 7,i7 ,individual active components ,with respect to individual active components1 controlled studies1 partially controlled or uncontrolled studies1 documented case reports1 pertinent marketing experiences that may influence a determination as to the safety of each individual active component1 and pertinent medical and scientific literature4 7,,ii7 ,combinations of individual active components ,with respect to combinations of the individual active components1 controlled studies1 partially controlled or uncontrolled studies1 documented case reports1 pertinent marketing experiences that may influence a determination as to the safety of combinations of the individual active component1 and pertinent medical and scientific literature4 7ii7 ,efficacy data 7,i7 ,individual active components ,with respect to individual active components1 controlled studies1 partially controlled or uncontrolled studies1 documented case reports1 pertinent marketing experiences that may influence a determination on the efficacy of each individual active component1 pertinent medical and scientific literature4 7,,ii7 ,combinations of individual active components ,with respect to combinations of the individual active components1 controlled studies1 partially controlled or uncontrolled studies1 documented case reports1 pertinent marketing experiences that may influence a determination on the efficacy of combinations of the individual active components1 and pertinent medical and scientific literature4 7iii7 ,data setting forth medical rationale and purpose ,a summary of the data and views setting forth the medical rationale and purpose 7or lack thereof7 for the sunscreen condition and the scientific basis 7or lack thereof7 for the conclusion that the condition has been proven safe and effective for the intended use4 ,if there is an absence of controlled studies in the material submitted1 an explanation as to why such studies are not considered necessary must be included4 7iv7 ,official drug monograph ,an applicable ,united ,states ,pharmacopoeia or ,national ,formulary for the sunscreen active ingredient or a proposed standard for inclusion in an article to be recognized in an official drug monograph for the active ingredient1 including information showing that the official or proposed compendial monograph for the active ingredient is consistent with the active ingredient used in the studies establishing safety and effectiveness and with the active ingredient marketed in the nonprescription product to a material extent and for a material time4 ,if differences exist between the official or proposed compendial monograph for the active ingredient and the active ingredient that is the subject of the application1 sponsor shall explain such differences4 7v7 ,adverse drug experiences ,a list of all serious adverse drug experiences1 as defined by the ,secretary1 from each country where the condition has been or is currently marketed as a prescription drug or as a nonprescription drug or product4 7,c7 ,optional animal safety data ,in addition to the information required under subparagraph 7,b71 the sponsor may submit information with respect to animal safety data1 including controlled studies and partially controlled or uncontrolled studies1 in the case of an application for individual active components1 and controlled studies and partially controlled or uncontrolled studies in the case of an application for combinations of individual active components4 7,d7 ,confidentiality of submissions ,the ,secretary shall make data and information submitted by the sponsor1 or pursuant to a notice requesting safety and effectiveness data published in the ,federal ,register1 publicly available1 with redactions for confidential commercial information or trade secret information1 and any other information exempt from disclosure pursuant to section #aije of title #ah1 ,united ,states ,code1 section #eeb7;b7 of title #e1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 7#c7 ,new sunscreen condition application submission to the advisory committee ,not later than #cj days after the end of the public comment period described in paragraph 7#b71 the ,secretary shall submit the application and the safety and effectiveness data submitted under paragraph 7#b7 to the ,nonprescription ,drugs ,advisory ,committee 7referred to in this section as the advisory committee7 for review4 7g7 ,pending sunscreen condition applications ,not later than #cj days after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall submit to the advisory committee all safety and effectiveness data submitted with respect to each application for review of sunscreen conditions that the ,secretary had determined1 prior to the date of enactment of the ,sunscreen ,innovation ,act1 to be eligible for review of safety and effectiveness and for which the information required under subsection 7f77#b7 has been submitted to the ,secretary prior to such date of enactment4 7h7 ,review and recommendation for nonprescription sunscreen condition 7#a7 ,in general ,the ,secretary shall require the advisory committee to evaluate the safety and effectiveness data submitted in accordance with subsection 7f77#b7 or 7g74 7#b7 ,standards ,in evaluating a nonprescription sunscreen condition under paragraph 7#a71 the advisory committee shall use the regulations in effect at the time of the application1 including regulations with respect to-- 7,a7 the safety of the nonprescription sunscreen condition2 7,b7 the effectiveness of the nonprescription sunscreen condition2 7,c7 the benefit-to-risk ratio of the nonprescription sunscreen condition2 and 7,d7 the labeling of the nonprescription sunscreen condition4 7#c7 ,communications between advisory committee and other individuals who submit data ,the advisory committee shall have the authority to communicate with the sponsor and other individuals who submit data during the advisory committee's review1 including requesting clarification or additional information4 7#d7 ,recommendations 7,a7 ,in general ,for each such submission under subsection 7f77#c7 or 7g71 the advisory committee shall make one of the following recommendations to the ,secretary3 7i7 ,the sunscreen condition is generally recognized as safe and effective 7including any or all indications71 including nonprescription sunscreen conditions for which a new drug application has been approved by the ,secretary4 7ii7 ,insufficient information has been provided to support a recommendation that the sunscreen condition is generally recognized as safe and effective 7including any or all indications74 7iii7 ,the sunscreen condition is not generally recognized as safe and effective to be marketed or sold unless an application with respect to such condition is approved under section #eje7;b74 7,b7 ,timing ,the advisory committee shall make a recommendation under subparagraph 7,a7 not later than #ahj days after the advisory committee receives the application and data submitted under subsection 7f77#c7 or subsection 7g74 7,c7 ,resubmission of data ,if the advisory committee recommends that insufficient information has been provided1 in accordance with subparagraph 7,a77ii71 the advisory committee shall make such recommendation not later than #ahj days after the date on which such additional information is submitted4 7i7 ,determination by the ,center for ,drug ,evaluation and ,research 7#a7 ,in general ,the ,center for ,drug ,evaluation and ,research shall respond to the recommendations of the advisory committee under subsection 7h77#d7 as follows3 7,a7 ,in the case of a recommendation by the advisory committee described in clause 7i7 of subsection 7h77#d71 not later than #de days after the advisory committee issues the recommendation1 the ,center for ,drug ,evaluation and ,research shall issue a determination affirming or denying the recommendation of the advisory committee4 ,if the ,center for ,drug ,evaluation and ,research affirms the recommendation of the advisory committee1 or if the ,center for ,drug ,evaluation and ,research takes no action regarding the recommendation within #de days of receiving such recommendation1 the nonprescription sunscreen condition shall be generally recognized as safe and effective1 not misbranded1 and permitted to be marketed and sold in accordance with all applicable rules and regulations for over-the-counter drugs4 7,b7 ,in the case of a recommendation described in clause 7ii7 of such subsection1 the ,center for ,drug ,evaluation and ,research shall issue a determination affirming or denying the recommendation of the advisory committee1 to be made publicly available1 within #de days of receiving the recommendation1 and inform the sponsor that the sponsor must submit additional information to the advisory committee in order to continue the review by the advisory committee4 7,c7 ,in the case of a recommendation described in clause 7iii7 of such subsection1 the ,center for ,drug ,evaluation and ,research shall issue a determination affirming or denying the recommendation of the advisory committee1 to be made publicly available1 within #de days of receiving such recommendation1 and indicate whether such sunscreen condition determined to be not generally recognized as safe and effective to be marketed and sold unless an application with respect to such condition is approved under section #eje7;b71 or whether additional data must be submitted to the advisory committee4 7#b7 ,supervisory review of determination 7,a7 ,in general ,any person may request a supervisory review of a determination of the ,center for ,drug ,evaluation and ,research to not accept a recommendation of an advisory committee4 ,such review may be conducted at the next supervisory or higher level above the individual who made the determination4 7,b7 ,request for supervisory review ,a request described in subparagraph 7,a7 shall be made to the ,secretary not later than #cj days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference4 ,the ,secretary shall schedule an in-person or teleconference review1 if so requested1 not later than #cj days after such request is made4 ,the ,secretary shall issue a decision to the person requesting a review under this paragraph not later than #de days after the meeting4 7,c7 ,standard of supervisory review ,the ,secretary shall be authorized to overturn a determination of the ,center for ,drug ,evaluation and ,research not to accept a recommendation of the advisory committee if the supervisory review results in a decision by the reviewer that the individual who made the determination did not provide reasonable and sufficient substantive support for the decision to disregard the advisory committee's recommendation4 7,d7 ,supervisory review decision ,if the ,secretary overturns a determination by the ,center for ,drug ,evaluation and ,research not to accept a favorable recommendation of an advisory committee1 the nonprescription sunscreen condition shall be generally recognized as safe and effective1 not misbranded1 and permitted to be marketed and sold in accordance with all applicable rules and regulations for over-the-counter drugs4 7,e7 ,final agency action ,a decision made through supervisory review shall constitute final agency action subject to judicial review4 7j7 ,reports 7#a7 ,in general ,not later than #a year after the date of enactment of the ,sunscreen ,innovation ,act1 on ,march #a1 #bjae1 and every #b years thereafter1 the ,secretary shall issue a report to ,congress describing actions taken under this section4 7#b7 ,contents ,the reports under paragraph 7#a7 shall include-- 7,a7 a review of the progress made in issuing in a timely manner decisions on the safety and effectiveness for sunscreen conditions for applications pending as of the date of enactment of the ,sunscreen ,innovation ,act1 including the number of pending applications-- 7i7 reviewed and the decision times for each application1 measured from the date of original eligibility application submission by the sponsor2 7ii7 resulting in a determination of generally recognized as safe and effective and not misbranded2 7iii7 resulting in a determination of not generally recognized as safe and effective and not misbranded and the reasons for such determinations2 and 7iv7 for which a determination has not been made1 an explanation for the delay1 a description of the current status of each such application1 and the length of time such applications have been pending1 measured from the date of original eligibility application submission by the sponsor2 7,b7 a review of the progress made in issuing in a timely manner a decision on safety and effectiveness for sunscreen condition applications submitted after the date of enactment of the ,sunscreen ,innovation ,act1 including the number of such applications-- 7i7 reviewed and the decision times for each application2 7ii7 resulting in a determination of generally recognized as safe and effective and not misbranded2 and 7iii7 resulting in a determination of not generally recognized as safe and effective and not misbranded and the reasons for such determinations2 7,c7 a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications2 7,d7 a review of the progress in meeting the deadlines with respect to processing applications under this section2 7,e7 to the extent the ,secretary determines appropriate1 recommendations for process improvements in the handling of pending and new applications2 and 7,f7 recommendations for expanding the applicability of this section to nonprescription active ingredients or conditions that are not related to the sunscreen category of over-the-counter drugs4 7#c7 ,method ,the ,secretary shall publish the reports required under this subsection in the manner the ,secretary determines to be the most effective for efficiently disseminating the report1 including publication of the report on the ,internet website of the ,food and ,drug ,administration4 7k7 ,rules of construction 7#a7 ,authority to withdraw or suspend ,nothing in this section shall be construed to alter the ,secretary's authority to withdraw or suspend from the market a drug that the ,secretary determines to be unsafe or ineffective4 7#b7 ,other conditions ,nothing in the section shall affect the ,secretary's authority to review nonprescription conditions other than sunscreen conditions4 4 #c4 ,sunscreen testing and labeling ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall issue determinations with respect to-- 7#a7 the appropriate testing and labeling requirements for sunscreens sold as an aerosol2 and 7#b7 whether sunscreen may contain a label indicating a sun protection factor greater than #ej4