,,ii ,calendar ,no4 #efh #aacth ,,congress #b;d ,session ,s4 #bada ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ac1 #bjad,mr4 ,reed 7for himself1 ,mr4 ,isakson1 ,mr4 ,coons1 ,mr4 ,brown1 ,mr4 ,carper1 ,mr4 ,portman1 ,ms4 ,ayotte1 ,mr4 ,roberts1 ,mr4 ,kirk1 ,ms4 ,warren1 ,mr4 ,mc,connell1 ,ms4 ,landrieu1 ,mr4 ,paul1 ,mr4 ,scott1 ,mr4 ,schumer1 ,mrs4 ,hagan1 ,mr4 ,harkin1 ,mr4 ,alexander1 ,mr4 ,burr1 and ,mr4 ,booker7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,september #ag 7legislative day1 ,september #af71 #bjad,reported by ,mr4 ,harkin1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,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 sold1 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 sold1 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 #a4 ,short title ,this ,act may be cited as the ,sunscreen ,innovation ,act4 #b4 ,regulation of nonprescription sunscreen active ingredients 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 ,i ,nonprescription sunscreen and other active ingredients #ehf4 ,definitions ,in this subchapter-- 7#a7 the term ,advisory ,committee means the ,nonprescription ,drug ,advisory ,committee of the ,food and ,drug ,administration or any successor to such ,committee2 7#b7 the term final sunscreen order means an order published by the ,secretary in the ,federal ,register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients-- 7,a7 is ,,grase and is not misbranded if marketed in accordance with such order2 or 7,b7 is not ,,grase and is misbranded2 7#c7 the term ,,grase means generally recognized1 among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs1 as safe and effective for use under the conditions prescribed1 recommended1 or suggested in the labeling of a drug as described in section #bja7p72 7#d7 the term ,,grase determination means1 with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients1 a determination of whether such ingredient or combination of ingredients is ,,grase2 7#e7 the term nonprescription means not subject to section #ejc7;b77#a72 7#f7 the term pending request means each request with respect to a nonprescription sunscreen active ingredient submitted under section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,sunscreen ,innovation ,act7 for consideration for inclusion in the over-the-counter drug monograph system-- 7,a7 that was determined to be eligible for such review by publication of a notice of eligibility in the ,federal ,register prior to the date of enactment of such ,act2 and 7,b7 for which safety and effectiveness data have been submitted to the ,secretary prior to such date of enactment2 7#g7 the term proposed sunscreen order means an order containing a tentative determination published by the ,secretary in the ,federal ,register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients-- 7,a7 is ,,grase and is not misbranded if marketed in accordance with such order2 7,b7 is not ,,grase and is misbranded2 or 7,c7 is not ,,grase and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as ,,grase and not misbranded and additional information is necessary to allow the ,secretary to determine otherwise2 7#h7 the term sponsor means the person that submitted-- 7,a7 a request under section #ehf;,a2 7,b7 a pending request2 or 7,c7 any other application subject to this subchapter2 7#i7 the term sunscreen means a drug containing one or more sunscreen active ingredients2 and 7#aj7 the term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing1 reflecting1 or scattering ultraviolet radiation4 #ehf;,a4 ,submission of requests ,any person may submit a request to the ,secretary for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients1 for use under specified conditions1 to be prescribed1 recommended1 or suggested in the labeling thereof 7including dosage form1 dosage strength1 and route of administration7 is ,,grase and should be included in part #ceb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 concerning nonprescription sunscreen4 #ehf;,b4 ,eligibility determinations2 data submission2 filing 7a7 ,eligibility determinations 7#a7 ,in general ,not later than #fj calendar days after the date of receipt of a request under section #ehf;,a1 the ,secretary shall-- 7,a7 determine1 in accordance with paragraph 7#b71 whether the request is eligible for further review under subsection 7b7 and section #ehf;,c2 7,b7 notify the sponsor of the determination of the ,secretary2 and 7,c7 make such determination publicly available in accordance with paragraph 7#c7 and subsection 7b77#a74 7#b7 ,criteria for eligibility 7,a7 ,in general ,to be eligible for review under subsection 7b7 and section #ehf;,c1 a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients1 for use under specified conditions1 to be prescribed1 recommended1 or suggested in the labeling thereof1 that-- 7i7 is not included in part #ceb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 concerning nonprescription sunscreen2 and 7ii7 has been used to a material extent and for a material time under such conditions1 as described in section #bja7p77#b74 7,b7 ,establishment of time and extent ,a sponsor shall include in a request under section #ehf;,a the information required under section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 to meet the standard described in subparagraph 7,a77ii74 7#c7 ,public availability 7,a7 ,redactions for confidential information ,if a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is determined under paragraph 7#a77;,a7 to be eligible for further review1 the ,secretary shall make the request publicly available1 with redactions for information that is treated as confidential under section #eeb7;b7 of title #e1 ,united ,states ,code1 section #aije of title #ah1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 7,b7 ,identification of confidential information by sponsor ,at the time that a request is made under section #ehf;,a1 the sponsor of such request shall identify any information that such sponsor considers to be confidential information described in subparagraph 7,a74 7,c7 ,confidentiality during eligibility review ,the information contained in a request under section #ehf;,a shall remain confidential during the ,secretary's consideration under this section of whether the request is eligible for further review consistent with section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7b7 ,data submission and filing of requests 7#a7 ,in general ,in the case of a request under section #ehf;,a that is determined to be eligible under subsection 7a7 for further review under this section and section #ehf;,c1 the ,secretary shall1 in notifying the public under subsection 7a77#a77;,c7 of such eligibility determination1 post the eligibility determination on the ,internet website of the ,food and ,drug ,administration1 invite the sponsor of such request and any other interested party to submit comments1 and provide a period of not less than #de calendar days for comments in support of or otherwise relating to a ,,grase determination1 including published and unpublished data and other information related to the safety and efficacy of such request4 7#b7 ,filing determination ,not later than #fj calendar days after the submission of data and other information described in paragraph 7#a7 by the sponsor1 the ,secretary shall determine whether the data and other information submitted by the sponsor under this section are sufficiently complete1 including being formatted in a manner that enables the ,secretary to determine the completeness of such data and information1 to enable the ,secretary to conduct a substantive review under section #ehf;,c with respect to such request4 ,not later than #fj calendar days after the submission of data and other information described in paragraph 7#a7 by the sponsor1 if the ,secretary determines-- 7,a7 that such data and other information are sufficiently complete1 the ,secretary shall-- 7i7 issue a written notification to the sponsor of the determination to file such request1 and make such notification publicly available2 and 7ii7 file such request made under section #ehf;,a2 or 7,b7 that such data and other information are not sufficiently complete1 the ,secretary shall issue a written notification to the sponsor of the determination to refuse to file the request1 which shall include the reasons for the refusal1 including why such data and other information are not sufficiently complete1 and make such notification publicly available4 7#c7 ,refusal to file a request 7,a7 ,request for meetings2 submission of additional data or other information ,if the ,secretary refuses to file a request made under section #ehf;,a1 the sponsor may-- 7i7 within #cj calendar days of receipt of written notification of such refusal1 request1 in writing1 a meeting with the ,secretary regarding the filing determination2 and 7ii7 submit additional data or other information4 7,b7 ,meetings 7i7 ,in general ,if a sponsor seeks a meeting under subparagraph 7,a77i71 the ,secretary shall convene the meeting within #cj calendar days of the request for such meeting4 7ii7 ,actions after meeting ,following any meeting held under clause 7i7-- 7,i7 the ,secretary may file the request within #fj calendar days2 7,,ii7 the sponsor may submit additional data or other information2 or 7,,iii7 if the sponsor elects1 within #abj calendar days1 to have the ,secretary file the request 7with or without amendments to correct any purported deficiencies to the request7-- 7aa7 the ,secretary shall file the request over protest1 not later than #cj calendar days after the sponsor makes such election2 7bb7 at the time of filing1 the ,secretary shall provide written notification of such filing to the sponsor2 and 7cc7 the ,secretary shall make such notification publicly available4 7iii7 ,requests filed over protest ,the ,secretary shall not require the sponsor to resubmit a copy of the request for purposes of filing a request filed over protest1 as described in clause 7ii77,,iii74 7,c7 ,submissions of additional data or other information ,within #fj calendar days of any submission of additional data or other information under subparagraph 7,a77ii7 or 7,b77ii77,,ii71 the ,secretary shall reconsider the previous determination made under paragraph 7#b7 with respect to the applicable request and make a new determination in accordance with paragraph 7#b74 7#d7 ,public availability 7,a7 ,redactions for confidential information ,after the period of confidentiality described in subsection 7a77#c77;,c71 the ,secretary shall make data and other information submitted in connection with a request under section #ehf;,a publicly available1 with redactions for information that is treated as confidential under section #eeb7;b7 of title #e1 ,united ,states ,code1 section #aije of title #ah1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 7,b7 ,identification of confidential information by sponsor ,a person submitting information under this section shall identify at the time of such submission the portions of such information that the person considers to be confidential information described in subparagraph 7,a74 #ehf;,c4 ,,grase determination 7a7 ,review of new request 7#a7 ,proposed sunscreen order ,in the case of a request under section #ehf;,a1 not later than #cjj calendar days after the date on which such request is filed under subsection 7b77#b77;,a7 or 7b77#c77;,b77ii77,,iii7 of section #ehf;,b1 the ,secretary-- 7,a7 may convene a meeting of the ,advisory ,committee to review such request2 and 7,b7 shall complete the review of such request and issue a proposed sunscreen order with respect to such request4 7#b7 ,proposed sunscreen order by ,commissioner ,if the ,secretary does not issue a proposed sunscreen order under paragraph 7#a77;,b7 within such #cjj-;day period1 the sponsor of such request may notify the ,office of the ,commissioner of such request and request review by the ,office of the ,commissioner4 ,if such sponsor so notifies the ,office of the ,commissioner1 the ,commissioner shall1 not later than #fj calendar days after the date of notification under this paragraph1 issue a proposed sunscreen order with respect to such request4 7#c7 ,public comment period ,a proposed sunscreen order issued under paragraph 7#a77;,b7 or 7#b7 with respect to a request shall provide for a period of #de calendar days for public comment4 7#d7 ,meeting ,a sponsor may request1 in writing1 a meeting with respect to a proposed sunscreen order issued under this subsection and described in subparagraph 7,b7 or 7,c7 of section #ehf7g71 not later than #cj calendar days after the ,secretary issues such order4 ,the ,secretary shall convene a meeting with such sponsor not later than #de calendar days after such request for a meeting4 7#e7 ,final sunscreen order ,with respect to a proposed sunscreen order under paragraph 7#a77;,b7 or 7#b7-- 7,a7 the ,secretary shall issue a final sunscreen order-- 7i7 in the case of a proposed sunscreen order described in subparagraph 7,a7 or 7,b7 of section #ehf7g71 not later than #ij calendar days after the end of the public comment period under paragraph 7#c72 or 7ii7 in the case of a proposed sunscreen order described in subparagraph 7,c7 of section #ehf7g71 not later than #baj calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order2 or 7,b7 if the ,secretary does not issue such final sunscreen order within such #ij- or #baj-;calendar-day period1 as applicable1 the sponsor of such request may notify the ,office of the ,commissioner of such request and request review by the ,office of the ,commissioner4 7#f7 ,final sunscreen order by ,commissioner ,the ,commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph 7#e77;,b7 not later than #fj calendar days after the date of notification under such paragraph4 7b7 ,review of pending requests 7#a7 ,in general ,the review of a pending request shall be carried out by the ,secretary in accordance with this subsection4 7#b7 ,inapplicability of sections #ehf;,a and #ehf;,b ,sections #ehf;,a and #ehf;,b shall not apply with respect to any pending request4 7#c7 ,feedback letters as proposed sunscreen order ,notwithstanding the requirements of section #ehf7g71 a letter issued pursuant to section #ccj4ad7;g7 of title #ba1 ,code of ,federal ,regulations before the date of enactment of the ,sunscreen ,innovation ,act1 with respect to a pending request1 shall be deemed to be a proposed sunscreen order and displayed on the ,internet website of the ,food and ,drug ,administration4 ,notification of the availability of such letter shall be published in the ,federal ,register not later than #de calendar days after the date of enactment of such ,act4 7#d7 ,proposed sunscreen order ,in the case of a pending request for which the ,secretary has not issued a letter pursuant to section #ccj4ad7;g7 of title #ba1 ,code of ,federal ,regulations before the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall complete review of such request and1 not later than #ij calendar days after the date of enactment of such ,act1 issue a proposed sunscreen order with respect to such request4 7#e7 ,proposed sunscreen order by ,commissioner ,if the ,secretary does not issue a proposed sunscreen order under paragraph 7#d71 or the ,secretary does not publish a notification of the availability of a letter under paragraph 7#c71 as applicable1 the sponsor of such request may notify the ,office of the ,commissioner of such request and request review by the ,office of the ,commissioner4 ,the ,commissioner shall1 not later than #fj calendar days after the date of notification under this paragraph1 issue a proposed order with respect to such request4 7#f7 ,public comment period ,a proposed sunscreen order issued under paragraph 7#d7 or 7#e71 or a notification of the availability of a letter under paragraph 7#c71 with respect to a pending request shall provide for a period of #de calendar days for public comment4 7#g7 ,meeting ,a sponsor may request1 in writing1 a meeting with respect to a proposed sunscreen order issued under this subsection1 including a letter deemed to be a proposed sunscreen order under paragraph 7#c71 not later than #cj calendar days after the ,secretary issues such order or the date upon which such feedback letter is deemed to be a proposed sunscreen order1 as applicable4 ,the ,secretary shall convene a meeting with such sponsor not later than #de calendar days after the date of such request for a meeting4 7#h7 ,advisory committee ,in the case of a proposed sunscreen order under paragraph 7#c71 7#d71 or 7#e71 an ,advisory ,committee meeting may be convened for the purpose of reviewing and providing recommendations regarding the pending request4 7#i7 ,final sunscreen order ,in the case of a proposed sunscreen order under paragraph 7#c71 7#d71 or 7#e7-- 7,a7 the ,secretary shall issue a final sunscreen order with respect to the request-- 7i7 in the case of a proposed sunscreen order described in subparagraph 7,a7 or 7,b7 of section #ehf7g71 not later than #ij calendar days after the end of the public comment period under paragraph 7#f72 or 7ii7 in the case of a proposed sunscreen order described in subparagraph 7,c7 of section #ehf7g7-- 7,i7 if the ,advisory ,committee is not convened under paragraph 7#h71 not later than #baj calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order1 which shall include a rationale for not convening such ,advisory ,committee2 or 7,,ii7 if the ,advisory ,committee is convened under paragraph 7#h71 not later than #bgj calendar days after the date on which the sponsor submits such additional information2 or 7,b7 if the ,secretary does not issue such final sunscreen order within such #ij-1 #baj-1 or #bgj-;calendar-day period1 as applicable1 the sponsor of such request may notify the ,office of the ,commissioner about such request and request review by the ,office of the ,commissioner4 7#aj7 ,final sunscreen order by ,commissioner ,the ,commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph 7#i77;,b7 not later than #fj calendar days after the date of notification under such paragraph4 7c7 ,advisory committee ,the ,secretary shall not be required to-- 7#a7 convene the ,advisory ,committee-- 7,a7 more than once with respect to any request under section #ehf;,a or any pending request2 or 7,b7 more than twice in any calendar year with respect to the review under this section2 or 7#b7 submit more than a total of #c requests under section #ehf;,a or pending requests to the ,advisory ,committee per meeting4 7d7 ,no delegation ,any responsibility vested in the ,commissioner by subsection 7a77#b71 7a77#f71 7b77#e71 or 7b77#aj7 shall not be delegated4 7e7 ,effect of final sunscreen order 7#a7 ,in general 7,a7 ,sunscreen active ingredients determined to be ,,grase ,upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and is not misbranded1 a sunscreen containing such ingredient or combination of ingredients shall be permitted to be introduced or delivered into interstate commerce for use under the conditions described in such final sunscreen order1 in accordance with all requirements applicable to drugs not subject to section #ejc7;b77#a71 for so long as such final sunscreen order remains in effect4 7,b7 ,sunscreen active ingredients determined not to be ,,grase ,upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not ,,grase and is misbranded1 a sunscreen containing such ingredient or combination of ingredients shall not be introduced or delivered into interstate commerce1 for use under the conditions described in such final sunscreen order1 unless an application is approved pursuant to section #eje with respect to a sunscreen containing such ingredient or combination of ingredients1 or unless conditions are later established under which such ingredient or combination of ingredients is later determined to be ,,grase and not misbranded under the over-the-counter drug monograph system4 7#b7 ,amendments to final sunscreen orders 7,a7 ,amendments at initiative of ,secretary ,in the event that information relevant to a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients becomes available to the ,secretary after issuance of a final sunscreen order1 the ,secretary may amend such final sunscreen order by issuing a new proposed sunscreen order under subsection 7a77#a7 and following the procedures set forth in this section4 7,b7 ,petition to amend final order ,any interested person may petition the ,secretary to amend a final sunscreen order under section #aj4cj1 title #ba ,code of ,federal ,regulations 7or any successor regulations74 ,if the ,secretary grants any petition under such section1 the ,secretary shall initiate the process for amending a final sunscreen order by issuing a new proposed sunscreen order under subsection 7a77#a7 and following the procedures set forth in this section4 7,c7 ,applicability of final orders ,once the ,secretary issues a new proposed sunscreen order to amend a final sunscreen order under subparagraph 7,a7 or 7,b71 such final sunscreen order shall remain in effect and paragraph 7#c7 shall not apply to such final sunscreen order until the ,secretary has issued a new final sunscreen order or has determined not to amend the final sunscreen order4 7#c7 ,inclusion of ,ingredients that are subjects of ,final ,orders in the ,sunscreen ,monograph 7,a7 ,amending regulations 7i7 ,requirement ,at any time that the ,secretary proposes to amend part #ceb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 concerning nonprescription sunscreen1 including pursuant to section #ehf;,e1 except as provided in clause 7iv71 the ,secretary shall include in such part #ceb 7or any successor regulations7 any nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of an effective final sunscreen order of the type described in section #ehf7b77;,a7 and issued since the time that the ,secretary last amended such regulations4 ,such regulation shall set forth conditions of use under which each such ingredient or combination of ingredients is ,,grase and not misbranded4 ,if these conditions differ from1 or are in addition to1 those previously set forth in the applicable final sunscreen order1 the ,secretary shall provide notice and opportunity for comment on such conditions in the rulemaking1 and the applicable final sunscreen order shall continue in effect until the effective date of a final regulation1 as set forth in clause 7iii74 7ii7 ,inclusion of orders ,in proposing to amend the regulations as described in clause 7i71 the ,secretary shall include in the proposed regulations a list of final sunscreen orders that shall cease to be effective on the effective date of a resulting final regulation4 ,such list shall include all final sunscreen orders of the type described in section #ehf7b77;,a7 that are in effect on the date that such regulations are proposed1 with the exception that such list shall not include any final sunscreen orders that1 on the date that the regulations are proposed1 the ,secretary is in the process of amending under paragraph 7#b74 7iii7 ,orders no longer effective ,any final sunscreen order included by the ,secretary in a list described in clause 7ii7 and in a list included in resulting final regulations shall cease to be effective on the date that such final regulations including such order in such list become effective4 7iv7 ,ingredients not ,,grase ,if1 notwithstanding a final sunscreen order stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and is not misbranded if marketed in accordance with such order1 while amending the regulations as described in clause 7i71 the ,secretary concludes that such ingredient or combination of ingredients is no longer ,,grase for use in nonprescription sunscreen1 the ,secretary shall1 at the discretion of the ,secretary1 either initiate the process for amending the final sunscreen order set forth in paragraph 7#b7 of this subsection or include in a proposed regulation an explanation and information supporting the determination of the ,secretary that such ingredient or combination of ingredients is no longer ,,grase for use in nonprescription sunscreen4 7,b7 ,procedure for updating regulations ,after the ,secretary amends and finalizes the regulations under part #ceb of title #ba1 ,code of ,federal ,regulations under section #ehf;,e and such regulations become effective1 the ,secretary may use direct final rulemaking to include in such regulations any nonprescription sunscreen active ingredients that are the subject of effective final sunscreen orders4 #ehf;,d4 ,guidance2 other provisions 7a7 ,guidance 7#a7 ,in general 7,a7 ,draft guidance ,not later than #a year after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall issue draft guidance on the implementation of1 and compliance with1 the requirements with respect to sunscreen under this subchapter1 including guidance on-- 7i7 the format and content of information submitted by a sponsor in support of a request under section #ehf;,a or a pending request2 7ii7 the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and is not misbranded2 7iii7 the process by which a request under section #ehf;,a or a pending request is withdrawn2 and 7iv7 the process by which the ,secretary will carry out section #ehf;,c7c71 including with respect to how the ,secretary will address the total number of requests received under section #ehf;,a and pending requests4 7,b7 ,final guidance ,the ,secretary shall finalize the guidance described in subparagraph 7,a7 not later than #b years after the date of enactment of the ,sunscreen ,innovation ,act4 7,c7 ,inapplicability of ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code shall not apply to collections of information made for purposes of guidance under this subsection4 7#b7 ,submissions pending issuance of final guidance ,irrespective of whether final guidance under paragraph 7#a7 has been issued-- 7,a7 persons may1 beginning on the date of enactment of the ,sunscreen ,innovation ,act1 make submissions under this subchapter2 and 7,b7 the ,secretary shall review and act upon such submissions in accordance with this subchapter4 7b7 ,rules of construction 7#a7 ,currently marketed sunscreens ,nothing in this subchapter shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before the date of enactment of this subchapter1 except as otherwise provided in this subchapter4 7#b7 ,ensuring safety and effectiveness ,nothing in this subchapter shall be construed to alter the authority of the ,secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded1 or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness1 except as otherwise provided in this subchapter1 including section #ehf;,c7e74 7#c7 ,other drugs ,except as otherwise provided in section #ehf;,f1 nothing in this subchapter shall be construed to affect the authority of the ,secretary under this ,act or the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 with respect to a drug other than a nonprescription sunscreen4 7#d7 ,effect on drugs otherwise approved ,nothing in this subchapter shall affect the marketing of a drug approved under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7c7 ,timelines ,the timelines for the processes and procedures under paragraphs 7#a71 7#b71 7#e71 and 7#f7 of section #ehf;,c7a7 shall not apply to any requests submitted to the ,secretary under section #ehf;,a after the date that is #f years after the date of enactment of the ,sunscreen ,innovation ,act4 #ehf;,e4 ,sunscreen monograph 7a7 ,in general ,not later than #e years after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall amend and finalize regulations under part #ceb of title #ba1 ,code of ,federal ,regulations concerning nonprescription sunscreen that are effective not later than #e years after such date of enactment4 ,the ,secretary shall publish such regulations not less than #cj calendar days before the effective date of such regulations4 7b7 ,reports ,if the regulations promulgated under subsection 7a7 do not include provisions related to the effectiveness of various sun protection factor levels1 and do not address all dosage forms known to the ,secretary to be used in sunscreens marketed in the ,united ,states without a new drug approval under section #eje1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the rationale for such provisions not being included in such regulations1 and a plan and timeline to compile any information necessary to address such provisions through final regulations4 4 7b7 ,rules of construction ,nothing in the amendment made by this section shall be construed to-- 7#a7 limit the right of a sponsor 7as defined in section #ehf7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a77 to request that the ,secretary of ,health and ,human ,services convene an advisory committee2 or 7#b7 limit the authority of the ,secretary of ,health and ,human ,services to meet with a sponsor 7as defined in section #ehf7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a774 #c4 ,non-sunscreen time and extent applications ,subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b1 is amended by adding at the end the following3 #ehf;,f4 ,non-sunscreen time and extent applications 7a7 ,pending time and extent applications 7#a7 ,in general 7,a7 ,request for framework for review ,if1 prior to the date of enactment of the ,sunscreen ,innovation ,act1 an application was submitted pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations for a ,,grase determination for a drug other than a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients and such drug was found to be eligible to be considered for inclusion in the over-the-counter drug monograph system pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 the sponsor of such application may request that the ,secretary provide a framework under paragraph 7#b7 for the review of such application4 7,b7 ,request requirements ,a request for a framework for review of an application made under subparagraph 7,a7 shall be made within #ahj calendar days of the date of enactment of the ,sunscreen ,innovation ,act and shall include the preference of such sponsor as to whether such application is reviewed by the ,secretary in accordance with-- 7i7 the processes and procedures set forth for pending requests under section #ehf;,c7b71 except that specific timelines shall be determined in accordance with other applicable requirements under this section2 7ii7 the processes and procedures set forth under part #ccj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7iii7 an initial filing determination under the processes and procedures described in section #ehf;,b7b7 and the processes and procedures set forth for pending requests under section #ehf;,c7b71 except that specific timelines shall be determined in accordance with other applicable requirements under this section2 or 7iv7 an initial filing determination under the processes and procedures described in section #ehf;,b7b7 and the processes and procedures set forth under part #ccj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,c7 ,no request ,if a sponsor described in subparagraph 7,a7 does not make such request within #ahj calendar days of the date of enactment of the ,sunscreen ,innovation ,act1 such application shall be reviewed by the ,secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection 7b74 7#b7 ,framework ,not later than #a year after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall provide1 in writing1 a framework to each sponsor that submitted a request under paragraph 7#a74 ,such framework shall set forth the various timelines1 in calendar days1 with respect to the processes and procedures for review under clauses 7i71 7ii71 7iii71 and 7iv7 of paragraph 7#a77;,b7 and-- 7,a7 such timelines shall account for the considerations under paragraph 7#e72 and 7,b7 the timelines for the various processes and procedures shall not be shorter than the timelines set forth for pending requests under sections #ehf;,b7b7 and #ehf;,c7b71 as applicable4 7#c7 ,governing processes and procedures for review 7,a7 ,election ,not later than #fj calendar days after the ,secretary provides a framework to a sponsor under paragraph 7#b71 such sponsor may provide an election to the ,secretary regarding the processes and procedures for review under clause 7i71 7ii71 7iii71 or 7iv7 of paragraph 7#a77;,b74 ,if such sponsor makes such election1 the ,secretary shall review the application that is the subject of such election pursuant to the processes and procedures elected by such sponsor and the applicable timelines in calendar days set forth under such framework1 which the ,secretary shall confirm in writing to the sponsor not later than the date upon which the ,secretary provides a report under paragraph 7#d74 ,if such sponsor does not make such election1 such application shall be reviewed by the ,secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection 7b74 7,b7 ,different processes and procedures ,at any time during review of an application1 the ,secretary may review such application under different processes and procedures under clause 7i71 7ii71 7iii71 or 7iv7 of paragraph 7#a77;,b7 than the processes and procedures the sponsor elected in accordance with subparagraph 7,a71 so long as the ,secretary proposes1 in writing1 the change and the sponsor agrees1 in writing1 to such change4 7,c7 ,inclusion of ingredients in monographs ,if the sponsor elects to use the processes and procedures for review in accordance with clause 7i7 or 7iii7 of paragraph 7#a77;,b71 the ,secretary may incorporate any resulting final order into a regulation addressing the conditions under which other drugs in the same therapeutic category are ,,grase and not misbranded1 including through direct final rulemaking1 and the final order so incorporated shall cease to be effective on the effective date of the final regulation that addresses such drug4 7#d7 ,letter regarding pending applications ,not later than #ah months after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 in writing1 regarding all pending applications subject to paragraph 7#a74 ,in such letter1 the ,secretary shall provide a report on the review of such applications1 including the timelines1 in calendar days1 for the review and ,,grase determination for each application4 ,such timelines shall account for the considerations under paragraph 7#e74 7#e7 ,timelines ,the timelines in calendar days established by the ,secretary pursuant to this subsection-- 7,a7 may vary based on the content1 complexity1 and format of the application submitted to the ,secretary2 and 7,b7 shall-- 7i7 reflect the public health priorities of the ,food and ,drug ,administration1 including the potential public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph system2 7ii7 take into consideration the resources available to the ,secretary for carrying out such priorities and the processes and procedures described in paragraphs 7#a77;,b7 and 7#b72 and 7iii7 be reasonable1 taking into consideration the requirements described in clauses 7i7 and 7ii74 7b7 ,new time and extent applications 7#a7 ,in general ,not later than #ah months after the date of enactment of the ,sunscreen ,innovation ,act1 the ,secretary shall issue proposed regulations establishing timelines for the review of applications for ,,grase determinations for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients that are submitted to the ,secretary after the date of enactment of the ,sunscreen ,innovation ,act1 under section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 and that are found to be eligible to be considered for inclusion in the over-the-counter drug monograph system pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 or that are subject to this subsection pursuant to paragraph 7#a7 or 7#c7 of subsection 7a71 as applicable1 providing-- 7,a7 timely and efficient completion of evaluations of applications under section #ccj4ad of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 for drugs other than sunscreens2 and 7,b7 timely and efficient completion of the review of the safety and effectiveness submissions pursuant to such applications1 including establishing-- 7i7 reasonable timelines1 in calendar days1 for the applicable proposed and final regulations for applications of various content1 complexity1 and format1 and timelines for internal procedures related to such processes2 and 7ii7 measurable metrics for tracking the extent to which the timelines set forth in the regulations are met4 7#b7 ,timelines ,the timelines in calendar days established in the regulations under paragraph 7#a7-- 7,a7 may vary based on the content1 complexity1 and format of the application submitted to the ,secretary2 and 7,b7 shall-- 7i7 reflect the public health priorities of the ,food and ,drug ,administration1 including the potential public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph system2 7ii7 take into consideration the resources available to the ,secretary for carrying out such priorities and the processes and procedures described in paragraph 7#a72 and 7iii7 be reasonable1 taking into consideration the requirements described in clauses 7i7 and 7ii74 7#c7 ,procedure ,in promulgating regulations under this subsection1 the ,secretary shall issue a notice of proposed rulemaking that includes a copy of the proposed regulation1 provide a period of not less than #fj calendar days for comments on the proposed regulation1 and publish the final regulation not less than #cj calendar days before the effective date of the regulation4 7#d7 ,restrictions ,notwithstanding any other provision of law1 the ,secretary shall promulgate regulations implementing this section only as described in paragraphs 7#a71 7#b71 and 7#c74 7#e7 ,final regulations ,the ,secretary shall finalize the regulations under this section not later than #bg months after the date of enactment of the ,sunscreen ,innovation ,act4 4 #d4 ,reports 7a7 ,initial ,,gao report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report reviewing the overall progress of the ,secretary of ,health and ,human ,services in carrying out subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #b and amended by section #c and subsection 7c771 including findings on and recommendations with respect to-- 7#a7 the progress made in completing the review of requests under subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including pending requests1 and the feasibility of the timelines associated with such subchapter2 7#b7 the role of the ,office of the ,commissioner of ,food and ,drugs in issuing determinations with respect to requests reviewed under such subchapter1 including the number of requests transferred to the ,office of the ,commissioner under section #ehf;,c of such ,act2 7#c7 the extent to which advisory committees were convened by the ,secretary regarding requests under subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including pending requests2 and 7#d7 the types of metrics that have been1 or should be1 established for the review of time and extent applications4 7b7 ,subsequent ,,gao report ,not later than #ea_/b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report reviewing the overall progress of the ,secretary of ,health and ,human ,services in carrying out subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #b and amended by section #c and subsection 7c77 and the regulation of over-the-counter drug products1 including findings on and recommendations with respect to-- 7#a7 updates on the matters reported on by the ,comptroller ,general under subsection 7a72 7#b7 significant factors impacting the ability of the ,food and ,drug ,administration to fulfill the mission of the agency with regard to the regulation of over-the-counter drug products1 including finalizing outstanding monographs and responding to emerging and novel safety issues2 7#c7 the performance of the ,secretary in carrying out section #ehf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#d7 the types of metrics that have been1 or should be1 established for the review and regulation of over-the-counter drug products2 and 7#e7 timeliness1 efficiency1 and accountability in reviewing time and extent applications and safety and effectiveness reviews for over-the-counter drug products4 7c7 ,,fda report ,subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #c1 is further amended by adding at the end the following3 #ehf;,g4 ,report 7a7 ,in general 7#a7 ,in general ,not later than #ah months after the date of enactment of the ,sunscreen ,innovation ,act1 and on the dates that are #b and #d years thereafter1 the ,secretary shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives describing actions taken under this subchapter4 7#b7 ,contents ,the reports under this subsection shall include-- 7,a7 a review of the progress made in issuing ,,grase determinations for pending requests1 including the number of pending requests-- 7i7 reviewed and the decision times for each request1 measured from the date of the original request for an eligibility determination submitted by the sponsor2 7ii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and is not misbranded2 7iii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not ,,grase and is misbranded and the reasons for such determinations2 and 7iv7 for which a determination has not been made1 and an explanation for the delay1 a description of the current status of each such request1 and the length of time each such request has been pending1 measured from the date of original request for an eligibility determination by the sponsor2 7,b7 a review of the progress made in issuing ,,grase determinations for requests not included in the reporting under subparagraph 7,a71 including the number of such requests-- 7i7 reviewed and the decision times for each request2 7ii7 resulting in a determination that the nonprescription sunscreen active ingredient1 combination of nonprescription sunscreen active ingredients1 or other ingredient is ,,grase and is not misbranded2 7iii7 resulting in a determination that the nonprescription sunscreen active ingredient1 combination of nonprescription sunscreen active ingredients1 or other ingredient is not ,,grase and is misbranded and the reasons for such determinations2 and 7iv7 for which a determination has not been made1 and an explanation for the delay1 a description of the current status of each such request1 and the length of time each such request has been pending1 measured from the date of original request for an eligibility determination by the sponsor2 7,c7 an annual accounting 7including information from years prior to the date of enactment of the ,sunscreen ,innovation ,act where such information is available7 of the total number of requests submitted1 pending1 or completed under this subchapter1 including whether such requests were the subject of an advisory committee convened by the ,secretary2 7,d7 a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to requests under this subchapter2 7,e7 a review of the progress made in meeting the deadlines with respect to processing requests under this subchapter2 and 7,f7 to the extent the ,secretary determines appropriate1 recommendations for process improvements in the handling of requests under this subchapter1 including the advisory committee review process4 7b7 ,method ,the ,secretary shall publish the reports under subsection 7a7 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 4 ,september #ag 7legislative day1 ,september #af71 #bjad,reported with an amendment