,i #aafth ,,congress #b;d ,session ,h4 ,r4 #egba ,,in ,,the ,,house ,,of ,,representatives ,january #cj1 #bjbj,mrs4 ,bustos introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to apply user fees with respect to tobacco products deemed subject to the requirements of chapter ,,ix of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 #a4 ,short title ,this ,act may be cited as the ,resources to ,prevent ,youth ,vaping ,act4 #b4 ,user fees 7a7 ,increase in total amount ,section #iai7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs7b77#a77 is amended by striking subparagraph 7,k7 and inserting the following subparagraphs3 7,k7 ,for fiscal year #bjai1 #gab1jjj1jjj4 7,l7 ,for fiscal year #bjbj1 #hab1jjj1jjj4 7,m7 ,for each subsequent fiscal year1 the amount that was applicable for the previous fiscal year1 adjusted by the total percentage change that occurred in the ,consumer ,price ,index for all urban consumers 7all items2 ,united ,states city average7 for the #ab-month period ending ,june #cj preceding the fiscal year4 4 7b7 ,application of user fees to all classes of tobacco products 7#a7 ,in general ,subparagraph 7,a7 of section #iai7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs7b77#b77 is amended to read as follows3 7,a7 ,in general 7i7 ,fiscal years #bjbj and #bjba ,for fiscal years #bjbj and #bjba1 user fees shall be assessed and collected under subsection 7a7 only with respect to the classes of tobacco products listed in subparagraph 7,b77i71 and the total such user fees with respect to each such class shall be an amount that is equal to the applicable percentage of each such class for the fiscal year multiplied by the amount specified in paragraph 7#a7 for the fiscal year4 7ii7 ,subsequent fiscal years ,for fiscal year #bjbb and each subsequent fiscal year1 user fees shall be assessed and collected under subsection 7a7 with respect to each class of tobacco products to which this chapter applies 7including tobacco products that the ,secretary by regulation deems to be subject to this chapter71 and the total user fees with respect to each such class shall be-- 7,i7 with respect to each class of tobacco products listed in subparagraph 7,b77i71 an amount that is calculated in the same way as the amounts calculated for fiscal years #bjbj and #bjba under clause 7i71 except that for purposes of fiscal years #bjbb and subsequent fiscal years1 instead of multiplying the applicable percentage of each such class by the amount specified in paragraph 7#a7 for the fiscal year1 the applicable percentage shall be multiplied by-- 7aa7 the amount specified in paragraph 7#a7 for the fiscal year1 reduced by 7bb7 the total user fees assessed and collected pursuant to subclause 7,,ii7 for the fiscal year2 and 7,,ii7 with respect to each class of tobacco products to which this chapter applies but which is not listed in subparagraph 7,b77i71 an amount determined pursuant to a formula under subparagraph 7,c74 4 7#b7 ,other tobacco products ,section #iai7;b77#b7 of the ,federal ,food ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs7b77#b771 as amended by paragraph 7#a71 is further amended by adding at the end the following new subparagraphs3 7,c7 ,allocation for other tobacco products 7i7 ,in general ,beginning with fiscal year #bjbb1 the total user fees assessed and collected under subsection 7a7 each fiscal year with respect to each class of tobacco products not listed in subparagraph 7,b77i7 shall be an amount that is determined pursuant to a formula developed by the ,secretary by regulation using information required to be submitted under subparagraph 7,d74 7ii7 ,allocation for other tobacco products ,for each class of tobacco products not listed in subparagraph 7,b77i71 the percentage of fees under the formula under clause 7i7 for the respective fiscal year shall be equal to the percentage of the gross domestic sales in the previous calendar year that is attributable to such class of tobacco products in such calendar year1 as determined by the ,secretary4 7iii7 ,allocation of assessment within each class of other tobacco products ,the percentage of the total user fee to be paid by each manufacturer or importer of tobacco products in a class not listed in subparagraph 7,b77i7 shall be determined by the ,secretary1 based on the percentage of the gross domestics sales of all such classes of tobacco products by all manufacturers and importers in the previous calendar year that is attributable to such manufacturer or importer4 7iv7 ,effect of failure to finalize formula on time ,if the ,secretary for any reason fails to finalize by fiscal year #bjbb the formula required by this subparagraph for the assessment and collection of user fees for classes of tobacco products not listed in subparagraph 7,b77i7-- 7,i7 the ,secretary shall continue to assess and collect fees under subsection 7a7 with respect to each class of tobacco products listed in subparagraph 7,b77i72 and 7,,ii7 until the first fiscal year commencing after the finalization of such formula1 the exception described in subparagraph 7,a77ii77,i7 shall not apply4 7v7 ,revisions by regulation ,any revisions to the formula promulgated pursuant to this subparagraph shall be by regulation4 7vi7 ,definition ,in this subparagraph1 the term gross domestic sales means the total value in dollars of the sale or distribution by manufacturers and importers of tobacco products in the ,united ,states in classes not listed in subparagraph 7,b77i71 as determined based on the aggregation of sales data from every manufacturer and importer of tobacco products that submits sales data to the ,secretary4 7,d7 ,information required to be submitted ,each manufacturer or importer of any tobacco product shall submit to the ,secretary the information required under this subparagraph by ,march #a1 #bjba1 for calendar year #bjbj1 by ,april #a1 #bjba1 for the period of ,january #a1 #bjba1 through ,march #cj1 #bjba1 and monthly thereafter4 ,such information shall include-- 7i7 the identification of the manufacturer or importer2 7ii7 the class or classes of tobacco products sold by the manufacturer or importer2 7iii7 the full listing of the finished tobacco products in a class not listed in subparagraph 7,b77i7 sold or distributed by the manufacturer or importer in the ,united ,states2 and 7iv7 the gross domestic sales data for each class of finished tobacco products sold or distributed by the manufacturer or importer in the ,united ,states4 4 7#c7 ,prohibited act ,section #cja7q77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7q77#a77;,b77 is amended by inserting #iai7;b77#b77;,d71 before or #ibj4 7c7 ,allocation of assessment within each class of tobacco product ,section #iai7;b77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs7b77#d77 is amended by striking shall be the percentage determined for purposes of allocations under subsections 7e7 through 7h7 of section #fbe of ,public ,law #ajh-ceg and inserting shall be the percentage determined by the ,secretary4 7d7 ,conforming amendments ,section #iai7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs7b77 is amended-- 7#a7 by striking paragraph 7#e72 7#b7 by redesignating paragraphs 7#f7 and 7#g7 as paragraphs 7#e7 and 7#f71 respectively2 and 7#c7 by amending paragraph 7#f71 as redesignated1 to read as follows3 7#f7 ,memorandum of understanding ,the ,secretary shall request the appropriate ,federal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the ,secretary of all necessary information regarding all tobacco product manufacturers and importers required to pay user fees4 ,the ,secretary shall maintain all disclosure restrictions established by the head of such agency regarding the information provided under the memorandum of understanding4 4 7e7 ,applicability ,the amendments made by subsections 7b71 7c71 and 7d7 apply beginning with fiscal year #bjbb4 ,subject to the amendment made by subsection 7a71 section #iai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs71 as in effect on the day before the date of enactment of this ,act1 shall apply with respect to fiscal years preceding fiscal year #bjbb4 #c4 ,annual report 7a7 ,in general ,for fiscal year #bjbj and each subsequent fiscal year for which fees are collected under section #iai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall1 not later than #ahj days after the end of the respective fiscal year for which the report is being prepared1 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate1 and the ,committee on ,energy and ,commerce and ,committee on ,appropriations of the ,house of ,representatives1 an annual report with respect to such fees that contains the information required under subsection 7b74 7b7 ,required information ,each report submitted under subsection 7a7 shall contain the following information with respect to the fiscal year for which the report is being submitted3 7#a7 ,a breakdown of the amount expended by the ,food and ,drug ,administration on each of the following activities3 7,a7 ,compliance and enforcement4 7,b7 ,public education campaigns4 7,c7 ,scientific research and research infrastructure4 7,d7 ,communications4 7,e7 ,leadership1 management1 oversight1 and administrative functions4 7,f7 ,related overhead activities4 7,g7 ,other activities4 7#b7 ,details on the amount expended1 and the purpose of such expenditures1 on each of the five largest expenditure amounts within each of the categories described in paragraph 7#a74 7#c7 ,a breakdown of the amount expended on activities related to deemed tobacco products versus how much was expended on activities related to combustible tobacco products outlined in the pre-existing categories of tobacco products under section #iai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs74 7#d7 ,an explanation for how the ,food and ,drug ,administration ensures that the amount of user fees allocated to public education campaigns on youth e-cigarette use and prevention is sufficient to meet the need for education of teens and minors on the dangers of e-cigarettes and other ,electronic ,nicotine ,delivery ,systems 7,,ends74 7#e7 ,a list of the status of submitted1 pending1 and approved tobacco product applications for each regulatory pathway and class of tobacco product as defined by the ,family ,smoking ,prevention and ,tobacco ,control ,act 7,public ,law #aaa-ca71 including subsequent regulations1 for the #c-;fiscal year period preceding the fiscal year for which the report is being prepared4 7#f7 ,when applicable1 a breakdown of the amount or user fees collected under the amendments made by this ,act from manufacturers of deemed tobacco products and the amount collected from manufacturers of each of the original pre-existing categories of tobacco products under section #iai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chgs74