Resources to Prevent Youth Vaping Act

II 116TH CONGRESS 2D SESSION S. 3223 To apply user fees with respect to tobacco products deemed subject to the requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act. IN THE SENATE OF THE UNITED STATES JANUARY 21, 2020 Mrs. SHAHEEN (for herself, Ms. MURKOWSKI, Mr. DURBIN, Mr. ROMNEY, Ms. BALDWIN, and Ms. COLLINS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To apply user fees with respect to tobacco products deemed subject to the requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Resources to Prevent 4 Youth Vaping Act’’. 5 SEC. 2. USER FEES. 6 (a) INCREASE IN TOTAL AMOUNT.—Section 7 919(b)(1) of the Federal Food, Drug, and Cosmetic Act 8 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3223 IS (21 U.S.C. 387s(b)(1)) is amended by striking subpara- 1 graph (K) and inserting the following subparagraphs: 2 ‘‘(K) For fiscal year 2019, $712,000,000. 3 ‘‘(L) For fiscal year 2020, $812,000,000. 4 ‘‘(M) For each subsequent fiscal year, the 5 amount that was applicable for the previous fis- 6 cal year, adjusted by the total percentage 7 change that occurred in the Consumer Price 8 Index for all urban consumers (all items; 9 United States city average) for the 12-month 10 period ending June 30 preceding the fiscal 11 year.’’. 12 (b) APPLICATION OF USER FEES TO ALL CLASSES 13 OF TOBACCO PRODUCTS.— 14 (1) IN GENERAL.—Subparagraph (A) of section 15 919(b)(2) of the Federal Food, Drug, and Cosmetic 16 Act (21 U.S.C. 387s(b)(2)) is amended to read as 17 follows: 18 ‘‘(A) IN GENERAL.— 19 ‘‘(i) FISCAL YEARS 2020 AND 2021.— 20 For fiscal years 2020 and 2021, user fees 21 shall be assessed and collected under sub- 22 section (a) only with respect to the classes 23 of tobacco products listed in subparagraph 24 (B)(i), and the total such user fees with re- 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3223 IS spect to each such class shall be an 1 amount that is equal to the applicable per- 2 centage of each such class for the fiscal 3 year multiplied by the amount specified in 4 paragraph (1) for the fiscal year. 5 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 6 For fiscal year 2022 and each subsequent 7 fiscal year, user fees shall be assessed and 8 collected under subsection (a) with respect 9 to each class of tobacco products to which 10 this chapter applies (including tobacco 11 products that the Secretary by regulation 12 deems to be subject to this chapter), and 13 the total user fees with respect to each 14 such class shall be— 15 ‘‘(I) with respect to each class of 16 tobacco products listed in subpara- 17 graph (B)(i), an amount that is cal- 18 culated in the same way as the 19 amounts calculated for fiscal years 20 2020 and 2021 under clause (i), ex- 21 cept that for purposes of fiscal years 22 2022 and subsequent fiscal years, in- 23 stead of multiplying the applicable 24 percentage of each such class by ‘the 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3223 IS amount specified in paragraph (1) for 1 the fiscal year’, the applicable percent- 2 age shall be multiplied by— 3 ‘‘(aa) the amount specified 4 in paragraph (1) for the fiscal 5 year, reduced by 6 ‘‘(bb) the total user fees as- 7 sessed and collected pursuant to 8 subclause (II) for the fiscal year; 9 and 10 ‘‘(II) with respect to each class of 11 tobacco products to which this chapter 12 applies but which is not listed in sub- 13 paragraph (B)(i), an amount deter- 14 mined pursuant to a formula under 15 subparagraph (C).’’. 16 (2) OTHER TOBACCO PRODUCTS.—Section 17 919(b)(2) of the Federal Food, Drug, and Cosmetic 18 Act (21 U.S.C. 387s(b)(2)), as amended by para- 19 graph (1), is further amended by adding at the end 20 the following new subparagraphs: 21 ‘‘(C) ALLOCATION FOR OTHER TOBACCO 22 PRODUCTS.— 23 ‘‘(i) IN GENERAL.—Beginning with 24 fiscal year 2022, the total user fees as- 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 3223 IS sessed and collected under subsection (a) 1 each fiscal year with respect to each class 2 of tobacco products not listed in subpara- 3 graph (B)(i) shall be an amount that is de- 4 termined pursuant to a formula developed 5 by the Secretary by regulation using infor- 6 mation required to be submitted under 7 subparagraph (D). 8 ‘‘(ii) ALLOCATION FOR OTHER TO- 9 BACCO PRODUCTS.—For each class of to- 10 bacco products not listed in subparagraph 11 (B)(i), the percentage of fees under the 12 formula under clause (i) for the respective 13 fiscal year shall be equal to the percentage 14 of the gross domestic sales in the previous 15 calendar year that is attributable to such 16 class of tobacco products in such calendar 17 year, as determined by the Secretary. 18 ‘‘(iii) ALLOCATION OF ASSESSMENT 19 WITHIN EACH CLASS OF OTHER TOBACCO 20 PRODUCTS.—The percentage of the total 21 user fee to be paid by each manufacturer 22 or importer of tobacco products in a class 23 not listed in subparagraph (B)(i) shall be 24 determined by the Secretary, based on the 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 3223 IS percentage of the gross domestics sales of 1 all such classes of tobacco products by all 2 manufacturers and importers in the pre- 3 vious calendar year that is attributable to 4 such manufacturer or importer. 5 ‘‘(iv) EFFECT OF FAILURE TO FINAL- 6 IZE FORMULA ON TIME.—If the Secretary 7 for any reason fails to finalize by fiscal 8 year 2022 the formula required by this 9 subparagraph for the assessment and col- 10 lection of user fees for classes of tobacco 11 products not listed in subparagraph 12 (B)(i)— 13 ‘‘(I) the Secretary shall continue 14 to assess and collect fees under sub- 15 section (a) with respect to each class 16 of tobacco products listed in subpara- 17 graph (B)(i); and 18 ‘‘(II) until the first fiscal year 19 commencing after the finalization of 20 such formula, the exception described 21 in subparagraph (A)(ii)(I) shall not 22 apply. 23 ‘‘(v) REVISIONS BY REGULATION.— 24 Any revisions to the formula promulgated 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 3223 IS pursuant to this subparagraph shall be by 1 regulation. 2 ‘‘(vi) DEFINITION.—In this subpara- 3 graph, the term ‘gross domestic sales’ 4 means the total value in dollars of the sale 5 or distribution by manufacturers and im- 6 porters of tobacco products in the United 7 States in classes not listed in subpara- 8 graph (B)(i), as determined based on the 9 aggregation of sales data from every man- 10 ufacturer and importer of tobacco products 11 that submits sales data to the Secretary. 12 ‘‘(D) INFORMATION REQUIRED TO BE SUB- 13 MITTED.—Each manufacturer or importer of 14 any tobacco product shall submit to the Sec- 15 retary the information required under this sub- 16 paragraph by March 1, 2021, for calendar year 17 2020, by April 1, 2021, for the period of Janu- 18 ary 1, 2021, through March 30, 2021, and 19 monthly thereafter. Such information shall in- 20 clude— 21 ‘‘(i) the identification of the manufac- 22 turer or importer; 23 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 3223 IS ‘‘(ii) the class or classes of tobacco 1 products sold by the manufacturer or im- 2 porter; 3 ‘‘(iii) the full listing of the finished to- 4 bacco products in a class not listed in sub- 5 paragraph (B)(i) sold or distributed by the 6 manufacturer or importer in the United 7 States; and 8 ‘‘(iv) the gross domestic sales data for 9 each class of finished tobacco products sold 10 or distributed by the manufacturer or im- 11 porter in the United States.’’. 12 (3) PROHIBITED ACT.—Section 301(q)(1)(B) of 13 the Federal Food, Drug, and Cosmetic Act (21 14 U.S.C. 331(q)(1)(B)) is amended by inserting 15 ‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 16 (c) ALLOCATION OF ASSESSMENT WITHIN EACH 17 CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 19 387s(b)(4)) is amended by striking ‘‘shall be the percent- 20 age determined for purposes of allocations under sub- 21 sections (e) through (h) of section 625 of Public Law 108– 22 357’’ and inserting ‘‘shall be the percentage determined 23 by the Secretary’’. 24 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 3223 IS (d) CONFORMING AMENDMENTS.—Section 919(b) of 1 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 387s(b)) is amended— 3 (1) by striking paragraph (5); 4 (2) by redesignating paragraphs (6) and (7) as 5 paragraphs (5) and (6), respectively; and 6 (3) by amending paragraph (6), as redesig- 7 nated, to read as follows: 8 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—The 9 Secretary shall request the appropriate Federal 10 agency to enter into a memorandum of under- 11 standing that provides for the regular and timely 12 transfer from the head of such agency to the Sec- 13 retary of all necessary information regarding all to- 14 bacco product manufacturers and importers required 15 to pay user fees. The Secretary shall maintain all 16 disclosure restrictions established by the head of 17 such agency regarding the information provided 18 under the memorandum of understanding.’’. 19 (e) APPLICABILITY.—The amendments made by sub- 20 sections (b), (c), and (d) apply beginning with fiscal year 21 2022. Subject to the amendment made by subsection (a), 22 section 919 of the Federal Food, Drug, and Cosmetic Act 23 (21 U.S.C. 387s), as in effect on the day before the date 24 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 3223 IS of enactment of this Act, shall apply with respect to fiscal 1 years preceding fiscal year 2022. 2 SEC. 3. ANNUAL REPORT. 3 (a) IN GENERAL.—For fiscal year 2020 and each 4 subsequent fiscal year for which fees are collected under 5 section 919 of the Federal Food, Drug, and Cosmetic Act 6 (21 U.S.C. 387s), the Secretary of Health and Human 7 Services, acting through the Commissioner of Food and 8 Drugs, shall, not later than 180 days after the end of the 9 respective fiscal year for which the report is being pre- 10 pared, submit to the Committee on Health, Education, 11 Labor, and Pensions and the Committee on Appropria- 12 tions of the Senate, and the Committee on Energy and 13 Commerce and Committee on Appropriations of the House 14 of Representatives, an annual report with respect to such 15 fees that contains the information required under sub- 16 section (b). 17 (b) REQUIRED INFORMATION.—Each report sub- 18 mitted under subsection (a) shall contain the following in- 19 formation with respect to the fiscal year for which the re- 20 port is being submitted: 21 (1) A breakdown of the amount expended by 22 the Food and Drug Administration on each of the 23 following activities: 24 (A) Compliance and enforcement. 25 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 3223 IS (B) Public education campaigns. 1 (C) Scientific research and research infra- 2 structure. 3 (D) Communications. 4 (E) Leadership, management, oversight, 5 and administrative functions. 6 (F) Related overhead activities. 7 (G) Other activities. 8 (2) Details on the amount expended, and the 9 purpose of such expenditures, on each of the five 10 largest expenditure amounts within each of the cat- 11 egories described in paragraph (1). 12 (3) A breakdown of the amount expended on 13 activities related to deemed tobacco products versus 14 how much was expended on activities related to com- 15 bustible tobacco products outlined in the pre-existing 16 categories of tobacco products under section 919 of 17 the Federal Food, Drug, and Cosmetic Act (21 18 U.S.C. 387s). 19 (4) An explanation for how the Food and Drug 20 Administration ensures that the amount of user fees 21 allocated to public education campaigns on youth e- 22 cigarette use and prevention is sufficient to meet the 23 need for education of teens and minors on the dan- 24 VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 3223 IS gers of e-cigarettes and other Electronic Nicotine 1 Delivery Systems (ENDS). 2 (5) A list of the status of submitted, pending, 3 and approved tobacco product applications for each 4 regulatory pathway and class of tobacco product as 5 defined by the Family Smoking Prevention and To- 6 bacco Control Act (Public Law 111–31), including 7 subsequent regulations, for the 3-fiscal year period 8 preceding the fiscal year for which the report is 9 being prepared. 10 (6) When applicable, a breakdown of the 11 amount or user fees collected under the amendments 12 made by this Act from manufacturers of deemed to- 13 bacco products and the amount collected from man- 14 ufacturers of each of the original pre-existing cat- 15 egories of tobacco products under section 919 of the 16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 17 387s). 18 Æ VerDate Sep 11 2014 20:44 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\S3223.IS S3223 pamtmann on DSKBC07HB2PROD with BILLS