Sec. 4. User fees relating to electronic nicotine delivery systems
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Chapter IX of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 et seq.) is amended by inserting after section 919 the following: Beginning with fiscal year 2021, the Secretary, acting through the Commissioner of Food and Drugs, shall assess user fees on, and collect such fees from, each manufacturer and importer of electronic nicotine delivery systems. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c). The total amount of user fees authorized to be assessed and collected under subsection
(a)for a fiscal year is the following, as applicable to the fiscal year involved: For fiscal year 2021, $200,000,000. For fiscal year 2022 and fiscal year 2023, the amount described in subparagraph (A), adjusted by the percentage change in the Consumer Price Index for all urban consumers (all items; United States city average) between 2021 and the applicable year. The total user fee to be paid by each manufacturer or importer of electronic nicotine delivery systems shall be determined for each quarter pursuant to a formula developed by the Secretary. The Secretary shall notify each manufacturer and importer of electronic nicotine delivery systems subject to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under this subsection for each quarter of each fiscal year. Such notifications shall occur not later than 30 days prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made by the last day of the quarter involved. Beginning not later than fiscal year 2020, and for each subsequent fiscal year, the Secretary shall ensure that the Food and Drug Administration is able to determine— the annual amount of total sales in the electronic nicotine delivery system market of the United States; and the applicable percentage shares under paragraph (2). Fees authorized under subsection
(a)shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration—Salaries and Expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. Fees appropriated under paragraph
(3)shall be— transferred to the Centers for Disease Control and Prevention; and available only for the purpose of paying the costs of carrying out section 317U of the Public Health Service Act. For fiscal year 2021 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equal to the amount specified in subsection (b)(1) for the fiscal year. If the date of enactment of the Providing Resources to End the Vaping Epidemic Now for Teenagers Act of 2020 occurs during fiscal year 2021, the following applies: The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of subsection
(b)to the amount specified in paragraph (1)(A) of such subsection (referred to in this subsection as the quarterly fee amount ). For the quarter in which such date of enactment occurs and any preceding quarter of fiscal year 2021, fees shall not be assessed or collected under this section. The amount specified in subsection (b)(1)(A) is deemed to be reduced by the quarterly amount for each quarter for which fees are not assessed or collected by operation of paragraph (3). For any quarter in fiscal year 2021 following the quarter in which the date of enactment of the Providing Resources to End the Vaping Epidemic Now for Teenagers Act of 2020 occurs, the full quarterly fee amount shall be assessed and collected. . Section 902(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387b(4) ) is amended by inserting , or the manufacturer or importer of electronic nicotine delivery systems fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919A by the date specified in section 919A or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee before the semicolon. The amendment made by paragraph
(1)shall take effect on the later of October 1, 2021, or the date of enactment of this Act. Section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 ) is amended— by redesignating paragraphs
(8)through
(22)as paragraphs
(9)through (23), respectively; and by inserting after paragraph
(7)the following: The term electronic nicotine delivery system — means a tobacco product that is an electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and does not include a product that is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose. .
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