Title: Resources To Prevent Youth Vaping Act
Policy area: Health

Summary:
Resources to Prevent Youth Vaping Act
This bill directs the Food and Drug Administration (FDA) to collect user fees on products that it deems by regulation to be tobacco products, including electronic nicotine delivery systems, and addresses related issues. Currently, the FDA is authorized to collect user fees only on specified classes of tobacco products.
The bill increases the total amount of such fees to be collected for FY2022. For each fiscal year after, the total amount of such fees shall be adjusted according to changes in a price index.
Starting in FY2024, the FDA must assess user fees on classes of products that it has deemed by regulation to be tobacco products, unless the FDA fails to finalize a formula for assessing such fees on time. Once it is finalized, the FDA may only revise this formula by regulation.
The bill also requires each tobacco manufacturer and importer to periodically submit certain information related to the tobacco products that it sells or distributes in the United States.
The FDA must annually report to Congress about its use of such tobacco product fees.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2445 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2445

 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

                             July 22, 2021

Mrs. Shaheen (for herself, Ms. Murkowski, Mr. Durbin, Ms. Collins, Ms. 
Baldwin, and Mr. Romney) 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Resources To Prevent Youth Vaping 
Act''.

SEC. 2. USER FEES.

    (a) Increase in Total Amount.--Section 919(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(1)) is amended by 
striking subparagraph (K) and inserting the following subparagraphs:
                    ``(K) For each of fiscal years 2019 through 2021, 
                $712,000,000.
                    ``(L) For fiscal year 2022, $812,000,000.
                    ``(M) For fiscal year 2023 and each subsequent 
                fiscal year, the amount that was applicable for the 
                previous fiscal year, adjusted by the total percentage 
                change that occurred in the Consumer Price Index for 
                all urban consumers (all items; United States city 
                average) for the 12-month period ending June 30 
                preceding the fiscal year.''.
    (b) Application of User Fees to All Classes of Tobacco Products.--
            (1) In general.--Subparagraph (A) of section 919(b)(2) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)) 
        is amended to read as follows:
                    ``(A) In general.--
                            ``(i) Fiscal years 2022 and 2023.--For 
                        fiscal years 2022 and 2023, user fees shall be 
                        assessed and collected under subsection (a) 
                        only with respect to the classes of tobacco 
                        products listed in subparagraph (B)(i), 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 (1) for the fiscal year.
                            ``(ii) Subsequent fiscal years.--For fiscal 
                        year 2024 and each subsequent fiscal year, user 
                        fees shall be assessed and collected under 
                        subsection (a) with respect to each class of 
                        tobacco products to which this chapter applies 
                        (including tobacco products that the Secretary 
                        by regulation deems to be subject to this 
                        chapter), and the total user fees with respect 
                        to each such class shall be--
                                    ``(I) with respect to each class of 
                                tobacco products listed in subparagraph 
                                (B)(i), an amount that is calculated in 
                                the same way as the amounts calculated 
                                for fiscal years 2022 and 2023 under 
                                clause (i), except that for purposes of 
                                fiscal years 2024 and subsequent fiscal 
                                years, instead of multiplying the 
                                applicable percentage of each such 
                                class by `the amount specified in 
                                paragraph (1) for the fiscal year', the 
                                applicable percentage shall be 
                                multiplied by--
                                            ``(aa) the amount specified 
                                        in paragraph (1) for the fiscal 
                                        year, reduced by
                                            ``(bb) the total user fees 
                                        assessed and collected pursuant 
                                        to subclause (II) for the 
                                        fiscal year; and
                                    ``(II) with respect to each class 
                                of tobacco products to which this 
                                chapter applies but which is not listed 
                                in subparagraph (B)(i), an amount 
                                determined pursuant to a formula under 
                                subparagraph (C).''.
            (2) Other tobacco products.--Section 919(b)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)), as 
        amended by paragraph (1), is further amended by adding at the 
        end the following new subparagraphs:
                    ``(C) Allocation for other tobacco products.--
                            ``(i) In general.--Beginning with fiscal 
                        year 2024, the total user fees assessed and 
                        collected under subsection (a) each fiscal year 
                        with respect to each class of tobacco products 
                        not listed in subparagraph (B)(i) 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 (D).
                            ``(ii) Allocation for other tobacco 
                        products.--For each class of tobacco products 
                        not listed in subparagraph (B)(i), the 
                        percentage of fees under the formula under 
                        clause (i) 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 year, as determined 
                        by the Secretary.
                            ``(iii) 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 
                        (B)(i) shall be determined by the Secretary, 
                        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 importer.
                            ``(iv) Effect of failure to finalize 
                        formula on time.--If the Secretary for any 
                        reason fails to finalize by fiscal year 2024 
                        the formula required by this subparagraph for 
                        the assessment and collection of user fees for 
                        classes of tobacco products not listed in 
                        subparagraph (B)(i)--
                                    ``(I) the Secretary shall continue 
                                to assess and collect fees under 
                                subsection (a) with respect to each 
                                class of tobacco products listed in 
                                subparagraph (B)(i); and
                                    ``(II) until the first fiscal year 
                                commencing after the finalization of 
                                such formula, the exception described 
                                in subparagraph (A)(ii)(I) shall not 
                                apply.
                            ``(v) Revisions by regulation.--Any 
                        revisions to the formula promulgated pursuant 
                        to this subparagraph shall be by regulation.
                            ``(vi) Definition.--In this subparagraph, 
                        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 (B)(i), as determined based on the 
                        aggregation of sales data from every 
                        manufacturer and importer of tobacco products 
                        that submits sales data to the Secretary.
                    ``(D) 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 1, 2023, for calendar year 
                2022, by April 1, 2023, for the period of January 1, 
                2023, through March 30, 2023, and monthly thereafter. 
                Such information shall include--
                            ``(i) the identification of the 
                        manufacturer or importer;
                            ``(ii) the class or classes of tobacco 
                        products sold by the manufacturer or importer;
                            ``(iii) the full listing of the finished 
                        tobacco products in a class not listed in 
                        subparagraph (B)(i) sold or distributed by the 
                        manufacturer or importer in the United States; 
                        and
                            ``(iv) the gross domestic sales data for 
                        each class of finished tobacco products sold or 
                        distributed by the manufacturer or importer in 
                        the United States.''.
            (3) Prohibited act.--Section 301(q)(1)(B) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(1)(B)) is 
        amended by inserting ``919(b)(2)(D),'' before ``or 920''.
    (c) Allocation of Assessment Within Each Class of Tobacco 
Product.--Section 919(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387s(b)(4)) is amended by striking ``shall be the percentage 
determined for purposes of allocations under subsections (e) through 
(h) of section 625 of Public Law 108-357'' and inserting ``shall be the 
percentage determined by the Secretary''.
    (d) Conforming Amendments.--Section 919(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended--
            (1) by striking paragraph (5);
            (2) by redesignating paragraphs (6) and (7) as paragraphs 
        (5) and (6), respectively; and
            (3) by amending paragraph (6), as redesignated, to read as 
        follows:
            ``(6) 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 fees. The 
        Secretary shall maintain all disclosure restrictions 
        established by the head of such agency regarding the 
        information provided under the memorandum of understanding.''.
    (e) Applicability.--The amendments made by subsections (b), (c), 
and (d) apply beginning with fiscal year 2024. Subject to the amendment 
made by subsection (a), section 919 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387s), as in effect on the day before the date 
of enactment of this Act, shall apply with respect to fiscal years 
preceding fiscal year 2024.

SEC. 3. ANNUAL REPORT.

    (a) In General.--For fiscal year 2022 and each subsequent fiscal 
year for which fees are collected under section 919 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387s), the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall, not later than 180 days after the end of the respective fiscal 
year for which the report is being prepared, submit to the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate, and the Committee on Energy and Commerce 
and Committee on Appropriations of the House of Representatives, an 
annual report with respect to such fees that contains the information 
required under subsection (b).
    (b) Required Information.--Each report submitted under subsection 
(a) shall contain the following information with respect to the fiscal 
year for which the report is being submitted:
            (1) A breakdown of the amount expended by the Food and Drug 
        Administration on each of the following activities:
                    (A) Compliance and enforcement.
                    (B) Public education campaigns.
                    (C) Scientific research and research 
                infrastructure.
                    (D) Communications.
                    (E) Leadership, management, oversight, and 
                administrative functions.
                    (F) Related overhead activities.
                    (G) Other activities.
            (2) Details on the amount expended, and the purpose of such 
        expenditures, on each of the five largest expenditure amounts 
        within each of the categories described in paragraph (1).
            (3) 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 919 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 387s).
            (4) 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 (commonly referred to as ``ENDS'').
            (5) A list of the status of submitted, pending, 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 (Public Law 111-31), 
        including subsequent regulations, for the 3-fiscal year period 
        preceding the fiscal year for which the report is being 
        prepared.
            (6) When applicable, 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 919 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s).
                                 <all>