[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9425 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 9425

To amend the Federal Food, Drug, and Cosmetic Act to authorize tobacco 
user fee assessments for all regulated tobacco products, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            August 30, 2024

Ms. McClellan introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to authorize tobacco 
user fee assessments for all regulated tobacco products, and for other 
                               purposes.

    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 ``Tobacco User Fee Modernization Act 
of 2024''.

SEC. 2. TOBACCO PRODUCT 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:
                    ``(K) For each of fiscal years 2019 through 2024, 
                $712,000,000.
                    ``(L) For fiscal year 2025, $826,200,000.
                    ``(M) For fiscal year 2026 and each subsequent 
                fiscal year, the amount that was applicable for the 
                previous fiscal year, increased 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 Tobacco Products.--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 2025 through 2027.--For 
                        fiscal years 2025 through 2027, 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, as determined in accordance 
                        with subparagraph (B)(ii), multiplied by the 
                        amount specified in paragraph (1) for the 
                        fiscal year.
                            ``(ii) Subsequent fiscal years.--Except as 
                        specified in subparagraph (C), for fiscal year 
                        2028 and each subsequent fiscal year, user fees 
                        shall be assessed and collected under 
                        subsection (a) with respect to each class of 
                        tobacco products listed in subparagraph (B)(i) 
                        and other tobacco products as follows:
                                    ``(I) For the classes of tobacco 
                                products listed in subparagraph (B)(i):
                                            ``(aa) For each fiscal 
                                        year, the total user fees 
                                        assessed and collected for all 
                                        the classes of tobacco products 
                                        listed in subparagraph (B)(i) 
                                        together shall be an amount 
                                        that is equal to the product 
                                        obtained by multiplying--

                                                    ``(AA) the total of 
                                                the sum of the gross 
                                                domestic sales for the 
                                                classes of tobacco 
                                                products listed in 
                                                subparagraph (B)(i) 
                                                during the previous 
                                                full calendar year, 
                                                divided by the sum of 
                                                the gross domestic 
                                                sales for the classes 
                                                of tobacco products 
                                                listed in subparagraph 
                                                (B)(i) and other 
                                                tobacco products during 
                                                such calendar year; by

                                                    ``(BB) the amount 
                                                specified in paragraph 
                                                (1) for such fiscal 
                                                year.

                                            ``(bb) For each fiscal 
                                        year, the total user fees 
                                        assessed and collected for each 
                                        individual class of tobacco 
                                        products listed in subparagraph 
                                        (B)(i) shall be an amount that 
                                        is equal to the product 
                                        obtained by multiplying--

                                                    ``(AA) the 
                                                applicable percentage 
                                                for each class as 
                                                determined under 
                                                subparagraph (B)(ii); 
                                                by

                                                    ``(BB) the amount 
                                                determined under 
                                                subitem (aa).

                                    ``(II) For other tobacco products, 
                                for each fiscal year, the total user 
                                fees assessed and collected for all 
                                such other tobacco products shall be an 
                                amount that is equal to the product 
                                obtained by multiplying--
                                            ``(aa) the total of the 
                                        gross domestic sales for other 
                                        tobacco products during the 
                                        previous full calendar year, 
                                        divided by the sum of the gross 
                                        domestic sales for the classes 
                                        of tobacco products listed in 
                                        subparagraph (B)(i) and other 
                                        tobacco products during such 
                                        calendar year; by
                                            ``(bb) the amount specified 
                                        in paragraph (1) for such 
                                        fiscal year.''.
    (c) Other Tobacco Products.--
            (1) Amendment.--Section 919(b)(2) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)) is amended by 
        adding at the end the following:
                    ``(C) Effect of failure to finalize regulations on 
                time.--The Secretary shall finalize updates to the 
                regulations under part 1150 of title 21, Code of 
                Federal Regulations, to provide for the assessment and 
                collection of user fees for other tobacco products 
                beginning not later than fiscal year 2028. 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) until 
                the first fiscal year commencing after the effective 
                date of the final regulation to implement provisions 
                for assessment and collection of user fees for other 
                tobacco products.
                    ``(D) Information to be submitted.--
                            ``(i) In general.--In addition to any other 
                        reporting requirements under this Act and any 
                        implementing regulation, each manufacturer or 
                        importer of any tobacco product shall submit to 
                        the Secretary the information required under 
                        this subparagraph--
                                    ``(I) not later than--
                                            ``(aa) March 1, 2027, for 
                                        calendar year 2026; and
                                            ``(bb) April 20, 2027, for 
                                        the period of January 1, 2027, 
                                        through March 30, 2027; and
                                    ``(II) quarterly thereafter, or in 
                                accordance with such other reporting 
                                requirements as the Secretary may 
                                establish by regulation.
                            ``(ii) Requirements.--The information 
                        required to be submitted under this 
                        subparagraph shall consist of--
                                    ``(I) the identification 
                                information of the manufacturer or 
                                importer, to include--
                                            ``(aa) the Employer 
                                        Identification Number (EIN);
                                            ``(bb) company name;
                                            ``(cc) the phone number 
                                        (including area code);
                                            ``(dd) the email address; 
                                        and
                                            ``(ee) the mailing address 
                                        where communications and 
                                        assessments from the Food and 
                                        Drug Administration can be 
                                        received;
                                    ``(II) the class or classes of 
                                tobacco products, to include the 
                                classes listed in subparagraph (B)(i) 
                                and other tobacco products, for which 
                                the manufacturer or importer has 
                                domestic sales; and
                                    ``(III) the gross domestic sales 
                                data, where the manufacturer or 
                                importer has domestic sales, for each 
                                class of tobacco products listed in 
                                subparagraph (B)(i) and other tobacco 
                                products.''.
            (2) 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''.
    (d) Allocation of Assessments.--Paragraph (4) of section 919(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended 
to read as follows:
            ``(4) Allocation of assessments.--The percentage share of 
        each manufacturer or importer of a particular class of tobacco 
        products listed in paragraph (2)(B)(i) and other tobacco 
        products of the total user fees to be paid by all manufacturers 
        or importers of that class of tobacco products listed in 
        paragraph (2)(B)(i) and other tobacco products shall be--
                    ``(A) for tobacco product classes listed in 
                paragraph (2)(B)(i), the percentage determined for 
                purposes of allocations under subsections (e) through 
                (h) of section 625 of Public Law 108-357 (7 U.S.C. 
                518d); and
                    ``(B) for other tobacco products, the percentage 
                determined by dividing--
                            ``(i) the total gross domestic sales of 
                        other tobacco products for a manufacturer or 
                        importer for the prior fiscal quarter; by
                            ``(ii) the total gross domestic sales of 
                        other tobacco products for all manufacturers 
                        and importers for that same quarter.''.
    (e) Reallocations.--Clause (iv) of section 919(b)(2)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)(B)) is 
amended to read as follows:
                            ``(iv) Reallocations.--In the case of a 
                        class or partial class of tobacco products that 
                        is not listed in section 901(b) or deemed by 
                        the Secretary in a regulation under section 
                        901(b) to be subject to this chapter, the 
                        amount of user fees that would otherwise be 
                        assessed to such class or partial class of 
                        tobacco products shall be reallocated to the 
                        classes or partial classes of tobacco products 
                        that are subject to this chapter in the same 
                        manner and based on the same relative 
                        percentages otherwise determined under clause 
                        (ii), adjusted as necessary to reflect partial 
                        classes if any.''.
    (f) Liability.--Paragraph (5) of section 919(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended to read as 
follows:
            ``(5) Assessment liability.--The quarterly assessment 
        amount owed by a manufacturer or importer of tobacco products 
        listed in paragraph (2)(B)(i) or other tobacco products shall 
        be--
                    ``(A) based on removals (as defined in section 
                5702(j) of the Internal Revenue Code of 1986) or gross 
                domestic sales, as relevant, during the prior fiscal 
                period; and
                    ``(B) remitted to the Food and Drug Administration 
                regardless of whether the manufacturer or importer 
                meets the definition of manufacturer or importer in the 
                fiscal quarter in which--
                            ``(i) the assessment is calculated; or
                            ``(ii) the manufacturer or importer 
                        receives notification of the amount of 
                        assessment owed to the Food and Drug 
                        Administration.''.
    (g) Conforming Amendments.--Paragraph (7) of section 919(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended to 
read as follows:
            ``(7) Memorandum of understanding.--The Secretary may 
        request any 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 information regarding any tobacco product manufacturer or 
        importer 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.''.
    (h) Definitions.--Section 919(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387s(b)) is amended by adding at the end the 
following:
            ``(8) Definitions.--For purposes of this subsection:
                    ``(A) The term `gross domestic sales' means the 
                total amount in dollars, not to include taxes, duties, 
                and fees, of the sale by manufacturers and importers of 
                finished tobacco products in the United States.
                    ``(B) The term `other tobacco product' means a 
                tobacco product that is made or derived from tobacco, 
                or contains nicotine from any source, that does not fit 
                within a product class listed in paragraph 
                (2)(B)(i).''.
    (i) Inspection Authority.--The fifth sentence of section 704(a)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is 
amended by striking ``sales data other than shipment data, pricing 
data'' and inserting ``sales data (other than shipment data and, for 
tobacco products, sales data relating to tobacco product user fees 
under section 919), pricing data (other than pricing data relating to 
tobacco product user fees under section 919)''.
    (j) Applicability.--
            (1) In general.--The amendments made by this section shall 
        apply--
                    (A) in the case of such amendments made by 
                subsections (a), (e), and (i), beginning on the date of 
                enactment of this Act; and
                    (B) in the case of other amendments made by this 
                section, beginning on October 1, 2027.
            (2) Special rule.--If the date of enactment of this Act 
        occurs after fiscal year 2024, then the Secretary of Health and 
        Human Services shall assess and collect the increase in total 
        amount by taking the amount specified in subparagraph (L) or 
        (M) of section 919(b)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 387c(b)(1)), as appropriate, and 
        assessing such amount equally across each fiscal quarter for 
        the relevant fiscal year.
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