[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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