§ 387s. User fees
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(a)Establishment of quarterly fee Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. 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).
(b)Assessment of user fee
(1)Amount of assessment 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:
(A)For fiscal year 2009, $85,000,000 (subject to subsection (e)).
(B)For fiscal year 2010, $235,000,000.
(C)For fiscal year 2011, $450,000,000.
(D)For fiscal year 2012, $477,000,000.
(E)For fiscal year 2013, $505,000,000.
(F)For fiscal year 2014, $534,000,000.
(G)For fiscal year 2015, $566,000,000.
(H)For fiscal year 2016, $599,000,000.
(I)For fiscal year 2017, $635,000,000.
(J)For fiscal year 2018, $672,000,000.
(K)For fiscal year 2019 and each subsequent fiscal year, $712,000,000.
(2)Allocations of assessment by class of tobacco products
(A)In general The total user fees assessed and collected under subsection
(a)each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph
(1)for the fiscal year.
(B)Applicable percentage
(i)In general For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):
(I)Cigarettes.
(II)Cigars, including small cigars and cigars other than small cigars.
(III)Snuff.
(IV)Chewing tobacco.
(V)Pipe tobacco.
(VI)Roll-your-own tobacco.
(ii)Allocations The applicable percentage of each class of tobacco product described in clause
(i)for a fiscal year shall be the percentage determined under section 518d(c) of title 7 for each such class of product for such fiscal year.
(iii)Requirement of regulations Notwithstanding clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco products is listed in section 387a(b) of this title or is deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter.
(iv)Reallocations In the case of a class of tobacco products that is not listed in section 387a(b) of this title or deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter, the amount of user fees that would otherwise be assessed to such class of tobacco products shall be reallocated to the classes of tobacco products that are subject to this subchapter in the same manner and based on the same relative percentages otherwise determined under clause (ii).
(3)Determination of user fee by company
(A)In general The total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying—
(i)such manufacturer’s or importer’s percentage share as determined under paragraph (4); by
(ii)the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).
(B)No fee in excess of percentage share No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the percentage share of such manufacturer or importer.
(4)Allocation of assessment within each class of tobacco product The percentage share of each manufacturer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of tobacco products shall be the percentage determined for purposes of allocations under subsections
(e)through
(h)of section 518d of title 7.
(5)Allocation for cigars Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percentage share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year.
(6)Timing of assessment The Secretary shall notify each manufacturer and importer of tobacco products 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.
(7)Memorandum of understanding
(A)In general 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 the information described in paragraphs (2)(B)(ii) and
(4)and 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.
(B)Assurances Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Secretary shall ensure that the Food and Drug Administration is able to determine the applicable percentages described in paragraph
(2)and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in subparagraph
(A)to continue to provide the necessary information.
(c)Crediting and availability of fees
(1)In general 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, subject to paragraph (2)(D). 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 appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
(2)Availability
(A)In general Fees appropriated under paragraph
(3)are available only for the purpose of paying the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this subchapter and the Family Smoking Prevention and Tobacco Control Act (referred to in this subsection as “tobacco regulation activities”), except that such fees may be used for the reimbursement specified in subparagraph (C).
(B)Prohibition against use of other funds
(i)In general Except as provided in clause (ii), fees collected under subsection
(a)are the only funds authorized to be made available for tobacco regulation activities.
(ii)Startup costs Clause
(i)does not apply until October 1, 2009. Until such date, any amounts available to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activities.
(C)Reimbursement of start-up amounts
(i)In general Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appropriated fees collected under subsection (a), in such manner as the Secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds otherwise available, for the period from October 1, 2008, through September 30, 2010, for Food and Drug Administration programs and activities (other than tobacco regulation activities) for such period.
(ii)Treatment of reimbursed amounts Amounts reimbursed under clause
(i)shall be available for the programs and activities for which funds allocated for the start-up period were available, prior to such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year.
(D)Fee collected during start-up period Notwithstanding the first sentence of paragraph (1), fees under subsection
(a)may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obligation and remain available until expended. Such offsetting collections shall be credited to the salaries and expenses account of the Food and Drug Administration.
(E)Obligation of start-up costs in anticipation of available fee collections Notwithstanding any other provision of law, following the enactment of an appropriation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1534 of title 31.
(3)Authorization of appropriations For fiscal year 2009 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.
(d)Collection of unpaid fees In any case where the Secretary does not receive payment of a fee assessed under subsection
(a)within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
(e)Applicability to fiscal year 2009 If the date of enactment of the Family Smoking Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c):
(1)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 amounts”).
(2)For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter.
(3)For the quarter following the quarter to which paragraph
(2)applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).
(June 25, 1938, ch. 675, § 919, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1826.)
Connections186 cite this · traces to 4
Cited by 186 sections · top 60
public-private-law
- Public Law 116-260Consolidated Appropriations Act, 2021
- Public Law 115-141Consolidated Appropriations Act, 2018
- Public Law 117-328Consolidated Appropriations Act, 2023
- Public Law 114-113Consolidated Appropriations Act, 2016
- Public Law 116-94Further Consolidated Appropriations Act, 2020
- Public Law 113-235Consolidated and Further Continuing Appropriations Act, 2015
- Public Law 113-76Consolidated Appropriations Act, 2014
- Public Law 115-31Consolidated Appropriations Act, 2017
- Public Law 117-103Consolidated Appropriations Act, 2022
- Public Law 113-6Consolidated and Further Continuing Appropriations Act, 2013
- Public Law 116-6Consolidated Appropriations Act, 2019
- Public Law 119-37Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
U.S. Code
- § 381Imports and exports
- § 387Definitions
- § 387eAnnual registration
- § 387fGeneral provisions respecting control of tobacco products
- § 387kModified risk tobacco products
- § 387dSubmission of health information to the Secretary
- § 387bAdulterated tobacco products
- § 387qTobacco Products Scientific Advisory Committee
- § 387uStudies of progress and effectiveness
- § 387vReporting on tobacco regulation activities
- § 387oRegulation requirement
- § 387rDrug products used to treat tobacco dependence
statutes-at-large
- Public LawMaking appropriations for the fiscal year ending September 30, 2017, and for other purposes
- Public Law 113–6Making consolidated appropriations and further continuing appropriations for the fiscal year ending September 30, 2013, and for other purposes
- Public Law 115–141To amend the State Department Basic Authorities Act of 1956 to include severe forms of trafficking in persons within the definition of transnational organized crime for purposes of the rewards program of the Department of State, and for other purposes
- Public Law 114–113Making appropriations for military construction, the Department of Veterans Affairs, and related agencies for the fiscal year ending September 30, 2016, and for other purposes
- Public Law 116–6
- Public Law 117–103Making consolidated appropriations for the fiscal year ending September 30, 2022, and for providing emergency assistance for the situation in Ukraine, and for other purposes
- Public Law 116–260Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes
- Public Law 111–80Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2010, and for other purposes
- Public Law 116–94Making further consolidated appropriations for the fiscal year ending September 30, 2020, and for other purposes
statute-compilations
- Sec. 1269Notwithstanding section 1101, the level for “Related Agencies and Food and Drug Administration, Food and Drug Administration, Salaries and Expenses” shall be $3,655,687,000: *Provided*, That of the amount provided under this heading, $667,057,000 shall be derived from prescription drug user fees authorized by section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), shall be credited to this account and remain available until expended, and shall not include any fees pursuant to paragraphs (2) and (3) of section 736(a) of such Act (21 U.S.C. 379h(a)(2) and (a)(3)) assessed for fiscal year 2012 but collected in fiscal year 2011; $61,860,000 shall be derived from medical device user fees authorized by section 738 of such Act (21 U.S.C. 379j), and shall be credited to this account and remain available until expended; $19,448,000 shall be derived from animal drug user fees authorized by section 740 of such Act (21 U.S.C. 379j-12), and shall be credited to this account and remain available until expended; $5,397,000 shall be derived from animal generic drug user fees authorized by section 741 of such Act (21 U.S.C. 379f), and shall be credited to this account and shall remain available until expended; and $450,000,000 shall be derived from tobacco product user fees authorized by section 919 of such Act (21 U.S.C. 387s) and shall be credited to this account and remain available until expended: *Provided** further*, That in addition and notwithstanding any other provision under this heading, amounts collected for prescription drug user fees that exceed the fiscal year 2011 limitation are appropriated and shall be credited to this account and remain available until expended: *Provided further*, That fees derived from prescription drug, medical device, animal drug, animal generic drug, and tobacco product assessments for fiscal year 2011 received during fiscal year 2011, including any such fees assessed prior to fiscal year 2011 but credited for fiscal year 2011, shall be subject to the fiscal year 2011 limitations: *Provided further,* That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.S.C. 9701: *Provided further*, That of the total amount appropriated under this heading: (1) $837,358,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $957,116,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $325,647,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $161,730,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $359,781,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $60,664,000 shall be for the National Center for Toxicological Research; (7) $421,463,000 shall be for the Center for Tobacco Products and for related field activities in the Office of Regulatory Affairs; (8) not to exceed $136,239,000 shall be for Rent and Related activities, of which $41,951,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent; (9) not to exceed $183,048,000 shall be for payments to the General Services Administration for rent; and (10) $212,642,000 shall be for other activities, including the Office of the Commissioner of Food and Drugs; the Office of Foods; the Office of the Chief Scientist; the Office of Policy, Planning and Budget; the Office of International Programs; the Office of Administration; and central services for these offices: *Provided further,* That none of the funds made available under this heading shall be used to transfer funds under section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd): *Provided further*, That not to exceed $25,000 of the amount provided under this heading shall be for official reception and representation expenses, not otherwise provided for, as determined by the Commissioner: *Provided further,* That funds may be transferred from one specified activity to another with the prior approval of the Committees on Appropriations of both Houses of Congress.
- Sec. 773### (a)
- Sec. 163Section 4144(d) of the Motor Carrier Safety Reauthorization Act of 2005 (49 U.S.C. 31100 note) shall be applied by substituting the date specified in section 106(3) of this Act for “September 30, 2025”.
- Sec. 4STATEMENT OF APPROPRIATIONS
- Sec. 6ADJUSTMENTS TO COMPENSATION
- Sec. 9OFFICE OF MANAGEMENT AND BUDGET REPORTING REQUIREMENT
- Sec. 8LAUNCH LIABILITY EXTENSION
- Sec. 5AVAILABILITY OF FUNDS
- Sec. 8CORRECTION
- Sec. 9ADJUSTMENTS TO COMPENSATION
- Sec. 7ADJUSTMENTS TO COMPENSATION
- Sec. 413None of the funds made available by this Act may be used by the Secretary of Veterans Affairs under section 5502 of title 38, United States Code, in any case arising out of the administration by the Secretary of laws and benefits under such title, to report a person who is deemed mentally incapacitated, mentally incompetent, or to be experiencing an extended loss of consciousness as a person who has been adjudicated as a mental defective under subsection (d)(4) or (g)(4) of section 922 of title 18, United States Code, without the order or finding of a judge, magistrate, or other judicial authority of competent jurisdiction that such person is a danger to himself or herself or others.
- Sec. 530Of amounts deposited in the Child Enrollment Contingency Fund prior to the beginning of fiscal year 2020 under section 2104(n)(2) of the Social Security Act and the income derived from investment of those funds pursuant to section 2104(n)(2)(C) of that Act, $6,093,181,000 shall not be available for obligation in this fiscal year.
- Sec. 112REPORTING ON TOBACCO REGULATION ACTIVITIES
register
- NoticesNotice
- NoticesNotice of availability
- Rules and RegulationsSemiannual regulatory agenda
- Rules and RegulationsFinal rule
- NoticesNotice
- NoticesSemiannual Regulatory Agenda
- Rules and RegulationsSemiannual regulatory agenda
- NoticesSemiannual Regulatory Agenda
- Rules and RegulationsNotice
- Proposed RulesProposed rule
- NoticesNotice
- Rules and RegulationsNotice
5 references not yet in our index
- June 25, 1938, ch. 675, § 919
- Pub. L. 111–31, div. A, title I, § 101(b)(3)
- 123 Stat. 1826
- Pub. L. 111–31
- 123 Stat. 1776
Citation graph
cites case law
§ 387s
User fees
Bills×104
Fed. Reg.×20
Stat. Comp.×18
Pub. L.×16
U.S.C.×14
Stat.×13
C.F.R.×1
ActJune 25, 1938, ch. 675, § 919
Pub. L.Pub. L. 111–31, div. A, title I, § 101(b)(3)
Stat.123 Stat. 1826
Pub. L.Pub. L. 111–31
Stat.123 Stat. 1776
Cites 9Cited by 186 across 7 sources