§387s — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must charge and collect quarterly user fees from every manufacturer and importer of tobacco products starting June 22, 2009. The total fees to be collected each fiscal year are: FY2009 $85,000,000 (subject to special 2009 timing rules), FY2010 $235,000,000, FY2011 $450,000,000, FY2012 $477,000,000, FY2013 $505,000,000, FY2014 $534,000,000, FY2015 $566,000,000, FY2016 $599,000,000, FY2017 $635,000,000, FY2018 $672,000,000, and FY2019 and later $712,000,000. Those totals are split among product classes (cigarettes; cigars; snuff; chewing tobacco; pipe tobacco; roll-your-own) using percentages set by another federal rule. If a class is not covered, its share is reallocated to the covered classes. Each maker’s or importer’s bill for a quarter is its percentage share of its product class times that class’s quarterly fee. For cigars, a maker’s share is based on the excise taxes it paid the year before. The Secretary must tell each maker or importer the amount at least 30 days before the quarter ends, and payments are due by the last day of the quarter. The Secretary will get necessary manufacturer and percentage information from the proper federal agency and must make sure the FDA can determine the percentages by fiscal year 2015. Collected fees can only be spent if Congress provides the money in appropriations Acts, and the fees are meant to pay FDA costs for regulating tobacco products. Fees remain available until spent. Until October 1, 2009, other FDA funds could be used for startup work and must be repaid from collected fees so overall funding does not change for the period October 1, 2008, through September 30, 2010. Fees may be collected through September 30, 2009 and credited to the FDA salaries account. Each year the amount listed above is authorized to be appropriated. If a fee is unpaid 30 days after it is due, it becomes a claim the U.S. government can collect under federal debt rules. If the law was enacted during fiscal year 2009, the fees for that quarter are prorated by days remaining and are assessed as described above, with collection timing adjusted so the prorated amount is collected the next quarter and the following quarter includes the full quarterly fee plus the prorated amount.

Title 21, §387s

Food and Drugs — Source: USLM XML via OLRC

(a)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)(1)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)(A)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)(i)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)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)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)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)(A)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 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)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)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)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)(A)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)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)(1)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)(A)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)(i)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)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)(i)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)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)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)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)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)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)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).

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see

Short Title

of 2009 Amendment note set out under section 301 of this title. The date of enactment of the Family Smoking Prevention and Tobacco Control Act and such date of enactment, referred to in subsec. (e), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.

§387s User Fees