PART 1150—USER FEES Authority: 21 U.S.C. 371, 387a, 387b, 387i, 387s, 21 CFR 1100.1. Source: 79 FR 39310, July 10, 2014, unless otherwise noted. § 1150.1 Scope. This part establishes requirements related to tobacco product user fees under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s). The total amount of user fees may not exceed the amount specified for that fiscal year in section 919(b) of the Federal Food, Drug, and Cosmetic Act. All domestic manufacturers and importers of tobacco products are required to pay to FDA their percentage share of the total assessment for a fiscal year. § 1150.3 Definitions. The following definitions are applicable to this part: Class of tobacco products Domestic manufacturer Fiscal year quarter Importer Total assessment Units of product (1) The number of sticks for cigarettes, or (2) The weight (measured in pounds) for snuff, chewing tobacco, and roll-your-own tobacco. Units of product (1) The number of sticks for cigarettes and cigars, or (2) The weight (measured in pounds) for snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco. Yearly class allocation [79 FR 39310, July 10, 2014, as amended at 81 FR 28715, May 10, 2016] § 1150.5 Required information. (a) General. (b) Contents. (1) Identification information. (ii) The name and a telephone number including area code of an office or individual that FDA may contact for further information; (iii) The email address and postal address at which it wishes to receive notifications FDA sends under this part; (iv) The Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit Number(s); and (v) The Employer Identification Number(s) (EIN). (2) Removal information. (i) This information must be reported for each TTB tobacco permit. (ii) If the domestic manufacturer or importer did not remove any amount of tobacco product, it must report that no tobacco product was removed into domestic commerce. (3) Certified copies. (i) The removal of tobacco products into domestic commerce (as defined by section 5702 of the Internal Revenue Code of 1986); and (ii) The payment of the Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986. (c) First report for cigars. (d) First report for pipe tobacco. [79 FR 39310, July 10, 2014, as amended at 81 FR 28715, May 10, 2016] § 1150.7 Yearly class allocation. For each fiscal year, FDA will allocate the total assessment among the classes of tobacco products. (a) Calculation. (1) Except for cigars, FDA will multiply the units of product removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for that class (class dollar figure). (2) For cigars, FDA will: (i) Multiply the units of small cigars removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for small cigars (small cigar subclass dollar figure). (ii) Multiply the units of large cigars removed and not tax exempt for the most recent full calendar year by the 2003 maximum Federal excise tax rate for large cigars (large cigar subclass dollar figure). (iii) Add the small cigar subclass dollar figure and the large cigar subclass dollar figure (cigar class dollar figure). (3) FDA will total the class dollar figures for all tobacco classes for the most recent full calendar year (total dollar figure). (4) FDA will divide the class dollar figure by the total dollar figure to determine the percentage share for each class. (5) FDA will calculate the allocation for each class of tobacco products by multiplying the percentage share for each class by the total assessment. (b) Reallocation. [79 FR 39310, July 10, 2014, as amended at 81 FR 28716, May 10, 2016] § 1150.9 Domestic manufacturer or importer assessment. Each quarter, FDA will calculate the assessment owed by each domestic manufacturer or importer for that quarter. (a) Calculation. (2) For the cigar class, FDA will calculate the percentage share for each domestic manufacturer and importer by dividing the Federal excise taxes that it paid for the class for the prior fiscal year by the total excise taxes that all domestic manufacturers and importers paid for the class for the prior fiscal year. (3) If the percentage share calculated for a domestic manufacturer or importer in this section, as applicable, is less than 0.0001 percent, the share is excluded from the assessment for that class of tobacco products. (4) Within each class of tobacco products, the assessment owed by a domestic manufacturer or importer for the quarter is the yearly class allocation, determined as described in § 1150.7, divided by four, multiplied by the domestic manufacturer's or importer's percentage share, truncated to the fourth decimal place, for that class of tobacco products. (b) Adjustments. [79 FR 39310, July 10, 2014, as amended at 81 FR 28716, May 10, 2016] § 1150.11 Notification of assessments. (a) Notification. (b) Content of notification. (1) The amount of the quarterly assessment imposed on the domestic manufacturer or importer and the date that payment of the assessment must be received by FDA; (2) Class assessment information, including each class' initial percentage share, the reallocation amount (if any) and each class' percentage share after any such reallocation, and the quarterly assessment for each class; (3) Domestic manufacturer or importer assessment information, including the domestic manufacturer's or importer's percentage share of each relevant class of tobacco products and invoice amount; (4) Any adjustments FDA has made under § 1150.9(b); (5) The manner in which assessments are to be remitted to FDA; (6) Information about the accrual of interest if a payment is late; and (7) Information regarding where to send a dispute and when it needs to be sent. § 1150.13 Payment of assessments. (a) Payment of an assessment must be received by FDA no later than the last day of each fiscal year quarter. (b) Payments must be submitted to FDA in U.S. dollars and in the manner specified in the notification. (c) Except as provided in paragraph (d) of this section, if an assessment is not received by the last day of the fiscal year quarter, FDA will begin assessing interest on the unpaid amount in accordance with 31 U.S.C. 3717. (d) If FDA does not send the notification described in § 1150.11(a) 30 calendar days before the end of a quarter, no interest will be assessed by FDA under paragraph (c) of this section until 30 calendar days have elapsed from the date FDA sent notification of the amount owed. (e) If a domestic manufacturer or importer disputes the amount of an assessment, it must still pay the assessment in accordance with paragraphs (a) and (b) of this section. § 1150.15 Disputes. (a) A domestic tobacco manufacturer or importer may dispute an FDA assessment. The dispute must include the basis for the dispute, and the dispute must be: (1) Submitted in writing; (2) Received by FDA no later than 45 days after the date on the assessment notification; (3) Legible and in English; and (4) Sent to the address found on our website ( https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fees (b) If FDA determines that there was an error related to the assessment and the assessment was too high, FDA will refund the amount assessed in error to the domestic manufacturer or importer. (c) FDA will provide a dated, written response, and its response will provide information about how to submit a request for further Agency review. (d) A request for further Agency review under § 10.75 of this chapter may be submitted. Such a request must be submitted in writing by the domestic manufacturer or importer and received by FDA within 30 days from the date on FDA's response. The request for further Agency review must be legible, in English, and submitted to the address found on our website ( https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fees [79 FR 39310, July 10, 2014, as amended at 89 FR 13980, Feb. 26, 2024] § 1150.17 Penalties. (a) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387b), a tobacco product is deemed adulterated if the domestic manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer by the later of the date the assessment is due, 30 days from the date FDA sent notification of the amount owed, or 30 days after final Agency action on a resolution of any dispute as to the amount of the fee. (b) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act, a tobacco product is deemed adulterated if the domestic manufacturer or importer of the tobacco product fails to report the information required by § 1150.5 to calculate assessments under this part. (c) The failure to report the information required by § 1150.5 to calculate assessments under this part is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act. (d) Information submitted under § 1150.5 is subject to 18 U.S.C. 1001 and other appropriate civil and criminal statutes.