90 FR 83 pgs. 18687-18688 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Type: NOTICEVolume: 90Number: 83Pages: 18687 - 18688
Pages: 18687, 18688Docket number: [Docket No. FDA-2025-N-0374]
FR document: [FR Doc. 2025-07585 Filed 4-30-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0374]
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products."
DATES:
Either electronic or written comments on the collection of information must be submitted by June 30, 2025.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 30, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. FDA-2025-N-0374 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
[top] With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether
User Fees for Domestic Manufacturers and Importers of Tobacco Products
OMB Control Number 0910-0749-Extension
This information collection supports Food and Drug Administration regulations. Tobacco products are generally governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C. 387-387t). Specifically, section 919 of the FD & C Act (21 U.S.C. 387s) governs tobacco user fees.
Section 919(a) requires FDA to "assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products" subject to the tobacco product provisions of the FD&C Act. Accordingly, section 919(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 387s (b)(2)(B)(i)) identifies those tobacco products as: cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.
To implement the tobacco user fee program as prescribed in the FD&C Act (as summarized above), FDA must collect the information needed to accurately calculate tobacco user fee assessments. On May 10, 2016, FDA published a final rule that requires domestic manufacturers and importers of the applicable tobacco products (listed above) to submit this information to the FDA (81 FR 28707).
FDA estimates the burden of this collection of information as follows:
| 21 CFR section | Number of respondents | Number of responses per respondent | Total number of annual responses | Average burden per response in hours | Total hours |
|---|---|---|---|---|---|
| 1150.5(a), (b)(1) and (2), and Form FDA 3852; Identification and removal information (monthly) | 820 | 12 | 9,840 | 3 | 29,520 |
| 1150.5(b)(3); Certified copies (monthly) | 820 | 12 | 9,840 | 1 | 9,840 |
| Voluntary premium cigar data submission (monthly) | 50 | 12 | 600 | 1.5 | 900 |
| 1150.13; Payment of user fee assessment (quarterly) | 319 | 4 | 1,276 | 1 | 1,276 |
| 1150.15(a); Submission of user fee dispute (at discretion of respondent) | 2 | 1 | 2 | 10 | 20 |
| 1150.15(d); Submission of request for further review of dispute of user fee (at discretion of respondent) | 1 | 1 | 1 | 5 | 5 |
| Total | 21,559 | 41,561 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
We have revised our burden estimates to this information collection request.
21 CFR 1150.5 is reflecting an increase in 120 respondents from 700 to 820. FDA considered the number of active Alcohol and Tobacco Tax and Trade Bureau (TTB) permits (based on TTB data) in FY23 for domestic manufacturers and importers of tobacco products subject to tobacco user fees.
Voluntary premium cigar data submission (monthly) is reflecting a reduction in 50 respondents from 100 to 50 and a reduction in average burden per response from 2.5 to 1.5 hours. FDA updated this data based on reasonable estimates of the burden of voluntary submissions in FY24. There may be some fluctuations in this number.
Section 1150.13 (21 CFR 1150.13) is reflecting a reduction in 57 respondents from 376 to 319. FDA considered the number of user fee assessments issued to domestic manufacturers and importers of tobacco products subject to tobacco user fees on average each quarter for FY23. Note, entities may have more than one TTB permit, however, tobacco user fee assessments are aggregated based on Employer Identification Number and not TTB permit number. Therefore, we expect the number of respondents to be lower for §?1150.13.
21 CFR 1150.15(a) is reflecting a reduction in 3 respondents from 5 to 2, and 21 CFR 1150.15(d) is reflecting a reduction in 2 respondents from 3 to 1 and a reduction in average burden per response from 10 to 5 hours. FDA considered the historical submission of tobacco user fee disputes and requests for additional Agency review.
The cumulative changes to the estimated burden for this information collection reflects an overall increase of 3,377 burden hours and a corresponding increase of 2,047 responses.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07585 Filed 4-30-25; 8:45 am]
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