Notice2025-14221
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35701-35702]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14221]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2193]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 28, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0749. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#17474556446376717157717376397f7f6439707861"><span class="__cf_email__" data-cfemail="154547544661747373557371743b7d7d663b727a63">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tobacco Products, User Fees, Requirements for the Submission of Data
Needed To Calculate 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.
FDA utilizes Form FDA 3852, entitled ``Report of Tobacco Product
Removals Subject to Tax for Tobacco Product User Fee Assessment'', to
facilitate the collection of data necessary for calculating tobacco
product user fee assessments. This form is used by domestic
manufacturers and importers of tobacco products to report the quantity
of products removed from manufacturing facilities or imported into the
United States for sale.
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).
In the Federal Register of May 1, 2025 (90 FR 18687), FDA published
a 60-day
[[Page 35702]]
notice requesting public comment on the proposed collection of
information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Total Average
Number of Number of number of burden per Total
21 CFR section respondents responses per annual response in hours
respondent responses hours
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1150.5(a), (b)(1) and (2), and Form FDA 3852; 820 12 9,840 3 29,520
Identification and removal information
(monthly)...................................
1150.5(b)(3); Certified copies (monthly)..... 820 12 9,840 1 9,840
Voluntary premium cigar data submission 50 12 600 1.5 900
(monthly)...................................
1150.13; Payment of user fee assessment 319 4 1,276 1 1,276
(quarterly).................................
1150.15(a); Submission of user fee dispute 2 1 2 10 20
(at discretion of respondent)...............
1150.15(d); Submission of request for further 1 1 1 5 5
review of dispute of user fee (at discretion
of respondent)..............................
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Total.................................... ........... .............. 21,559 ........... 41,561
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\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 requires the use of Form FDA 3852 to capture the
monthly identification and removal information specified under Sec.
1150.5(b)(1) and (b)(2). The form also directs manufacturers and
importers to attach supporting documentation required by Sec.
1150.5(b)(3). 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 Sec. 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: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14221 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
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