[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18687-18688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07585]
[[Page 18687]]
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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.
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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,
[email protected].
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.
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
[[Page 18688]]
the information will have practical utility; (2) the accuracy of FDA's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
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:
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 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: 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]
BILLING CODE 4164-01-P