Notice2025-17222
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Establishment Registration and Listing
Primary source
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Published
September 9, 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 172 (Tuesday, September 9, 2025)</title>
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[Federal Register Volume 90, Number 172 (Tuesday, September 9, 2025)]
[Notices]
[Pages 43455-43458]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17222]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5943]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Product
Establishment Registration and Listing
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 October 9, 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 0910-0650. 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#316163706245505757715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="411113001235202727012725206f2929326f262e37">[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 Product Establishment Registration and Listing
OMB Control Number 0910-0650--Revision
This information collection supports the Food and Drug
Administration (FDA, us, or we) regulations and guidance. Tobacco
products are generally governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (sections 900 through 921) (21 U.S.C.
387 through 21 U.S.C. 387u).
Section 905 of the FD&C Act requires the annual registration of any
``establishment in any State engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.''
Section 905 of the FD&C Act requires this registration be completed by
December 31 of each year. The Secretary of Health and Human Services
(Secretary) has delegated to the FDA Commissioner the responsibility
for administering the FD&C Act, including section 905. Section 905 of
the FD&C Act requires owners or operators of each establishment to
register: (1) their name; (2) places of business; (3) a list of all
tobacco products which are manufactured by that person; (4) a copy of
all labeling and a reference to the authority for the marketing of any
tobacco product subject to a tobacco
[[Page 43456]]
product standard under section 907 of the FD&C Act (21 U.S.C. 387g) or
to premarket review under section 910 of the FD&C Act (21 U.S.C. 387j);
(5) a copy of all consumer information and other labeling; (6) a
representative sampling of advertisements; (7) upon request made by the
Secretary for good cause, a copy of all advertisements for a particular
tobacco product; and (8) upon request made by the Secretary, if the
registrant has determined that a tobacco product contained in the
product list is not subject to a tobacco product standard established
under section 907 of the FD&C Act, a brief statement of the basis upon
which the registrant made such determination.
FDA collects the information submitted pursuant to section 905 of
the FD&C Act through the Tobacco Registration and Product Listing
Module Next Generation (TRLM NG) electronic portal, and through paper
forms; Form FDA 3741, ``Registration and Listing for Owners and
Operators of Domestic Tobacco Product Establishments,'' available at
<a href="http://www.fda.gov/media/77915/download">www.fda.gov/media/77915/download</a>, and Form FDA 3741a, ``Registration
and Listing for Owners and Operators of Domestic Deemed Tobacco Product
Establishments,'' available at <a href="http://www.fda.gov/media/99863/download">www.fda.gov/media/99863/download</a>, for
those individuals who are unable to submit online through TRLM NG. TRLM
NG is designed to streamline the data entry process for registration
and product listing. FDA strongly encourages electronic submission
through TRLM NG, available at <a href="http://www.fda.gov/tobacco-products/manufacturing/tobacco-registration-and-listing-module-next-generation-trlm-ng-instructions">www.fda.gov/tobacco-products/manufacturing/tobacco-registration-and-listing-module-next-generation-trlm-ng-instructions</a>, to facilitate efficiency and timeliness of data
submission and management.
FDA has published a guidance for industry titled ``Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments'' (March 2023; <a href="http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf">www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf</a>). This guidance is
intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA.
At this time, FDA is proposing several updates to the information
submitted pursuant to section 905 of the FD&C Act through Form FDA
3741, Form FDA 3741a, and the corresponding information submitted
electronically through TRLM NG. The updates include: (1) merging the
contents of Form FDA 3741a into Form FDA 3741 to create an updated and
comprehensive Form FDA 3741, ``Registration and Product Listing of
Tobacco Product Manufacturing Establishments''; (2) restructuring and
developing sections of the updated Form FDA 3741 for ease of navigation
and data input; (3) updating terminology of the updated Form FDA 3741
for clarity; (4) updating instructions of the updated Form FDA 3741 for
clarity; and (5) aligning tobacco product categories and subcategories
of the updated Form FDA 3741 to be consistent with other FDA tobacco
forms. Since the publication of the 60-day Federal Register notice, the
following changes have been applied to the updated Form FDA 3741: (1)
material file data elements have been added and are captured in TRLM
NG; and (2) product listing updates can be entered directly in TRLM NG
and relevant data elements have been added to Form FDA 3741 in case of
paper submissions. Finally, as discussed in the 60-day Federal Register
notice, FDA is proposing to add Form FDA 3741b, a new product listing
spreadsheet, to this information collection. FDA anticipates the new
Form FDA 3741b will streamline product listing submissions and
subsequent FDA review. Since the publication of the 60-day Federal
Register notice, the following changes have been applied to the product
listing spreadsheet (Form FDA 3741b): (1) removal of the ``Material
Files'' tab, which will now be captured through TRLM NG user interface
as part of Form FDA 3741; (2) restriction of form usage to initial
product list submissions only, as this form will be used exclusively
for initial submissions; (3) addition of ``Universal Product Code''
field to improve data quality and traceability; (4) removal of multiple
data elements regarding manufacturer information, product marketing,
and product status fields from the spreadsheet, which will be
incorporated into Form FDA 3741 and TRLM NG for improved efficiency.
Although these proposed updates will increase the overall length of
the updated and comprehensive Form FDA 3741 and the corresponding
information submitted electronically through TRLM NG, FDA anticipates
these updates will streamline the navigation and completion of Form FDA
3741, reduce redundancies, increase overall user efficiency and
ultimately enable industry to more accurately convey the required
registration and listing information to FDA as required by section 905
of the FD&C Act. Both current versions of Form FDA 3741, ``Registration
and Listing for Owners and Operators of Domestic Tobacco Product
Establishments''; and Form FDA 3741a, ``Registration and Listing for
Owners and Operators of Domestic Deemed Tobacco Product
Establishments'', will be discontinued upon implementation of the
updated and comprehensive Form FDA 3741, ``Registration and Product
Listing of Tobacco Product Manufacturing Establishments''.
Section 904(a)(1) of the FD&C Act requires that each tobacco
product manufacturer or importer submit ``a listing of all ingredients,
including tobacco, substances, compounds, and additives that are, as of
such date, added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand'' by December 22, 2009. This section applies only to
those tobacco products manufactured and distributed before June 22,
2009, and which are still manufactured as of the date of the ingredient
listing submission.
Section 904(c) of the FD&C Act requires that a tobacco product
manufacturer: (1) provide all information required under section 904(a)
of the FD&C Act to FDA ``at least 90 days prior to the delivery for
introduction into interstate commerce of a tobacco product not on the
market on the date of enactment''; (2) advise FDA in writing at least
90 days prior to adding any new tobacco additive or increasing in
quantity an existing tobacco additive, except for those additives that
have been designated by FDA through regulation as not a human or animal
carcinogen, or otherwise harmful to health under intended conditions of
use; and (3) advise FDA in writing at least 60 days of such action of
eliminating or decreasing an existing additive, or adding or increasing
an additive that has been designated by FDA through regulation as not a
human or animal carcinogen, or otherwise harmful to health under
intended conditions of use.
FDA collects the information submitted pursuant to section
904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and
through a paper form (Form FDA 3742, ``Listing of Ingredients in
Tobacco Products'' available at <a href="http://www.fda.gov/media/77661/download">www.fda.gov/media/77661/download</a>) for
those individuals who choose not to use the electronic portal.
In addition to the development of the electronic portal and paper
form, FDA published a guidance titled ``Listing of Ingredients in
Tobacco Products'' (March 2023; <a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/listing-ingredients-tobacco-products">www.fda.gov/regulatory-information/search-fda-guidance-documents/listing-ingredients-tobacco-products</a>).
This guidance is intended to assist persons making tobacco product
[[Page 43457]]
ingredient listing submissions. FDA also provides a technical guide,
embedded hints, and a web tutorial to the electronic portal, available
at <a href="http://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions">www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions</a>. The Tobacco Control Act also gave FDA the
authority to issue a regulation deeming all other products that meet
the statutory definition of a tobacco product <SUP>1 2</SUP> to be
subject to Chapter 9 of the FD&C Act (section 901(b) of the FD&C Act
(21 U.S.C. 387a(b))). On May 10, 2016, FDA issued that rule, extending
FDA's tobacco product authority to all products that meet the
definition of tobacco product in the law (except for accessories of
newly regulated tobacco products), including electronic nicotine
delivery systems, cigars, hookah tobacco, pipe tobacco, nicotine gels,
and dissolvables that were not already subject to the FD&C Act, and
other tobacco products that may be developed in the future (81 FR 28974
at 28976) (``the final deeming rule'').
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\1\ Tobacco Product: as stated in section 201(rr) of the FD&C
Act in relevant part, a tobacco product: (1) means any product made
or derived from tobacco, or containing nicotine from any source,
that is intended for human consumption, including any component,
part, or accessory of a tobacco product (except for raw materials
other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product); and (2) does not mean an article
that is a drug defined under section 201(g)(1) of the FD&C Act, a
device defined under section 201(h) of the FD&C Act, or a
combination product described in section 503(g) of the FD&C Act, or
a food under section 201(f) of the FD&C Act if it contains no
nicotine, or no more than trace amounts of naturally occurring
nicotine.
\2\ Premium Cigars: on August 9, 2023, the U.S. District Court
for the District of Columbia issued an order vacating FDA's rule
deeming tobacco products to be subject to FDA's tobacco product
authorities ``insofar as it applies to premium cigars.'' Cigar Ass'n
of Am. v. FDA, No. 16-cv-01460, Dkt. No. 277 (D.D.C. Aug. 9, 2023),
appeal filed No. 23-5220 (D.C. Cir. Sep. 29, 2023).
For purposes of its ruling, the court specified that premium
cigars are those cigars that:
(1) are wrapped in whole tobacco leaf; (2) contain a 100 percent
leaf tobacco binder; (3) contain at least 50 percent (of the filler
by weight) long filler tobacco; (4) are handmade or hand rolled; (5)
have no filter, nontobacco tip, or nontobacco mouthpiece; (6) do not
have a characterizing flavor other than tobacco; (7) contain only
tobacco, water, and vegetable gum with no other ingredients or
additives; and (8) weigh more than 6 pounds per 1,000 units.
FDA recognizes that, absent further relief, it is bound by the
District Court's order. The Agency is continuing to evaluate the
evolving legal and practical circumstances surrounding premium
cigars and will provide further information as it is available.
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In the Federal Register of January 17, 2025 (90 FR 5909), FDA
published a 60-day 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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No. of
FDA form/activity/FD&C act Number of responses per Total annual Hours per response Total hours
section respondents respondent responses
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Establishment Registration 37 1 37 1.65 (99 minutes). 61
(Initial), the initial
registration of a tobacco
product establishment using
Form FDA 3741, Form FDA 3741a,
and the new Form FDA 3741
(Electronic and Paper
submissions) \2\ Sections
905(b), 905(c), 905(d),
905(h), or 905(i).
Establishment Registration 900 1 900 0.28 (17 minutes). 252
(Renewal), the registration
renewal of a tobacco product
establishment using Form FDA
3741, Form FDA 3741a, and the
new Form FDA 3741 (Electronic
and Paper submissions) \3\
Sections 905(b), 905(c),
905(d), 905(h), or 905(i).
Product Listing (Initial), the 37 1 37 0.22 (13 minutes). 8
initial listing of tobacco
products (New) Form FDA 3741b,
``Tobacco Product List
Spreadsheet''.
Tobacco Product Listing Form 16 1 16 2 (120 minutes)... 32
FDA 3742, ``Listing of
Ingredients in Tobacco
Products'' Section 904(a)(1).
Tobacco Product Listing Form 37 10 370 0.40 (24 minutes). 148
FDA 3742, ``Listing of
Ingredients'' Section 904(c).
Obtaining a Dun & Bradstreet D- 37 1 37 0.5 (30 minutes).. 19
U-N-S Number.
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Total...................... .............. .............. 1,397 .................. 520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This initial submission is averaged over the three years of the information collection utilizing the current
Form FDA 3741 and 3741a, which will be combined in updated Form FDA 3741 in Spring 2026.
\3\ This renewal submission is averaged over the three years of the information collection utilizing the current
Form FDA 3741 and 3741a, which will be combined in Form FDA 3741 ``Registration and Product Listing of Tobacco
Product Manufacturing Establishments'' with product listing and material file information updates.
Since publication of the 60-day Federal Register notice, we have
revised our estimates to consolidate like activities, and the estimated
annual reporting burden for establishment registration and product
listing based on updated center data. We believe this is a more
accurate picture of what our annualized burden would be. FDA has based
these estimates on experience with this information collection,
information we have available from interactions with industry,
registration and listing reports, and TRLM NG.
FDA estimates that the updated Form FDA 3741 will be available and
required to be used by tobacco product manufacturers in Spring 2026. As
mentioned previously in this notice, this new form will replace both
the current Form FDA 3741 and Form 3741a, which is scheduled to be
discontinued in Spring 2026. To capture this consolidation accurately
in the burden table, we have combined like activities from the 60-day
Federal Register notice and averaged the burden
[[Page 43458]]
over the 3-year approved information collection request (ICR) period
for a more comprehensive burden table.
Based on updated data, we have revised our estimate for sections
905(b), 905(c), 905(d), 905(h), or 905(i) of the FD&C Act. Based on
FDA's experience with current establishment registration and product
listing information submitted to the agency, FDA has lowered the
estimated annual respondents for (1) initial tobacco product
establishment registration and listing (via Form FDA 3741) from 200 to
37 respondents, and (2) renewal of tobacco product establishment and
listing (via Form FDA 3741) from 2,572 to 900 respondents.
The agency estimates that up to 37 new establishments will each
submit one initial establishment registration and product listing via
the current Form FDA 3741. The agency retains the hours per response
estimate of 1.60 hours (or 96 minutes) for the initial tobacco product
establishment registration and listing via the current Form FDA 3741,
which FDA estimates manufacturers will need to use through the first
year of the 3-year ICR approval period. Once the updated Form FDA 3741
is released, FDA estimates its completion to take 1.67 hours (100
minutes) for an initial registration of a tobacco product establishment
and material file submission. As shown in Table 1, averaged across the
3-year ICR period, FDA estimates an average annual burden of 1.65 hours
(99 minutes) for a total of 61 burden hours (across the 37 annual
respondents). FDA estimates up to 37 establishments will each submit 1
initial product listing spreadsheet each year using the new Form FDA
3741b, which is expected to take 0.33 hours (20 minutes), for a total
of 12 burden hours. Averaged across the 3-year ICR approval period, FDA
estimates an average annual hours per response of 0.22 hours (8 average
total hours) because, as noted above, the agency estimates that tobacco
product manufacturers will not start using this new form until Year 2
of the 3-year ICR approval period.
Based on updated data, FDA estimates that the annual number of
respondents for establishment registration and product listing renewals
required under FD&C Act section 905 (Form FDA 3741) will decrease from
2,572 to 900. FDA retains the hours per response estimate of 10 minutes
(0.17 hours) for the registration renewal via the current Form FDA
3741, which FDA estimates manufacturers will need to use through the
first year of the 3-year ICR approval period. For Years 2 and 3, FDA
estimates that the updated Form FDA 3741 will take 20 minutes (0.33
hours) for registration renewal. The renewal time increases with the
updated Form FDA 3741 because the consolidated registration renewal
process now encompasses establishment registration, product listing
updates, and material file updates. Averaged across the 3-year ICR
period, FDA estimates an average annual burden of 0.28 hours (17
minutes) for a total of 252 burden hours (across the 900 annual
respondents).
FDA estimates that the submission of ingredient listings required
by section 904(a)(1) of the FD&C Act for each establishment will take 2
hours initially. Ingredients may be submitted electronically through
the CTP Portal Next Generation or if unable to submit ingredients
electronically then by mail using Form FDA 3742. FDA estimates that 16
establishments will initially submit one report annually at 2 hours per
report, for a total of 32 hours.
Based on FDA's experience and the number of new products authorized
to be introduced or delivered for introduction into interstate commerce
submitted over the past 3 years, FDA estimates that 37 establishments
will each submit 10 reports (one every 6 months). FDA also estimates
that the confirmation or updating of product (ingredient) listing
information required by section 904(c) of the FD&C Act is expected to
take 0.40 hour (24 minutes) for a total 148 burden hours. FDA estimates
that obtaining a D-U-N-S number will take 30 minutes. FDA assumes that
all new establishment facilities that will be required to initially
register under section 905 of the FD&C Act would obtain a D-U-N-S
number. FDA estimates that up to 37 establishments that would need to
obtain this number each year. The total industry burden to obtain a D-
U-N-S number is 19 hours.
Our estimated burden for the information collection reflects an
overall decrease of 442 hours and a decrease of 1,861 annual responses.
We attribute this adjustment to the proposed revisions to this
information collection to add the updated and comprehensive Form FDA
3741, ``Registration and Product Listing of Tobacco Product
Manufacturing Establishments'' and add Form FDA 3741b, ``Tobacco
Product List Spreadsheet''.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17222 Filed 9-8-25; 8:45 am]
BILLING CODE 4164-01-P
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