[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5909-5913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01217]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5943]
Agency Information Collection Activities; Proposed Collection;
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 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 revision 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 Product Establishment Registration and
Listing.''
DATES: Either electronic or written comments on the collection of
information must be submitted by March 18, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be
[[Page 5910]]
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of March
18, 2025. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received 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-2024-N-5943 for ``Tobacco Product Establishment Registration and
Listing.'' 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: 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,
[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 revision 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 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.
Tobacco Product Establishment Registration and Listing
OMB Control Number 0910-0650--Revision
This information collection supports the Food and Drug
Administration 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 Commissioner of Food and Drugs 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 5911]]
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
https://www.fda.gov/media/77915/download, and Form FDA 3741a,
``Registration and Listing for Owners and Operators of Domestic Deemed
Tobacco Product Establishments,'' available at https://www.fda.gov/media/99863/download) 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 https://www.fda.gov/tobacco-products/manufacturing/tobacco-registration-and-listing-module-next-generation-trlm-ng-instructions, to facilitate
efficiency and timeliness of data submission and management.
FDA has also published a guidance for industry entitled
``Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments'' (March 2023; https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf). 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. Finally, FDA is proposing to add a new product listing
spreadsheet (Form FDA 3741b) to this information collection. FDA
anticipates the new Form FDA 3741b will streamline product listing
submissions and subsequent FDA review.
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, cut down on redundancies, increase overall user efficiency and
ultimately enable industry to more accurately and efficiently convey
the required registration and listing information to FDA as required by
section 905 of the FD&C Act. Both ``Registration and Listing for Owners
and Operators of Domestic Tobacco Product Establishments''; Form FDA
3741 and ``Registration and Listing for Owners and Operators of
Domestic Deemed Tobacco Product Establishments''; Form FDA 3741a 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 https://www.fda.gov/media/77661/download) 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 entitled ``Listing of Ingredients in
Tobacco Products'' (March 2023; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/listing-ingredients-tobacco-products). This guidance is intended to assist persons making tobacco
product ingredient listing submissions. FDA also provides a technical
guide, embedded hints, and a web tutorial to the electronic portal,
available at https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions.
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 1 2 to be subject to Chapter
9 of
[[Page 5912]]
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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FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden1
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Number of
FDA form/activity/FD&C section Number of responses per Total annual Hours per Total hours
respondents respondent responses response
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Establishment Registration 75 1 75 1.6 (96 minutes) 120
(Initial), the initial
registration of a tobacco
product establishment
(Current) Form FDA 3741,
Registration and Product
Listing for Owners and
Operators of Domestic
Establishments; Form FDA
3741a-Registration and
Listing for Owners and
Operators of Domestic Deemed
Tobacco Product
Establishments (Electronic
and Paper submissions)
Sections 905(b), 905(c),
905(d), 905(h), or 905(i).
Establishment Registration 75 1 75 1.5 (90 mins)... 113
(Initial), the initial
registration of a tobacco
product establishment
(Updated) Form FDA 3741,
Registration and Product
Listing of Tobacco Product
Manufacturing Establishments
Sections 905(b), 905(c),
905(d), 905(h), or 905(i).
Establishment Registration 1,003 1 1,003 .17 (10 minutes) 171
(Renewal), the registration
renewal of a tobacco product
establishment (Current) Form
FDA 3741, Registration and
Product Listing for Owners
and Operators of Domestic
Establishments; Form 3741a-
Registration and Listing for
Owners and Operators of
Domestic Deemed Tobacco
Product Establishments
(Electronic and Paper
submissions) Sections 905(b),
905(c), 905(d), 905(h), or
905(i).
Establishment Registration 1,003 1 1,003 .33 (20 min).... 331
(Renewal), the registration
renewal of a tobacco product
establishment (Updated) Form
FDA 3741, Registration and
Product Listing of Tobacco
Product Manufacturing
Establishments Sections
905(b), 905(c), 905(d),
905(h), or 905(i).
Product Listing (Initial), the 75 1 75 2 (120 mins).... 150
initial listing of tobacco
products (New) Form FDA
3741b, (New) Product List and
Material File Information
Spreadsheet.
Product Listing (Renewal) 1,003 1 1,003 .5 (30 mins).... 502
updates to the tobacco
product listings (New) Form
FDA 3741b, (New) Product List
and Material File Information
Spreadsheet.
Tobacco Product Listing Form 16 1 16 2 (120 mins).... 32
FDA 3742, Listing of
Ingredients Section 904(a)(1).
Tobacco Product Listing Form 37 10 370 .40 (24 minutes) 148
FDA 3742, Listing of
Ingredients Section 904(c).
Obtaining a Dun and Bradstreet 100 1 100 0.5 (30 minutes) 50
D-U-N-S Number.
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Total..................... .............. .............. 2,642 ................ 1,617
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We have revised our burden estimates to this information
collection. 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.
[[Page 5913]]
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. ``Tobacco
Product Establishment Initial Registration and Listing''; Form FDA
3741: ``Registration and Product Listing for Owners and Operators of
Domestic Establishments''; Form FDA 3741a: ``Registration and Listing
for Owners and Operators of Domestic Deemed Tobacco Product
Establishments'' (Electronic and Paper submissions) reflects a
reduction from 200 to 75 respondents and ``Tobacco Product
Establishment Renewal Registration and Listing''; Form FDA 3741:
``Registration and Product Listing for Owners and Operators of Domestic
Establishments''; Form FDA 3741a: ``Registration and Listing for Owners
and Operators of Domestic Deemed Tobacco Product Establishments''
(Electronic and Paper submissions) reflects a reduction from 2,572 to
1,003 respondents.
Under sections 905(b), 905(c), 905(d), 905(h), or 905(i) of the
FD&C Act, FDA estimates up to 75 new establishments will submit one
initial establishment registration and product listing report each
year. These estimates reflect the burden that will be associated with
this information collection upon OMB approval of the revision and
implementation of the proposed updates. The Agency estimates that up to
75 tobacco establishments will each submit 1 initial establishment
registration and product listing report each year using the new Form
FDA 3741, ``Registration and Product Listing of Tobacco Product
Manufacturing Establishments'', which is expected to take 1.5 hours,
for a total 113 burden hours.
FDA estimates up to 75 establishments will submit one initial
listing of tobacco products report each year. These estimates reflect
the burden that will be associated with this information collection
upon OMB approval of the revision and implementation of the proposed
updates. The Agency estimates that up to 75 tobacco establishments will
each submit 1 initial product list and material file information
spreadsheet each year using the new Form FDA 3741b, which is expected
to take 2 hours, for a total 150 burden hours.
FDA estimates that the confirmation or updating of establishment
registration and product listing information as required by section 905
of the FD&C Act will take 20 minutes annually per confirmation or
update per establishment. These estimates reflect the burden that will
be associated with this information collection upon OMB approval of the
revision and implementation of the proposed updates. Based on FDA's
experience with current establishment registration and product listings
submitted to the Agency, the Agency estimates that on average 1,003
establishments will each submit one confirmation or updated report each
year, using the new Form FDA 3741, which is expected to take 0.33 hour
(20 minutes) for a total 331 burden hours.
FDA estimates that the confirmation or updating of listing of
tobacco products will take 30 minutes annually per confirmation or
update per establishment. These estimates reflect the burden that will
be associated with this information collection upon OMB approval of the
revision and implementation of the proposed updates. Based on FDA's
experience with current establishment registration and product listings
submitted to the Agency, the Agency estimates that on average 1,003
establishments will each submit one confirmation or updated report each
year, using the new Form FDA 3741b, which is expected to take 0.5 hour
(30 minutes) for a total 502 burden hours.
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 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 DUNS (data universal numbering system) 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 DUNS number. FDA estimates that up to 100
establishments that would need to obtain this number each year. The
total industry burden to obtain a DUNS number is 50 hours.
Our estimated burden for the information collection reflects an
overall increase of 655 hours and a decrease of 616 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, ``Product List and Material
File Information Spreadsheet''.
Dated: January 14, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-01217 Filed 1-16-25; 8:45 am]
BILLING CODE 4164-01-P