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[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
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