Notice2025-11961
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27632-27634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11961]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0352]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of February
15, 2007
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 Guidance for Industry on Establishing That
a Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-0352 for ``Guidance for Industry on Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#d585879486a1b4b3b395b3b1b4fbbdbda6fbb2baa3"><span class="__cf_email__" data-cfemail="a2f2f0e3f1d6c3c4c4e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.
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 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
[[Page 27633]]
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.
Guidance for Industry on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007
OMB Control Number--0910-0775 Extension
This information collection supports Food and Drug Administration
guidance. The Federal Food, Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors.
Tobacco products are governed by chapter IX of the FD&C Act
(sections 900 through 920) (21 U.S.C. 387 through 387t). Section
201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended, defines a
tobacco product as 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).
Section 910 of the FD&C Act sets out premarket requirements for new
tobacco products. The term new tobacco product is defined as any
tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 15, 2007, or
any modification (including a change in design, any component, any
part, or any constituent, including a smoke constituent, or in the
content, delivery, or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified product was
commercially marketed in the United States after February 15, 2007
(section 910(a)(1) of the FD&C Act).
FDA refers to tobacco products that were commercially marketed
(including those products in test markets) in the United States as of
February 15, 2007, as Pre-Existing tobacco products. Pre-Existing
tobacco products are not considered new tobacco products and are not
subject to the premarket requirements of section 910 of the FD&C Act.
The guidance document associated with this information collection
provides information on how a manufacturer may establish that a tobacco
product was commercially marketed in the United States as of February
15, 2007. A Pre-Existing tobacco product (except such products
exclusively in test markets) may also serve as the predicate tobacco
product in a section 905(j) report (intended to be used toward
demonstrating substantial equivalence) for a new tobacco product
(section 905(j)(1)A)(i)) of the FD&C Act.
The guidance document ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007
(Revised)'' (2023) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007-revised">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007-revised</a>) recommends that the
manufacturer submit information adequate to demonstrate that the
tobacco product was commercially marketed in the United States as of
February 15, 2007. Examples of such information may include, but are
not limited to, the following: dated copies of advertisements, dated
catalog pages, dated promotional material, and dated bills of lading.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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Submit evidence of commercial marketing in the United States as of 500 1 500 5 2,500
February 15, 2007.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimate of the number of respondents is based on the fact
that requesting an Agency determination of the Pre-Existing status of a
tobacco product under the guidance is not required and also on the
number of Pre-Existing tobacco product submissions received from 2011
to October 2024. All new tobacco products require a marketing
authorization order from FDA before introducing such products in the
U.S. market. If a deemed new tobacco product was on the market as of
August 8, 2016, a marketing application was required to be submitted by
September 9, 2020 as required by the Court, and as set forth in the
Center for Tobacco Products compliance policy (see exception for
premium cigars).\1\ A marketing application must be submitted and
receive authorization to market a new tobacco product that was not on
the market as of August 8, 2016.\2\ The number of hours to gather the
evidence is FDA's estimate of how long it might take a manufacturer to
review, gather, and submit dated information if making a request for
Agency determination.
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\1\ Cigar Ass'n of Am. v. FDA, No. 16-cv-01460, Dkt. No. 277
(D.D.C. Aug. 9, 2023). FDA has appealed this decision. See <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market</a>.
\2\ See https://www.fda.gov/tobacco-products/manufacturing/
submit-tobacco-product-applications-deemed-tobacco-
products#:~:text=On%20August%208%2C%202016%2C%20all,authorization%20r
equirements%20in%20the%20Federal.
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FDA further estimates it would take a manufacturer approximately 5
hours to put together this collection of evidence and to submit the
package to FDA for review. FDA estimates that it would take
approximately 2,500 hours annually to respond to this collection of
information.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Our estimated burden for the
information collection reflects an overall decrease of 2,500 hours and
a corresponding decrease of 500 responses. The number of submissions
FDA received to establish marketing as of February 15, 2007 has
decreased and we have therefore revised the number of respondents to
the information collection based on this data.
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Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11961 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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