[Federal Register Volume 90, Number 186 (Monday, September 29, 2025)]
[Notices]
[Pages 46609-46610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18806]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0352]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Establishing That a Tobacco Product Was Commercially Marketed in the
United States
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 29, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0775. 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, 10 a.m.-12 p.m,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
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) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007-revised) 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.
In the Federal Register of June 27, 2025 (90 FR 27632), 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:
[[Page 46610]]
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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market.
\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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18806 Filed 9-26-25; 8:45 am]
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