Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form

Issuing agencies

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.

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<title>Federal Register, Volume 91 Issue 167 (Monday, August 31, 2026)</title>
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[Federal Register Volume 91, Number 167 (Monday, August 31, 2026)]
[Notices]
[Pages 55856-55857]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-6540]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Potential Tobacco 
Product Violations Reporting Form

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 September 30, 2026.

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 0910-0716. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Barrett, 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#247476657750454242644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="722220332106131414321416135c1a1a015c151d04">[email&#160;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.

Potential Tobacco Product Violations Reporting Form

OMB Control Number 0910-0716--Extension

    This information collection supports the opportunity to accept 
consumer and other stakeholder feedback and notification of potential 
violations of the FD&C Act, as amended by the Tobacco Control Act. 
Tobacco products are generally governed by chapter IX of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 
U.S.C. 387 through 21 U.S.C. 387u). The FD&C Act provides FDA authority 
to monitor compliance with Federal tobacco laws and regulations and 
take corrective action when violations occur.
    As part of its enforcement strategy, FDA accepts information from 
the public regarding potential tobacco product violations of the FD&C 
Act. Potential tobacco product violations include (but are not limited 
to): (1) sales to underage purchasers (persons under 21); (2) flavored 
cigarette sales; (3) illegal marketing and advertising; (4) 
distribution of free samples of tobacco products except in limited 
circumstances; (5) placement of cigarette or smokeless tobacco product 
vending machines in prohibited areas (or providing access to self-
service or direct access of tobacco products in prohibited areas); (6) 
the manufacture or sale of unauthorized tobacco products; and (7) sale 
of cigarettes in packages of less than 20.
    FDA currently provides a form that may be used to collect this 
information from the public (Form FDA 3779, Potential Tobacco Product 
Violations Report). The Potential Tobacco Product Violations Report, 
Form FDA 3779, asks for the following information: (1) date potential 
violation occurred; (2) product type (e.g., cigarette, smokeless, roll-
your-own, cigar, e-cigarette, hookah, pipe tobacco); (3) tobacco brand; 
(4) potential violation type; (5) type of potentially violative 
promotional materials; (6) description of the potential violation (7) 
who potentially violated; (8) name and address of the potential 
violator (if known); (9) potential violator's website or internet 
address URL (if available); (10) Optional filer contact information if 
additional information is needed or to receive notification the 
complaint was received; and (11) any additional files or information 
pertinent to the potential violation.
    The public and interested stakeholders can report possible tobacco 
product violations of the FD&C Act by submitting information on Form 
FDA 3779 online, via email or postal mail, or by calling FDA's Tobacco 
Call Center. Information on how to submit possible tobacco product 
violations using the options above can be found at <a href="https://www.accessdata.fda.gov/scripts/ptvr/index.cfm">https://www.accessdata.fda.gov/scripts/ptvr/index.cfm</a>. Further details about 
reporting possible tobacco product violations of the FD&C Act can also 
be found at <a href="https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation">https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation</a>.
    In the Federal Register of June 23, 2026 (91 FR 37410), 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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                                                                  Number of
          Activity and form FDA 3779              Number of     responses per   Total annual      Average burden per response in hours      Total hours
                                                 respondents     respondent       responses
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Reporting potential tobacco product                     3,000               2           6,000  0.25 (15 minutes)........................           1,500
 violations of the FD&C Act.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were 
based on the type and rate of reporting submitted through the Potential 
Tobacco Violation Report Form and based on a review of the information 
collection since our last request for OMB approval. FDA estimates that 
submitting the information (online, telephone, email, or mail) will 
take 0.25 hours (i.e., 15 minutes) per response.
    FDA estimates the number of annual respondents to this collection 
of information will be 3,000, who will each submit 2 reports. Each 
report is

[[Page 55857]]

expected to take 0.25 hours to complete and submit; therefore, total 
burden hours for this collection of information is estimated to be 
1,500 hours (6,000 responses x 0.25 hours per response).
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17677 Filed 8-28-26; 8:45 am]
BILLING CODE 4164-01-P


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