Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form
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 cle...
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
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 0910-0716. 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,
PRAStaff@fda.hhs.gov.
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.
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
Activity and form FDA 3779
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response in hours
Total hours
Reporting potential tobacco product violations of the FD&C Act
3,000
2
6,000
0.25 (15 minutes)
1,500
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
( printed 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 × 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.
www.reginfo.gov/public/do/PRAMain
44 U.S.C. 3507
www.accessdata.fda.gov/scripts/ptvr/index.cfm
www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation