[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47145-47146]
[FR Doc No: 2023-15459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0086]

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 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by August 21, 2023.

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 0910-0716. 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[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.

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 Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Tobacco Control Act. Tobacco products are generally
governed by chapter IX of the

FD&C Act (sections 900 through 920) (21 U.S.C. 387 through 21 U.S.C.
387t). 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); and
(6) 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) who potentially violated; (7) name, address,
phone number, and email address of the potential violator (if known);
(8) potential violator's website or internet address URL (if
available); (9) description of the potential violation; and (10) 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 https://www.accessdata.fda.gov/scripts/ptvr/index.cfm. Further details about
reporting possible tobacco product violations of the FD&C Act can also
be found at https://www.fda.gov/tobacco-products/compliance-enforcement-training/report-potential-tobacco-product-violation.
    In the Federal Register of February 2, 2023 (88 FR 7091), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that was PRA
related.
    (Comment) The form does not have a specific option under
``Potential violation type'' for reporting products that have not gone
through any of the new pathways to market required by the Tobacco
Control Act, including the Premarket Tobacco Product Application
(PMTA). The lack of this option may be confusing and make it difficult
for members of the public who want to report such violations to
determine what sort of violation they are reporting. Thus, we recommend
FDA add ``Product without a marketing authorization'' or a similar
category title, as an option under ``Potential violation type''.
    (Response) FDA has reviewed the comment requesting revisions to the
Potential Tobacco Product Violations Report, Form FDA 3779 (Potential
Tobacco Violation Report Form). The comment correctly points out that
the Potential Tobacco Violation Report Form provides the public with a
mechanism to report potential violations of the tobacco laws and
regulations enforced by the FDA. FDA agrees that a revision to the
Potential Tobacco Violation Report Form is warranted and would assist
the public in reporting potential violations related to the premarket
review and authorization requirements under the law.
    The Potential Tobacco Violation Report Form includes some specific
options related to potential violation types that are often reported,
including, but not limited to, those related to the retail sale of
tobacco products to underage purchasers, flavored cigarette sales, the
distribution of free samples of tobacco products, and other marketing
and advertising requirements. The form has been updated to include an
additional potential violation type: ``Unauthorized Tobacco Product.''
    The Potential Tobacco Violation Report Form is one of many ways the
public can report potential tobacco product violations directly to FDA.
The public and interested stakeholders can also provide detailed
descriptions of potential violations by phone, email, and through the
mail.
    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       Total hours
                                                    respondents       respondent       responses
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Reporting potential tobacco product violations             3,000                2            6,000   0.25 (15 minutes).................           1,500
 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 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).
    Our estimated burden for the information collection reflects an
overall increase of 157 hours and a corresponding increase of 630
responses. FDA attributes this adjustment to an increase in the number
of submissions received over the last few years.

    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15459 Filed 7-20-23; 8:45 am]
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