Notice2023-02172
Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
Primary source
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Published
February 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 the Potential Tobacco Product Violations Reporting Form.
Full Text
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<title>Federal Register, Volume 88 Issue 22 (Thursday, February 2, 2023)</title>
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[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7091-7093]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0086]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) 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 the Potential Tobacco Product
Violations Reporting Form.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 3, 2023.
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 April 3, 2023. 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-2014-N-0086 for ``Potential Tobacco Product Violations Reporting
Form.'' 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
[[Page 7092]]
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: Amber Sanford, 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#f3a3a1b2a087929595b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="045456455770656262446260652a6c6c772a636b72">[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 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.
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. 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 <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>.
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 Total hours
respondents respondent responses per response
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Reporting potential tobacco 3,000 2 6,000 0.25 (15 1,500
product violations of the minutes).
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
[[Page 7093]]
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. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: January 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02172 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P
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