[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Pages 7091-7093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02172]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
  Activity and form FDA 3779       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Reporting potential tobacco              3,000               2           6,000  0.25 (15                   1,500
 product violations of the                                                       minutes).
 FD&C Act.
----------------------------------------------------------------------------------------------------------------
\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