[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27644-27646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0190]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Warning Plans for Smokeless Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection provisions 
associated with warning plans for smokeless tobacco products.

DATES: Submit either electronic or written comments on the collection 
of information by July 8, 2022.

[[Page 27645]]


ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 8, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 8, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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-2013-N-0190 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Warning Plans for Smokeless 
Tobacco Products.'' 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 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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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.

Warning Plans for Smokeless Tobacco Products

OMB Control Number 0910-0671--Extension

    Tobacco products are governed by chapter IX of the Federal Food, 
Drug, and Cosmetic Act (sections 900 through 920) (21 U.S.C. 387 
through 21 U.S.C. 387t). Section 3 of the Comprehensive Smokeless 
Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act) (15 
U.S.C. 4402) requires, among other things, that all smokeless tobacco 
product packages and advertisements bear one of four required warning 
statements. Section (b)(3)(A) of 15 U.S.C. 4402 requires that the 
warnings be displayed on packaging and advertising for each brand of 
smokeless tobacco ``in accordance with a plan submitted by the tobacco 
product manufacturer, importer, distributor, or retailer'' to, and 
approved by, FDA.
    To implement these statutory requirements, warning plans are 
reviewed by FDA, upon submission by respondents. FDA published a draft 
guidance entitled ``Submission of

[[Page 27646]]

Warning Plans for Cigarettes and Smokeless Tobacco Products'' on 
September 9, 2011, which describes the information and format to be 
submitted for smokeless plans (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products). Submitters may also visit a 
web page that describes the smokeless tobacco labeling and warning 
statement requirements (https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements). Additionally, FDA considers a 
submission to be a supplement if the submitter is seeking approval of a 
change to an FDA-approved warning plan. Warning plans can be submitted 
either electronically or in paper format. The Center for Tobacco 
Products (CTP) Portal, available at https://ctpportal.fda.gov/ctpportal/login.jsp, provides a secure online system for electronically 
submitting documents and receiving messages from CTP.
    Based on our experience with the information collection over the 
past 3 years, we retain our estimate of 60 hours to complete an initial 
rotational plan. We estimate half this time for preparing and 
submitting a supplement to an approved plan (30 hours).
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Submission of initial rotational               1               1               1              60              60
 plans for health warning
 statements.....................
Supplement to approved plan.....               4               1               4              30             120
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    Total.......................  ..............  ..............  ..............  ..............             180
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates a total of 1 respondent will submit a new original 
warning plan yearly and take 60 hours to complete a rotational warning 
plan for a total of 60 burden hours. In addition, FDA estimates a total 
of 4 respondents will submit a supplement to an approved warning plan 
at 30 hours per response for a total of 120 hours. After receiving the 
initial influx of original warnings plans, FDA does not expect to 
receive as many original warning plans annually. We expect that a few 
supplements will continue to be received as new products are marketed 
or as warning plans are revised. Therefore, we have decreased our 
estimate burden by 360 hours.

    Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09885 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-P


