Document ID: FDA-2013-N-0190-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Warning Plans for
Smokeless Tobacco Products
Posted Date: 2022-10-18T04:00Z

[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22615]

[[Page 63075]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Warning Plans for 
Smokeless Tobacco Products

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 November 17, 2022.

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 0910-0671. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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).
    In the Federal Register of May 9, 2022 (87 FR 27644), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. Two comments that were not PRA-related were received.
    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: October 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22615 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P