Notice2022-22615
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Smokeless Tobacco Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 200 (Tuesday, October 18, 2022)</title>
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[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63075]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#4e1e1c0f1d3a2f28280e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="8adad8cbd9feebececcaeceeeba4e2e2f9a4ede5fc">[email protected]</span></a>.
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 (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-warning-plans-cigarettes-and-smokeless-tobacco-products</a>).
Submitters may also visit a web page that describes the smokeless
tobacco labeling and warning statement requirements (<a href="https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/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</a>). 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 <a href="https://ctpportal.fda.gov/ctpportal/login.jsp">https://ctpportal.fda.gov/ctpportal/login.jsp</a>, 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
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