Notice2022-09885
Agency Information Collection Activities; Proposed Collection; Comment Request; Warning Plans for Smokeless Tobacco Products
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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
May 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 89 (Monday, May 9, 2022)</title>
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[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27644-27646]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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 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: 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#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="035351425077626565436567622d6b6b702d646c75">[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.
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 (<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).
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
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