Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Smokeless Tobacco Products, 63075 [2022-22615]
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63075
Federal Register / Vol. 87, No. 200 / Tuesday, October 18, 2022 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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, PRAStaff@
fda.hhs.gov.
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
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
Warning Plans for Smokeless Tobacco
Products
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.
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
AGENCY:
SUMMARY:
OMB Control Number 0910–0671—
Extension
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-cigarettesand-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-warningstatements-tobacco-products/smokelesstobacco-labeling-and-warningstatement-requirements). Additionally,
FDA considers a submission to be a
supplement if the submitter is seeking
approval of a change to an FDAapproved 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 PRArelated were received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Submission of initial rotational plans for health warning
statements ........................................................................
Supplement to approved plan ..............................................
1
4
1
1
1
4
60
30
60
120
Total ..............................................................................
........................
........................
........................
........................
180
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
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
VerDate Sep<11>2014
19:52 Oct 17, 2022
Jkt 259001
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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18OCN1.SGM
18OCN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Submission of initial rotational 1 1 1 60 60
plans for health warning
statements.....................
Supplement to approved plan..... 4 1 4 30 120
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 180
----------------------------------------------------------------------------------------------------------------
\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
