Notice2022-24218
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs
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
November 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, 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 214 (Monday, November 7, 2022)</title>
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67043-67045]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24218]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0350]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Retailer
Training Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 67044]]
SUMMARY: The Food and Drug Administration (FDA, Agency, 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 December 7, 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 0910-0745. 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#4d1d1f0c1e392c2b2b0d2b292c6325253e632a223b"><span class="__cf_email__" data-cfemail="a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6">[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.
Tobacco Retailer Training Programs
OMB Control Number 0910-0745--Extension
Tobacco products are governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C.
387 through 21 U.S.C. 387u). FDA intends to issue regulations
establishing standards for approved tobacco retailer training programs
under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)). In the
interim, FDA published a guidance document entitled ``Tobacco Retailer
Training Programs (Revised)'' (2018) that can be downloaded at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs</a>. The guidance is intended to assist
tobacco retailers to voluntarily implement effective training programs
for employees.
The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to youth and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws and regulations
prohibiting their sale to underage persons; (5) age verification
methods; (6) practical guidelines for refusing sales; and (7) testing
to ensure that employees have the required knowledge. The guidance
recommends that retailers require current and new employees to take a
written test prior to selling tobacco products and that refresher
training be provided at least annually and more frequently as needed.
The guidance recommends that retailers maintain certain written records
documenting that all individual employees have been trained and that
retailers retain these records for 4 years in order to be able to
provide evidence of a training program during the 48-month time period
covered by the civil money penalty schedules outlined in the law.
The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
underage persons. In addition, FDA recommends that retailers implement
an internal compliance check program and document the procedures and
corrective actions for the program.
In the Federal Register of May 5, 2022 (87 FR 26766), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; guidance section IV Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Develop training program........ 79,700 1 79,700 16 1,275,200
Develop written policy against 79,700 1 79,700 1 79,700
sales to youth and employee
acknowledgement................
Develop internal compliance 79,700 1 79,700 8 637,600
check program..................
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Total....................... .............. .............. .............. .............. 1,992,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; guidance section IV Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Training program.......................... 79,700 4 318,800 0.25 (15 minutes)........................... 79,700
Written policy against sales to youth and 79,700 4 318,800 0.10 (6 minutes)............................ 31,880
employee acknowledgement.
Internal compliance check program......... 79,700 2 159,400 0.5 (30 minutes)............................ 79,700
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Total................................. .............. .............. .............. ............................................ 191,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 67045]]
FDA's estimate of the number of respondents in tables 1 and 2 is
based on data from the deeming rule Final Regulatory Impact
Analysis,\1\ which showed there are an estimated 362,273 retail
establishments that currently sell tobacco products. The Agency
reviewed these numbers again for this notice, and believe they are an
accurate estimation. We assume that 75 percent of tobacco retailers
already have some sort of age and identification verification training
program in place. We expect that some of those retailer training
programs already meet the elements in the guidance, some retailers
would update their training program to meet the elements in the
guidance, and other retailers would develop a training program for the
first time. Thus, we estimate that two-thirds of tobacco retailers
would develop a training program that meets the elements in the
guidance (66 percent of 362,273 = 239,100; then annualized to 79,700).
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\1\ Deeming Tobacco Products to be Subject to the [Federal]
Food, Drug, and Cosmetic Act, as Amended by the Family Smoking
Prevention and Tobacco Control Act: Final Regulatory Impact
Analysis, 2016 <a href="https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf">https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf</a>.
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We have adjusted our burden estimate and the number of respondents,
which has resulted in a decrease to the currently approved burden and
respondent count. This adjustment is based on available data estimating
the number of retail establishments that sell tobacco products in the
United States. Additionally, the burden chart was updated to reflect a
change from an estimation over the course of 3 years to annualized
burden.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24218 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P
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