[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67043-67045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0745. 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, 
[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.

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs. 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 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf.
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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