[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62539-62540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24785]


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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; Guidance for Tobacco 
Retailers on Tobacco Retailer Training Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by 
December 16, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0745. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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.

Guidance for Tobacco Retailers on Tobacco Retailer Training Programs

OMB Control Number 0910-0745--Extension

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) does not require retailers to implement 
retailer training programs. However, the statute does provide for 
lesser civil money penalties for violations of access, advertising, and 
promotion restrictions of regulations issued under section 906(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)), as 
amended by the Tobacco Control Act, for retailers who have implemented 
a training program that complies with standards developed by FDA for 
such programs. FDA intends to issue regulations establishing standards 
for approved retailer training programs. In the interim, the guidance 
is intended to assist tobacco retailers in implementing 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 minors 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 prohibiting their 
sale to persons under the age of 18; (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 in section 103(q)(2)(A) of the 
Tobacco Control Act.
    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 
persons under the age of 18. 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 June 17, 2019 (84 FR 28059), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was PRA 
related.
    The comment suggested that FDA should adjust the burden calculation 
for two areas, develop training programs and review and updating 
training programs. The comment suggested that it would reasonably take 
1000 hours to develop a training program. FDA disagrees with this 
comment and does not intend to adjust the burden calculations for these 
areas. FDA has not made significant changes to this guidance and 
expects that many 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 a smaller number of other 
retailers would develop a training program for the first time. FDA has 
not received any comments from affected retailers regarding the time 
needed to develop retailer training programs, or that the burden 
calculation was insufficient. Additionally, FDA has provided several 
resources, such as webinars and

[[Page 62540]]

downloadable materials through FDA's ``This is Our Watch'' Program, to 
assist retailers in complying with the requirements under the law. 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                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Develop training program........         273,900               1         273,900              16       4,382,400
Develop written policy against           273,900               1         273,900               1         273,900
 sales to minors and employee
 acknowledgement................
Develop internal compliance              273,900               1         273,900               8       2,191,200
 check program..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       6,847,500
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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                Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
Training program..............         273,900               4       1,095,600  0.25 (15                 273,900
                                                                                 minutes).
Written policy against sales           273,900               4       1,095,600  0.10 (6 minutes)         109,560
 to minors and employee
 acknowledgement.
Internal compliance check              273,900               2         547,800  0.5 (30 minutes)         273,900
 program.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         657,360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents in tables 1 and 2 is 
based on data reported to the U.S. Department of Health and Human 
Services Substance Abuse and Mental Health Services Administration. 
According to the fiscal year 2009 Annual Synar Report, there are 
372,677 total retail tobacco outlets in the 50 States, District of 
Columbia, and 8 U.S. territories that are accessible to youth (meaning 
that there is no State law restricting access to these outlets to 
individuals older than age 18). Inflating this number by about 10 
percent to account for outlets in States that sell tobacco but are, by 
law, inaccessible to minors, results in an estimated total number of 
tobacco outlets of 410,000. We assume that 75 percent of tobacco 
retailers already have some sort of training program for age and 
identification verification. 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% of 410,000 = 270,600).
    FDA estimates that the total burden for this collection will be 
7,504,860 hours (6,847,500 reporting + 657,360 recordkeeping).
    We also estimate that there are approximately 5,000 to 10,000 vape 
shops; we assume that 66 percent of them, or 3,300 (66% x 5,000) of the 
low estimate, currently engage in retailing activities (Ref. 1).
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

II. Reference

    The following reference is on display with the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not 
available electronically at https://www.regulations.gov as this 
reference is copyright protected. It may be available at the website 
address, if listed. FDA has verified the website addresses, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.

    1. Burke, D., ``Trends & Insights in the Nicotine Delivery 
Category.'' Management Science Associates, Inc. Presentation at NATO 
Show, April 23, 2015.


    Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24785 Filed 11-14-19; 8:45 am]
BILLING CODE 4164-01-P


