[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26766-26768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Retailer Training Programs

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 ``Tobacco Retailer Training Programs.''

DATES: Submit either electronic or written comments on the collection 
of information by July 5, 2022.

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 5, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 5, 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2010-D-0350 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Tobacco Retailer Training 
Programs.'' 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts

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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, 
[email protected].

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.

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 (sections 900 through 920) (21 U.S.C. 387 
through 21 U.S.C. 387u). The FDA intends to issue regulations 
establishing standards for approved tobacco retailer training programs 
under section 906(d) of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 387f(d)). In the interim, FDA published a guidance document 
which 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.
    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.


[[Page 26768]]


                                                   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 recordkeeper          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.

    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 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: April 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09628 Filed 5-4-22; 8:45 am]
BILLING CODE 4164-01-P