[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28059-28062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12677]


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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; 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 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

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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 
aspects of the Guidance for Tobacco Retailers on Tobacco Retailer 
Training Programs.

DATES: Submit either electronic or written comments on the collection 
of information by August 16, 2019.

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 August 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 16, 2019. 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 ``Guidance for Tobacco Retailers on 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.
     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.gpo.gov/fdsys/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 and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), 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.

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

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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.
    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
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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      Number of records     Total annual
               Activity                   recordkeepers     per recordkeeper       records          Average burden per recordkeeper       Total hours
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Training program......................            273,900                  4          1,095,600  0.25 (15 minutes)...................            273,900
Written policy against sales to minors            273,900                  4          1,095,600  0.10 (6 minutes)....................            109,560
 and employee acknowledgement.
Internal compliance check program.....            273,900                  2            547,800  0.5 (30 minutes)....................            273,900
                                       -----------------------------------------------------------------------------------------------------------------
    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 percent 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.

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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: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12677 Filed 6-14-19; 8:45 am]
BILLING CODE 4164-01-P


