[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
[[Page 28060]]
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,
[email protected].
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..................
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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
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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