Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer Training Programs, 62539-62540 [2019-24785]
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Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
62539
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Total ..............................................................................
1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Hours per
response
........................
........................
........................
........................
Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24780 Filed 11–14–19; 8:45 am]
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
BILLING CODE 4164–01–P
OMB Control Number 0910–0745—
Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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
Food and Drug Administration,
HHS.
ACTION:
90
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate for the information
collection reflects an overall increase of
burden. This increase corresponds to an
increase in submissions we have
received over the last few years.
AGENCY:
Total hours
Notice.
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.
SUMMARY:
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
VerDate Sep<11>2014
16:58 Nov 14, 2019
Jkt 250001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 48month 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
E:\FR\FM\15NON1.SGM
15NON1
62540
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
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
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Develop training program ....................................................
Develop written policy against sales to minors and employee acknowledgement .................................................
Develop internal compliance check program ......................
273,900
1
273,900
16
4,382,400
273,900
273,900
1
1
273,900
273,900
1
8
273,900
2,191,200
Total ..............................................................................
........................
........................
........................
........................
6,847,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeper
Total hours
Training program ............................................................
Written policy against sales to minors and employee
acknowledgement.
Internal compliance check program ...............................
273,900
273,900
4
4
1,095,600
1,095,600
0.25 (15 minutes)
0.10 (6 minutes) ..
273,900
109,560
273,900
2
547,800
0.5 (30 minutes) ..
273,900
Total ........................................................................
........................
........................
........................
.............................
657,360
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).
VerDate Sep<11>2014
16:58 Nov 14, 2019
Jkt 250001
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% × 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Q-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 0910–0756. Also
include the FDA docket number found
SUMMARY:
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[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.
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
