Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer Training Programs, 9862-9864 [2016-04176]
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9862
Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
HS grant and budget instrument .....................................................................
2,000
1
33
66,000
Estimated Total Annual Burden
Hours: 66,000.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax:
202–395–7285, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration
for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–04166 Filed 2–25–16; 8:45 am]
BILLING CODE 4184–01–P
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
SUMMARY:
VerDate Sep<11>2014
20:41 Feb 25, 2016
Jkt 238001
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 of
the guidance entitled ‘‘Tobacco Retailer
Training Programs.’’
DATES: Submit either electronic or
written comments on the collection of
information by April 26, 2016.
ADDRESSES: You may submit comments
as follows:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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 will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
E:\FR\FM\26FEN1.SGM
26FEN1
9863
Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
Information Request Regarding
Guidance for Tobacco Retailers on
Tobacco Retailer Training Programs—
OMB Control Number 0910–0745—
Extension
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) 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 the 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
and smokeless 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; (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 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 and that
they should be required to sign an
acknowledgement stating that they have
read and understand the information. In
addition, FDA recommends that
retailers implement an internal
compliance check program and
document the procedures and corrective
actions for the program.
FDA’s estimate of the number of
respondents in tables 1 and 2 of this
document is based on data reported to
the U.S. Department of Health and
Human Services Substance Abuse and
Mental Health Services Administration
(SAMHSA). 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 the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Develop training program ....................................................
Develop written policy against sales to minors and employee acknowledgement .................................................
VerDate Sep<11>2014
20:41 Feb 25, 2016
Jkt 238001
PO 00000
Frm 00060
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
270,600
1
270,600
16
4,329,600
270,600
1
270,600
1
270,600
Fmt 4703
Sfmt 4703
E:\FR\FM\26FEN1.SGM
26FEN1
9864
Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Develop internal compliance check program ......................
270,600
1
270,600
8
2,164,800
Total ..............................................................................
........................
........................
........................
........................
6,765,000
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 ................
270,600
270,600
4
4
1,082,400
1,082,400
0.25 (15 minutes) ...............
0.10 (6 minutes) .................
270,600
108,240
270,600
2
541,200
0.5 (30 minutes) .................
270,600
Total .........................................................
........................
........................
........................
.............................................
649,440
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04176 Filed 2–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Gastrointestinal
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Gastrointestinal Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Gastrointestinal
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until March 3, 2018.
DATES: Authority for the Gastrointestinal
Drugs Advisory Committee will expire
on March 3, 2018, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Division of Advisory
Committee and Consultant
Management, Office of Executive
Programs, Food and Drug
Administration, 10903 New Hampshire
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:41 Feb 25, 2016
Jkt 238001
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, email:
GIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 41
CFR 102–3.65 and approval by the
Department of Health and Human
Services under 45 CFR part 11 and by
the General Services Administration,
FDA is announcing the renewal of the
Gastrointestinal Drugs Advisory
Committee. The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of gastrointestinal
diseases and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
gastroenterology, endocrinology,
surgery, clinical pharmacology,
physiology, pathology, liver function,
motility, esophagitis, and statistics.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
PO 00000
Frm 00061
Fmt 4703
Sfmt 9990
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
GastrointestinalDrugsAdvisory
Committee/default.htm or by contacting
the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: February 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04093 Filed 2–25–16; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\26FEN1.SGM
26FEN1
]]>Agencies
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9862-9864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04176]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 of the guidance entitled ``Tobacco Retailer Training
Programs.''
DATES: Submit either electronic or written comments on the collection
of information by April 26, 2016.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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
[[Page 9863]]
and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
Information Request Regarding Guidance for Tobacco Retailers on Tobacco
Retailer Training Programs--OMB Control Number 0910-0745--Extension
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) 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 the 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 and smokeless 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; (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 and that they should be required to sign an
acknowledgement stating that they have read and understand the
information. In addition, FDA recommends that retailers implement an
internal compliance check program and document the procedures and
corrective actions for the program.
FDA's estimate of the number of respondents in tables 1 and 2 of
this document is based on data reported to the U.S. Department of
Health and Human Services Substance Abuse and Mental Health Services
Administration (SAMHSA). 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 the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Develop training program........ 270,600 1 270,600 16 4,329,600
Develop written policy against 270,600 1 270,600 1 270,600
sales to minors and employee
acknowledgement................
[[Page 9864]]
Develop internal compliance 270,600 1 270,600 8 2,164,800
check program..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 6,765,000
----------------------------------------------------------------------------------------------------------------
\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 per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training program......................... 270,600 4 1,082,400 0.25 (15 minutes)............................ 270,600
Written policy against sales to minors 270,600 4 1,082,400 0.10 (6 minutes)............................. 108,240
and employee acknowledgement.
Internal compliance check program........ 270,600 2 541,200 0.5 (30 minutes)............................. 270,600
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Total................................ .............. .............. .............. ............................................. 649,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04176 Filed 2-25-16; 8:45 am]
BILLING CODE 4164-01-P
