Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tobacco Retailer Training Programs, 18609-18611 [2013-06982]
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Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices
burden of approximately 1 hour, taking
into account that some respondents may
not have readily available Internet
access. Thus, the total annual burden for
cancelling Shell Egg Producer
registrations is estimated to be 15 hours
(15 cancellations × 1 hour).
Dated: March 20, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07032 Filed 3–26–13; 8:45 am]
BILLING CODE 4160–01–P
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
Industry on Tobacco Retailer Training
Programs
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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 April 26,
2013.
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–NEW and
title ‘‘Guidance for Industry on Tobacco
Retailer Training Programs.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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.
VerDate Mar<15>2010
18:10 Mar 26, 2013
Jkt 229001
Guidance for Industry on Tobacco
Retailer Training Programs—(OMB
Control Number 0910–NEW)
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act grants FDA
important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
The Tobacco Control Act provides for
lower civil money penalties for
violations of sale and distribution,
including youth access, and advertising
and promotion restrictions issued under
section 906(d) of the Federal Food,
Drug, and Cosmetic Act (FD&C 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 (section
103(q)(2) of the Tobacco Control Act).
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
training programs for employees.
The guidance discusses the elements
that should be covered in a training
program, such as: (1) Federal laws
restricting the sale and distribution,
including youth 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 the sale of
cigarettes and smokeless tobacco to
minors; (4) identification of the
cigarettes and smokeless tobacco sold in
the retail establishment that are subject
to the Federal laws prohibiting their sale
to persons under the age of 18; and (5)
age verification methods.
The guidance recommends that
retailers train current employees as soon
as practicable and that new employees
be trained prior to selling cigarettes and
smokeless tobacco. Refresher training
should be provided at least annually
and more frequently, as needed. In
addition, the guidance recommends that
retailers review and update their
training program, as needed, and take
appropriate corrective action after any
violation of the regulations restricting
sale and distribution, including youth
access, and advertising and promotion
of cigarettes and smokeless tobacco. The
guidance recommends that retailers
document any modifications to the
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
18609
training program following such a
review.
The guidance recommends that
retailers maintain certain 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 a
retailer training program.
In the Federal Register of July 16,
2010 (75 FR 41498), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received seven
comments in response to the notice,
with four comments on the information
collection. In the Federal Register of
November 25, 2011 (76 FR 72710), FDA
republished notice of the proposed
collection of information in order to
comply with section 3506(c)(2)(A) of the
Paperwork Reduction Act. FDA received
two comments that were beyond the
scope of the information request (e.g.,
raising fines will be more successful
than retailer training, support for
educating retail employees about the
negative effects of using tobacco
products). Comments relevant to the
information request are addressed in
this document.
(Comment 1) Several comments stated
that it would be burdensome and costly
to keep training records for 4 years due
to the high turnover in the retail
industry.
(Response) The Tobacco Control Act
does not require retailers to implement
retailer training programs. However, it
provides for two schedules of civil
money penalties for violations of
restrictions issued under section 906(d)
of the FD&C Act pertaining to the sale
and distribution of tobacco products,
including access, advertising, and
promotion restrictions—a schedule of
lower penalties for retailers who have
implemented a training program that
complies with the standards set by FDA
and a schedule of higher penalties for
those who have not. Until FDA issues
regulations establishing standards for
approved retailer training programs, the
Agency intends to seek penalties within
the range provided by section
103(q)(2)(A)(i) of the Tobacco Control
Act (for retailers with an approved
retailer training program) whether or not
the retailer has implemented a training
program. FDA may consider further
reducing the civil money penalty for
retailers who have implemented a
E:\FR\FM\27MRN1.SGM
27MRN1
18610
Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices
training program. Retailers who wish to
implement training programs should
retain their records for 4 years 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.
(Comment 2) Several comments
suggested that retailers be allowed to
keep electronic and/or written records
of their training programs.
(Response) We agree. The guidance
provides that retailers may determine
the format of the records to be
maintained (e.g., paper, electronic).
(Comment 3) Several comments
suggested that, due to the high
employee turnover in the retail
industry, it would be burdensome for
retailers to have job applicants sign an
acknowledgment stating that they have
read and understand the importance of
complying with laws prohibiting the
sale of cigarettes and smokeless tobacco.
(Response) We agree with these
comments and revised the guidance
accordingly. However, we do not
believe these changes will affect the
burden for this information collection.
In light of the comments’ statements
about the high turnover in the retail
industry, it is possible that we
underestimated the annual frequency
for this recordkeeping. Therefore, we
invite comments on the burden for
employee acknowledgments to assist
FDA in determining more accurate
burden estimates in the future.
(Comment 4) One comment suggested
that retailers who receive a Complaint
for Civil Money Penalties from FDA and
who seek to have their penalty reduced
because they have a training program
should show that all staff involved in
the violation had received the initial
training and that remedial action was
taken after the violation.
(Response) We agree with this
comment and revised the guidance to
provide recommendations regarding
when retailers should review and
update their training program. Table 2
of this document includes our burden
estimates for reviewing and updating
retailer training programs. We estimate
that retailers will review and update
their training programs, on average,
once a year. We invite comment on this
burden estimate to assist FDA in
determining a more accurate burden
estimate in the future.
As discussed in this document, FDA
has adjusted the burden for this
information collection based on public
comments received for 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 on a one-time basis that meets
the elements in the guidance (66 percent
of 410,000 = 270,600).
With regard to reporting burden, we
expect that all 270,600 retailers would
develop a training program on a onetime basis. Table 1 estimates the onetime burden for retailers. In addition,
we expect that all 270,600 retailers
would maintain records. Table 2
estimates the recordkeeping burden for
retailers.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Activity
Develop training program ......................
Develop written policy against sales to
minors & employee acknowledgment
Develop internal compliance check program ...................................................
Total ................................................
Annual frequency
per response
Total annual
responses
Hours per
response
Total hours
270,600
1
270,600
16
4,329,600
270,600
1
270,600
1
270,600
270,600
1
270,600
8
2,164,800
..............................
..............................
..............................
..............................
6,765,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
the reporting burden in this table is for one-time activities only, the annualized burden for this table is estimated to be 2,255,000
(6,765,000 one-time burden hours divided by 3 years expected OMB approval).
2 Because
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Annual frequency
per recordkeeping
Total annual
records
mstockstill on DSK4VPTVN1PROD with NOTICES
Training program ....................................
270,600
4
1,082,400
Review and update training program ....
270,600
1
270,600
Written policy against sales to minors &
employee acknowledgment ................
270,600
4
1,082,400
Internal compliance check program .......
270,600
2
541,200
VerDate Mar<15>2010
18:10 Mar 26, 2013
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Fmt 4703
Sfmt 4703
E:\FR\FM\27MRN1.SGM
Hours per record
Total hours
0.25
(15 minutes)
0.5
(30 minutes)
270,600
0.10
(6 minutes)
0.5
(30 minutes)
108,240
27MRN1
135,300
270,600
Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices
18611
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Annual frequency
per recordkeeping
Total annual
records
Hours per record
..............................
..............................
..............................
..............................
Activity
Total ................................................
1 There
[FR Doc. 2013–06982 Filed 3–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0257]
Summit on Color in Medical Imaging;
Cosponsored Public Workshop;
Request for Comments
Food and Drug Administration,
HHS.
Notice of cosponsored public
workshop; request for comments.
ACTION:
mstockstill on DSK4VPTVN1PROD with NOTICES
784,740
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Total hours
SUMMARY: The Food and Drug
Administration (FDA) and cosponsor
International Color Consortium (ICC) are
announcing the following public
workshop entitled ‘‘Summit on Color in
Medical Imaging: An International
Workshop on the Technical Framework
for Consistency and Interoperability
Approaches for Dealing with Color in
Medical Images.’’ The purpose of the
workshop is to bring together key
stakeholders to clearly identify areas of
need, investigate solutions, and propose
best-practice approaches. The
recommendations of the summit might
include the creation of a technical
special interest group either as part of
the ICC or in some other forum and the
establishment of best-practice
guidelines for industry.
DATES: Date and Time: The workshop
will be held on May 8 and 9, 2013, from
8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
VerDate Mar<15>2010
18:10 Mar 26, 2013
Jkt 229001
Contact: Aldo Badano, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 3116,
Silver Spring, MD 20993–0002, 301–
796–2534, Aldo.Badano@fda.hhs.gov.
Registration: Registration is free and
on a first-come, first-served basis.
Persons interested in attending this
public workshop must register online by
5 p.m. on April 26, 2013. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permit, onsite registration on the
day of the public workshop will be
provided beginning at 7:30 a.m.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://www.fda.
gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.) Please provide
complete contact information for each
attendee, including name, title,
affiliation, mailing address, email
address, and telephone number. Those
without Internet access should contact
Susan Monahan at 301–796–5661 to
register. Registrants will receive
confirmation after they have been
accepted. You will be notified if you are
on a waiting list.
If you need special accommodations
due to a disability, please contact Susan
Monahan (Susan.Monahan@fda.hhs.gov
or 301–796–5661) no later than April
26, 2013.
Streaming Webcast of the Public
Workshop: This workshop will also be
available via Webcast. Persons
interested in viewing the Webcast must
register online by 5 p.m. on April 26,
2013. Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and will be sent connection
access information after May 2, 2013. If
you have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
program, visit https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This
workshop includes a public comment
session. If you wish to present during a
public comment session, you must
indicate this at the time of registration.
You shall also submit a title and short
abstract of your comments to Veronika
Lovell at
Veronika.lovell@sunchemical.com.
Comments: FDA is holding this public
workshop to obtain information on the
topics identified in Section II. No
commercial or promotional material
will be permitted to be presented or
distributed at the workshop. In order to
permit the widest possible opportunity
to obtain public comment, FDA is
soliciting either electronic or written
comments on all aspects of the public
workshop topics. The deadline for
submitting comments related to this
public workshop is May 31, 2013.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic or written
comments. Submit electronic comments
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. Please identify comments
with the docket number found in
brackets in the heading of this
document. In addition, when
responding to specific topics as outlined
in section II, please identify the topic
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday and will be
posted to the docket at https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18609-18611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06982]
-----------------------------------------------------------------------
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 Industry
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 April
26, 2013.
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-NEW and
title ``Guidance for Industry on Tobacco Retailer Training Programs.''
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@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 Industry on Tobacco Retailer Training Programs--(OMB
Control Number 0910-NEW)
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act grants FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
The Tobacco Control Act provides for lower civil money penalties
for violations of sale and distribution, including youth access, and
advertising and promotion restrictions issued under section 906(d) of
the Federal Food, Drug, and Cosmetic Act (FD&C 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 (section 103(q)(2) of the Tobacco Control
Act). 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 training programs
for employees.
The guidance discusses the elements that should be covered in a
training program, such as: (1) Federal laws restricting the sale and
distribution, including youth 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 the sale of
cigarettes and smokeless tobacco to minors; (4) identification of the
cigarettes and smokeless tobacco sold in the retail establishment that
are subject to the Federal laws prohibiting their sale to persons under
the age of 18; and (5) age verification methods.
The guidance recommends that retailers train current employees as
soon as practicable and that new employees be trained prior to selling
cigarettes and smokeless tobacco. Refresher training should be provided
at least annually and more frequently, as needed. In addition, the
guidance recommends that retailers review and update their training
program, as needed, and take appropriate corrective action after any
violation of the regulations restricting sale and distribution,
including youth access, and advertising and promotion of cigarettes and
smokeless tobacco. The guidance recommends that retailers document any
modifications to the training program following such a review.
The guidance recommends that retailers maintain certain 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 a retailer
training program.
In the Federal Register of July 16, 2010 (75 FR 41498), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received seven comments in response to
the notice, with four comments on the information collection. In the
Federal Register of November 25, 2011 (76 FR 72710), FDA republished
notice of the proposed collection of information in order to comply
with section 3506(c)(2)(A) of the Paperwork Reduction Act. FDA received
two comments that were beyond the scope of the information request
(e.g., raising fines will be more successful than retailer training,
support for educating retail employees about the negative effects of
using tobacco products). Comments relevant to the information request
are addressed in this document.
(Comment 1) Several comments stated that it would be burdensome and
costly to keep training records for 4 years due to the high turnover in
the retail industry.
(Response) The Tobacco Control Act does not require retailers to
implement retailer training programs. However, it provides for two
schedules of civil money penalties for violations of restrictions
issued under section 906(d) of the FD&C Act pertaining to the sale and
distribution of tobacco products, including access, advertising, and
promotion restrictions--a schedule of lower penalties for retailers who
have implemented a training program that complies with the standards
set by FDA and a schedule of higher penalties for those who have not.
Until FDA issues regulations establishing standards for approved
retailer training programs, the Agency intends to seek penalties within
the range provided by section 103(q)(2)(A)(i) of the Tobacco Control
Act (for retailers with an approved retailer training program) whether
or not the retailer has implemented a training program. FDA may
consider further reducing the civil money penalty for retailers who
have implemented a
[[Page 18610]]
training program. Retailers who wish to implement training programs
should retain their records for 4 years 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.
(Comment 2) Several comments suggested that retailers be allowed to
keep electronic and/or written records of their training programs.
(Response) We agree. The guidance provides that retailers may
determine the format of the records to be maintained (e.g., paper,
electronic).
(Comment 3) Several comments suggested that, due to the high
employee turnover in the retail industry, it would be burdensome for
retailers to have job applicants sign an acknowledgment stating that
they have read and understand the importance of complying with laws
prohibiting the sale of cigarettes and smokeless tobacco.
(Response) We agree with these comments and revised the guidance
accordingly. However, we do not believe these changes will affect the
burden for this information collection. In light of the comments'
statements about the high turnover in the retail industry, it is
possible that we underestimated the annual frequency for this
recordkeeping. Therefore, we invite comments on the burden for employee
acknowledgments to assist FDA in determining more accurate burden
estimates in the future.
(Comment 4) One comment suggested that retailers who receive a
Complaint for Civil Money Penalties from FDA and who seek to have their
penalty reduced because they have a training program should show that
all staff involved in the violation had received the initial training
and that remedial action was taken after the violation.
(Response) We agree with this comment and revised the guidance to
provide recommendations regarding when retailers should review and
update their training program. Table 2 of this document includes our
burden estimates for reviewing and updating retailer training programs.
We estimate that retailers will review and update their training
programs, on average, once a year. We invite comment on this burden
estimate to assist FDA in determining a more accurate burden estimate
in the future.
As discussed in this document, FDA has adjusted the burden for this
information collection based on public comments received for 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 on a one-time basis that meets the
elements in the guidance (66 percent of 410,000 = 270,600).
With regard to reporting burden, we expect that all 270,600
retailers would develop a training program on a one-time basis. Table 1
estimates the one-time burden for retailers. In addition, we expect
that all 270,600 retailers would maintain records. Table 2 estimates
the recordkeeping burden for retailers.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual frequency Total annual Hours per
Activity respondents per response responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop training program................................. 270,600 1 270,600 16 4,329,600
Develop written policy against sales to minors & employee 270,600 1 270,600 1 270,600
acknowledgment..........................................
Develop internal compliance check program................ 270,600 1 270,600 8 2,164,800
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Total................................................ ................. ................. ................. ................. 6,765,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Because the reporting burden in this table is for one-time activities only, the annualized burden for this table is estimated to be 2,255,000
(6,765,000 one-time burden hours divided by 3 years expected OMB approval).
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Annual frequency Total annual
Activity recordkeepers per recordkeeping records Hours per record Total hours
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Training program......................................... 270,600 4 1,082,400 0.25 270,600
(15 minutes)
Review and update training program....................... 270,600 1 270,600 0.5 135,300
(30 minutes)
Written policy against sales to minors & employee 270,600 4 1,082,400 0.10 108,240
acknowledgment.......................................... (6 minutes)
Internal compliance check program........................ 270,600 2 541,200 0.5 270,600
(30 minutes)
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[[Page 18611]]
Total................................................ ................. ................. ................. ................. 784,740
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06982 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P
