[Federal Register Volume 75, Number 136 (Friday, July 16, 2010)]
[Notices]
[Pages 41498-41500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0350]
Draft Guidance for Tobacco Retailers on Tobacco Retailer Training
Programs; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for tobacco retailers entitled
``Tobacco Retailer Training Programs.'' The Family Smoking Prevention
and Tobacco Control Act (Tobacco Control Act) does not require
retailers to implement retailer training programs. However, the Tobacco
Control Act does provide for lower civil money penalties for violations
of access, advertising, and promotion restrictions issued under section
906(d) of the Federal Food, Drug, and Cosmetic Act (the act), 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 In the interim, this draft
guidance document is intended to assist tobacco retailers who wish to
implement effective training programs for employees.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
and on the proposed collection of information by September 14, 2010.
ADDRESSES: Submit electronic comments on the draft guidance, including
comments regarding the proposed collection of information to http://www.regulations.gov. Submit written comments on the draft guidance,
including comments regarding the proposed collection of information to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket number found in brackets in the
heading of this document.
Submit written requests for single copies of the draft guidance
document entitled ``Tobacco Retailer Training Programs'' to the Center
for Tobacco Products, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label
to assist that office in processing your request or include a fax
number to which the draft guidance document may be sent. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Beth Buckler, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 1-877-287-1373, [email protected].
With regard to the proposed collection of information: JonnaLynn
Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50, Rockville, MD 20850, 301-796-
3794.
[[Page 41499]]
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act grants FDA
important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
Among its many provisions, section 906(d) of the act, as amended by
the Tobacco Control Act, states that ``[t]he Secretary may by
regulation require restrictions on the sale and distribution of a
tobacco product, including restrictions on the access to, and the
advertising and promotion of, the tobacco product, if the Secretary
determines that such regulation would be appropriate for the protection
of the public health.''
In accordance with section 102 of the Tobacco Control Act, FDA re-
issued its 1996 final regulation restricting the sale and distribution
of cigarettes and smokeless tobacco products. The regulation is deemed
to be issued under Chapter 9 of the act, as amended by the Tobacco
Control Act. The regulation contains: Provisions designed to limit
young people's access to cigarettes and smokeless tobacco products, as
well as restrictions on advertising and promotion of such products, to
curb the appeal of these products to minors (75 FR 13225; March 19,
2010).
Section 103(q) of the Tobacco Control Act directs the agency to
issue guidance regarding penalties retailers are subject to for
violations of the restrictions issued under section 906(d) of the act,
as amended by the Tobacco Control Act. FDA intends to issue a draft
guidance document shortly that will describe the penalties that apply
to retailers for violations of the requirements of the act, as amended
by the Tobacco Control Act, and implementing regulations and establish
the policies and procedures for assessing civil money penalties.
Section 103(q)(2) of the Tobacco Control Act includes two schedules
for assessing civil money penalties against retailers for violations of
restrictions issued under section 906(d) of the act, as amended by the
Tobacco Control Act, pertaining to the sale and distribution of a
tobacco product, including access, promotion, and advertising
restrictions. Under each schedule, violators are subject to increasing
penalties for multiple violations within prescribed time periods. For
the first three violations in a 24-month period, retailers with an
approved training program are subject to lower penalties than retailers
without such programs. Section 103(q)(2)(B) defines ``approved training
program'' as a training program that complies with standards developed
by FDA for such programs. The act further provides that the amount of
the civil money penalty ultimately assessed shall take into account,
among other things, the degree of culpability of the violator. (21
U.S.C. 333(f)(5)(B), as amended by the Tobacco Control Act).
FDA intends to issue regulations establishing standards for
approved retailer training programs. In the interim, however, FDA is
issuing this draft guidance to provide recommendations on elements the
agency believes should be included in an effective retailer training
program. Until FDA issues these regulations, the agency intends to use
the lower maximum civil money penalties schedule for all retailers who
violate the regulations restricting the sale and distribution of
cigarettes and smokeless tobacco products (75 FR 13225; March 19,
2010), whether or not they have implemented a training program.
However, FDA may consider further reducing the civil money penalty for
retailers who have implemented a training program.
In the Federal Register of December 9, 2009 (74 FR 65129), FDA
established a public docket to obtain information on suggested elements
for tobacco retailer training programs. The draft guidance incorporates
information FDA received in response to the request for comments.
II. Significance of Guidance
FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on
``Tobacco Retailer Training Programs.'' It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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 collection of information associated with this
draft guidance, 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.
The 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 act, as amended by the Tobacco Control Act, for retailers who have
implemented a training program that complies with standards developed
by the FDA for such programs. The FDA intends to issue regulations
establishing standards for approved retailer training programs. In the
interim, the draft guidance is intended to assist tobacco retailers in
implementing effective training programs for employees.
Draft Guidance for Tobacco Retailer Training Programs--(OMB Control
Number 0910-NEW)
This draft guidance discusses the elements that should be covered
in a training program, such as: (1) Federal
[[Page 41500]]
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; and (5) age verification methods. The draft
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 draft 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 draft guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The draft 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 draft
guidance, some retailers would update their training program to meet
the elements in the draft 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 draft guidance (66 percent of 410,000=270,600).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated One Time Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Develop training program 270,600 1 270,600 16 4,329,600
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Develop written policy against sales to minors & 270,600 1 270,600 1 270,600
employee acknowledgment
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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.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. 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 .25 270,600
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Written policy against sales to minors & employee 270,600 4 1,082,400 .10 108,240
acknowledgment
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Internal compliance check program 270,600 2 541,200 .5 270,600
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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.
V. Electronic Access
An electronic version of the guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: July 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17312 Filed 7-15-10; 8:45 am]
BILLING CODE 4160-01-S