[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Draft Guidance for Tobacco Retailers on Tobacco Retailer Training 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availability of a draft guidance for tobacco retailers entitled 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 In the interim, this draft 
guidance document is intended to assist tobacco retailers who wish to 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this draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 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ADDRESSES:  Submit electronic comments on the draft guidance, including 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 Submit written comments on the draft guidance, 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