[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54657-54658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]


Guidance for Tobacco Retailers on Tobacco Retailer Training 
Programs; Availability

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 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 sale and 
distribution, including youth access, advertising, and promotion 
restrictions issued under the Federal Food, Drug, and Cosmetic Act

[[Page 54658]]

(the FD&C 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 guidance document is intended to assist tobacco retailers 
who wish to implement training programs for employees.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of this guidance 
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 guidance document may be sent. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for tobacco 
retailers entitled ``Tobacco Retailer Training Programs.'' This 
guidance document is intended to assist tobacco retailers who wish to 
implement training programs for employees.
    On June 22, 2009, the President signed the Tobacco Control Act 
(Pub. L. 111-31; 123 Stat. 1776) 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.
    Among its many provisions, section 906(d) of the FD&C Act (21 
U.S.C. 387f(d)), 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 (21 
U.S.C. 387a-1), FDA re-issued its 1996 final regulation restricting the 
sale and distribution of cigarettes and smokeless tobacco products (75 
FR 13225, March 19, 2010). The regulation is deemed to be issued under 
chapter 9 of the FD&C Act, as amended by the Tobacco Control Act 
(section 102(a)(1)(A) of 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 (part 1140 (21 CFR part 1140)).
    Section 103(q)(2) of the Tobacco Control Act (21 U.S.C. 333 note) 
includes two schedules for assessing the maximum civil money penalties 
against retailers for violations of restrictions issued under section 
906(d) of the FD&C Act, as amended by the Tobacco Control Act, 
pertaining to the sale and distribution, including youth access, and 
advertising and promotion of tobacco products. 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.
    FDA intends to issue regulations establishing standards for 
approved retailer training programs. In the interim, however, FDA is 
issuing this guidance to provide recommendations on elements the Agency 
believes should be included in a 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 (part 1140), 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 July 16, 2010 (75 FR 41498), FDA 
announced the availability of a draft guidance entitled ``Tobacco 
Retailer Training Programs.'' The Agency considered received comments 
as it finalized this guidance. In addition, editorial changes were made 
to improve clarity.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
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 statutes 
and regulations.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0745.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21547 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P