80 FR 52299 - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 167 (August 28, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The guidance represents FDA's current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.

[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52299-52300]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0404]


Determination of the Period Covered by a No-Tobacco-Sale Order 
and Compliance With an Order; Guidance for Tobacco Retailers; 
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 
``Determination of the Period Covered by a No-Tobacco-Sale Order and 
Compliance With an Order.'' The guidance represents FDA's current 
thinking with respect to imposing no-tobacco-sale orders (NTSOs) on 
retailers who have committed repeated violations of certain 
restrictions on the sale and distribution of tobacco products. This 
guidance discusses, among other things, the period of time covered by 
an NTSO and a retailer's compliance with an NTSO.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Center for Tobacco Products, Food and Drug Administration, 10903 
New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the guidance may be sent. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen Maschal, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877-
287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for tobacco 
retailers entitled ``Determination of the Period Covered by a No-
Tobacco-Sale Order and Compliance With an Order.'' On June 22, 2009, 
President Obama signed the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The 
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) to give FDA authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect public 
health generally and to reduce tobacco use by minors. Section 906(d) of 
the FD&C Act (21 U.S.C. 387f(d)) authorizes FDA to issue regulations 
that restrict the sale and distribution of tobacco products if FDA 
determines such regulations would be appropriate for the protection of 
the public health. Section 303(f)(8) of the FD&C Act (21 U.S.C. 
333(f)(8)) authorizes FDA to impose an NTSO against a person found to 
have committed repeated violations, at a particular retail outlet, of 
restrictions on the sale and distribution of tobacco products issued 
under section 906(d) of the FD&C Act, such as FDA's ``Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco to Protect Children and Adolescents'' (21 CFR part 1140). The 
term ``no-tobacco-sale order'' refers to an order prohibiting the sale 
of tobacco products at a retail outlet indefinitely or for a specified 
period of time under section 303(f)(8) of the FD&C Act. A ``repeated 
violation'' means ``at least 5 violations of particular requirements 
over a 36-month period at a particular retail outlet that constitute a 
repeated violation . . .'' (section 103(q)(1)(A) of the Tobacco Control 
Act).
    FDA conducts inspections of retail outlets to evaluate compliance 
with the requirements of the FD&C Act and its implementing regulations. 
This guidance discusses the period of time to be covered by an NTSO 
where there is evidence of ``repeated violations'' at a particular 
retail outlet. It also discusses a retailer's compliance with an NTSO. 
This guidance is meant to supplement FDA's guidances entitled ``Civil 
Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers'' and 
``Civil Money Penalties for Tobacco Retailers and No-Tobacco-Sale 
Orders: Responses to Frequently Asked Questions.''
    In the Federal Register of May 13, 2015 (80 FR 27318), FDA 
announced the availability of the draft guidance of the same title. FDA 
received comments on the draft guidance and those comments were 
considered as the guidance was finalized.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA with respect to the period of time to be 
covered by NTSOs and retailers' compliance with NTSOs. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Comments

A. General Information About Submitting Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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.

B. Public Availability of Comments

    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://

[[Page 52300]]

www.regulations.gov. As a matter of Agency practice, FDA generally does 
not post comments submitted by individuals in their individual capacity 
on http://www.regulations.gov. This is determined by information 
indicating that the submission is written by an individual, for 
example, the comment is identified with the category ``Individual 
Consumer'' under the field titled ``Category (Required),'' on the 
``Your Information'' page on http://www.regulations.gov. For this 
docket, however, FDA will not be following this general practice. 
Instead, FDA will post on http://www.regulations.gov comments to this 
docket that have been submitted by individuals in their individual 
capacity. If you wish to submit any information under a claim of 
confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21271 Filed 8-27-15; 8:45 am]
 BILLING CODE 4164-01-P