[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27318-27319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11538]


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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and Compliance With an Order; Draft Guidance for Tobacco Retailers; 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availability of a draft guidance for tobacco retailers entitled 
``Determination of the Period Covered by a No-Tobacco-Sale Order and 
Compliance With an Order.'' The draft guidance, when finalized, will 
represent 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 This draft guidance discusses, among other things, the period 
of time covered by an NTSO and a retailer's compliance with an NTSO.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 29, 2015.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Center for Tobacco Products, Food and Drug 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request or include a fax number to which the draft guidance may be 
sent. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-
287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    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 implementing regulations. 
This draft 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 draft 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.''

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking with respect to 
the period of time to be covered by NTSOs and retailers' compliance 
with NTSOs. 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.

[[Page 27319]]

III. Requests for 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://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 draft guidance at either http://www.regulations.gov or 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11538 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P