[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and Compliance With an Order; Draft Guidance for Tobacco Retailers;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availability of a draft guidance for tobacco retailers entitled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 The draft guidance, when finalized, will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 This draft guidance discusses, among other things, the period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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 29, 2015.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Center for Tobacco Products, Food and Drug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request or include a fax number to which the draft guidance may be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electronic access to the draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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