[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52299-52300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21271]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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