[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55124-55125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23001]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1600]
Enforcement Policy for Certain (Provisional) Tobacco Products
That the Food and Drug Administration Finds Not Substantially
Equivalent; Guidance for Industry and 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 industry entitled ``Enforcement Policy
for Certain (Provisional) Tobacco Products that FDA Finds Not
Substantially Equivalent.'' This guidance provides information to
tobacco retailers on FDA's enforcement policy regarding certain so-
called provisional tobacco products that become subject to not
substantially equivalent (NSE) orders issued under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act).
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,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993-2000. 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 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: Annette Marthaler, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000,
email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Enforcement Policy for Certain (Provisional) Tobacco
Products that FDA Finds Not Substantially Equivalent.'' This guidance
provides information to tobacco retailers on FDA's enforcement policy
regarding certain so-called provisional tobacco products that become
subject to NSE orders issued under the FD&C Act. We received several
comments to the draft guidance (79 FR 10534, February 25, 2014), 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 on ``Enforcement Policy for Certain
(Provisional) Tobacco Products that FDA Finds Not Substantially
Equivalent.'' It does not
[[Page 55125]]
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://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 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: September 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23001 Filed 9-11-15; 8:45 am]
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