[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Page 10534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1600]
Draft Guidance for Industry and Tobacco Retailers; Enforcement
Policy for Certain (Provisional) Tobacco Products That the Food and
Drug Administration Finds Not Substantially Equivalent; 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availability of the draft guidance entitled ``Enforcement Policy for
Certain (Provisional) Tobacco Products That FDA Finds Not Substantially
Equivalent.'' This draft guidance provides information to tobacco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: 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 28, 2014.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. 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 document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Annette Marthaler, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for tobacco
retailers entitled ``Enforcement Policy for Certain (Provisional)
Tobacco Products That FDA Finds Not Substantially Equivalent.'' In this
draft guidance, FDA provides information on its enforcement policy
regarding so-called provisional tobacco products that become subject to
NSE orders under the FD&C Act. The provisional products addressed by
this draft guidance are tobacco products that were first introduced or
delivered for introduction into interstate commerce for commercial
distribution after February 15, 2007, and prior to March 22, 2011, and
for which a section 905(j) (21 U.S.C. 387e(j)) (or substantial
equivalent) report was submitted no later than March 22, 2011. Because
the FD&C Act permitted this specific group of products to remain on the
market pending FDA's review of the report, there will very likely be
products at retail locations within the United States when FDA issues
an order finding a tobacco product NSE. This draft guidance explains
that FDA does not intend to take enforcement action for at least 30
calendar days from the date the NSE order issues for those products
that are in the retailer's current inventory at a specific retail
location on the date FDA issues the NSE order.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
``Enforcement Policy for Certain (Provisional) Tobacco Products That
FDA Finds Not Substantially Equivalent.'' 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.
II. 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. 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.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03978 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P