[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28780-28781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA-2014-N-0189]
The Food and Drug Administration Deems Certain Tobacco Products
Subject to FDA Authority, Sales and Distribution Restrictions, and
Health Warning Requirements for Packages and Advertisements; Small
Entity Compliance Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``FDA Deems Certain
Tobacco Products Subject to FDA Authority, Sales and Distribution
Restrictions, and Health Warning Requirements for Packages and
Advertisements; Small Entity Compliance Guide.'' This small entity
compliance guide (SECG) is intended to set forth in plain language the
requirements of the deeming regulation and to help small businesses
understand and comply with the regulation.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0189 for ``FDA Deems Certain Tobacco Products Subject to FDA
Authority, Sales and Distribution Restrictions, and Health Warning
Requirements for Packages and Advertisements; Small Entity Compliance
Guide.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
[[Page 28781]]
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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 document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000,
1-877-287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``FDA Deems Certain Tobacco Products Subject to FDA Authority,
Sales and Distribution Restrictions, and Health Warning Requirements
for Packages and Advertisements, Small Entity Compliance Guide.'' This
guidance is intended to help small businesses understand and comply
with FDA's implementation of the final rule entitled ``Deeming Tobacco
Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and Tobacco Control Act;
Restrictions on the Sale and Distribution of Tobacco Products and
Required Warning Statements for Tobacco Products'' (Deeming rule),
which is published elsewhere in this edition of the Federal Register.
Specifically, this guidance is intended to help small businesses
understand how to comply with FDA's final rule deeming tobacco products
to be subject to the Federal Food, Drug, and Cosmetic Act (``FD&C
Act''), as amended by the Family Smoking Prevention and Tobacco Control
Act (``Tobacco Control Act''). The Deeming rule extends FDA's authority
in Chapter IX of the FD&C Act to include all tobacco products, except
accessories of newly deemed tobacco products. The Deeming rule also
prohibits the sale of covered tobacco products to individuals under the
age of 18, prohibits vending machine sales unless sold in adult-only
facilities, and requires the display of health warning statements on
cigarette tobacco, roll-your-own tobacco, and covered tobacco product
packages and in advertisements.
In compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104-121), FDA is making available
this SECG stating in plain language the legal requirements of the
Deeming final rule, set forth in 21 CFR parts 1100, 1140, and 1143.
II. Significance of Guidance
FDA is issuing this SECG as a level 2 guidance, consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The guidance
represents the current thinking of FDA on this topic. It does not
establish any rights for any person and is not binding on FDA or the
public unless specific regulatory or statutory requirements are cited.
You can use an alternative approach if it satisfies the requirements of
the applicable statutes and regulations.
III. 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/Labeling/RulesRegulationsGuidance/default.htm.
Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10684 Filed 5-5-16; 8:45 am]
BILLING CODE 4164-01-P