
[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]


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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.

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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: AskCTP@fda.hhs.gov.

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


