[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28781-28783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2015-D-2496]


Premarket Tobacco Product Applications for Electronic Nicotine 
Delivery Systems; Draft Guidance for Industry; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment Request

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availability of a draft guidance for industry entitled ``Premarket 
Tobacco Product Applications for Electronic Nicotine Delivery 
Systems.'' Given the relatively new presence of electronic nicotine 
delivery systems (ENDS) on the U.S. market and FDA's final rule deeming 
these products to be subject to the tobacco product authorities in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive 
premarket tobacco product application (PMTA) submissions from 
manufacturers of ENDS. This draft guidance is intended to assist 
persons with their PMTA submissions for ENDS products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 11, 2016.

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

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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-2015-D-2496 for ``Premarket Tobacco Product Application for 
Electronic Nicotine Delivery Systems.'' 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 
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 draft 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 20993-2000. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Colleen Lee, 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 protected].
    With regard to the proposed collection of information: FDA PRA 
Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Premarket Tobacco Product Applications for Electronic 
Nicotine Delivery Systems.''
    On June 22, 2009, the President 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) and granted FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
Under section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), FDA's tobacco 
product authorities in chapter IX of the FD&C Act apply to all 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco and to any other tobacco products that the Secretary of Health 
and Human Services by regulation deems to be subject to chapter IX. 
Concurrently with issuing this draft guidance, FDA is publishing 
elsewhere in this issue of the Federal Register, its final rule, 
``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) to deem all products meeting the statutory definition of 
``tobacco product'' in section 201(rr) of the FD&C Act (21 U.S.C. 
321(rr)), except accessories to newly deemed tobacco products, to be 
subject to chapter IX of the FD&C Act (21 U.S.C. 387 through 387u).
    Under section 910 of the FD&C Act (21 U.S.C. 387j), persons seeking 
to market a new tobacco product (as defined in section 910(a)(1) of the 
FD&C Act) must first submit a PMTA to FDA and obtain a marketing 
authorization order, unless FDA has issued an order that the new 
tobacco product is substantially equivalent to a tobacco product 
commercially marketed in the United States as of February 15, 2007, or 
the new tobacco product is exempt from demonstrating substantial 
equivalence pursuant to the reasons outlined in section 905(j)(3) of 
the FD&C Act (21 U.S.C. 387e(j)(3)). The ENDS products that are the 
subject of this draft guidance likely would be considered new tobacco 
products.
    Given the relatively new presence of ENDS on the U.S. market, FDA 
anticipates that many manufacturers of these new tobacco products will 
seek a marketing authorization order by filing a PMTA. This draft 
guidance explains, among other things, products to which the guidance 
applies, when a PMTA is required, general procedures for review of an 
ENDS PMTA, what information the FD&C Act requires applicants to submit 
in a PMTA, and what information FDA recommends applicants submit in an 
ENDS PMTA to show whether permitting such new tobacco product to be 
marketed is appropriate for the protection of the public health.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance

[[Page 28783]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on PMTAs for 
ENDS. 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. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information described 
in FDA's Deeming rule, which this draft guidance is intended to 
interpret. The collections of information in the Deeming rule are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As 
required by the PRA, FDA has published an analysis of the information 
collection provisions elsewhere in this issue of the Federal Register 
and has submitted them for OMB approval.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the draft 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. 2016-10687 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P