[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Rules and Regulations]
[Pages 27200-27201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12389]


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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; Guidance for Industry; 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 final guidance for industry entitled ``Premarket 
Tobacco Product Applications for Electronic Nicotine Delivery Systems, 
Guidance for Industry.'' 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 guidance is 
intended to assist applicants to prepare PMTAs for ENDS products.

DATES: The announcement of the guidance is published in the Federal 
Register on June 12, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 Applications for 
Electronic Nicotine Delivery Systems, Guidance for Industry.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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

[[Page 27201]]

the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 20993-0002. 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: Paul Hart, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
1-877-CTP-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a 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 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. On May 10, 2016, in the Federal Register, FDA 
published 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) extending FDA's tobacco product 
authority to ENDS, among other products (81 FR 28973). In the same 
issue of the Federal Register, FDA concurrently announced the 
availability of the draft guidance, ``Premarket Tobacco Product 
Applications for Electronic Nicotine Delivery Systems, Draft Guidance 
for Industry; Availability; Agency Information Collection Activities; 
Proposed Collection; Comment Request'' (81 FR 28781). FDA received 
comments on the draft guidance and those comments were considered as 
the guidance was finalized. Changes made as a result of public comments 
include recommendations for constituent testing, single applications 
for new tobacco products that an applicant intends to market as a 
modified risk tobacco product, and the number batches and replicates 
related to product testing.
    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)). ENDS products, the subject of this 
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 guidance explains, 
among other things, 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 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 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. This guidance is not subject to 
Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 1107.1 have been approved under 
OMB control number 0910-0768.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidance at either https://www.regulations.gov or 
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance.

    Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12389 Filed 6-11-19; 8:45 am]
 BILLING CODE 4164-01-P