[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55613-55614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0227]


Tobacco Product Manufacturing Practice; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting public 
input on updated recommendations for regulations on good manufacturing 
practice for electronic nicotine delivery systems (ENDS) that were 
submitted to FDA by a group of 13 tobacco companies (tobacco companies' 
ENDS recommendations). FDA is providing an opportunity for interested 
parties to comment on the tobacco companies' ENDS recommendations.

DATES: Submit electronic or written comments on the tobacco companies' 
ENDS recommendations by December 22, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 22, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 22, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

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-2013-N-0227 for ``Tobacco Product Manufacturing Practice; 
Establishment of a Public Docket.'' Received comments, those filed in a 
timely manner (see ADDRESSES), 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 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.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco

[[Page 55614]]

Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law, 
amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and giving 
FDA authority to regulate tobacco product manufacturing, distribution, 
and marketing. The new provisions include, among other things, the 
authority to issue regulations related to tobacco product manufacturing 
practice in order to protect the public health and to assure that 
tobacco products are in compliance with the FD&C Act. Specifically, 
section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that in 
applying manufacturing restrictions to tobacco, the Secretary shall 
prescribe regulations (which may differ based on the type of tobacco 
product involved) requiring that the methods used in, and the 
facilities and controls used for, the manufacture, preproduction design 
validation (including a process to assess the performance of a tobacco 
product), packing, and storage of a tobacco product conform to current 
good manufacturing practice, or hazard analysis and critical control 
point methodology.
    On May 10, 2016, FDA published a 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'' (81 FR 28974) (the 
deeming rule) that became effective on August 8, 2016. Under the 
deeming rule, newly deemed tobacco products, including ENDS, are now 
subject to the provisions of the Tobacco Control Act that apply 
automatically to all products that meet the statutory definition of a 
tobacco product in section 201(rr) of the FD&C Act (21 U.S.C. 321(r)).
    On January 10, 2012, industry stakeholders submitted 
recommendations for good manufacturing practice requirements (and a 
draft preamble) for tobacco products that were immediately subject to 
FDA's jurisdiction when the Tobacco Control Act went into effect. This 
January 10, 2012, letter was posted to this Docket No. FDA-2013-N-0227 
on March 12, 2013, as part of a request for comments on the 
recommendations contained in the letter. On June 7, 2017, a group of 13 
tobacco companies submitted to FDA: (1) Recommendations for good 
manufacturing practice requirements for ENDS and (2) an attachment 
letter with a meeting request (Ref. 1). The tobacco companies' ENDS 
recommendations are intended to supplement an earlier letter dated 
January 10, 2012. According to the June 7, 2017, letter, the tobacco 
companies' ENDS recommendations seek to account for the differences in 
manufacturing ENDS.
    FDA is providing an opportunity for all interested parties to 
comment only on the tobacco companies' ENDS recommendations submitted 
on June 7, 2017.

II. References

    The following reference has been placed on display in the Dockets 
Management Staff (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday and is available 
electronically at https://www.regulations.gov.

1. Proposed Good Manufacturing Practices Regulation to Account for 
FDA's Deeming Regulation and Request for Meeting, submitted to FDA, 
June 7, 2017.

    Dated: November 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25245 Filed 11-21-17; 8:45 am]
 BILLING CODE 4164-01-P