[Federal Register Volume 84, Number 68 (Tuesday, April 9, 2019)]
[Notices]
[Pages 14120-14121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0661]


Modifications to Compliance Policy for Certain Deemed Tobacco 
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the draft guidance for industry 
entitled ``Modifications to Compliance Policy for Certain Deemed 
Tobacco Products'' that appeared in the Federal Register of March 14, 
2019. In the draft guidance for industry, FDA requested comments on 
changes to the compliance policies for premarket review requirements 
for certain deemed tobacco products and how FDA intends to prioritize 
its enforcement resources with regard to the marketing of certain 
deemed tobacco products that do not have premarket authorization. The 
Agency is taking this action in response to requests for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance for 
industry published March 14, 2019 (84 FR 9345). Submit either 
electronic or written comments by April 30, 2019, to ensure that the 
Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You must submit your comment(s) on or before April 30, 2019, 
to ensure that the Agency considers your comment(s) before it begins 
work on the final version of the guidance.

[[Page 14121]]

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-2019-D-0661 for ``Modifications to Compliance Policy for Certain 
Deemed Tobacco Products.'' 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 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: Gerie Voss, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 14, 2019, 
FDA published a draft guidance for industry with a 30-day comment 
period to request comments on changes to the compliance policies for 
premarket review requirements and how FDA plans to prioritize its 
enforcement resources with regard to certain deemed tobacco products in 
the United States that do not have the required FDA premarket 
authorization for marketing. Comments on the draft guidance for 
industry will inform how FDA intends to finalize the guidance.
    The Agency has received requests for an extension of the comment 
period for the draft guidance for industry. The requests conveyed 
concern that the current 30-day comment period does not allow 
sufficient time to develop a response to the draft guidance for 
industry.
    FDA has considered the requests and is extending the comment period 
for the draft guidance for industry for 15 days, until April 30, 2019. 
The Agency believes that a 15-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
the process to finalize this guidance.

    Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06952 Filed 4-8-19; 8:45 am]
 BILLING CODE 4164-01-P


