[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extending the comment period for the draft guidance for industry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 In the draft guidance for industry, FDA requested comments on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DATES: FDA is extending the comment period on the draft guidance for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Agency considers your comment on this draft guidance before it begins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