Notice2023-20516
In-Home Disposal Systems for Opioid Analgesics; Request for Information; Reopening of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the notice entitled "In-Home Disposal Systems for Opioid Analgesics; Request for Information" published in the Federal Register of April 4, 2023. FDA is reopening the comment period to allow interested persons additional time to develop and submit comments.
Full Text
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<title>Federal Register, Volume 88 Issue 183 (Friday, September 22, 2023)</title>
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[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65397-65398]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20516]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0917]
In-Home Disposal Systems for Opioid Analgesics; Request for
Information; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
[[Page 65398]]
ACTION: Notice; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
reopening the comment period for the notice entitled ``In-Home Disposal
Systems for Opioid Analgesics; Request for Information'' published in
the Federal Register of April 4, 2023. FDA is reopening the comment
period to allow interested persons additional time to develop and
submit comments.
DATES: FDA is reopening the comment period on the notice published
April 4, 2023 (88 FR 19959). Either electronic or written comments must
be submitted by November 6, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-0917 for ``In-Home Disposal Systems for Opioid Analgesics;
Request for Information.'' 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#276c4e4a4542554b5e096b424f5541424b4367414346094f4f5409404851"><span class="__cf_email__" data-cfemail="b4ffddd9d6d1c6d8cd9af8d1dcc6d2d1d8d0f4d2d0d59adcdcc79ad3dbc2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 4, 2023 (88
FR 19959), FDA published a notice requesting information and comments
that will assist the Agency in assessing whether in-home disposal
products can be expected to meet the public health goal of mitigating
the risk of nonmedical use or overdose if the Agency were to require
drug manufacturers to make in-home disposal products available to
patients under a risk evaluation and mitigation strategy. The Agency
requested information and comments on the issues that were discussed at
the public workshop convened by the National Academies of Sciences,
Engineering, and Medicine's Forum on Drug Discovery, Development, and
Translation entitled ``Defining and Evaluating In-Home Disposal Systems
for Opioid Analgesics'' on June 26 and 27, 2023. Interested persons
were originally given until August 28, 2023, to submit comments on in-
home disposal systems for opioid analgesics.
FDA is reopening the public docket to allow interested persons
additional time to submit comments. We note that there is a listening
session on October 5, 2023, with federally recognized American Indian
and Alaska Native tribes on the safe disposal of opioid analgesics. The
Agency believes that reopening the comment period for an additional 45
days will allow adequate time for interested persons to submit comments
without significantly delaying Agency decision-making on these
important issues. FDA is reopening the comment period for 45 days,
until November 6, 2023.
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20516 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P
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