[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65397-65398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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, [email protected].

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