[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19959-19961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06650]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information; establishment of a public 
docket.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of a docket to obtain 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 (REMS). The Agency 
would like information and comments on the issues to be discussed at 
the public workshop convened by the National Academies of Sciences, 
Engineering and Medicine's (NASEM'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.

DATES: Submit either electronic or written comments, data, or 
information by August 28, 2023.

ADDRESSES: You may submit data and comments as follows. Please note 
that late, untimely filed comments will not be considered. The docket 
will close on August 28, 2023. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of August 28, 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:

[[Page 19960]]

     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: 

I. Background

    Nonmedical use,\1\ accidental exposure, and overdose associated 
with prescription opioid analgesics remain a serious problem in the 
United States. Patients commonly report having unused opioid analgesics 
after treatment of acute pain, such as pain following surgical 
procedures (Refs. 1 and 2). Opioid analgesics prescribed to treat 
chronic pain conditions can also result in unused drugs. When not 
properly disposed, these opioid analgesics provide opportunities for 
nonmedical use, accidental exposure, and overdose. Accordingly, FDA's 
efforts to address the opioid crisis include a focus on encouraging 
appropriate disposal of unused opioid analgesics (for additional 
information, see the Federal Register notice ``Providing Mail-Back 
Envelopes and Education on Safe Disposal With Opioid Analgesics 
Dispensed in an Outpatient Setting; Establishment of a Public Docket; 
Request for Comments'' (April 21, 2022, 87 FR 23869; Sec. I., 
Background (Docket No. FDA-2022-N-0165)). The Substance Use-Disorder 
Prevention That Promotes Opioid Recovery and Treatment for Patients and 
Communities Act (SUPPORT Act) (Pub. L. 115-271), signed into law on 
October 24, 2018, provides FDA authorities to address the opioid 
crisis. The SUPPORT Act authorized FDA to require through a REMS that a 
safe disposal packaging or safe disposal system be dispensed to certain 
patients with opioids or other drugs that pose a serious risk of abuse 
or overdose if, among other things, FDA determines that such safe 
disposal packaging or system may mitigate such risks and is 
sufficiently available (21 U.S.C. 355-1(e)(4)).
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    \1\ We use the term ``nonmedical'' in this document to refer to 
misuse of a drug, abuse of a drug, or both. ``Misuse'' is the 
intentional use, for therapeutic purposes, of a drug in a manner 
other than prescribed. ``Abuse'' is the intentional, non-therapeutic 
use of a drug, even once, for its desirable psychological or 
physiological effects.
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II. Topic for Public Input

    This request for information is part of FDA's ongoing efforts to 
determine 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 these products 
available to patients under a REMS. On June 26 and 27, 2023, NASEM's 
Forum on Drug Discovery, Development, and Translation will hold a 
public workshop entitled ``Defining and Evaluating In-Home Disposal 
Systems for Opioid Analgesics.''
    The purpose of the workshop is to provide an opportunity for 
stakeholders to examine in-home drug disposal systems, with a focus on 
removing unused opioid analgesics from the home. The workshop will 
feature invited presenters and discussions to explore the types of in-
home drug disposal options, other than mail-back envelopes, which could 
be used to remove unused opioid analgesics from the home. This will 
include, among other things, a discussion of the scientific, 
behavioral, health equity, and policy considerations for assessing the 
safety, use, and effectiveness of in-home drug disposal options.
    Workshop participants will address questions about the methods 
(e.g., sequestration, adsorption, absorption) used in in-home disposal 
options for rendering opioids unavailable for nonmedical use, assuming 
the in-home disposal product is used as intended. In addition, workshop 
participants will discuss approaches and methodologies needed to 
evaluate the safe and correct use of in-home drug disposal options in 
real-world settings. Finally, workshop participants will consider 
potential strategies for encouraging and assessing the development and 
use of in-home drug disposal options. Additional meeting information, 
including the briefing document, agenda, and presentations, will be 
made available at https://www.nationalacademies.org/our-work/advancing-regulatory-science-for-defining-and-evaluating-in-home-safe-disposal-systems-a-workshop closer to the workshop date. FDA is seeking 
information and comments on the topics discussed at this meeting.

III. References

    The following references are not on public display at https://www.regulations.gov because they have copyright restriction. Some 
references may be available at the website address, if listed. The 
references below are available for viewing only at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday. FDA has verified the web addresses, as of the date this

[[Page 19961]]

document publishes in the Federal Register, but websites are subject to 
change over time.

    1. Bicket, M.C., J.J. Long, P.J. Pronovost, et al., 
``Prescription Opioid Analgesics Commonly Unused After Surgery: A 
Systematic Review,'' JAMA Surgery, vol. 152(11), pp. 1066-1071, 
2017, https://doi.org/10.1001/jamasurg.2017.0831.
    2. Mallama, C.A., C.A. Greene, A.A. Alexandridis, et al., 
``Patient-Reported Opioid Analgesic Use After Discharge from 
Surgical Procedures: A Systematic Review,'' Pain Medicine, vol. 
23(1), pp. 22-44, 2022, https://doi.org/10.1093/pm/pnab244.

    Dated: March 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06650 Filed 4-3-23; 8:45 am]
BILLING CODE 4164-01-P


