Notice2023-06650
In-Home Disposal Systems for Opioid Analgesics; Request for Information
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
April 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 64 (Tuesday, April 4, 2023)</title>
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[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19959-19961]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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:
[[Page 19960]]
<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#e7ac8e8a8582958b9ec9ab828f9581828b83a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="450e2c28272037293c6b09202d3723202921052321246b2d2d366b222a33">[email protected]</span></a>.
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 <a href="https://www.nationalacademies.org/our-work/advancing-regulatory-science-for-defining-and-evaluating-in-home-safe-disposal-systems-a-workshop">https://www.nationalacademies.org/our-work/advancing-regulatory-science-for-defining-and-evaluating-in-home-safe-disposal-systems-a-workshop</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="https://doi.org/10.1001/jamasurg.2017.0831">https://doi.org/10.1001/jamasurg.2017.0831</a>.
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, <a href="https://doi.org/10.1093/pm/pnab244">https://doi.org/10.1093/pm/pnab244</a>.
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
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