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https://www.federalregister.gov/documents/2023/04/04/2023-06650/in-home-disposal-systems-for-opioid-analgesics-request-for-infor...
Submission: On August 16 via api from US — Scanned from DE
Submission: On August 16 via api from US — Scanned from DE
Form analysis 3 forms found in the DOM
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DOCUMENT DETAILS
Information about this document as published in the Federal Register.
Printed version: PDF Publication Date: 04/04/2023 Agencies: Food and Drug
Administration Dates: Submit either electronic or written comments, data, or
information by August 28, 2023. Comments Close: 08/28/2023 Document Type: Notice
Document Citation: 88 FR 19959 Page: 19959-19961 (3 pages) Agency/Docket Number:
Docket No. FDA-2023-N-0917 Document Number: 2023-06650
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In-Home Safe Disposal Systems; Request for Information
FDA-2023-N-0917
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* AGENCY:
* ACTION:
* SUMMARY:
* DATES:
* ADDRESSES:
* Electronic Submissions
* Written/Paper Submissions
* FOR FURTHER INFORMATION CONTACT:
* SUPPLEMENTARY INFORMATION:
* I. Background
* II. Topic for Public Input
* III. References
* Footnotes
ENHANCED CONTENT - TABLE OF CONTENTS
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* ENHANCED CONTENT - SUBMIT PUBLIC COMMENT
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Docket Title Document ID Comments In-Home Safe Disposal Systems; Request
for Information FDA-2023-N-0917-0001 27
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PUBLISHED DOCUMENT
This document has been published in the Federal Register. Use the PDF linked in
the document sidebar for the official electronic format.
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; request for information; establishment of a public docket.
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
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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: Start Printed 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.
Start Further Info
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, Kimberly.Lehrfeld@fda.hhs.gov.
End Further Info End Preamble Start Supplemental Information
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)).
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 Start Printed 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.
Start Signature
Dated: March 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
End Signature End Supplemental Information
FOOTNOTES
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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