Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comment on what specifications for in-home disposal systems, if application holders are required to make them available under the Opioid Analgesic Risk Evaluation and Mitigation Strategy, would be necessary to show that these systems may mitigate the serious risks of abuse or overdose involving these medications.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-1001] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comment on what specifications for in-home disposal systems, if application holders are required to make them available under the Opioid Analgesic Risk Evaluation and Mitigation Strategy, would be necessary to show that these systems may mitigate the serious risks of abuse or overdose involving these medications. DATES: Submit either electronic or written comments by April 6, 2026. ADDRESSES: FDA is establishing a docket for public comment on this notice. The docket number is FDA-2026-N-1001. The docket will close on April 6, 2026. Submit either electronic or written comments by April 6, 2026. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 6, 2026. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 6, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. You may submit comments as follows: Electronic Submissions Submit electronic comment…
Citation: 91 FR 11077
