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 a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. Such a requirement could reduce the amount of unused opioid analgesics in patients' homes, thereby reducing opportunities for nonmedical use, accidental exposure, and overdose, and possibly reducing the development of new opioid addiction.
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-2022-N-0165] AGENCY: Food and Drug Administration, Health and Human Services (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 a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. Such a requirement could reduce the amount of unused opioid analgesics in patients' homes, thereby reducing opportunities for nonmedical use, accidental exposure, and overdose, and possibly reducing the development of new opioid addiction. DATES: Submit either electronic or written comments by June 21, 2022. ADDRESSES: FDA is establishing a docket for public comment on this notice. The docket number is FDA-2022-N-0165. The docket will close on June 21, 2022. Submit either electronic or written comments by June 21, 2022. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 21, 2022. Comments received by mail/hand delivery/courier (for written/paper submi…
Citation: 87 FR 23869
