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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
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prescription pain reliever use disorder and 438,000 people with heroin use disorder. This population likely is at risk of abusing butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene. Individuals who initiate i.e., use a drug for the first time use of these benzimidazole-opioids are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics e.g., fentanyl, morphine, etc.. Law enforcement or toxicology reports demonstrate that the seven substances at issue are being distributed illicitly and abused.
Factor 6. What, if Any, Risk There Is to the Public Health The increase in opioid overdose deaths in the United States has been exacerbated recently by the availability of potent synthetic opioids in the illicit drug market. Data obtained from preclinical studies demonstrate that butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene exhibit pharmacological profiles similar to that of schedule I substances such as etonitazene, isotonitazene, and other mu-opioid receptor agonists. These seven benzimidazole-opioids bind to and act as agonists at the mu-opioid receptors. It is well established that substances that act as mu-opioid receptor agonists have a high potential for abuse and addiction and can induce dose-dependent respiratory depression.
As with any mu-opioid receptor agonist, the potential health and safety risks for users of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene are high. Consistently, these substances have been identified in toxicology cases. The public health risks attendant to the abuse of mu-opioid receptor agonists are well established.
These risks include large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.
According to the Centers for Disease Control and Prevention CDC, opioids, mainly synthetic opioids other than methadone, are predominantly responsible for drug overdose deaths in recent years. According to CDC data, synthetic opioid-related overdose deaths in the United States increased from 36,359 in 2019, to 56,688 in 2020 CDC, 2021.7 Of the drug overdose death data 7 12 Month-ending Provisional Number of Drug Overdose Deaths. Reported provisional data as of
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70,630 for 2019, synthetic opioids were involved in about 51.4 percent 36,359 of all drug-involved overdose deaths.
According to a recent publication, since November 2020, there has been an increase in metonitazene-related adverse events, including deaths.8
Metonitazene has been co-identified with other substances in biological samples from 20 post-mortem cases from seven different states: Florida 1, Illinois 5, Iowa 1, Ohio 1, South Carolina 1, Tennessee 10, and Wisconsin 1. Information gathered from case histories and autopsy findings show that deaths involving metonitazene were similar to those of opioid-related deaths. Identified material or paraphernalia from deathscene investigations were consistent with opioid use. Reports obtained from autopsy findings showed that deaths involving metonitazene presented pulmonary and cerebral edema, as well as distended bladder and signs of intravenous drug use. Of the cases for which death certificate data were available, metonitazene was reported as a cause of death in four cases, of which three cases listed metonitazene as the only cause.
According to recent reports, butonitazene 1 instance, etodesnitazene 5, flunitazene 4, metodesnitazene 1, metonitazene 20, protonitazene 5, and N-pyrrolidino etonitazene 10 have been identified in toxicology cases in the United States.9
For cases involving N-pyrrolidino etonitazene, it was co-identified with fentanyl in four cases and with novel benzodiazepines e.g., flualprazolam, etizolam, and clonazolam in six others.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C.
811h3, based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene pose July 4, 2021. https www.cdc.gov/nchs/nvss/vsrr/
drug-overdose-data.htm.
8 Krotulski AJ, Papsun DM, Walton SE, Logan BK.
Metonitazene in the United States-Forensic toxicology assessment of a potent new synthetic opioid using liquid chromatography mass spectrometry. Drug Test Anal. 2021 Jun 16. doi:
10.1002/dta.3115. Epub ahead of print.
9 Center for Forensic Science Research and Education. NPS Opioids in the United States Trend Report Q1 and Q2, 2021.

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imminent hazards to public safety. DEA
is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C.
811h1, may only be placed in schedule I. Substances in schedule I
must have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene indicate that these substances meet the three statutory criteria. As required by 21 U.S.C.
811h4, the then-Acting Administrator transmitted to the Assistant Secretary for Health, via letter dated June 16, 2021, notice of his intent to place butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene in schedule I on a temporary basis. In a letter to the Assistant Secretary for Health dated August 25, 2021, the Administrator transmitted notice of her intent to place N-pyrrolidino etonitazene in schedule I on a temporary basis.
Conclusion This Notice of Intent provides the 30day notice pursuant to 21 U.S.C.
811h1 of DEAs intent to issue a temporary scheduling order. In accordance with 21 U.S.C. 811h1 and 3, the Administrator considered available data and information, herein set forth the grounds for her determination that it is necessary to temporarily schedule butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, Npyrrolidino etonitazene, and protonitazene in schedule I of the CSA, and finds that placement of these substances in schedule I is necessary to avoid an imminent hazard to the public safety.
The temporary placement of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before January 6, 2022. Because the Administrator hereby finds this temporary scheduling order necessary to avoid an imminent hazard to the public safety, it will take effect on the date the order is published in the Federal Register, and remain in effect for two
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