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Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations Department of Health and Human Services HHS of his intention to temporarily place a substance in schedule I.2 21 U.S.C. 811h4. The Acting Administrator transmitted such notice regarding brorphine to the Assistant Secretary for Health of HHS
Assistant Secretary by letter dated September 22, 2020. The Assistant Secretary responded to this notice by letter dated October 27, 2020, and advised that based on a review by the Food and Drug Administration FDA, there are currently no investigational new drug applications INDs or approved new drug applications NDAs for brorphine. The Assistant Secretary also stated that HHS had no objection to the temporary placement of brorphine in schedule I of the CSA.
DEA has taken into consideration the Assistant Secretarys comments as required by subsection 811h4.
Brorphine is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for brorphine under 21 U.S.C. 355. DEA has found that the control of brorphine in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety.
As required by 21 U.S.C. 811h1A, DEA published a notice of intent to temporarily schedule brorphine on December 3, 2020. 85 FR 78047. That notice of intent discussed findings from DEAs three-factor analysis dated August 2020, which DEA made available on www.regulations.gov.
To find that placing a substance temporarily in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811c: The substances history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21
U.S.C. 811h3. Consideration of these factors includes actual abuse diversion from legitimate channels; and clandestine importation, manufacture, or distribution. 21 U.S.C. 811h3.
A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21
U.S.C. 811h1. Substances in schedule I 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. 21 U.S.C.
812b1.
2 The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.

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Available data and information for brorphine summarized below indicate that it has 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. DEAs August 2020 three-factor analysis and the Assistant Secretarys October 27, 2020, letter are available in their entirety under the tab Supporting Documents of the public docket of this action at www.regulations.gov.
Brorphine The availability of synthetic opioids on the illicit drug market continues to pose an imminent hazard to the public safety. Adverse health effects associated with the abuse of synthetic opioids and the increased popularity of these substances have posed serious health concerns in recent years. The presence of new synthetic opioids with no approved medical use exacerbates the unprecedented opioid epidemic in the United States continues to experience.
The trafficking and abuse of new synthetic opioids are deadly new trends.
The identification of brorphine on the illicit drug market has been reported in the United States, Canada, Belgium, and Sweden. Data obtained from preclinical pharmacology studies show that brorphine has a pharmacological profile similar to that of other potent opioids such as morphine and fentanyl, schedule II controlled substances.
Because of the pharmacological similarities between brorphine and other potent opioids, the use of brorphine presents a high risk of abuse and may negatively affect users and their communities. The positive identification of this substance in law enforcement seizures and post-mortem toxicology reports is a serious concern to the public safety. The abuse of brorphine has been associated with at least seven fatalities between June and July 2020 in the United States. Thus, brorphine poses an imminent hazard to public safety.
Available data and information for brorphine, as summarized below, indicates that this substance has 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. DEAs three-factor analysis is available in its entirety under Supporting and Related Material of the public docket for this action at www.regulations.gov under Docket Number DEA716.

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Factor 4. History and Current Pattern of Abuse Brorphine is part of a structural class of compounds known as substituted piperidine benzimidazolones. The general synthesis of brorphine was first reported in the literature in 2018.
Brorphine is not an approved pharmaceutical product and is not approved for medical use anywhere in the world. The Assistant Secretary, by a letter to DEA dated October 27, 2020, stated that there are no FDA-approved NDAs or INDs for brorphine in the United States. Hence, DEA notes there is no legitimate channel for brorphine as a marketed drug product. The appearance of brorphine on the illicit drug market is similar to other designer drugs trafficked for their psychoactive effects.
Since 2014, numerous synthetic opioids structurally related to fentanyl and several synthetic opioids from other structural classes have begun to emerge on the illicit drug market as evidenced by the identification of these drugs in forensic drug exhibits and toxicology samples. Beginning in June 2019, brorphine emerged in the United States illicit, synthetic drug market as evidenced by brorphines identification in drug seizures. Authorities Between July and September 2019, brorphine was first reported in drug casework in Canada and was first reported in police seizures in Sweden in March 2020.3
Brorphine has been encountered by United States law enforcement in powder form. In the United States, brorphine has been identified as a single substance and in combination with other substances. Between June 2019
and August 2020, there are twenty reports of brorphine in the National Forensic Laboratory Information System NFLIS from three different states see Factor 5.4 In several NFLIS encounters, brorphine was found in combination 3 Health Canada Drug Analysis Service 2019;
Analyzed Drug Report Canada 2019Q3 July to September; European Monitoring Centre for Drugs and Drug Addiction EMCDDA 2020; EU Early Warning System Situation Report, Situation report 1June 2020.
4 NFLIS represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive information system that includes data from forensic laboratories that handle the nations drug analysis cases. NFLIS-Drug participation rate, defined as the percentage of the national drug caseload represented by laboratories that have joined NFLIS, is currently 98.5 percent. NFLIS includes drug chemistry results from completed analyses only.
While NFLIS data is not direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See 76 FR 77330, 77332, December 12, 2011. NFLIS data was queried on August 18, 2020.

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