Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 51 / Thursday, March 18, 2021 / Proposed Rules of the 12 2 other fentanyl-related substances none of which included the four substances named in this proposed rule. In October 2020 and March 2021, DEA issued two scheduling actions for these 11 substances, with one action permanently controlling one of the 11
substances, and another action proposing the continued control of 10
substances.3
On March 2, 2021, the Acting Assistant Secretary submitted to the Acting Administrator, HHSs scientific and medical evaluation and scheduling recommendation for the four fentanylrelated substances named in this proposed rule. Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed these documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of the four substances in accordance with 21 U.S.C. 811c.

jbell on DSKJLSW7X2PROD with PROPOSALS

Proposed Determination to Permanently Schedule Fentanyl Carbamate, ortho-Fluoroacryl Fentanyl, ortho-Fluoro Isobutyryl Fentanyl, and para-Fluoro Furanyl Fentanyl As discussed in the background section, the Acting Administrator is initiating proceedings to permanently add fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl to schedule I. DEA has reviewed the scientific and medical evaluation and scheduling recommendation from HHS, and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of these four substances.
Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its proposed scheduling action. Please note that both the DEA and HHS 8-Factor analyses and the Acting Assistant Secretarys March 2, 2021, letter are available in their entirety under the tab Supporting Documents of the public docket for this action at http
2 HHS scientific and medical evaluation for benzodioxole fentanyl is ongoing. DEA will not further discuss this substance in this proposed rule.
3 On October 2, 2020, DEA issued a final order 85
FR 62215 for crotonyl fentanyl and maintained its placement in schedule I, using DEAs authority under 21 U.S.C. 811d1, to meet obligations under the 1961 Single Convention on Narcotic Drugs, March 30, 1961, 18 U.S.T. 1407, 570 U.N.T.S. 151, as amended. On March 3, 2021, DEA issued a general notice of proposed rulemaking 86 FR
12296 to permanently control 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl in schedule I.

VerDate Sep<11>2014

16:14 Mar 17, 2021

Jkt 253001

www.regulations.gov under Docket Number DEA806.
1. The Drugs Actual or Relative Potential for Abuse: The term abuse is not defined in the CSA. However, the legislative history of the CSA suggests that DEA consider the following criteria when determining whether a particular drug or substance has a potential for abuse: 4
a There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or b There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or c Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or d The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.
The abuse potential of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl is associated with their pharmacological similarity to other schedule I acetyl fentanyl and furanyl fentanyl and II
mu-opioid receptor agonist substances, which have a high potential for abuse.
Similar to schedule II substances morphine and fentanyl, these four fentanyl-related substances have been shown to bind and act as mu-opioid receptor agonists.
These four substances have no approved medical use in the United States and have been encountered on the illicit drug market. The use of some fentanyl-related substances has been associated with adverse health outcomes, including death. The appearance of several substances structurally related to fentanyl in the 4 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 911444, 91st Cong., Sess. 1 1970; reprinted in 1970
U.S.C.C.A.N. 4566, 4603.

PO 00000

Frm 00015

Fmt 4702

Sfmt 4702

14709

illicit drug market has resulted in a significant increase in drug overdose deaths in the United States. According to the Centers for Disease Control and Prevention CDC overdose death data for 2019, there continues to be an increase in the number of deaths related to synthetic opioids. Opioids were involved in about 71 percent of all druginvolved overdose deaths in 2019.
Further, CDC reports demonstrate that the increase in synthetic opioid overdose deaths are largely attributed to an increase in the supply of illicitly manufactured fentanyl and substances structurally related to fentanyl. Because fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl are not Food and Drug Administration FDA-approved drug products, a practitioner may not legally prescribe them, and these substances cannot be dispensed to an individual.
Therefore, the use of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl is without medical advice, and accordingly leads to the conclusion that these four substances are abused for their opioidergic properties.
There are no legitimate drug channels for fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl as marketed FDA-approved drug products, but these substances are available for purchase from legitimate chemical companies for research purposes. However, despite the limited legitimate research use of these four substances, reports from public health and law enforcement data indicate that all four substances are being abused and taken in amounts sufficient to create a hazard to an individuals health. Data from forensic databases can be used as an indicator of illicit activity with drugs and abuse 5 within the United States.
According to the National Forensic Laboratory Information System NFLIS,6 which collects and analyzes drug exhibits submitted to Federal, State, and local forensic laboratories, there were 187 total reports of these substances between 2017 and 2020
queried on February 22, 2021.
5 While law enforcement 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, Dec. 12, 2011.
6 NFLIS is a DEA program and a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories in the United States. The NFLIS database also contains Federal data from U.S. Customs and Border Protection. NFLIS only includes drug chemistry results from completed analyses.

E:FRFM18MRP1.SGM

18MRP1