Quiero saber acerca de...

12298

Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS

fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.
Background On February 6, 2018, pursuant to 21
U.S.C. 811h1, the then-Acting Administrator of DEA published an order in the Federal Register 83 FR
5188 temporarily placing fentanylrelated substances, as defined in that order, in schedule I of the CSA upon finding that these substances pose an imminent hazard to the public safety.
The 10 substances named in this proposed rule 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl meet the existing definition of fentanyl-related substances. On April 19, 2019, DEA
specifically identified four of these 10
substances 2-fluoro orthofluorofentanyl, b-phenyl fentanyl, ortho-methyl acetylfentanyl, and thiofuranyl fentanyl as meeting the definition of fentanyl-related substances. 84 FR 16397. Although DEA
did not issue a Federal Register publication to identify the other six substances, the February 6, 2018, temporary scheduling order emphasized that, even still, a substance is controlled by virtue of the order if it falls within the definition of fentanyl-related substances. 83 FR 5188, 5189. As discussed below in Factor 3, all 10
substances meet the definition as they are not otherwise controlled in any other schedule i.e., not included under another Administration Controlled Substance Code Number and are structurally related to fentanyl by one or more of the five modifications listed under the definition.
That temporary order was effective upon the date of publication. Pursuant to 21 U.S.C. 811h2, the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the 10 specific substances already covered by that order, was set to expire on February 6, 2020. However, as explained in DEAs April 10, 2020, correcting amendment 85 FR 20155, Congress overrode and extended that expiration date until May 6, 2021, by enacting on February 6, 2020
the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act Pub. L. 116
114, sec. 2, 134 Stat. 103. By operation of law, the temporary control of fentanyl-related substances, which
VerDate Sep<11>2014

16:34 Mar 02, 2021

Jkt 253001

includes these 10 covered substances, will remain in effect until May 6, 2021, unless DEA permanently places them in schedule I prior to May 6, 2021. As discussed in the above Legal Authority section, proceedings under 21 U.S.C.
811a may be initiated by the Administrator of DEA on his own motion.
The Acting Administrator, on his own motion, is initiating proceedings to permanently schedule the following 10
fentanyl-related substances: 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-phenyl fentanyl, b-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl. DEA gathered the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these 10
fentanyl-related substances, as well as for six other fentanyl-related substances benzodioxole fentanyl, crotonyl fentanyl, fentanyl carbamate, orthofluoro isobutyryl fentanyl, orthofluoroacryl fentanyl, and para-fluoro furanyl fentanyl. On April 3, and October 2, 2019, the then-Acting Administrator submitted this data to the Assistant Secretary, and requested that HHS provide DEA with a scientific and medical evaluation and a scheduling recommendation for the 16 fentanylrelated substances named above, in accordance with 21 U.S.C. 811b and c.
Upon evaluating the scientific and medical evidence, on July 2, 2020, the Assistant Secretary submitted to the Acting Administrator, HHSs scientific and medical evaluation and scheduling recommendation for 11 of the 16
fentanyl-related substances, including the 10 named substances in this proposed rule as well as crotonyl fentanyl.1 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 10 substances in accordance with 21 U.S.C. 811c. On October 2, 2020, DEA issued a final order 85 FR 62215 for crotonyl fentanyl to remain as a schedule I
substance under the CSA in order to meet the United States obligations 1 HHS scientific and medical evaluation for the other five fentanyl-related substances benzodioxole fentanyl, fentanyl carbamate, ortho-fluoro isobutyryl fentanyl, ortho-fluoroacryl fentanyl, and para-fluoro furanyl fentanyl is ongoing. DEA will not further discuss these five substances in this proposed rule.

PO 00000

Frm 00006

Fmt 4702

Sfmt 4702

under the 1961 Single Convention on Narcotic Drugs Single Convention, March 30, 1961, 18 U.S.T. 1407, 570
U.N.T.S. 151, as amended.2 As such, crotonyl fentanyl will not be discussed further in this scheduling action.
Proposed Determination To Permanently Schedule 2-Fluoro orthoFluorofentanyl, 4-Methyl Acetyl Fentanyl, b-Methyl Fentanyl, b-Phenyl Fentanyl, ortho-Fluorobutyryl fentanyl, ortho-Methyl Acetylfentanyl, orthoMethyl Methoxyacetyl Fentanyl, paraMethylfentanyl, Phenyl Fentanyl, and Thiofuranyl Fentanyl As discussed in the background section, the Acting Administrator is initiating proceedings to permanently add 2-fluoro ortho-fluorofentanyl, 4methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl 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 10 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 Assistant Secretarys July 2, 2020, letter are available in their entirety under the tab Supporting Documents of the public docket for this action at http
www.regulations.gov under Docket Number DEA476.
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:3
a There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a 2 In November 2019, the Director-General of the World Health Organization recommended to the Secretary-General that crotonyl fentanyl be placed in Schedule I of the Single Convention. On May 7, 2020, the Secretary-General advised the Secretary of State of the United States, by letter, that during its 63rd session in March 2020, the Commission on Narcotic Drugs voted to place crotonyl fentanyl in Schedule I of the Single Convention CND Mar/63/
2.
3 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.

E:FRFM03MRP1.SGM

03MRP1