[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Rules and Regulations]
[Page 20155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06984]



[[Page 20155]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-597]


Schedules of Controlled Substances: Temporary Placement of 
Fentanyl-Related Substances in Schedule I; Correction

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Correcting amendment.

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SUMMARY: In the February 6, 2018, issue of the Federal Register, the 
Drug Enforcement Administration published a temporary scheduling order 
placing fentanyl-related substances, as defined in the order, and their 
isomers, esters, ethers, salts and salts of isomers, esters, and ethers 
in schedule I of the Controlled Substances Act. That order was set to 
expire on February 6, 2020. However, the ``Temporary Reauthorization 
and Study of the Emergency Scheduling of Fentanyl Analogues Act,'' 
which became law on February 6, 2020, extended the temporary control of 
fentanyl-related substances until May 6, 2021. This correcting 
amendment reflects the new expiration date mandated by Congress for the 
temporary scheduling order.

DATES: This correcting amendment is effective April 10, 2020 through 
May 6, 2021, and is applicable beginning February 6, 2018 until May 6, 
2021. If the temporary scheduling of fentanyl-related substances is 
made permanent, Drug Enforcement Administration (DEA) will publish a 
document in the Federal Register on or before May 6, 2021.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION: 

Background

    In response to the rapid evolution of substances structurally 
related to fentanyl on the illicit drug market, the former Acting 
Administrator of DEA published a temporary scheduling order placing 
fentanyl-related substances, as defined in the order, in schedule I of 
the Controlled Substances Act (CSA) pursuant to the temporary 
scheduling provisions of 21 United States Code (U.S.C.) 811(h)(1). 83 
FR 5188, February 6, 2018. That order was effective on the date of 
publication, and was based on findings by the former Acting 
Administrator that the temporary scheduling of these substances was 
necessary to avoid an imminent hazard to the public safety. The 
temporary scheduling order was codified at 21 Code of Federal 
Regulations (CFR) 1308.11(h)(30). Under 21 U.S.C. 811(h)(2), the 
temporary control of fentanyl-related substances was set to expire two 
years from the effective date of the scheduling order, i.e., on 
February 6, 2020.
    On February 6, 2020, the President signed the Temporary 
Reauthorization and Study of the Emergency Scheduling of Fentanyl 
Analogues Act into law as Public Law 116-114. Section 2 of this Act 
stated, ``notwithstanding any other provision of law, [21 CFR 
1308.11(h)(30)] shall remain in effect until May 6, 2021.'' Public Law 
116-114 thereby ensured that there was no lapse in the temporary 
placement in schedule I of fentanyl-related substances. In other words, 
by operation of law, the temporary placement in schedule I of fentanyl-
related substances that began on February 6, 2018, has continued 
uninterrupted and will remain in effect until May 6, 2021, unless DEA 
permanently places such substances in schedule I prior to May 6, 2021.

Need for Correction

    The February 6, 2018, temporary order placed fentanyl-related 
substances in 21 CFR 1308.11(h)(30). As discussed above, this order was 
set to expire on February 6, 2020, but that expiration date was 
overridden by Congress through enactment of Public Law 116-114. 
However, the CFR has not yet been updated to reflect the new expiration 
date. Rather, the reference to fentanyl-related substances in 21 CFR 
1308.11(h)(30) was removed from the electronic version of the CFR after 
February 6, 2020--even though fentanyl-related substances remained in 
schedule I by virtue of Public Law 116-114. In accordance with the 
public law, paragraph (h)(30) is hereby being put back into the CFR, 
along with the new expiration date of May 6, 2021.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is corrected by 
making the following correcting amendment:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. In Sec.  1308.11, add paragraph (h)(30) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

 
 
 
(30) Fentanyl-related substances, their isomers, esters,            9850
 ethers, salts and salts of isomers, esters and ethers.........
 

    (i) Fentanyl-related substance means any substance not otherwise 
listed under another Administration Controlled Substance Code Number, 
and for which no exemption or approval is in effect under section 505 
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is 
structurally related to fentanyl by one or more of the following 
modifications:
    (A) Replacement of the phenyl portion of the phenethyl group by any 
monocycle, whether or not further substituted in or on the monocycle;
    (B) Substitution in or on the phenethyl group with alkyl, alkenyl, 
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
    (C) Substitution in or on the piperidine ring with alkyl, alkenyl, 
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro 
groups;
    (D) Replacement of the aniline ring with any aromatic monocycle 
whether or not further substituted in or on the aromatic monocycle; 
and/or
    (E) Replacement of the N-propionyl group by another acyl group.
    (ii) This definition includes, but is not limited to, the following 
substances: (A)-(B) [Reserved]
* * * * *

Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-06984 Filed 4-9-20; 8:45 am]
 BILLING CODE 4410-09-P