[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Rules and Regulations]
[Pages 21834-21835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10009]



[[Page 21833]]

Vol. 83

Thursday,

No. 91

May 10, 2018

Part III





Department of Justice





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Drug Enforcement Administration





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21 CFR Part 1308





Schedules of Controlled Substances: Extension of Temporary Placement of 
beta-Hydroxythiofentanyl in Schedule I of the Controlled Substances 
Act; Temporary Rule

Federal Register / Vol. 83 , No. 91 / Thursday, May 10, 2018 / Rules 
and Regulations

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-484]


Schedules of Controlled Substances: Extension of Temporary 
Placement of beta-Hydroxythiofentanyl in Schedule I of the Controlled 
Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary rule; temporary scheduling order; extension.

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SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this temporary scheduling order to extend the 
temporary schedule I status of beta-hydroxythiofentanyl (N-[1-[2-
hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide) 
also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N-
phenylpropanamide including its isomers, esters, ethers, salts and 
salts of isomers, esters and ethers. The schedule I status of beta-
hydroxythiofentanyl currently is in effect through May 12, 2018. This 
temporary order will extend the temporary scheduling of beta-
hydroxythiofentanyl for one year, or until the permanent scheduling 
action for this substance is completed, whichever occurs first.

DATES: This temporary scheduling order, which extends the final order 
(81 FR 29492, May 12, 2016), is effective May 12, 2018 and expires on 
May 12, 2019. If this order is made permanent, the DEA will publish a 
document in the Federal Register on or before May 12, 2019.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority

    On May 12, 2016, the Acting Administrator of the Drug Enforcement 
Administration (DEA) published a final order in the Federal Register 
(81 FR 29492) temporarily placing beta-hydroxythiofentanyl (N-[1-[2-
hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide) in 
schedule I of the Controlled Substances Act (CSA) pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). That final order 
was effective on the date of publication, and was based on findings by 
the Acting Administrator of the DEA that the temporary scheduling of 
beta-hydroxythiofentanyl was necessary to avoid an imminent hazard to 
the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of 
the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of 
this substance expires two years from the effective date of the 
scheduling order, or on May 12, 2018. However, the CSA also provides 
that during the pendency of proceedings under 21 U.S.C. 811(a)(1) with 
respect to the substance, the temporary scheduling \1\ of that 
substance could be extended for up to one year. Proceedings for the 
scheduling of a substance under 21 U.S.C. 811(a) may be initiated by 
the Attorney General (delegated to the Administrator of the DEA 
pursuant to 28 CFR 0.100) on his own motion, at the request of the 
Secretary of Health and Human Services,\2\ or on the petition of any 
interested party.
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice adheres to the 
statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
    \2\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this 
temporary order, all subsequent references to ``Secretary'' have 
been replaced with ``Assistant Secretary.''
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    The Acting Administrator of the DEA, on his own motion pursuant to 
21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) 
to permanently schedule beta-hydroxythiofentanyl. The DEA has gathered 
and reviewed the available information regarding the pharmacology, 
chemistry, trafficking, actual abuse, pattern of abuse, and the 
relative potential for abuse for this substance. On December 8, 2016, 
the DEA submitted a request to the HHS to provide the DEA with a 
scientific and medical evaluation of available information and a 
scheduling recommendation for butyryl fentanyl and beta-
hydroxythiofentanyl, and in accordance with 21 U.S.C. 811(b) and (c). 
In a letter dated November 1, 2017, DEA notified HHS that it no longer 
required a scientific and medical evaluation for butyryl fentanyl 
because the Commission on Narcotic Drugs (CND), at its 60th session, 
added butyryl fentanyl to Schedule I of the Single Convention on 
Narcotic Drugs, 1961. On April 20, 2018, the DEA published a final 
scheduling order for butyryl fentanyl (83 FR17486) to meet 
international treaty obligations pursuant to 21 U.S.C. 811(d)(1).
    Upon evaluating the scientific and medical evidence, on April 27, 
2018, the HHS submitted to the Acting Administrator of the DEA its 
scientific and medical evaluation and scheduling recommendation for 
beta-hydroxythiofentanyl. Upon receipt of the scientific and medical 
evaluation and scheduling recommendation from the HHS, the DEA reviewed 
the documents and all other relevant data, and conducted its own eight-
factor analysis of the abuse potential of beta-hydroxythiofentanyl in 
accordance with 21 U.S.C. 811(c). The DEA published a notice of 
proposed rulemaking for the placement of beta-hydroxythiofentanyl in 
schedule I elsewhere in this issue of the Federal Register. If this 
order is made permanent, the DEA will publish a final rule in the 
Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator of the 
DEA orders that the temporary scheduling of beta-hydroxythiofentanyl, 
including its isomers, esters and ethers and salts of isomers, esters, 
ethers, be extended for one year, or until the permanent scheduling 
proceeding is completed, whichever occurs first.
    In accordance with this temporary scheduling order, the schedule I 
requirements for handling beta- hydroxythiofentanyl, including its 
isomers, esters and ethers and salts of isomers, esters, ethers, will 
remain in effect for one year, or until the permanent scheduling 
proceeding is completed, whichever occurs first.

Regulatory Matters

    The CSA provides for an expedited temporary scheduling action where 
such action is necessary to avoid an imminent hazard to the public 
safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule 
a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) 
also provides that the temporary scheduling of a substance shall expire 
at the end of two years from the date of the issuance of the order 
scheduling such substance, except that the Attorney General may, during 
the pendency of proceedings to permanently schedule the substance, 
extend the temporary scheduling for up to one year.
    To the extent that 21 U.S.C. 811(h) directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued and extended, the DEA believes that 
the notice and comment requirements of section 553 of the 
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this

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extension of the temporary scheduling action. In the alternative, even 
assuming that this action might be subject to section 553 of the APA, 
the Acting Administrator finds that there is good cause to forgo the 
notice and comment requirements of section 553, as any further delays 
in the process for extending the temporary scheduling order would be 
impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety. 
Further, the DEA believes that this order extending the temporary 
scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, 
accordingly, is not subject to the requirements of the Regulatory 
Flexibility Act (RFA). The requirements for the preparation of an 
initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not 
applicable where, as here, the DEA is not required by section 553 of 
the APA or any other law to publish a general notice of proposed 
rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the CRA, ``any rule 
for which an agency for good cause finds that notice and public 
procedure thereon are impracticable, unnecessary, or contrary to the 
public interest, shall take effect at such time as the federal agency 
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the 
public interest to maintain the temporary placement of beta-
hydroxythiofentanyl in schedule I because it poses a public health 
risk. The temporary scheduling action was taken pursuant to 21 U.S.C. 
811(h), which is specifically designed to enable the DEA to act in an 
expeditious manner to avoid an imminent hazard to the public safety. 
Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to 
notice and comment rulemaking procedures. The DEA understands that the 
CSA frames temporary scheduling actions as orders rather than rules to 
ensure that the process moves swiftly, and this extension of the 
temporary scheduling order continues to serve that purpose. For the 
same reasons that underlie 21 U.S.C. 811(h), that is, the need to place 
this substance in schedule I because it poses an imminent hazard to 
public safety, it would be contrary to the public interest to delay 
implementation of this extension of the temporary scheduling order. 
Therefore, in accordance with section 808(2) of the CRA, this order 
extending the temporary scheduling order shall take effect immediately 
upon its publication. The DEA has submitted a copy of this temporary 
order to both Houses of Congress and to the Comptroller General, 
although such filing is not required under the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 
5 U.S.C. 801-808 because, as noted above, this action is an order, not 
a rule.

    Dated: May 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-10009 Filed 5-9-18; 8:45 am]
 BILLING CODE 4410-09-P