83 FR 21834 - Schedules of Controlled Substances: Extension of Temporary Placement of beta-Hydroxythiofentanyl in Schedule I of the Controlled Substances Act
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 91 (May 10, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 91 (May 10, 2018)
| Page Range | 21834-21835 | |
| FR Document | 2018-10009 |
[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)] [Rules and Regulations] [Pages 21834-21835] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10009] [[Page 21833]] Vol. 83 Thursday, No. 91 May 10, 2018 Part III Department of Justice ----------------------------------------------------------------------- Drug Enforcement Administration ----------------------------------------------------------------------- 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 [[Page 21834]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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.'' --------------------------------------------------------------------------- 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 [[Page 21835]] 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
![21834 Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Rules and Regulations
DEPARTMENT OF JUSTICE by the Acting Administrator of the DEA international treaty obligations pursuant
that the temporary scheduling of beta- to 21 U.S.C. 811(d)(1).
Drug Enforcement Administration hydroxythiofentanyl was necessary to Upon evaluating the scientific and
avoid an imminent hazard to the public medical evidence, on April 27, 2018, the
21 CFR Part 1308 safety pursuant to 21 U.S.C. 811(h)(1). HHS submitted to the Acting
Section 201(h)(2) of the CSA, 21 U.S.C. Administrator of the DEA its scientific
[Docket No. DEA–484]
811(h)(2), requires that the temporary and medical evaluation and scheduling
Schedules of Controlled Substances: control of this substance expires two recommendation for beta-
Extension of Temporary Placement of years from the effective date of the hydroxythiofentanyl. Upon receipt of
beta-Hydroxythiofentanyl in Schedule I scheduling order, or on May 12, 2018. the scientific and medical evaluation
of the Controlled Substances Act However, the CSA also provides that and scheduling recommendation from
during the pendency of proceedings the HHS, the DEA reviewed the
AGENCY: Drug Enforcement under 21 U.S.C. 811(a)(1) with respect documents and all other relevant data,
Administration, Department of Justice. to the substance, the temporary and conducted its own eight-factor
ACTION: Temporary rule; temporary scheduling 1 of that substance could be analysis of the abuse potential of beta-
scheduling order; extension. extended for up to one year. hydroxythiofentanyl in accordance with
Proceedings for the scheduling of a 21 U.S.C. 811(c). The DEA published a
SUMMARY: The Acting Administrator of notice of proposed rulemaking for the
the Drug Enforcement Administration is substance under 21 U.S.C. 811(a) may
be initiated by the Attorney General placement of beta-hydroxythiofentanyl
issuing this temporary scheduling order in schedule I elsewhere in this issue of
to extend the temporary schedule I (delegated to the Administrator of the
the Federal Register. If this order is
status of beta-hydroxythiofentanyl (N- DEA pursuant to 28 CFR 0.100) on his
made permanent, the DEA will publish
[1-[2-hydroxy-2-(thiophen-2- own motion, at the request of the
a final rule in the Federal Register.
yl)ethyl]piperidin-4-yl]-N- Secretary of Health and Human Pursuant to 21 U.S.C. 811(h)(2), the
phenylpropionamide) also known as N- Services,2 or on the petition of any Acting Administrator of the DEA orders
[1-[2-hydroxy-2-(2-thienyl)ethyl]-4- interested party. that the temporary scheduling of beta-
piperidinyl]-N-phenylpropanamide The Acting Administrator of the DEA, hydroxythiofentanyl, including its
including its isomers, esters, ethers, on his own motion pursuant to 21 isomers, esters and ethers and salts of
salts and salts of isomers, esters and U.S.C. 811(a), has initiated proceedings isomers, esters, ethers, be extended for
ethers. The schedule I status of beta- under 21 U.S.C. 811(a)(1) to one year, or until the permanent
hydroxythiofentanyl currently is in permanently schedule beta- scheduling proceeding is completed,
effect through May 12, 2018. This hydroxythiofentanyl. The DEA has whichever occurs first.
temporary order will extend the gathered and reviewed the available In accordance with this temporary
temporary scheduling of beta- information regarding the scheduling order, the schedule I
hydroxythiofentanyl for one year, or pharmacology, chemistry, trafficking, requirements for handling beta-
until the permanent scheduling action actual abuse, pattern of abuse, and the hydroxythiofentanyl, including its
for this substance is completed, relative potential for abuse for this isomers, esters and ethers and salts of
whichever occurs first. substance. On December 8, 2016, the isomers, esters, ethers, will remain in
DATES: This temporary scheduling DEA submitted a request to the HHS to effect for one year, or until the
order, which extends the final order (81 provide the DEA with a scientific and permanent scheduling proceeding is
FR 29492, May 12, 2016), is effective medical evaluation of available completed, whichever occurs first.
May 12, 2018 and expires on May 12, information and a scheduling Regulatory Matters
2019. If this order is made permanent, recommendation for butyryl fentanyl
and beta-hydroxythiofentanyl, and in The CSA provides for an expedited
the DEA will publish a document in the
accordance with 21 U.S.C. 811(b) and temporary scheduling action where
Federal Register on or before May 12,
(c). In a letter dated November 1, 2017, such action is necessary to avoid an
2019.
DEA notified HHS that it no longer imminent hazard to the public safety. 21
FOR FURTHER INFORMATION CONTACT: U.S.C. 811(h). The Attorney General
required a scientific and medical
Michael J. Lewis, Diversion Control may, by order, schedule a substance in
evaluation for butyryl fentanyl because
Division, Drug Enforcement schedule I on a temporary basis. Id. 21
the Commission on Narcotic Drugs
Administration; Mailing Address: 8701 U.S.C. 811(h) also provides that the
(CND), at its 60th session, added butyryl
Morrissette Drive, Springfield, Virginia temporary scheduling of a substance
fentanyl to Schedule I of the Single
22152; Telephone: (202) 598–6812. shall expire at the end of two years from
Convention on Narcotic Drugs, 1961. On
SUPPLEMENTARY INFORMATION: April 20, 2018, the DEA published a the date of the issuance of the order
final scheduling order for butyryl scheduling such substance, except that
Background and Legal Authority
fentanyl (83 FR17486) to meet the Attorney General may, during the
On May 12, 2016, the Acting pendency of proceedings to
Administrator of the Drug Enforcement 1 Though DEA has used the term ‘‘final order’’
permanently schedule the substance,
Administration (DEA) published a final with respect to temporary scheduling orders in the extend the temporary scheduling for up
order in the Federal Register (81 FR past, this notice adheres to the statutory language to one year.
29492) temporarily placing beta- of 21 U.S.C. 811(h), which refers to a ‘‘temporary To the extent that 21 U.S.C. 811(h)
hydroxythiofentanyl (N-[1-[2-hydroxy-2- scheduling order.’’ No substantive change is directs that temporary scheduling
intended.
daltland on DSKBBV9HB2PROD with RULES2
(thiophen-2-yl)ethyl]piperidin-4-yl]-N- 2 Because the Secretary of the Department of actions be issued by order and sets forth
phenylpropionamide) in schedule I of Health and Human Services has delegated to the the procedures by which such orders are
the Controlled Substances Act (CSA) Assistant Secretary for Health of the Department of to be issued and extended, the DEA
pursuant to the temporary scheduling Health and Human Services the authority to make believes that the notice and comment
domestic drug scheduling recommendations, for
provisions of 21 U.S.C. 811(h). That purposes of this temporary order, all subsequent
requirements of section 553 of the
final order was effective on the date of references to ‘‘Secretary’’ have been replaced with Administrative Procedure Act (APA), 5
publication, and was based on findings ‘‘Assistant Secretary.’’ U.S.C. 553, do not apply to this
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![Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Rules and Regulations 21835
extension of the temporary scheduling relationship between the national rulemaking procedures. The DEA
action. In the alternative, even assuming government and the States, or on the understands that the CSA frames
that this action might be subject to distribution of power and temporary scheduling actions as orders
section 553 of the APA, the Acting responsibilities among the various rather than rules to ensure that the
Administrator finds that there is good levels of government. Therefore, in process moves swiftly, and this
cause to forgo the notice and comment accordance with Executive Order 13132 extension of the temporary scheduling
requirements of section 553, as any (Federalism) it is determined that this order continues to serve that purpose.
further delays in the process for action does not have sufficient For the same reasons that underlie 21
extending the temporary scheduling federalism implications to warrant the U.S.C. 811(h), that is, the need to place
order would be impracticable and preparation of a Federalism Assessment. this substance in schedule I because it
contrary to the public interest in view poses an imminent hazard to public
As noted above, this action is an
of the manifest urgency to avoid an safety, it would be contrary to the public
order, not a rule. Accordingly, the
imminent hazard to the public safety. interest to delay implementation of this
Further, the DEA believes that this order Congressional Review Act (CRA) is
inapplicable, as it applies only to rules. extension of the temporary scheduling
extending the temporary scheduling order. Therefore, in accordance with
action is not a ‘‘rule’’ as defined by 5 However, if this were a rule, pursuant
to the CRA, ‘‘any rule for which an section 808(2) of the CRA, this order
U.S.C. 601(2), and, accordingly, is not
agency for good cause finds that notice extending the temporary scheduling
subject to the requirements of the
and public procedure thereon are order shall take effect immediately upon
Regulatory Flexibility Act (RFA). The
impracticable, unnecessary, or contrary its publication. The DEA has submitted
requirements for the preparation of an
initial regulatory flexibility analysis in 5 to the public interest, shall take effect at a copy of this temporary order to both
U.S.C. 603(a) are not applicable where, such time as the federal agency Houses of Congress and to the
as here, the DEA is not required by promulgating the rule determines.’’ 5 Comptroller General, although such
section 553 of the APA or any other law U.S.C. 808(2). It is in the public interest filing is not required under the Small
to publish a general notice of proposed to maintain the temporary placement of Business Regulatory Enforcement
rulemaking. beta-hydroxythiofentanyl in schedule I Fairness Act of 1996 (Congressional
Additionally, this action is not a because it poses a public health risk. Review Act), 5 U.S.C. 801–808 because,
significant regulatory action as defined The temporary scheduling action was as noted above, this action is an order,
by Executive Order 12866 (Regulatory taken pursuant to 21 U.S.C. 811(h), not a rule.
Planning and Review), section 3(f), and, which is specifically designed to enable Dated: May 7, 2018.
accordingly, this action has not been the DEA to act in an expeditious manner
Robert W. Patterson,
reviewed by the Office of Management to avoid an imminent hazard to the
and Budget (OMB). public safety. Under 21 U.S.C. 811(h), Acting Administrator.
This action will not have substantial temporary scheduling orders are not [FR Doc. 2018–10009 Filed 5–9–18; 8:45 am]
direct effects on the States, on the subject to notice and comment BILLING CODE 4410–09–P
daltland on DSKBBV9HB2PROD with RULES2
VerDate Sep<11>2014 16:56 May 09, 2018 Jkt 244001 PO 00000 Frm 00003 Fmt 4701 Sfmt 9990 E:\FR\FM\10MYR2.SGM 10MYR2](https://thefederalregister.org/doc/83_FR_21925/page/2.svg)
Document Created: 2018-11-02 09:47:02
Document Modified: 2018-11-02 09:47:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Temporary rule; temporary scheduling order; extension. | |
| 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. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 83 FR 21834 |
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