Schedules of Controlled Substances: Extension of Temporary Placement of N, 37672-37674 [2021-15113]
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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2021–0176; Airspace
Docket No. 21–ACE–8]
RIN 2120–AA66
Amendment of Class D and Class E
Airspace; Sioux City, IA
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
AGENCY:
This action corrects the final
rule published in the Federal Register
on June 11, 2021, amending the Class D
and Class E airspace at Sioux Gateway
Airport/Brigadier General Bud Day
Field, Sioux City, IA. The geographic
coordinates for Sioux Gateway Airport/
Brigadier General Bud Day Field were
incorrectly published as ‘‘(Lat. 42°24′09″
N, long. 96°23′05″ W)’’ vice ‘‘(Lat.
42°24′05″ N, long. 96°23′04″ W)’’ in the
Class D and Class E airspace legal
descriptions.
SUMMARY:
Effective date 0901 UTC, August
12, 2021. The Director of the Federal
Register approves this incorporation by
reference action under Title 1 Code of
Federal Regulations part 51, subject to
the annual revision of FAA Order
7400.11 and publication of conforming
amendments.
ADDRESSES: FAA Order 7400.11E,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed online at https://
www.faa.gov/air_traffic/publications/.
For further information, you can contact
the Rules and Regulations Group,
Federal Aviation Administration, 800
Independence Avenue SW, Washington,
DC 20591; telephone: (202) 267–8783.
The Order is also available for
inspection at the National Archives and
Records Administration (NARA). For
information on the availability of FAA
Order 7400.11E at NARA, email:
fedreg.legal@nara.gov or go to https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Claypool, Federal Aviation
Administration, Operations Support
Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX
76177; telephone (817) 222–5711.
SUPPLEMENTARY INFORMATION:
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DATES:
History
The FAA published a final rule in the
Federal Register (86 FR 31105; June 11,
2021) for Docket No. FAA–2021–0176
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amending the Class D and Class E
airspace at Sioux Gateway Airport/
Brigadier General Bud Day Field, Sioux
City, IA. Subsequent to publication, the
FAA identified the geographic
coordinates for Sioux Gateway Airport/
Brigadier General Bud Day Field were
incorrectly published as ‘‘(Lat. 42°24′09″
N, long. 96°23′05″ W)’’ vice ‘‘(Lat.
42°24′05″ N, long. 96°23′04″ W)’’ in the
Class D and Class E airspace legal
descriptions. This action corrects that
error.
Class D and Class E airspace
designations are published in paragraph
5000, 6002, and 6005, respectively, of
FAA Order 7400.11E dated July 21,
2020, and effective September 15, 2020,
which is incorporated by reference in 14
CFR 71.1. The Class D and Class E
airspace designations listed in this
document will be subsequently
published in the Order.
DEPARTMENT OF JUSTICE
Availability and Summary of
Documents for Incorporation by
Reference
SUMMARY:
This document amends FAA Order
7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020,
and effective September 15, 2020. FAA
Order 7400.11E is publicly available as
listed in the ADDRESSES section of this
document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
Correction to Final Rule
Accordingly, pursuant to the
authority delegated to me, Amendment
of Class D and Class E Airspace; Sioux
City, IA, published in the Federal
Register of June 11, 2021 (86 FR 31105),
Docket No. FAA–2021–0176, is
corrected as follows:
71.1
[Corrected]
On page 31107, column 1, line 37,
replace ‘‘(lat. 42°24′09″N., long.
96°23′05″W.)’’ with ‘‘(Lat. 42°24′05″ N,
long. 96°23′04″ W)’’.
■ On page 31107, column 1, line 63,
replace ‘‘(lat. 42°24′09″N., long.
96°23′05″W.)’’ with ‘‘(Lat. 42°24′05″ N,
long. 96°23′04″ W)’’.
■ On page 31107, column 2, line 25,
replace ‘‘(lat. 42°24′09″N., long.
96°23′05″W.)’’ with ‘‘(Lat. 42°24′05″ N,
long. 96°23′04″ W)’’.
■
Issued in Fort Worth, Texas, on July 12,
2021.
Martin A. Skinner,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2021–15040 Filed 7–15–21; 8:45 am]
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Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–495]
Schedules of Controlled Substances:
Extension of Temporary Placement of
N-Ethylhexedrone, alphaPyrrolidinohexanophenone, 4-Methylalpha-ethylaminopentiophenone, 4′Methyl-alphapyrrolidinohexiophenone, alphaPyrrolidinoheptaphenone, and 4′Chloro-alphapyrrolidinovalerophenone in Schedule
I of the Controlled Substances Act
Drug Enforcement
Administration, Department of Justice.
ACTION: Temporary rule; temporary
scheduling order; extension.
AGENCY:
The Administrator of the Drug
Enforcement Administration is issuing
this order to extend the temporary
schedule I status of six synthetic
cathinones, as identified in this order.
The schedule I status of these six
substances currently is in effect until
July 18, 2021. This temporary order
extends the temporary scheduling of
these six substances for one year, or
until the permanent scheduling action
for these substances is completed,
whichever occurs first.
DATES: This order, which extends the
temporary scheduling order that DEA
previously issued for these substances
(84 FR 34291, July 18, 2019), is effective
July 18, 2021 and expires on July 18,
2022. If DEA publishes a final rule
making this scheduling action
permanent, this order will expire on the
effective date of that rule, if the effective
date is earlier than July 18, 2022.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Ph.D., Drug and
Chemical Evaluation Section, Diversion
Control Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
In this
order, the Drug Enforcement
Administration (DEA) extends the
temporary scheduling of the following
six controlled substances in schedule I
of the Controlled Substances Act (CSA),
including their optical, positional, and
geometric isomers, salts, and salts of
isomers:
• N-ethylhexedrone (other name: 2(ethylamino)-1-phenylhexan-1-one),
• alpha-pyrrolidinohexanophenone
(other names: a-PHP, alphapyrrolidinohexiophenone, 1-phenyl-2(pyrrolidin-1-yl)hexan-1-one),
SUPPLEMENTARY INFORMATION:
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• 4-methyl-alphaethylaminopentiophenone (other names:
4-MEAP, 2-(ethylamino)-1-(4methylphenyl)pentan-1-one),
• 4′-methyl-alphapyrrolidinohexiophenone (other names:
MPHP, 4′-methyl-alphapyrrolidinohexanophenone; 1-(4methylphenyl)-2-(pyrrolidin-1-yl)hexan1-one),
• alpha-pyrrolidinoheptaphenone
(other names: PV8, 1-phenyl-2(pyrrolidin-1-yl)heptan-1-one), and
• 4′-chloro-alphapyrrolidinovalerophenone (other names:
4-chloro-a-PVP, 4′-chloro-alphapyrrolidinopentiophenone, 1-(4chlorophenyl)-2-(pyrrolidin-1yl)pentan-1-one).
Background and Legal Authority
On July 18, 2019, the Acting
Administrator of DEA (Acting
Administrator) published a temporary
scheduling order in the Federal Register
(84 FR 34291) placing N-ethylhexedrone
(other name: 2-(ethylamino)-1phenylhexan-1-one); alphapyrrolidinohexanophenone (other
names: a-PHP, alphapyrrolidinohexiophenone, 1-phenyl-2(pyrrolidin-1-yl)hexan-1-one); 4-methylalpha-ethylaminopentiophenone (other
names: 4-MEAP, 2-(ethylamino)-1-(4methylphenyl)pentan-1-one); 4′-methylalpha-pyrrolidinohexiophenone (other
names: MPHP, 4′-methyl-alphapyrrolidinohexanophenone; 1-(4methylphenyl)-2-(pyrrolidin-1-yl)hexan1-one); alpha-pyrrolidinoheptaphenone
(other names: PV8, 1-phenyl-2(pyrrolidin-1-yl)heptan-1-one); and 4′chloro-alpha-pyrrolidinovalerophenone
(other names: 4-chloro-a-PVP, 4′-chloroalpha-pyrrolidinopentiophenone, 1-(4chlorophenyl)-2-(pyrrolidin-1yl)pentan-1-one), synthetic cathinones,
in schedule I of the CSA pursuant to the
temporary scheduling provisions of 21
U.S.C. 811(h).1 That order was effective
on the date of publication, and was
based on findings by the Acting
Administrator that the temporary
scheduling of these substances was
necessary to avoid an imminent hazard
to the public safety pursuant to 21
U.S.C. 811(h)(1). Subsection (h)(2)
provides that the temporary control of
these substances expires two years from
the effective date of the temporary
scheduling order, i.e., on July 18, 2021.
21 U.S.C. 811(h)(2). However, this same
subsection also provides that, during the
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.
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pendency of proceedings under 21
U.S.C. 811(a)(1) with respect to the
substance, the temporary scheduling of
that substance can 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 DEA (Administrator) pursuant to 28
CFR 0.100) on his own motion, at the
request of the Secretary of Health and
Human Services (HHS),2 or on the
petition of any interested party.
The Administrator, on her own
motion, has initiated proceedings under
21 U.S.C. 811(a)(1) to permanently
schedule N-ethylhexedrone, a-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-aPVP. DEA is simultaneously publishing
a notice of proposed rulemaking for the
permanent placement of Nethylhexedrone, a-PHP, 4-MEAP,
MPHP, PV8, and 4-chloro-a-PVP in
schedule I elsewhere in this issue of the
Federal Register. If that proposed rule is
finalized, DEA will publish a final rule
in the Federal Register to make
permanent the schedule I status of these
substances.
Pursuant to 21 U.S.C. 811(h)(2), the
Administrator orders that the temporary
scheduling of N-ethylhexedrone, alphapyrrolidinohexanophenone, 4-methylalpha-ethylaminopentiophenone, 4′methyl-alpha-pyrrolidinohexiophenone,
alpha-pyrrolidinoheptaphenone, and 4′chloro-alpha-pyrrolidinovalerophenone,
and their optical, positional, and
geometric isomers, salts, and salts of
isomers, be extended 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.
Under 21 U.S.C. 811(h), the
Administrator, as delegated by the
Attorney General, may, by order, place
a substance in schedule I on a
temporary basis. This same subsection
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 Administrator may,
during the pendency of proceedings
under 21 U.S.C. 811(a)(1) to
permanently schedule the substance,
extend the temporary scheduling for up
to one year.
2 The Secretary of HHS has delegated to the
Assistant Secretary for Health of HHS the authority
to make domestic drug scheduling
recommendations.
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To the extent that section 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, 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
extension of the temporary scheduling
order. The specific language chosen by
Congress indicates an intention for DEA
to proceed through the issuance of an
order instead of proceeding by
rulemaking. Given that Congress
specifically requires the Attorney
General to follow rulemaking
procedures for other kinds of scheduling
actions, see 21 U.S.C. 811(a), it is
noteworthy that, in subsection 811(h),
Congress authorized the issuance of
temporary scheduling actions by order
rather than by rule. In the alternative,
even assuming that this action might be
subject to section 553 of the APA, the
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
that these substances would present if
scheduling expired, for the reasons
expressed in the temporary scheduling
order (84 FR 34291, July 18, 2019).
Further, 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. The
requirements for the preparation of an
initial regulatory flexibility analysis in 5
U.S.C. 603(a) are not applicable where,
as here, 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 (E.O.) 12866
(Regulatory Planning and Review),
section 3(f), and the principles
reaffirmed in E.O. 13563 (Improving
Regulation and Regulatory Review).
Accordingly, this action has not been
reviewed by the Office of Management
and Budget.
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 E.O. 13132
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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Rules and Regulations
(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) 3 is
inapplicable, as it applies only to rules.
5 U.S.C. 801, 804(3). It is in the public
interest to maintain the temporary
placement of N-ethylhexedrone, a-PHP,
4-MEAP, MPHP, PV8, and 4-chloro-aPVP in schedule I because they pose a
public health risk, for the reasons
expressed in the temporary scheduling
order (84 FR 34291, July 18, 2019). The
temporary scheduling action was taken
pursuant to 21 U.S.C. 811(h), which is
specifically designed to enable 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. 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 these substances in
schedule I because they pose 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. DEA will submit a copy
of this extension of the temporary
scheduling order to both Houses of
Congress and to the Comptroller
General, although such filing is not
required under the CRA, 5 U.S.C. 801–
808, because, as noted above, this action
is an order, not a rule.
Anne Milgram,
Administrator.
[FR Doc. 2021–15113 Filed 7–15–21; 8:45 am]
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3 This is the colloquial name for Subtitle E of the
Small Business Regulatory Enforcement Fairness
Act of 1996.
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DEPARTMENT OF JUSTICE
28 CFR Part 50
[Docket No. OAG 174; AG Order No. 5077–
2021]
RIN 1105–AB61
Processes and Procedures for
Issuance and Use of Guidance
Documents
Office of the Attorney General,
Department of Justice.
ACTION: Interim final rule; request for
comments.
AGENCY:
This interim final rule
(‘‘rule’’) implements Executive Order
13992, which, among other things,
revoked Executive Order 13891 and
directed the heads of all agencies to
promptly take steps to rescind any
orders, rules, regulations, guidelines, or
policies, or portions thereof,
implementing or enforcing the revoked
Executive Order. By this rule, the
Department of Justice (‘‘Department’’ or
‘‘DOJ’’) revokes amendments to its
regulations that were made during 2020
pursuant to Executive Order 13891,
which imposed limitations on the
issuance and use of guidance
documents. For further information on
how the Department intends to address
guidance documents going forward,
interested parties should consult an
Attorney General Memorandum the
Department of Justice is issuing on its
website in conjunction with this rule.
DATES:
Effective date: This rule is effective
July 16, 2021.
Applicability date: July 1, 2021.
Comments: Comments are due on or
before August 16, 2021.
ADDRESSES: To ensure proper handling
of comments, please reference Docket
No. OAG 174 on all electronic and
written correspondence. The
Department encourages the electronic
submission of all comments through
https://www.regulations.gov using the
electronic comment form provided on
that site. For ease of reference, an
electronic copy of this document is also
available at that website. It is not
necessary to submit paper comments
that duplicate the electronic
submission, as comments submitted to
https://www.regulations.gov will be
posted for public review and are part of
the official docket record. However,
should you wish to submit written
comments through regular or express
mail, they should be sent to Robert
Hinchman, Senior Counsel, Office of
Legal Policy, U.S. Department of Justice,
Room 4252 RFK Building, 950
SUMMARY:
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Pennsylvania Avenue NW, Washington,
DC 20530. Comments received by mail
will be considered timely if they are
postmarked on or before August 16,
2021. The electronic Federal
eRulemaking portal will accept
comments until Midnight Eastern Time
at the end of that day.
FOR FURTHER INFORMATION CONTACT:
Robert Hinchman, Senior Counsel,
Office of Legal Policy, U.S. Department
of Justice, telephone (202) 514–8059
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
www.regulations.gov. Information made
available for public inspection includes
personal identifying information (such
as your name, address, etc.) voluntarily
submitted by the commenter.
You are not required to submit
personal identifying information in
order to comment on this rule.
Nevertheless, if you want to submit
personal identifying information (such
as your name, address, etc.) as part of
your comment, but do not want it to be
posted online, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also locate
all the personal identifying information
that you do not want posted online in
the first paragraph of your comment and
identify what information you want the
agency to redact. Personal identifying
information identified and located as set
forth above will be placed in the
agency’s public docket file, but not
posted online.
If you want to submit confidential
business information as part of your
comment but do not want it to be posted
online, you must include the phrase
‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, the agency may choose not to
post that comment (or to post that
comment only partially) on https://
www.regulations.gov. Confidential
business information identified and
located as set forth above will not be
placed in the public docket file, nor will
it be posted online.
If you want to inspect the agency’s
public docket file in person by
appointment, please see the FOR
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[Federal Register Volume 86, Number 134 (Friday, July 16, 2021)]
[Rules and Regulations]
[Pages 37672-37674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15113]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-495]
Schedules of Controlled Substances: Extension of Temporary
Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-
Methyl-alpha-ethylaminopentiophenone, 4'-Methyl-alpha-
pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-
alpha-pyrrolidinovalerophenone 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 Administrator of the Drug Enforcement Administration is
issuing this order to extend the temporary schedule I status of six
synthetic cathinones, as identified in this order. The schedule I
status of these six substances currently is in effect until July 18,
2021. This temporary order extends the temporary scheduling of these
six substances for one year, or until the permanent scheduling action
for these substances is completed, whichever occurs first.
DATES: This order, which extends the temporary scheduling order that
DEA previously issued for these substances (84 FR 34291, July 18,
2019), is effective July 18, 2021 and expires on July 18, 2022. If DEA
publishes a final rule making this scheduling action permanent, this
order will expire on the effective date of that rule, if the effective
date is earlier than July 18, 2022.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this order, the Drug Enforcement
Administration (DEA) extends the temporary scheduling of the following
six controlled substances in schedule I of the Controlled Substances
Act (CSA), including their optical, positional, and geometric isomers,
salts, and salts of isomers:
N-ethylhexedrone (other name: 2-(ethylamino)-1-
phenylhexan-1-one),
alpha-pyrrolidinohexanophenone (other names: [alpha]-PHP,
alpha-pyrrolidinohexiophenone, 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-
one),
[[Page 37673]]
4-methyl-alpha-ethylaminopentiophenone (other names: 4-
MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one),
4'-methyl-alpha-pyrrolidinohexiophenone (other names:
MPHP, 4'-methyl-alpha-pyrrolidinohexanophenone; 1-(4-methylphenyl)-2-
(pyrrolidin-1-yl)hexan-1-one),
alpha-pyrrolidinoheptaphenone (other names: PV8, 1-phenyl-
2-(pyrrolidin-1-yl)heptan-1-one), and
4'-chloro-alpha-pyrrolidinovalerophenone (other names: 4-
chloro-[alpha]-PVP, 4'-chloro-alpha-pyrrolidinopentiophenone, 1-(4-
chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one).
Background and Legal Authority
On July 18, 2019, the Acting Administrator of DEA (Acting
Administrator) published a temporary scheduling order in the Federal
Register (84 FR 34291) placing N-ethylhexedrone (other name: 2-
(ethylamino)-1-phenylhexan-1-one); alpha-pyrrolidinohexanophenone
(other names: [alpha]-PHP, alpha-pyrrolidinohexiophenone, 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one); 4-methyl-alpha-ethylaminopentiophenone
(other names: 4-MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one);
4'-methyl-alpha-pyrrolidinohexiophenone (other names: MPHP, 4'-methyl-
alpha-pyrrolidinohexanophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-
yl)hexan-1-one); alpha-pyrrolidinoheptaphenone (other names: PV8, 1-
phenyl-2-(pyrrolidin-1-yl)heptan-1-one); and 4'-chloro-alpha-
pyrrolidinovalerophenone (other names: 4-chloro-[alpha]-PVP, 4'-chloro-
alpha-pyrrolidinopentiophenone, 1-(4-chlorophenyl)-2-(pyrrolidin-1-
yl)pentan-1-one), synthetic cathinones, in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h).\1\
That order was effective on the date of publication, and was based on
findings by the Acting Administrator that the temporary scheduling of
these substances was necessary to avoid an imminent hazard to the
public safety pursuant to 21 U.S.C. 811(h)(1). Subsection (h)(2)
provides that the temporary control of these substances expires two
years from the effective date of the temporary scheduling order, i.e.,
on July 18, 2021. 21 U.S.C. 811(h)(2). However, this same subsection
also provides that, during the pendency of proceedings under 21 U.S.C.
811(a)(1) with respect to the substance, the temporary scheduling of
that substance can 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 DEA
(Administrator) pursuant to 28 CFR 0.100) on his own motion, at the
request of the Secretary of Health and Human Services (HHS),\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\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations.
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The Administrator, on her own motion, has initiated proceedings
under 21 U.S.C. 811(a)(1) to permanently schedule N-ethylhexedrone,
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. DEA is
simultaneously publishing a notice of proposed rulemaking for the
permanent placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP,
PV8, and 4-chloro-[alpha]-PVP in schedule I elsewhere in this issue of
the Federal Register. If that proposed rule is finalized, DEA will
publish a final rule in the Federal Register to make permanent the
schedule I status of these substances.
Pursuant to 21 U.S.C. 811(h)(2), the Administrator orders that the
temporary scheduling of N-ethylhexedrone, alpha-
pyrrolidinohexanophenone, 4-methyl-alpha-ethylaminopentiophenone, 4'-
methyl-alpha-pyrrolidinohexiophenone, alpha-pyrrolidinoheptaphenone,
and 4'-chloro-alpha-pyrrolidinovalerophenone, and their optical,
positional, and geometric isomers, salts, and salts of isomers, be
extended 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. Under 21 U.S.C. 811(h), the Administrator, as delegated by the
Attorney General, may, by order, place a substance in schedule I on a
temporary basis. This same subsection 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 Administrator may, during the pendency of proceedings under 21
U.S.C. 811(a)(1) to permanently schedule the substance, extend the
temporary scheduling for up to one year.
To the extent that section 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, 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 extension of the temporary
scheduling order. The specific language chosen by Congress indicates an
intention for DEA to proceed through the issuance of an order instead
of proceeding by rulemaking. Given that Congress specifically requires
the Attorney General to follow rulemaking procedures for other kinds of
scheduling actions, see 21 U.S.C. 811(a), it is noteworthy that, in
subsection 811(h), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule. In the alternative,
even assuming that this action might be subject to section 553 of the
APA, the 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 that
these substances would present if scheduling expired, for the reasons
expressed in the temporary scheduling order (84 FR 34291, July 18,
2019). Further, 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. The requirements for the preparation of an initial
regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable
where, as here, 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 (E.O.) 12866 (Regulatory Planning and
Review), section 3(f), and the principles reaffirmed in E.O. 13563
(Improving Regulation and Regulatory Review). Accordingly, this action
has not been reviewed by the Office of Management and Budget.
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 E.O. 13132
[[Page 37674]]
(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) \3\ is inapplicable, as it applies
only to rules. 5 U.S.C. 801, 804(3). It is in the public interest to
maintain the temporary placement of N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I because they
pose a public health risk, for the reasons expressed in the temporary
scheduling order (84 FR 34291, July 18, 2019). The temporary scheduling
action was taken pursuant to 21 U.S.C. 811(h), which is specifically
designed to enable 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. 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 these substances in schedule I
because they pose 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.
DEA will submit a copy of this extension of the temporary scheduling
order to both Houses of Congress and to the Comptroller General,
although such filing is not required under the CRA, 5 U.S.C. 801-808,
because, as noted above, this action is an order, not a rule.
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\3\ This is the colloquial name for Subtitle E of the Small
Business Regulatory Enforcement Fairness Act of 1996.
Anne Milgram,
Administrator.
[FR Doc. 2021-15113 Filed 7-15-21; 8:45 am]
BILLING CODE 4410-09-P
