Specific Listing for 1-boc-4-AP, a Currently Controlled List I Chemical, 67550-67553 [2022-24155]
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Rules and Regulations
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA. As
noted in the above discussion regarding
the applicability of the APA, DEA was
not required to publish a general notice
of proposed rulemaking. Consequently,
the RFA does not apply to this final
rule.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined that this action would not
result in any Federal mandate that may
result ‘‘in the expenditure by State,
local, and tribal governments, in the
aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any 1 year.’’
Therefore, neither a Small Government
Agency Plan nor any other action is
required under UMRA of 1995.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of this final rule to both Houses
of Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
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PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
Accordingly, the interim final rule
amending 21 CFR part 1308, which
published on June 1, 2022 (87 FR
32991), is adopted as a final rule
without change.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on November 1, 2022, by Administrator
Anne Milgram. That document with the
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16:01 Nov 08, 2022
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original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
4-anilinopiperidine, and 4-AP). NPhenylpiperidin-4-amine, including its
amides, its carbamates, and its salts, is
listed as a list I chemical at 21 CFR
1310.02(a). See 85 FR 20822 (April 1,
2020) (effective May 15, 2020). The
chemical structure of 1-boc-4-AP
defines it as a carbamate of Nphenylpiperidin-4-amine. Accordingly,
under 21 CFR 1310.02(b), 1-boc-4-AP, as
a carbamate of N-phenylpiperidin-4amine, is and continues to be a
regulated list I chemical.1
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
Legal Authority
The Controlled Substances Act (CSA)
and the Drug Enforcement
Administration’s (DEA) implementing
regulations give the Attorney General, as
delegated to the Administrator of DEA
(Administrator), the authority to specify,
by regulation, a chemical as a ‘‘list I
chemical.’’ 2 This term refers to a
chemical that is used in manufacturing
a controlled substance in violation of
subchapter I (Control and Enforcement)
of the CSA and is important to the
manufacture of the controlled
substance.3 The current list of all list I
chemicals is available in 21 CFR
1310.02(a).
In addition, the United States is a
Party to the 1988 United Nations
Convention Against Illicit Traffic in
Narcotic Drugs and Psychotropic
Substances (1988 Convention),
December 20, 1988, 1582 U.N.T.S. 95.
Under Article 12 of the 1988
Convention, when the United States
receives notification that a chemical has
been added to Table I or Table II of the
1988 Convention, the United States is
required to take measures it deems
appropriate to monitor the manufacture
and distribution of that chemical within
the United States and to prevent its
diversion, including measures related to
international trade.
[FR Doc. 2022–24157 Filed 11–8–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA–1046]
Specific Listing for 1-boc-4-AP, a
Currently Controlled List I Chemical
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
The Drug Enforcement
Administration (DEA) is establishing a
specific listing and DEA Chemical
Control Number for tert-butyl 4(phenylamino)piperidine-1-carboxylate
(also known as 1-boc-4-AP; and CAS
Number: 125541–22–2) and its salts as
a list I chemical under the Controlled
Substances Act. Although 1-boc-4-AP is
not specifically listed as a list I chemical
of the Controlled Substances Act with
its own unique Chemical Control
Number, it has been regulated as a list
I chemical in the United States since
May 15, 2020, as a carbamate of Nphenylpiperidin-4-amine, a list I
chemical. Therefore, DEA is simply
amending the list I chemicals list in its
regulations to include a separate listing
for 1-boc-4-AP, a currently controlled
list I chemical.
DATES: Effective date November 9, 2022.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION: tert-Butyl
4-(phenylamino)piperidine-1carboxylate (also known as 1-boc-4-AP)
is a chemical that is structurally related
to N-phenylpiperidin-4-amine (also
known as N-phenyl-4-piperidinamine,
SUMMARY:
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Background
In a letter dated May 27, 2022, the
United Nations Office on Drugs and
Crime, in accordance with Article 12,
paragraph 6 of the 1988 Convention,
informed the Permanent Mission of the
United States of America to the United
Nations (Vienna) that the Commission
on Narcotic Drugs (CND) decided to
place the chemical 1-boc-4-AP in Table
I of the 1988 Convention (CND Dec/65/
5) at its 65th Session on March 16, 2022.
1 N-phenylpiperidin-4-amine, including its
amides, its carbamates, and its salts, has been
subject to list I chemical regulations since May 15,
2020, pursuant to a final rule (April 15, 2020; 85
FR 20822).
2 21 U.S.C. 802(34) and 871(b) and 21 CFR
1310.02(c).
3 21 U.S.C. 802(34) and 21 CFR 1300.02(b).
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Rules and Regulations
As discussed above in this final rule, 1boc-4-AP—by virtue of being a
carbamate of N-phenylpiperidin-4amine—has been regulated as a list I
chemical of the CSA since May 15,
2020.4 Therefore, all regulations and
criminal sanctions applicable to list I
chemicals have been and remain
applicable to 1-boc-4-AP.
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Effect of Action
As discussed above, this rule does not
affect the continuing status of 1-boc-4AP as a list I chemical in any way. This
action, as an administrative matter,
merely establishes a separate, specific
listing for 1-boc-4-AP in list I of the CSA
and assigns a DEA chemical control
number for the substance. This action
will allow DEA to effectively monitor
regulated transactions of 1-boc-4-AP,
including the manufacture, distribution,
importation, or exportation of 1-boc-4AP, and to provide accurate reporting to
the International Narcotics Control
Board.
Chemical Mixtures of 1-boc-4-AP
Pursuant to the final rule published
on April 15, 2020,5 chemical mixtures
containing 1-boc-4-AP have been and
continue to be subject to regulatory
requirements at any concentration—
unless a manufacturer submits to DEA
an application for exemption of a
chemical mixture, DEA accepts the
application for filing, and DEA exempts
the chemical mixture in accordance
with 21 CFR 1310.13 (Exemption of
chemical mixtures by application).
Since even a small amount of 1-boc4-AP can potentially yield a significant
amount of controlled substances, DEA
believes that the continued regulation of
chemical mixtures containing any
amount of 1-boc-4-AP as a list I
chemical is necessary to prevent its
illicit extraction, isolation, and use. 1boc-4-AP is already subject to domestic
control under list I as a carbamate of Nphenylpiperidin-4-amine, and DEA’s
current regulations provide that a
chemical mixture containing any
amount of N-phenylpiperidin-4-amine
is a List I chemical. As a technical,
conforming change in connection with
the separate listing of 1-boc-4-AP, this
rule modifies the ‘‘Table of
Concentration Limits’’ in 21 CFR
1310.12(c) to reflect that a chemical
mixture containing any amount of 1boc-4-AP is subject to CSA chemical
control provisions, including 21 CFR
parts 1309, 1310, 1313, and 1316. No
additional requirements are being
imposed.
4 85
5 85
FR 20822 (April 15, 2020).
FR 20822.
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16:01 Nov 08, 2022
DEA has implemented an application
process to exempt certain chemical
mixtures from the requirements of the
CSA and its implementing regulations.6
Manufacturers may submit an
application for exemption for those
mixtures that do not meet the criteria set
forth in 21 CFR 1310.12(d) for an
automatic exemption. Pursuant to 21
CFR 1310.13(a), DEA may grant exempt
status to a chemical mixture by
publishing a final rule in the Federal
Register, if DEA determines that: (1) The
mixture is formulated in such a way that
it cannot be easily used in the illicit
production of a controlled substance,
and (2) the listed chemical or chemicals
cannot be readily recovered.
Requirements for Handling List I
Chemicals
The listing of 1-boc-4-AP as a list I
chemical continues to subject handlers
(manufacturers, distributors, importers,
and exporters) and proposed handlers to
all of the regulatory controls and
administrative, civil, and criminal
actions applicable to the manufacture,
distribution, importation, and
exportation of a list I chemical. Since
May 15, 2020, persons handling 1-boc4-AP, including regulated chemical
mixtures containing 1-boc-4-AP, have
been required to comply with list I
chemical regulations, including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
imports, or exports), or proposes to
engage in such handling, of 1-boc-4-AP
or a chemical mixture containing 1-boc4-AP, must obtain a registration
pursuant to 21 U.S.C. 822, 823, 957, and
958. Regulations describing registration
for list I chemical handlers are set forth
in 21 CFR part 1309.
2. Records and Reports. Every DEA
registrant must maintain records and
submit reports to DEA with respect to 1boc-4-AP pursuant to 21 U.S.C. 830 and
in accordance with 21 CFR 1310.
Pursuant to 21 CFR 1310.04, a record
must be made and maintained for two
years after the date of a transaction
involving a listed chemical, provided
the transaction is a regulated
transaction.
3. Importation and Exportation. All
importation and exportation of 1-boc-4AP must be done in compliance with 21
U.S.C. 957, 958, and 971 and in
accordance with 21 CFR part 1313.
4. Security. All applicants and
registrants must provide effective
controls against theft and diversion in
accordance with 21 CFR 1309.71–
1309.73.
6 21
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CFR 1310.13.
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5. Administrative Inspection. Places,
including factories, warehouses, or
other establishments and conveyances,
where registrants or other regulated
persons may lawfully hold,
manufacture, distribute, or otherwise
dispose of a list I chemical or where
records relating to those activities are
maintained, are controlled premises as
defined in 21 U.S.C. 880(a) and 21 CFR
1316.02(c). The CSA allows for
administrative inspections of these
controlled premises as provided in 21
CFR part 1316, subpart A.7
6. Liability. Any activity involving 1boc-4-AP not authorized by, or in
violation of, the CSA is unlawful, and
would subject the person to
administrative, civil, and/or criminal
action.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to
exempt a rule from certain provisions of
the Administrative Procedure Act (APA)
(5 U.S.C. 553), including notice of
proposed rulemaking and the
opportunity for public comment, if it is
determined to be unnecessary,
impracticable, or contrary to the public
interest.
As discussed above, 1-boc-4-AP is
currently and continues to be regulated
as a list I chemical as a carbamate of Nphenylpiperidin-4-amine.
Pursuant to 5 U.S.C. 553(b)(3)(B), DEA
finds that notice and comment
rulemaking is unnecessary and that
good cause exists to dispense with these
procedures. The addition of a separate
listing for 1-boc-4-AP and its DEA
chemical control number in the list of
list I chemicals in 21 CFR 1310.02(a)
makes no substantive difference in the
status of this chemical as a list I
chemical, but instead is ‘‘a minor or
merely technical amendment in which
the public is not particularly
interested.’’ National Nutritional Foods
Ass’n v. Kennedy, 572 F.2d 377, 385 (2d
Cir. 1978) (quoting S. Rep. No. 79–752,
at 200 (1945)). See also Utility Solid
Waste Activities Group v. E.P.A., 236
F.3d 749, 755 (D.C. Cir. 2001) (the
‘‘unnecessary’’ prong ‘‘is confined to
those situations in which the
administrative rule is a routine
determination, insignificant in nature
and impact, and inconsequential to the
industry and to the public’’) (internal
quotations and citation omitted). This
rule is a ‘‘minor’’ or ‘‘technical’’
amendment to 21 CFR 1310 as it is
‘‘insignificant in nature and impact, and
inconsequential to the industry and
7 21
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U.S.C. 880.
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Rules and Regulations
public.’’ Therefore, publishing a notice
of proposed rulemaking and soliciting
public comment are unnecessary.
In addition, because 1-boc-4-AP is
already subject to domestic control
under list I as a carbamate of Nphenylpiperidin-4-amine and no
additional requirements are being
imposed through this action, DEA finds
good cause exists to make this rule
effective immediately upon publication
in accordance with 5 U.S.C. 553(d)(3).
DEA is concerned that delaying the
effective date of this rule potentially
could cause confusion regarding the
regulatory status of 1-boc-4-AP. 1-boc-4AP is currently regulated as a list I
chemical, and this level of control does
not change with this rulemaking.
Executive Orders 12866 and 13563,
Regulatory Planning and Review and
Improving Regulation and Regulatory
Review
This rule was developed in
accordance with the principles of
Executive Orders (E.O.) 12866 and
13563. This rule is not a significant
regulatory action under E.O. 12866. 1boc-4-AP is already regulated as a list I
chemical in the United States, as a
carbamate of the list I chemical Nphenylpiperidin-4-amine. In this final
rule, DEA is merely making an
administrative change by amending its
regulations to separately list 1-boc-4-AP
as a list I chemical and to assign the
DEA chemical control number 8336 to
this chemical. A separate listing for 1boc-4-AP will not alter the status of 1boc-4-AP as a list I chemical.
Accordingly, this rule has not been
reviewed by the Office of Management
and Budget (OMB).
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, minimize
litigation, provide a clear legal standard
for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The rule does
not have substantial direct effects on the
States, on the relationship between the
national government and the States, or
the distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA or other
laws. As noted in the above section
regarding the applicability of the APA,
DEA determined that there is good
cause to exempt this final rule from
notice and comment. Consequently, the
RFA does not apply.
Unfunded Mandates Reform Act of 1995
(UMRA)
In accordance with the UMRA, 2
U.S.C. 1501 et seq., DEA has determined
and certifies that this rule will not result
in any Federal mandate that may result
‘‘in the expenditure by State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more (adjusted annually for inflation) in
any 1 year * * *.’’ Therefore, neither a
Small Government Agency Plan nor any
other action is required under the
UMRA.
Paperwork Reduction Act
The action does not impose a new
collection of information requirement
under the Paperwork Reduction Act, 44
U.S.C. 3501–3521. This action will not
impose recordkeeping or reporting
requirements on State or local
governments, individuals, businesses, or
organizations. An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
Congressional Review Act
This final rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of this final rule to both Houses
of Congress and to the Comptroller
General.
List of Subjects 21 CFR Part 1310
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Reporting and recordkeeping
requirements.
Accordingly, for the reasons set forth
in the preamble, DEA amends 21 CFR
part 1310 as follows:
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES;
IMPORTATION AND EXPORTATION OF
CERTAIN MACHINES
1. The authority citation for 21 CFR
part 1310 continues to read as follows:
■
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
2. In § 1310.02, add reserved
paragraph (a)(38) and paragraph (a)(39)
to read as follows:
■
§ 1310.02
*
Substances covered.
*
*
*
(a) * * *
(38) [Reserved]
*
(39) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1-carboxylate) and its salts ..................................................................................
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*
*
*
*
*
■ 3. In § 1310.04:
■ a. Redesignate paragraphs (g)(1)(iii)
through (xviii) as paragraphs (g)(1)(iv)
through (xix), respectively; and
■ b. Add new paragraph (g)(1)(iii).
The addition reads as follows:
§ 1310.04
*
*
Maintenance of records.
*
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*
*
16:01 Nov 08, 2022
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(g) * * *
(1) * * *
*
*
*
*
*
(iii) 1-boc-4-AP (tert-butyl 4(phenylamino)piperidine-1-carboxylate)
and its salts.
*
*
*
*
*
■ 4. Section 1310.12 is amended by
adding in alphabetical order in the table
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8336
in paragraph (c) an entry for 1-boc-4-AP
(tert-butyl 4-(phenylamino)piperidine-1carboxylate) and its salts to read as
follows:
§ 1310.12
*
*
Exempt chemical mixtures.
*
(c) * * *
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*
67553
Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Rules and Regulations
TABLE OF CONCENTRATION LIMITS
DEA chemical
code No.
Concentration
Special conditions
List I Chemicals
*
*
1-boc-4-AP (tert-butyl 4(phenylamino)piperidine-1-carboxylate) and
its salts.
*
*
*
*
*
*
*
Scott Brinks,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2022–24155 Filed 11–8–22; 8:45 am]
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Parts 630 and 635
[FHWA Docket No. FHWA–2018–0017]
RIN 2125–AF83
Indefinite Delivery and Indefinite
Quantity Contracts for Federal-Aid
Construction
Federal Highway
Administration (FHWA), U.S.
Department of Transportation (DOT).
ACTION: Final rule.
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On November 16, 2020,
FHWA published an interim final rule
(IFR) amending FHWA’s regulations to
allow States the ability to use the
Indefinite Delivery and Indefinite
Quantity (ID/IQ) method of contracting,
including job order contracting (JOC),
on Federal-aid highway projects, under
Jkt 259001
*
certain circumstances, on a permanent
basis. This action adopts the IFR with a
few minor changes and technical
amendments. Most provisions from the
IFR remain unchanged. This action also
restores a missing provision
inadvertently removed during an earlier,
unrelated rulemaking.
DATES: This final rule is effective
December 9, 2022.
FOR FURTHER INFORMATION CONTACT: Mr.
James DeSanto, Office of
Preconstruction, Construction, and
Pavements, james.desanto@dot.gov,
(614) 357–8515, or Mr. Patrick Smith,
Office of the Chief Counsel,
patrick.c.smith@dot.gov, (202) 366–
1345, Federal Highway Administration,
1200 New Jersey Avenue SE,
Washington, DC 20590. Office hours are
from 8 a.m. to 4:30 p.m., EST, Monday
through Friday, except Federal holidays.
SUPPLEMENTARY INFORMATION:
This document, as well as the IFR,
advance notice of proposed rulemaking,
supporting materials, and all comments
received may be viewed online through
the Federal eRulemaking portal at:
www.regulations.gov. An electronic
copy of this document may also be
downloaded from the Office of the
Federal Register’s home page at:
www.FederalRegister.gov and the
Government Publishing Office’s web
page at: www.GovInfo.gov.
The ID/IQ method of contracting
allows a project owner to procure an
unknown quantity of supplies or
services for a fixed time. As described
in FHWA’s IFR, 85 FR 72919 (Nov. 16,
2020), government agencies use this
method when they cannot determine,
above a specified minimum, the precise
quantities of supplies or services that
they will require during the contract
period. Contracting agencies use other
names for these and similar types of
contracts, including JOC contracts,
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*
*
Chemical mixtures containing any amount of
1-boc-4-AP (tert-butyl 4(phenylamino)piperidine-1-carboxylate) and
its salts are not exempt.
*
Background
AGENCY:
SUMMARY:
*
*
Not exempt at any concentration.
Electronic Access and Filing
BILLING CODE 4410–09–P
16:01 Nov 08, 2022
8336
*
Signing Authority
This document of the Drug
Enforcement Administration was signed
on November 1, 2022, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
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*
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*
*
master contracts, on-call contracts, areawide contracts, continuing contracts,
design-build push-button contracts,
push-button contracts, stand-by
contracts, and task order contracts.
With the publication of FHWA’s IFR,
FHWA operationalized the ID/IQ
method of contracting, including JOC,
for Federal-aid construction projects.
Previously, this contracting technique
was only authorized on an experimental
basis under FHWA’s Special
Experimental Project No. 14 (SEP–14).
Allowing ID/IQ contracting on a
permanent basis provides benefits to
State departments of transportation
(State DOT) and other contracting
agencies, including expediting project
delivery, increasing administrative
efficiency, reducing project costs, and
increasing flexibility for State DOTs to
use Federal-aid funds on certain
projects. Additional discussion on State
DOT and local public agency experience
with ID/IQ contracting under FHWA’s
SEP–14 program, as well as FHWA’s
previous steps to operationalize ID/IQ
contracting, is provided in the IFR.
Interim Final Rule
On November 16, 2020, FHWA
published its IFR in the Federal
Register at 85 FR 72919, adopting new
regulations and soliciting public
comments on its proposal. Comments
were submitted by six State DOTs, one
metropolitan planning organization, one
business, and one individual. The
comments are available for examination
in the docket (FHWA–2018–0017) at
www.regulations.gov.
Analysis of Interim Final Rule
Comments and FHWA Response
The following discussion summarizes
the comments submitted to the docket
on the IFR, notes where and why FHWA
has made changes in the final rule, and
explains why certain recommendations
or suggestions have not been
incorporated into the final rule.
In general, most commenters
supported the rule. Comments generally
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]]>Agencies
[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Rules and Regulations]
[Pages 67550-67553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24155]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-1046]
Specific Listing for 1-boc-4-AP, a Currently Controlled List I
Chemical
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is establishing a
specific listing and DEA Chemical Control Number for tert-butyl 4-
(phenylamino)piperidine-1-carboxylate (also known as 1-boc-4-AP; and
CAS Number: 125541-22-2) and its salts as a list I chemical under the
Controlled Substances Act. Although 1-boc-4-AP is not specifically
listed as a list I chemical of the Controlled Substances Act with its
own unique Chemical Control Number, it has been regulated as a list I
chemical in the United States since May 15, 2020, as a carbamate of N-
phenylpiperidin-4-amine, a list I chemical. Therefore, DEA is simply
amending the list I chemicals list in its regulations to include a
separate listing for 1-boc-4-AP, a currently controlled list I
chemical.
DATES: Effective date November 9, 2022.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: tert-Butyl 4-(phenylamino)piperidine-1-
carboxylate (also known as 1-boc-4-AP) is a chemical that is
structurally related to N-phenylpiperidin-4-amine (also known as N-
phenyl-4-piperidinamine, 4-anilinopiperidine, and 4-AP). N-
Phenylpiperidin-4-amine, including its amides, its carbamates, and its
salts, is listed as a list I chemical at 21 CFR 1310.02(a). See 85 FR
20822 (April 1, 2020) (effective May 15, 2020). The chemical structure
of 1-boc-4-AP defines it as a carbamate of N-phenylpiperidin-4-amine.
Accordingly, under 21 CFR 1310.02(b), 1-boc-4-AP, as a carbamate of N-
phenylpiperidin-4-amine, is and continues to be a regulated list I
chemical.\1\
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\1\ N-phenylpiperidin-4-amine, including its amides, its
carbamates, and its salts, has been subject to list I chemical
regulations since May 15, 2020, pursuant to a final rule (April 15,
2020; 85 FR 20822).
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Legal Authority
The Controlled Substances Act (CSA) and the Drug Enforcement
Administration's (DEA) implementing regulations give the Attorney
General, as delegated to the Administrator of DEA (Administrator), the
authority to specify, by regulation, a chemical as a ``list I
chemical.'' \2\ This term refers to a chemical that is used in
manufacturing a controlled substance in violation of subchapter I
(Control and Enforcement) of the CSA and is important to the
manufacture of the controlled substance.\3\ The current list of all
list I chemicals is available in 21 CFR 1310.02(a).
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\2\ 21 U.S.C. 802(34) and 871(b) and 21 CFR 1310.02(c).
\3\ 21 U.S.C. 802(34) and 21 CFR 1300.02(b).
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In addition, the United States is a Party to the 1988 United
Nations Convention Against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances (1988 Convention), December 20, 1988, 1582
U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United
States receives notification that a chemical has been added to Table I
or Table II of the 1988 Convention, the United States is required to
take measures it deems appropriate to monitor the manufacture and
distribution of that chemical within the United States and to prevent
its diversion, including measures related to international trade.
Background
In a letter dated May 27, 2022, the United Nations Office on Drugs
and Crime, in accordance with Article 12, paragraph 6 of the 1988
Convention, informed the Permanent Mission of the United States of
America to the United Nations (Vienna) that the Commission on Narcotic
Drugs (CND) decided to place the chemical 1-boc-4-AP in Table I of the
1988 Convention (CND Dec/65/5) at its 65th Session on March 16, 2022.
[[Page 67551]]
As discussed above in this final rule, 1-boc-4-AP--by virtue of being a
carbamate of N-phenylpiperidin-4-amine--has been regulated as a list I
chemical of the CSA since May 15, 2020.\4\ Therefore, all regulations
and criminal sanctions applicable to list I chemicals have been and
remain applicable to 1-boc-4-AP.
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\4\ 85 FR 20822 (April 15, 2020).
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Effect of Action
As discussed above, this rule does not affect the continuing status
of 1-boc-4-AP as a list I chemical in any way. This action, as an
administrative matter, merely establishes a separate, specific listing
for 1-boc-4-AP in list I of the CSA and assigns a DEA chemical control
number for the substance. This action will allow DEA to effectively
monitor regulated transactions of 1-boc-4-AP, including the
manufacture, distribution, importation, or exportation of 1-boc-4-AP,
and to provide accurate reporting to the International Narcotics
Control Board.
Chemical Mixtures of 1-boc-4-AP
Pursuant to the final rule published on April 15, 2020,\5\ chemical
mixtures containing 1-boc-4-AP have been and continue to be subject to
regulatory requirements at any concentration--unless a manufacturer
submits to DEA an application for exemption of a chemical mixture, DEA
accepts the application for filing, and DEA exempts the chemical
mixture in accordance with 21 CFR 1310.13 (Exemption of chemical
mixtures by application).
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\5\ 85 FR 20822.
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Since even a small amount of 1-boc-4-AP can potentially yield a
significant amount of controlled substances, DEA believes that the
continued regulation of chemical mixtures containing any amount of 1-
boc-4-AP as a list I chemical is necessary to prevent its illicit
extraction, isolation, and use. 1-boc-4-AP is already subject to
domestic control under list I as a carbamate of N-phenylpiperidin-4-
amine, and DEA's current regulations provide that a chemical mixture
containing any amount of N-phenylpiperidin-4-amine is a List I
chemical. As a technical, conforming change in connection with the
separate listing of 1-boc-4-AP, this rule modifies the ``Table of
Concentration Limits'' in 21 CFR 1310.12(c) to reflect that a chemical
mixture containing any amount of 1-boc-4-AP is subject to CSA chemical
control provisions, including 21 CFR parts 1309, 1310, 1313, and 1316.
No additional requirements are being imposed.
DEA has implemented an application process to exempt certain
chemical mixtures from the requirements of the CSA and its implementing
regulations.\6\ Manufacturers may submit an application for exemption
for those mixtures that do not meet the criteria set forth in 21 CFR
1310.12(d) for an automatic exemption. Pursuant to 21 CFR 1310.13(a),
DEA may grant exempt status to a chemical mixture by publishing a final
rule in the Federal Register, if DEA determines that: (1) The mixture
is formulated in such a way that it cannot be easily used in the
illicit production of a controlled substance, and (2) the listed
chemical or chemicals cannot be readily recovered.
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\6\ 21 CFR 1310.13.
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Requirements for Handling List I Chemicals
The listing of 1-boc-4-AP as a list I chemical continues to subject
handlers (manufacturers, distributors, importers, and exporters) and
proposed handlers to all of the regulatory controls and administrative,
civil, and criminal actions applicable to the manufacture,
distribution, importation, and exportation of a list I chemical. Since
May 15, 2020, persons handling 1-boc-4-AP, including regulated chemical
mixtures containing 1-boc-4-AP, have been required to comply with list
I chemical regulations, including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, or exports), or proposes to engage in such handling, of 1-boc-
4-AP or a chemical mixture containing 1-boc-4-AP, must obtain a
registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations
describing registration for list I chemical handlers are set forth in
21 CFR part 1309.
2. Records and Reports. Every DEA registrant must maintain records
and submit reports to DEA with respect to 1-boc-4-AP pursuant to 21
U.S.C. 830 and in accordance with 21 CFR 1310. Pursuant to 21 CFR
1310.04, a record must be made and maintained for two years after the
date of a transaction involving a listed chemical, provided the
transaction is a regulated transaction.
3. Importation and Exportation. All importation and exportation of
1-boc-4-AP must be done in compliance with 21 U.S.C. 957, 958, and 971
and in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants must provide effective
controls against theft and diversion in accordance with 21 CFR 1309.71-
1309.73.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where registrants
or other regulated persons may lawfully hold, manufacture, distribute,
or otherwise dispose of a list I chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for
administrative inspections of these controlled premises as provided in
21 CFR part 1316, subpart A.\7\
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\7\ 21 U.S.C. 880.
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6. Liability. Any activity involving 1-boc-4-AP not authorized by,
or in violation of, the CSA is unlawful, and would subject the person
to administrative, civil, and/or criminal action.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553),
including notice of proposed rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest.
As discussed above, 1-boc-4-AP is currently and continues to be
regulated as a list I chemical as a carbamate of N-phenylpiperidin-4-
amine.
Pursuant to 5 U.S.C. 553(b)(3)(B), DEA finds that notice and
comment rulemaking is unnecessary and that good cause exists to
dispense with these procedures. The addition of a separate listing for
1-boc-4-AP and its DEA chemical control number in the list of list I
chemicals in 21 CFR 1310.02(a) makes no substantive difference in the
status of this chemical as a list I chemical, but instead is ``a minor
or merely technical amendment in which the public is not particularly
interested.'' National Nutritional Foods Ass'n v. Kennedy, 572 F.2d
377, 385 (2d Cir. 1978) (quoting S. Rep. No. 79-752, at 200 (1945)).
See also Utility Solid Waste Activities Group v. E.P.A., 236 F.3d 749,
755 (D.C. Cir. 2001) (the ``unnecessary'' prong ``is confined to those
situations in which the administrative rule is a routine determination,
insignificant in nature and impact, and inconsequential to the industry
and to the public'') (internal quotations and citation omitted). This
rule is a ``minor'' or ``technical'' amendment to 21 CFR 1310 as it is
``insignificant in nature and impact, and inconsequential to the
industry and
[[Page 67552]]
public.'' Therefore, publishing a notice of proposed rulemaking and
soliciting public comment are unnecessary.
In addition, because 1-boc-4-AP is already subject to domestic
control under list I as a carbamate of N-phenylpiperidin-4-amine and no
additional requirements are being imposed through this action, DEA
finds good cause exists to make this rule effective immediately upon
publication in accordance with 5 U.S.C. 553(d)(3). DEA is concerned
that delaying the effective date of this rule potentially could cause
confusion regarding the regulatory status of 1-boc-4-AP. 1-boc-4-AP is
currently regulated as a list I chemical, and this level of control
does not change with this rulemaking.
Executive Orders 12866 and 13563, Regulatory Planning and Review and
Improving Regulation and Regulatory Review
This rule was developed in accordance with the principles of
Executive Orders (E.O.) 12866 and 13563. This rule is not a significant
regulatory action under E.O. 12866. 1-boc-4-AP is already regulated as
a list I chemical in the United States, as a carbamate of the list I
chemical N-phenylpiperidin-4-amine. In this final rule, DEA is merely
making an administrative change by amending its regulations to
separately list 1-boc-4-AP as a list I chemical and to assign the DEA
chemical control number 8336 to this chemical. A separate listing for
1-boc-4-AP will not alter the status of 1-boc-4-AP as a list I
chemical. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the States, on the relationship between the national
government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or other laws. As noted in the above section regarding the
applicability of the APA, DEA determined that there is good cause to
exempt this final rule from notice and comment. Consequently, the RFA
does not apply.
Unfunded Mandates Reform Act of 1995 (UMRA)
In accordance with the UMRA, 2 U.S.C. 1501 et seq., DEA has
determined and certifies that this rule will not result in any Federal
mandate that may result ``in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year *
* *.'' Therefore, neither a Small Government Agency Plan nor any other
action is required under the UMRA.
Paperwork Reduction Act
The action does not impose a new collection of information
requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.
This action will not impose recordkeeping or reporting requirements on
State or local governments, individuals, businesses, or organizations.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule to both Houses of Congress and to
the Comptroller General.
List of Subjects 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, DEA amends
21 CFR part 1310 as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
0
1. The authority citation for 21 CFR part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. In Sec. 1310.02, add reserved paragraph (a)(38) and paragraph
(a)(39) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(38) [Reserved]
(39) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1- 8336
carboxylate) and its salts......................................
* * * * *
0
3. In Sec. 1310.04:
0
a. Redesignate paragraphs (g)(1)(iii) through (xviii) as paragraphs
(g)(1)(iv) through (xix), respectively; and
0
b. Add new paragraph (g)(1)(iii).
The addition reads as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
* * * * *
(iii) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1-
carboxylate) and its salts.
* * * * *
0
4. Section 1310.12 is amended by adding in alphabetical order in the
table in paragraph (c) an entry for 1-boc-4-AP (tert-butyl 4-
(phenylamino)piperidine-1-carboxylate) and its salts to read as
follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
[[Page 67553]]
Table of Concentration Limits
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DEA chemical
code No. Concentration Special conditions
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
1-boc-4-AP (tert-butyl 4- 8336 Not exempt at any Chemical mixtures
(phenylamino)piperidine-1-carboxylate) concentration. containing any amount of
and its salts. 1-boc-4-AP (tert-butyl 4-
(phenylamino)piperidine-1-
carboxylate) and its
salts are not exempt.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
November 1, 2022, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-24155 Filed 11-8-22; 8:45 am]
BILLING CODE 4410-09-P
