Establishment of Drug Codes for 26 Substances, 664-666 [2012-31698]
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Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Rules and Regulations
‘‘cannabimimetic agents’’ 1 and 26
substances in Schedule I. Public Law
112–144, Title XI, Subtitle D, Section
1152. DEA is publishing this rule to
establish drug codes for these 26
substances. These 26 substances include
15 cannabimimetic agents, 9
phenethylamines, and 2 cathinones and
are listed in the regulatory text section,
below.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–368]
Establishment of Drug Codes for 26
Substances
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
On July 9, 2012, the President
signed into law the Synthetic Drug
Abuse Prevention Act of 2012 (SDAPA).
SDAPA amends the Controlled
Substances Act by placing 26 substances
in Schedule I. DEA is publishing this
rule to establish drug codes for these 26
substances, and to make technical and
conforming amendments in accordance
with SDAPA.
DATES: Effective Date: January 4, 2013.
FOR FURTHER INFORMATION CONTACT: John
W. Partridge, Executive Assistant, Office
of Diversion Control, Drug Enforcement
Administration, Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone (202) 307–7165.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Legal Authority
sroberts on DSK5SPTVN1PROD with
DEA administers, implements, and
enforces Titles II and III of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, often referred
to as the Controlled Substances Act and
the Controlled Substances Import and
Export Act (21 U.S.C. 801–971), as
amended (hereinafter, ‘‘CSA’’). The
implementing regulations for these
statutes are found in Title 21 of the
Code of Federal Regulations (CFR), parts
1300 to 1321. Under the CSA, controlled
substances are classified in one of five
schedules based upon their potential for
abuse, their currently accepted medical
use, the lack of accepted safety for use
under medical supervision, and the
degree of dependence the substance
may cause. 21 U.S.C. 812. The list of
legislatively scheduled controlled
substances is found at 21 U.S.C. 812(c)
and the current list of scheduled
substances is published at 21 CFR part
1308. These initial schedules may be
modified either by legislation or by
rulemaking.
Purpose of This Rulemaking
On July 9, 2012, the SDAPA of 2012,
Public Law 112–144, Title XI, Subtitle
D, became effective. SDAPA amended
the CSA by legislatively placing
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Related Procedural Matters
At the time SDAPA became effective
on July 9, 2012, a total of 8 substances
were covered by temporary scheduling
final orders: 5 synthetic cannabinoids
(JWH–018, JWH–073, JWH–200, CP–
47,497, and CP–47,497 C8 homologue) 2
and 3 synthetic cathinones
(mephedrone, MDPV, and methylone).3
DEA also issued a Notice of Proposed
Rulemaking (NPRM) in March 2012, to
place the 5 synthetic cannabinoids
(JWH–018, JWH–073, JWH–200, CP–
47,497, and CP–47,497 C8 homologue)
permanently in Schedule I.4 With the
sole exception of methylone,5 these
substances were specifically placed in
Schedule I by SDAPA. Therefore, it is
no longer necessary to finalize the
NPRM regarding the 5 synthetic
1 SDAPA also included a definition of
‘‘cannabimimetic agents.’’ Although this rule is
only addressing the 26 specific substances, DEA
intends to issue a separate rulemaking that will
address the broader definition of cannabimimetic
agents. Even in the absence of such a rulemaking
as of July 9, 2012, cannabimimetic agents, as
defined in SDAPA are controlled under Schedule
I.
2 See DEA Notice of Intent entitled ‘‘Schedules of
Controlled Substances: Temporary Placement of
Five Synthetic Cannabinoids Into Schedule I,’’
published in the Federal Register on November 24,
2010, at 75 FR 71635, DEA Notice of Intent;
correction entitled ‘‘Schedules of Controlled
Substances: Temporary Placement of Five Synthetic
Cannabinoids Into Schedule I; Correction,’’
published in the Federal Register on January 13,
2011, at 76 FR 2287, DEA Final Order entitled
‘‘Schedules of Controlled Substances: Temporary
Placement of Five Synthetic Cannabinoids into
Schedule I,’’ published in the Federal Register on
March 1, 2011, at 76 FR 11075, and DEA Final
Order entitled ‘‘Schedules of Controlled
Substances: Extension of Temporary Placement of
Five Synthetic Cannabinoids Into Schedule I of the
Controlled Substances Act,’’ published in the
Federal Register on February 29, 2012, at 77 FR
12201.
3 See DEA Notice of Intent entitled ‘‘Schedules of
Controlled Substances: Temporary Placement of
Three Synthetic Cathinones Into Schedule I,’’
published in the Federal Register on September 8,
2011, at 76 FR 55616 and DEA Final Order entitled
‘‘Schedules of Controlled Substances: Temporary
Placement of Three Synthetic Cathinones Into
Schedule I,’’ published in the Federal Register on
October 21, 2011, at 76 FR 65371.
4 See Schedules of Controlled Substances:
Placement of Five Synthetic Cannabinoids Into
Schedule I, 77 FR 12508, Mar. 1, 2012.
5 DEA extended the temporary scheduling of
methylone in a Final Order published in the
Federal Register on October 18, 2012 at 77 FR
64032.
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cannabinoids (JWH–018, JWH–073,
JWH–200, CP–47,497, and CP–47,497
C8 homologue), or to take further action
with respect to 2 of the 3 synthetic
cathinones (mephedrone and MDPV).
However, DEA has posted a copy of the
Secretary of Health and Human Services
(HHS) Scientific and Medical
Evaluation and Scheduling
Recommendations regarding the 5
synthetic cannabinoids on
www.regulations.gov so that the public
can benefit from the scientific review
that was undertaken with respect to
these substances.6 These HHS
documents can be found on
www.regulations.gov under Docket ID
‘‘DEA–2012–0001.’’
In addition to establishing drug codes
for these 26 substances,7 this
rulemaking makes several technical and
conforming amendments to 21 CFR
1308.11 in accordance with SDAPA.
This rulemaking adds a new subsection
(g) to 21 CFR 1308.11 and gives it the
title ‘‘cannabimimetic agents,’’
redesignates the old subsection (g) as (h)
and retains its title as ‘‘[t]emporary
listing of substances subject to
emergency scheduling,’’ and transfers 7
of the 8 substances currently listed in 21
CFR 1308.11(g) under the title of
‘‘[t]emporary listing of substances
subject to emergency scheduling,’’ to
either the new subsection (g) entitled
‘‘cannabimimetic agents’’ or to the
previously existing subsection (d)
entitled ‘‘[h]allucinogenic substances.’’
In summary, as a result of SDAPA, a
new subsection entitled
‘‘cannabimimetic agents’’ will be
created and will initially contain 15
substances, the existing subsection
entitled ‘‘[h]allucinogenic substances’’
will increase by 11 substances, and the
existing subsection entitled ‘‘temporary
listing of substances subject to
emergency scheduling’’ will be
redesignated from (g) to (h) and will
decrease from 8 substances to 1
substance (methylone).
6 HHS did not provide a Scientific and Medical
Evaluation and Scheduling Recommendation
regarding mephedrone and MDPV.
7 Some of these substances (for example, JWH–
018) had already received drug codes by virtue of
the prior temporary scheduling actions discussed
above. Such substances will retain their previously
established drug codes but are included in this rule
for purposes of completeness and to ensure that
each of these 26 substances are properly classified
in the Code of Federal Regulations. Substances for
which a drug code has not previously been
established (for example, 2-(2,5-Dimethoxy-4ethylphenyl)ethanamine (2C–E)) will have a drug
code assigned to them by this rule.
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Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Rules and Regulations
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. This rule merely establishes
drug codes for the 26 substances placed
in Schedule I by SDAPA, and makes
several technical and conforming
amendments in accordance with
SDAPA. Because DEA has no discretion
with respect to these changes,
publishing a notice of proposed
rulemaking and soliciting public
comment are unnecessary. In addition,
because the placement of these 26
substances in Schedule I has already
been in effect since July 9, 2012, DEA
finds good cause exists to make this rule
effective immediately upon publication.
Executive Orders 12866 and 13563
This rule, establishing drug codes for
the 26 substances placed in Schedule I
by SDAPA, and making technical and
conforming amendments in accordance
with SDAPA has been developed in
accordance with the principles of
Executive Orders 12866 and 13563.
Executive Order 12988
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform to eliminate ambiguity,
minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of State law,
impose enforcement responsibilities on
any State, or diminish the power of any
State to enforce its own laws.
Accordingly, this rulemaking does not
have federalism implications warranting
the application of Executive Order
13132.
Executive Order 13175
This rule is required by statute, will
not have tribal implications, and will
not impose substantial direct
compliance costs on Indian tribal
governments.
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Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612), has reviewed this regulation,
and by approving it certifies that this
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regulation will not have a significant
economic impact on a substantial
number of small entities.
Paperwork Reduction Act of 1995
This rule does not involve a collection
of information within the meaning of
the Paperwork Reduction Act of 1995,
44 U.S.C. 3501–3521.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $136,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995. 2 U.S.C.
1532.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (5 U.S.C. 804). This rule will not
result in an annual effect on the
economy of $100,000,000 or more, a
major increase in cost or prices, or have
significant adverse effects on
competition, employment, investment,
productivity, innovation, or the ability
of United States-based companies to
compete with foreign based companies
in domestic and export markets.
However, DEA has submitted a copy of
this 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.
For the reasons set out above, 21 CFR
part 1308 is amended as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted.
2. Amend § 1308.11 by:
a. Adding new paragraphs (d)(36)
through (d)(46);
■ b. Redesignating paragraph (g) as
paragraph (h) and revising newly
redesignated paragraph (h)(1); and
■ c. Adding a new paragraph (g).
The additions and revisions read as
follows:
■
■
§ 1308.11
*
PO 00000
Schedule I.
*
*
(d) * * *
Frm 00003
*
Fmt 4700
*
Sfmt 4700
(36)
4-methylmethcathinone
(Mephedrone) ...............................
(37)
3,4methylenedioxypyrovalerone
(MDPV) .........................................
(38)
2-(2,5-Dimethoxy-4ethylphenyl)ethanamine (2C–E) ..
(39)
2-(2,5-Dimethoxy-4methylphenyl)ethanamine (2C–
D) ..................................................
(40)
2-(4-Chloro-2,5dimethoxyphenyl)ethanamine
(2C–C) ...........................................
(41)
2-(4-Iodo-2,5dimethoxyphenyl)ethanamine
(2C–I) ............................................
(42)
2-[4-(Ethylthio)-2,5dimethoxyphenyl]ethanamine
(2C–T–2) .......................................
(43)
2-[4-(Isopropylthio)-2,5dimethoxyphenyl]ethanamine
(2C–T–4) .......................................
(44)
2-(2,5Dimethoxyphenyl)ethanamine
(2C–H) ...........................................
(45)
2-(2,5-Dimethoxy-4-nitrophenyl)ethanamine (2C–N) .........
(46)
2-(2,5-Dimethoxy-4-(n)propylphenyl)ethanamine (2C–P)
665
1248
7535
7509
7508
7519
7518
7385
7532
7517
7521
7524
*
*
*
*
*
(g) Cannabimimetic agents. Unless
specifically exempted or unless listed in
another schedule, any material,
compound, mixture, or preparation
which contains any quantity of the
following substances, or which contains
their salts, isomers, and salts of isomers
whenever the existence of such salts,
isomers, and salts of isomers is possible
within the specific chemical
designation:
(1) 5-(1,1-dimethylheptyl)-2[(1R,3S)-3hydroxycyclohexyl]-phenol
(CP–47,497) ..........................
(2) 5-(1,1-dimethyloctyl)-2[(1R,3S)-3hydroxycyclohexyl]-phenol
(cannabicyclohexanol or
CP–47,497 C8-homolog) ......
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and
AM678) .................................
(4) 1-butyl-3-(1-naphthoyl)indole (JWH–073) .......
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH–019) .......
(6) 1-[2-(4-morpholinyl)ethyl]3-(1-naphthoyl)indole
(JWH–200) ............................
(7) 1-pentyl-3-(2methoxyphenylacetyl)indole
(JWH–250) ............................
(8) 1-pentyl-3-[1-(4methoxynaphthoyl)]indole
(JWH–081) ............................
(9) 1-pentyl-3-(4-methyl-1naphthoyl)indole (JWH–122)
(10) 1-pentyl-3-(4-chloro-1naphthoyl)indole (JWH–398)
(11) 1-(5-fluoropentyl)-3-(1naphthoyl)indole (AM2201)
(12) 1-(5-fluoropentyl)-3-(2iodobenzoyl)indole (AM694)
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7298
7118
7173
7019
7200
6250
7081
7122
7398
7201
7694
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Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Rules and Regulations
(13) 1-pentyl-3-[(4-methoxy)benzoyl]indole (SR–19 and
RCS–4) ..................................
(14) 1-cyclohexylethyl-3-(2methoxyphenylacetyl)indole
7008 (SR–18 and RCS–8) .....
(15) 1-pentyl-3-(2chlorophenylacetyl)indole
(JWH–203) ............................
(h) * * *
(1) 3,4-methylenedioxy-Nmethylcathinone (Other
names: methylone) ...............
*
*
*
*
*
Dated: December 21, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–31698 Filed 1–3–13; 8:45 am]
BILLING CODE 4410–09–P
Background
On December 5, 2011, temporary
7104
regulations (TD 9561) relating to the
federal income tax treatment of Treasury
7008 Inflation-Protected Securities issued
with more than a de minimis amount of
premium were published in the Federal
7203 Register (76 FR 75781). See § 1.1275–
7T. A notice of proposed rulemaking
(REG–130777–11) cross-referencing the
temporary regulations was published in
7540 the Federal Register for the same day
(76 FR 75829). No comments were
received on the notice of proposed
rulemaking. No public hearing was
requested or held.
The proposed regulations are adopted
without substantive change by this
Treasury decision, and the
corresponding temporary regulations are
removed.
DEPARTMENT OF THE TREASURY
Explanation of Provisions
Internal Revenue Service
1. Final Regulations—Treasury
Inflation-Protected Securities (TIPS)
Issued With More Than a De Minimis
Amount of Premium
The following is a general explanation
of the provisions in the final
regulations, which are the same as the
provisions in the temporary regulations.
However, the provisions that were in
the temporary regulations are now
contained in newly designated
paragraphs (g)(2) and (h)(2) of § 1.1275–
7 of the final regulations.
TIPS are securities issued by the
Department of the Treasury. The
principal amount of a TIPS is adjusted
for any inflation or deflation that occurs
over the term of the security. The rules
for the taxation of inflation-indexed
debt instruments, including TIPS, are
contained in § 1.1275–7 of the Income
Tax Regulations. See also § 1.171–3(b)
(rules for inflation-indexed debt
instruments with bond premium).
Under § 1.1275–7(d)(2)(i), the coupon
bond method described in § 1.1275–7(d)
is not available with respect to inflationindexed debt instruments that are
issued with more than a de minimis
amount of premium (that is, an amount
greater than .0025 times the stated
principal amount of the security times
the number of complete years to the
security’s maturity). Prior to 2011, TIPS
had not been issued with more than a
de minimis amount of premium, and the
coupon bond method had applied to
TIPS rather than the more complex
discount bond method described in
§ 1.1275–7(e).
In 2011, the Treasury Department
anticipated that TIPS might be issued
with more than a de minimis amount of
premium. As a result, in Notice 2011–
21 (2011–19 IRB 761), to provide a more
26 CFR Part 1
[TD 9609]
RIN 1545–BK45; 1545–BL29
Treasury Inflation-Protected Securities
Issued at a Premium; Bond Premium
Carryforward
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
AGENCY:
This document contains final
regulations that provide guidance on the
tax treatment of Treasury InflationProtected Securities issued with more
than a de minimis amount of premium.
This document also contains temporary
regulations that provide guidance on the
tax treatment of a debt instrument with
a bond premium carryforward in the
holder’s final accrual period, including
a Treasury bill acquired at a premium.
The regulations in this document
provide guidance to holders of Treasury
Inflation-Protected Securities and other
debt instruments. The text of the
temporary regulations in this document
also serves as the text of the proposed
regulations (REG–140437–12) set forth
in the Proposed Rules section in this
issue of the Federal Register.
DATES: Effective Date: These regulations
are effective on January 4, 2013.
Applicability Dates: For the dates of
applicability, see §§ 1.171–
2T(a)(4)(i)(C)(2) and 1.1275–7(h)(2).
FOR FURTHER INFORMATION CONTACT:
William E. Blanchard, (202) 622–3900
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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uniform method for the federal income
taxation of TIPS, the Treasury
Department and the IRS announced that
regulations would be issued to provide
that taxpayers must use the coupon
bond method described in § 1.1275–7(d)
for TIPS issued with more than a de
minimis amount of premium. As a
result, the discount bond method
described in § 1.1275–7(e) would not
apply to TIPS issued with more than a
de minimis amount of premium. Notice
2011–21 provided that the regulations
would be effective for TIPS issued on or
after April 8, 2011. On December 5,
2011, the Treasury Department and the
IRS published the temporary regulations
in the Federal Register. These
temporary regulations contained the
rules described in Notice 2011–21 and
applied to TIPS issued on or after April
8, 2011. As noted earlier in this
preamble, the final regulations are
substantively the same as the temporary
regulations.
Under the final regulations, a taxpayer
must use the coupon bond method
described in § 1.1275–7(d) for a TIPS
that is issued with more than a de
minimis amount of premium. The final
regulations include the example from
the temporary regulations illustrating
how to apply the coupon bond method
to a TIPS issued with more than a de
minimis amount of premium and a
negative yield. As stated in Notice
2011–21, the final regulations apply to
TIPS issued on or after April 8, 2011.
See § 601.601(d)(2)(ii)(b).
2. Temporary Regulations—Treatment
of Bond Premium Carryforward in a
Holder’s Final Accrual Period
During the consideration of the final
regulations relating to TIPS issued with
more than a de minimis amount of
premium, the Treasury Department and
the IRS received questions about the
holder’s treatment of a taxable zero
coupon debt instrument, including a
Treasury bill, acquired at a premium
and a negative yield. In this situation, as
described in more detail below, under
§§ 1.171–2 and 1.1016–5(b) of the
current regulations, a holder that elected
to amortize the bond premium generally
would have a capital loss upon the sale,
retirement, or other disposition of the
debt instrument rather than an ordinary
deduction under section 171(a)(1) for all
or a portion of the bond premium. This
situation, which has arisen as a result of
recent market conditions, was not
contemplated when the current
regulations were adopted in 1997.
Under section 171 and § 1.171–2 of
the current regulations, an electing
holder amortizes bond premium by
offsetting the qualified stated interest (as
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]]>Agencies
[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Rules and Regulations]
[Pages 664-666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31698]
[[Page 664]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-368]
Establishment of Drug Codes for 26 Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On July 9, 2012, the President signed into law the Synthetic
Drug Abuse Prevention Act of 2012 (SDAPA). SDAPA amends the Controlled
Substances Act by placing 26 substances in Schedule I. DEA is
publishing this rule to establish drug codes for these 26 substances,
and to make technical and conforming amendments in accordance with
SDAPA.
DATES: Effective Date: January 4, 2013.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration, Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Legal Authority
DEA administers, implements, and enforces Titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, often
referred to as the Controlled Substances Act and the Controlled
Substances Import and Export Act (21 U.S.C. 801-971), as amended
(hereinafter, ``CSA''). The implementing regulations for these statutes
are found in Title 21 of the Code of Federal Regulations (CFR), parts
1300 to 1321. Under the CSA, controlled substances are classified in
one of five schedules based upon their potential for abuse, their
currently accepted medical use, the lack of accepted safety for use
under medical supervision, and the degree of dependence the substance
may cause. 21 U.S.C. 812. The list of legislatively scheduled
controlled substances is found at 21 U.S.C. 812(c) and the current list
of scheduled substances is published at 21 CFR part 1308. These initial
schedules may be modified either by legislation or by rulemaking.
Purpose of This Rulemaking
On July 9, 2012, the SDAPA of 2012, Public Law 112-144, Title XI,
Subtitle D, became effective. SDAPA amended the CSA by legislatively
placing ``cannabimimetic agents'' \1\ and 26 substances in Schedule I.
Public Law 112-144, Title XI, Subtitle D, Section 1152. DEA is
publishing this rule to establish drug codes for these 26 substances.
These 26 substances include 15 cannabimimetic agents, 9
phenethylamines, and 2 cathinones and are listed in the regulatory text
section, below.
---------------------------------------------------------------------------
\1\ SDAPA also included a definition of ``cannabimimetic
agents.'' Although this rule is only addressing the 26 specific
substances, DEA intends to issue a separate rulemaking that will
address the broader definition of cannabimimetic agents. Even in the
absence of such a rulemaking as of July 9, 2012, cannabimimetic
agents, as defined in SDAPA are controlled under Schedule I.
---------------------------------------------------------------------------
Related Procedural Matters
At the time SDAPA became effective on July 9, 2012, a total of 8
substances were covered by temporary scheduling final orders: 5
synthetic cannabinoids (JWH-018, JWH-073, JWH-200, CP-47,497, and CP-
47,497 C8 homologue) \2\ and 3 synthetic cathinones (mephedrone, MDPV,
and methylone).\3\ DEA also issued a Notice of Proposed Rulemaking
(NPRM) in March 2012, to place the 5 synthetic cannabinoids (JWH-018,
JWH-073, JWH-200, CP-47,497, and CP-47,497 C8 homologue) permanently in
Schedule I.\4\ With the sole exception of methylone,\5\ these
substances were specifically placed in Schedule I by SDAPA. Therefore,
it is no longer necessary to finalize the NPRM regarding the 5
synthetic cannabinoids (JWH-018, JWH-073, JWH-200, CP-47,497, and CP-
47,497 C8 homologue), or to take further action with respect to 2 of
the 3 synthetic cathinones (mephedrone and MDPV). However, DEA has
posted a copy of the Secretary of Health and Human Services (HHS)
Scientific and Medical Evaluation and Scheduling Recommendations
regarding the 5 synthetic cannabinoids on www.regulations.gov so that
the public can benefit from the scientific review that was undertaken
with respect to these substances.\6\ These HHS documents can be found
on www.regulations.gov under Docket ID ``DEA-2012-0001.''
---------------------------------------------------------------------------
\2\ See DEA Notice of Intent entitled ``Schedules of Controlled
Substances: Temporary Placement of Five Synthetic Cannabinoids Into
Schedule I,'' published in the Federal Register on November 24,
2010, at 75 FR 71635, DEA Notice of Intent; correction entitled
``Schedules of Controlled Substances: Temporary Placement of Five
Synthetic Cannabinoids Into Schedule I; Correction,'' published in
the Federal Register on January 13, 2011, at 76 FR 2287, DEA Final
Order entitled ``Schedules of Controlled Substances: Temporary
Placement of Five Synthetic Cannabinoids into Schedule I,''
published in the Federal Register on March 1, 2011, at 76 FR 11075,
and DEA Final Order entitled ``Schedules of Controlled Substances:
Extension of Temporary Placement of Five Synthetic Cannabinoids Into
Schedule I of the Controlled Substances Act,'' published in the
Federal Register on February 29, 2012, at 77 FR 12201.
\3\ See DEA Notice of Intent entitled ``Schedules of Controlled
Substances: Temporary Placement of Three Synthetic Cathinones Into
Schedule I,'' published in the Federal Register on September 8,
2011, at 76 FR 55616 and DEA Final Order entitled ``Schedules of
Controlled Substances: Temporary Placement of Three Synthetic
Cathinones Into Schedule I,'' published in the Federal Register on
October 21, 2011, at 76 FR 65371.
\4\ See Schedules of Controlled Substances: Placement of Five
Synthetic Cannabinoids Into Schedule I, 77 FR 12508, Mar. 1, 2012.
\5\ DEA extended the temporary scheduling of methylone in a
Final Order published in the Federal Register on October 18, 2012 at
77 FR 64032.
\6\ HHS did not provide a Scientific and Medical Evaluation and
Scheduling Recommendation regarding mephedrone and MDPV.
---------------------------------------------------------------------------
In addition to establishing drug codes for these 26 substances,\7\
this rulemaking makes several technical and conforming amendments to 21
CFR 1308.11 in accordance with SDAPA. This rulemaking adds a new
subsection (g) to 21 CFR 1308.11 and gives it the title
``cannabimimetic agents,'' redesignates the old subsection (g) as (h)
and retains its title as ``[t]emporary listing of substances subject to
emergency scheduling,'' and transfers 7 of the 8 substances currently
listed in 21 CFR 1308.11(g) under the title of ``[t]emporary listing of
substances subject to emergency scheduling,'' to either the new
subsection (g) entitled ``cannabimimetic agents'' or to the previously
existing subsection (d) entitled ``[h]allucinogenic substances.'' In
summary, as a result of SDAPA, a new subsection entitled
``cannabimimetic agents'' will be created and will initially contain 15
substances, the existing subsection entitled ``[h]allucinogenic
substances'' will increase by 11 substances, and the existing
subsection entitled ``temporary listing of substances subject to
emergency scheduling'' will be redesignated from (g) to (h) and will
decrease from 8 substances to 1 substance (methylone).
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\7\ Some of these substances (for example, JWH-018) had already
received drug codes by virtue of the prior temporary scheduling
actions discussed above. Such substances will retain their
previously established drug codes but are included in this rule for
purposes of completeness and to ensure that each of these 26
substances are properly classified in the Code of Federal
Regulations. Substances for which a drug code has not previously
been established (for example, 2-(2,5-Dimethoxy-4-
ethylphenyl)ethanamine (2C-E)) will have a drug code assigned to
them by this rule.
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[[Page 665]]
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. This rule merely establishes drug
codes for the 26 substances placed in Schedule I by SDAPA, and makes
several technical and conforming amendments in accordance with SDAPA.
Because DEA has no discretion with respect to these changes, publishing
a notice of proposed rulemaking and soliciting public comment are
unnecessary. In addition, because the placement of these 26 substances
in Schedule I has already been in effect since July 9, 2012, DEA finds
good cause exists to make this rule effective immediately upon
publication.
Executive Orders 12866 and 13563
This rule, establishing drug codes for the 26 substances placed in
Schedule I by SDAPA, and making technical and conforming amendments in
accordance with SDAPA has been developed in accordance with the
principles of Executive Orders 12866 and 13563.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform
to eliminate ambiguity, minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law, impose enforcement responsibilities on any State, or diminish the
power of any State to enforce its own laws. Accordingly, this
rulemaking does not have federalism implications warranting the
application of Executive Order 13132.
Executive Order 13175
This rule is required by statute, will not have tribal
implications, and will not impose substantial direct compliance costs
on Indian tribal governments.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities.
Paperwork Reduction Act of 1995
This rule does not involve a collection of information within the
meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$136,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995. 2 U.S.C. 1532.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (5 U.S.C. 804). This rule will not result in an annual
effect on the economy of $100,000,000 or more, a major increase in cost
or prices, or have significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based companies to compete with foreign based companies
in domestic and export markets. However, DEA has submitted a copy of
this 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.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Amend Sec. 1308.11 by:
0
a. Adding new paragraphs (d)(36) through (d)(46);
0
b. Redesignating paragraph (g) as paragraph (h) and revising newly
redesignated paragraph (h)(1); and
0
c. Adding a new paragraph (g).
The additions and revisions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(36) 4-methylmethcathinone (Mephedrone)........................ 1248
(37) 3,4-methylenedioxypyrovalerone (MDPV)..................... 7535
(38) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).......... 7509
(39) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)......... 7508
(40) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)......... 7519
(41) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)........... 7518
(42) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2).. 7385
(43) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 7532
4)............................................................
(44) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).................. 7517
(45) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)......... 7521
(46) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)..... 7524
* * * * *
(g) Cannabimimetic agents. Unless specifically exempted or unless
listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following substances, or
which contains their salts, isomers, and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation:
(1) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 7297
phenol (CP-47,497)........................................
(2) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 7298
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)......
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)..... 7118
(4) 1-butyl-3-(1-naphthoyl)indole (JWH-073)................ 7173
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH-019)................ 7019
(6) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 7200
200)......................................................
(7) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)..... 6250
(8) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).... 7081
(9) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)...... 7122
(10) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)..... 7398
(11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201)..... 7201
(12) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).... 7694
[[Page 666]]
(13) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS- 7104
4)........................................................
(14) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 7008
(SR-18 and RCS-8).........................................
(15) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)..... 7203
(h) * * *
(1) 3,4-methylenedioxy-N-methylcathinone (Other names: 7540
methylone)................................................
* * * * *
Dated: December 21, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-31698 Filed 1-3-13; 8:45 am]
BILLING CODE 4410-09-P
