[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Proposed Rules]
[Pages 1776-1780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00217]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-385]
Schedules of Controlled Substances: Temporary Placement of Four
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of Intent.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this notice of intent to temporarily
schedule four synthetic cannabinoids into Schedule I pursuant to the
temporary scheduling provisions of the Controlled Substances Act (CSA).
The substances are: quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-
22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate
(5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-
3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-
PINACA). This action is based on a finding by the Deputy Administrator
that the placement of these synthetic cannabinoids into Schedule I of
the CSA is necessary to avoid an imminent hazard to the public safety.
Any final order will impose the administrative, civil, and criminal
sanctions and regulatory controls applicable to Schedule I substances
under the CSA on the manufacture, distribution, possession,
importation, exportation, research, and conduct of instructional
activities of these synthetic cannabinoids.
DATES: January 10, 2014.
FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Acting Chief, Policy
Evaluation and Analysis Section, Office of Diversion Control, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone (202) 598-6812.
SUPPLEMENTARY INFORMATION: Any final order will be published in the
Federal Register and may not be effective prior to February 10, 2014.
Background
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a substance into
Schedule I of the CSA for two years without regard to the requirements
of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid
imminent hazard to the public safety. 21 U.S.C. 811(h). In addition, if
proceedings to control a substance are initiated under 21 U.S.C.
811(a)(1), the Attorney General may extend the temporary scheduling for
up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1); 21 CFR part 1308. The Attorney General has delegated his
authority under 21 U.S.C. 811 to the Administrator of the DEA, who in
turn has delegated her authority to the Deputy Administrator of the
DEA. 28 CFR 0.100, 0.104, Appendix to Subpart R of Part 0, Sec. 12.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Deputy Administrator to notify the Secretary of the Department of
Health and Human Services (HHS) of his intention to temporarily place a
substance into Schedule I of the CSA.\1\ As PB-22, 5F-
[[Page 1777]]
PB-22, AB-FUBINACA, and ADB-PINACA are not currently listed in any
schedule under the CSA, the DEA believes that the conditions of 21
U.S.C. 811(h)(1) have been satisfied. Any comments submitted by the
Assistant Secretary in response to the notice transmitted to the
Assistant Secretary on November 7, 2013, shall be taken into
consideration before a final order is published. 21 U.S.C. 811(h)(4).
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\1\ Because the Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the authority to make
domestic drug scheduling recommendations, for purposes of this
Notice of Intent, all subsequent references to ``Secretary'' have
been replaced with ``Assistant Secretary.'' As set forth in a
memorandum of understanding entered into by HHS, the Food and Drug
Administration (FDA), and the National Institute on Drug Abuse
(NIDA), FDA acts as the lead agency within HHS in carrying out the
Assistant Secretary's scheduling responsibilities under the CSA,
with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
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To make a finding that placing a substance temporarily into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety, the Deputy Administrator is required to consider three
of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C.
811(c): the substance's history and current pattern of abuse; the
scope, duration and significance of abuse; and what, if any, risk there
is to the public health. 21 U.S.C. 811(h)(3). Consideration of these
factors includes actual abuse, diversion from legitimate channels, and
clandestine importation, manufacture, or distribution. 21 U.S.C.
811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling may only be placed in Schedule I. 21 U.S.C. 811(h)(1).
Substances in Schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1). Available data and information for
PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA indicate that these four
synthetic cannabinoids have a high potential for abuse, no currently
accepted medical use in treatment in the United States, and a lack of
accepted safety for use under medical supervision.
Synthetic Cannabinoids
Synthetic cannabinoids are a large family of compounds that are
functionally (biologically) similar to delta9-tetrahydrocannabinol
(THC), the main active ingredient in marijuana. Synthetic cannabinoids,
however, are not organic but are chemicals created in a laboratory. Two
of the synthetic cannabinoids currently controlled (CP-47,497 and
cannabicyclohexanol) were first synthesized in the early 1980's for
research purposes in the investigation of the cannabinoid system. JWH-
018, JWH-073, and JWH-200 (temporarily scheduled on March 1, 2011 at 76
FR 11075 and permanently scheduled on July 9, 2012, by Section 1152 of
the Food and Drug Administration Safety and Innovation Act (FDASIA),
Pub. L. 112-144) were synthesized in the mid-1990s and studied to
further advance the understanding of drug-receptor interactions
regarding the cannabinoid system. Synthesized as research tools, no
other known legitimate uses have been identified for these five
synthetic cannabinoids.
According to forensic laboratory reports, the initial appearance of
synthetic cannabinoids in herbal incense products in the United States
occurred in November 2008 when U.S. Customs and Border Protection (CBP)
first encountered products using brand names such as ``Spice.'' Prior
to appearing on the U.S. market, synthetic cannabinoids were marketed
in herbal incense products in several European countries. After
experiencing numerous health-related incidents, some European countries
banned these products/chemicals. According to CBP, a number of the
synthetic cannabinoids appeared to originate from foreign sources.
Detailed chemical analyses by DEA and other agencies have found
synthetic cannabinoids applied on plant material in herbal incense
products marketed to the general public. Product analyses have found
variations in both the type of synthetic cannabinoid and the amount of
the substance found on the plant material.
The vast majority of cannabinoids are manufactured in Asia by
individuals who are not bound by any manufacturing requirements or
quality control standards. The bulk products are smuggled into the
United States typically as misbranded imports. These chemicals are
generally found in powder form or are dissolved in solvents, such as
acetone, before being applied to the plant material comprising the
``herbal incense'' products. After local distributors apply the drug to
the leafy material, they package it for retail distribution, ignoring
any control mechanisms to prevent contamination or to ensure a
consistent, uniform concentration of drug in each package. According to
Internet discussion boards and law enforcement encounters, spraying or
mixing the synthetic cannabinoids on plant material provides a vehicle
for the most common route of administration- smoking (using a pipe, a
water pipe, or rolling the drug-spiked plant material in cigarette
papers). They are sold under hundreds of different brand names,
including ``Spice,'' ``K2,'' ``Blaze,'' ``Red X Dawn,'' ``Paradise,''
``Demon,'' ``Black Magic,'' ``Spike,'' ``Mr. Nice Guy,'' ``Ninja,''
``Zohai,'' ``Dream,'' ``Genie,'' ``Sence,'' ``Smoke,'' ``Skunk,''
``Serenity,'' ``Yucatan,'' ``Fire,'' and ``Crazy Clown.''
Law enforcement personnel have encountered dosage form and
packaging operations in residential neighborhoods, garages, and
warehouses. Throughout this process, there is no concern for preventing
contamination of the product, consistent dosage, or the adverse health
consequences that may occur from ingesting the drug. As proposed in the
scientific literature, the risk of adverse health effects is further
increased by the fact that similarly labeled products vary in the
composition and concentration of synthetic cannabinoids applied on the
plant material.
There is an incorrect assumption that these products are safe.
Numerous states, local jurisdictions, and the international community
have controlled many synthetic cannabinoids. These substances have no
accepted medical use in the United States and have been reported to
produce adverse health effects in those who abuse them.
PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA are synthetic
cannabinoids that have pharmacological effects similar to the Schedule
I hallucinogen delta-9-tetrahydrocannabinol (THC). PB-22 and 5F-PB-22
were not reported in the scientific literature prior to their
appearance on the illicit drug market. First appearing in a 2009 patent
filed by the pharmaceutical manufacturer Pfizer, AB-FUBINACA was most
recently reported in the scientific literature as a component of so-
called ``herbal products'' purchased via the Internet in July 2012.
ADB-PINACA was first encountered by law enforcement following reports
of serious adverse events in Georgia and Colorado in August and
September 2013, respectively.
From January through November 2013, according to the System to
Retrieve Information from Drug Evidence (STRIDE)\2\ there were 189
reports involving PB-22, 155 reports involving 5F-PB-22, and 42 reports
involving AB-FUBINACA (Queried on December 18, 2013). From January
through November 2013, the National Forensic Laboratory Information
System (NFLIS)\3\ registered 1,092 reports containing PB-22 in 29
states, 1,058 reports containing 5F-PB-22 in 25 states, 458 reports
containing AB-FUBINACA in 17 states and 9 reports containing ADB-PINACA
in one state
[[Page 1778]]
(Queried on December 18, 2013). No reports in NFLIS or STRIDE were
identified for PB-22 or 5F-PB-22 prior to February 2013. No reports in
NFLIS or STRIDE were identified for AB-FUBINACA prior to June 2013 or
for ADB-PINACA prior to August 2013.
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\2\ STRIDE is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from the
DEA, other federal agencies, and local law enforcement agencies.
\3\ NFLIS is a national drug forensic laboratory reporting
system that systematically collects results from drug chemistry
analyses conducted by state and local forensic laboratories across
the country.
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Factor 4. History and Current Pattern of Abuse
Synthetic cannabinoids have been developed over the last 30 years
as tools for investigating the cannabinoid system. Synthetic
cannabinoids intended for illicit use were first reported in the United
States in a November 2008 encounter, where a shipment of ``Spice'' was
seized and analyzed by CBP in Dayton, Ohio. Additionally around the
same time, in December 2008, JWH-018 and cannabicyclohexanol (CP-47,497
C8 homologue) were identified by German forensic laboratories. Since
the initial identification of JWH-018, many additional synthetic
cannabinoids have been found applied on plant material and encountered
as designer drug products. The majority of the substances encountered
on the illicit market have not been tested beyond preliminary pre-
clinical laboratory screens before clandestine operators apply them on
plant material.
JWH-018 was the first synthetic cannabinoid to be identified as a
product adulterant in Germany in 2008. This substance was initially
synthesized as a research tool to investigate the cannabinoid system.
Since then, numerous other synthetic cannabinoids have been identified
as product adulterants and law enforcement has seized bulk amounts of
these substances. The first synthetic cannabinoids identified as being
abused included JWH-018, JWH-200, JWH-073, CP-47,497 and CP-47,497 C8
homologue, followed shortly thereafter by new generations of synthetic
cannabinoids that included AM2201 and others, and eventually UR-144,
XLR11 and AKB48. JWH-018, JWH-073, JWH-200, CP-47,497, and CP-47,497 C8
were temporarily scheduled on March 1, 2011 (76 FR 11075), and later
permanently placed in Schedule I by Section 1152 of FDASIA on July 9,
2012. Section 1152 of FDASIA amended the CSA by placing cannabimimetic
agents and 26 specific substances (including 15 synthetic cannabinoids,
2 synthetic cathinones, and 9 synthetic phenethylamines of the 2C-
series) in Schedule I. UR-144, XLR11 and AKB-48 were temporarily
scheduled on May 16, 2013 (78 FR 28735). The most recent synthetic
cannabinoids emerging as drugs of abuse include PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA. These four synthetic cannabinoids, along with
UR-144, XLR11 and AKB-48, were not included among the 15 specific named
synthetic cannabinoids, and do not fall under the definition of
cannabimimetic agents, under FDASIA.
Synthetic cannabinoid products are marketed directly to adolescents
and youth who appear to be the primary abusers of synthetic
cannabinoids and synthetic cannabinoid-containing products. This is
supported by law enforcement encounters and reports from emergency
rooms; however, all age groups have been reported by media as abusing
these substances and related products.
According to recent testimony given by the Deputy Director of the
Office of National Drug Control Policy (ONDCP) to the United States
Senate Caucus on International Narcotics Control (September 25, 2013),
current drug testing misses significant populations of synthetic
cannabinoid users. This testimony describes a study showing that in a
sample of men 30 years old or younger within the District of Columbia
parole and probation system, 39 percent of those who cleanly passed a
traditional drug screen tested positive for synthetic cannabinoids. The
study continued that between one-quarter and one-third of young men who
were tested in the Washington, DC criminal justice system had positive
test results for synthetic cannabinoids, regardless of whether they had
failed or passed a traditional drug screen.
Factor 5. Scope, Duration and Significance of Abuse
Recently, increased exposure incidents have been documented by
poison control centers in the United States as the abuse of synthetic
cannabinoids has been associated with both acute and long-term public
health and safety concerns. From January through November 2013,
according to STRIDE there were 189 reports involving PB-22; 155 reports
involving 5F-PB-22; and 42 reports involving AB-FUBINACA (Queried on
December 18, 2013). From January through November 2013, NFLIS
registered 1,092 reports containing PB-22 in 29 states (Arkansas,
Arizona, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Kansas,
Kentucky, Louisiana, Maryland, Minnesota, Missouri, North Dakota,
Nebraska, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma,
Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Wisconsin
and Wyoming); 1,058 reports containing 5F-PB-22 in 25 states (Arkansas,
Arizona, Colorado, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana,
Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Nevada,
Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah,
Virginia, Wisconsin and Wyoming); 458 reports containing AB-FUBINACA in
17 states (Arizona, Colorado, Florida, Georgia, Iowa, Indiana, Kansas,
Louisiana, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio,
Oklahoma, Pennsylvania and Texas); and 9 reports containing ADB-PINACA
in one state (Colorado) (Queried on December 18, 2013). No reports in
NFLIS or STRIDE were identified for PB-22 or 5F-PB-22 prior to February
2013. No reports in NFLIS or STRIDE were identified for AB-FUBINACA
prior to June 2013 or for ADB-PINACA prior to August 2013.
ADB-PINACA was first encountered in the United States following
reports of serious adverse events in Georgia on August 23, 2013.
Reports of ADB-PINACA were not found in the scientific literature prior
to its emergence on the designer drug market. The Georgia Bureau of
Investigation (GBI) reported on September 12, 2013 that ADB-PINACA was
detected in ``herbal incense'' products sold under the brand name
``Crazy Clown.'' It was later confirmed by the Centers for Disease
Control and Prevention (CDC) as the substance responsible for severe
adverse events in at least 22 persons who consumed the product. In
addition, on August 30, 2013, the Colorado Department of Public Health
and Environment (CDPHE) was notified by several hospitals of an
increase in the number of patients visiting their emergency departments
(EDs) with altered mental status after using synthetic marijuana. On
September 8, 2013, CDPHE, with the assistance of CDC, began an
epidemiologic investigation whereby 221 cases of severe illness due to
ingestion of a synthetic cannabinoid were identified. Those that
presented at emergency rooms in the Denver, Colorado area around
September 1, 2013, had symptoms similar to those found in the August
2013 Georgia incident. Laboratory analysis of samples from the Colorado
incident confirmed that the substance abused in the ``herbal incense''
products was ADB-PINACA.
The American Association of Poison Control Centers (AAPCC) reported
receiving over 2,436 calls from January to November 2013, regarding
exposures to products purportedly containing synthetic cannabinoids,
although the data provided does not generally include biological sample
testing that would confirm to which cannabinoids the user was exposed.
A majority of
[[Page 1779]]
these exposure incidents resulted in individuals seeking medical
attention at health care facilities.
Factor 6. What, if Any, Risk There is to the Public Health
The earliest reported encounter of PB-22 was by Finnish Customs
(Tulli) in Helsinki who intercepted a consignment of 54 kilograms en
route from China to Russia on October 27, 2012. From January through
November 2013, CBP shared information related to synthetic cannabinoid
shipments encountered at United States Ports of Entry and intended for
destinations within the United States: PB-22--25 encounters involving
69.6 kg; 5F-PB-22--23 encounters involving 32.9 kg; and AB-FUBINACA--9
encounters involving 16.1 kg. The DEA has reported multiple encounters
of large quantities of PB-22, 5F-PB-22 and/or AB-FUBINACA that have
been confirmed by forensic laboratories (STRIDE).
In late August 2013, local law enforcement in Brunswick, Georgia
reported that 22 persons ranging in age from 16 to 57 presented to
emergency departments with severe adverse reactions after consuming a
synthetic product called ``Crazy Clown.'' Adverse effects included the
inability to stand, foaming at the mouth, violence towards police and
paramedics and memory lapse. The substance responsible for these
effects was later identified by the GBI as ADB-PINACA. In early
September 2013, 221 patients presented to emergency departments in
Colorado after having adverse reactions to a synthetic product labeled
as ``Black Mamba.'' Adverse effects included having no gag reflex,
inability to breathe on their own, hallucinations and psychotic
episodes as described by nurses and attending physicians. The substance
in the product consumed was identified as ADB-PINACA. In addition to
the incidents in Georgia and Colorado, ADB-PINACA was also identified
in exhibits of plant material labeled ``10X'' and ``20X'' submitted to
a laboratory in Illinois on October 7, 2013.
Health warnings have been issued by numerous state public health
departments and poison control centers describing adverse health
effects associated with smoking (inhaling) synthetic cannabinoid
products including, agitation, vomiting, tachycardia, elevated blood
pressure, seizures, hallucinations, and non-responsiveness.
Medical examiner and postmortem toxicology reports demonstrate the
involvement of 5F-PB-22 in the death of at least five individuals.
These reports demonstrated that 5F-PB-22 was qualitatively identified
in the blood and/or urine of all five of the deceased individuals. In
addition, 5F-PB-22 intoxication was the sole cause of death in one
case, while a second case stated that the cause of death was a fatal
cardiac arrhythmia and/or fatal seizure in association with the use of
5F-PB-22.
Since abusers obtain these drugs through unknown sources, the
identity, purity, and quantity of these substances is uncertain and
inconsistent, thus posing significant adverse health risks to users.
There are no recognized therapeutic uses of these substances in the
United States.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
Based on the above summarized data and information, the continued
uncontrolled manufacture, distribution, importation, exportation, and
abuse of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA pose an imminent
hazard to the public safety. The DEA is not aware of any currently
accepted medical uses for these synthetic cannabinoids in the United
States. A substance meeting the statutory requirements for temporary
scheduling, 21 U.S.C. 811(h)(1), may only be placed in Schedule I.
Substances in Schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. Available data and information for PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA indicate that these four synthetic
cannabinoids have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and a lack of accepted
safety for use under medical supervision. As required by section
201(h)(4) of the CSA, 21 U.S.C. 811(h), the Deputy Administrator,
through a letter dated November 7, 2013, notified the Assistant
Secretary of the DEA's intention to temporarily place these four
synthetic cannabinoids in Schedule I.
Conclusion
This notice of intent initiates an expedited temporary scheduling
action and provides the 30-day notice pursuant to section 201(h) of the
CSA, 21 U.S.C. 811(h). In accordance with the provisions of section
201(h) of the CSA, 21 U.S.C. 811(h), the Deputy Administrator
considered available data and information, herein set forth the grounds
for his determination that it is necessary to temporarily schedule four
synthetic cannabinoids, quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate
(PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-
carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-
2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA); and
N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide (ADB-PINACA), in Schedule I of the CSA, and finds that
placement of these synthetic cannabinoids into Schedule I of the CSA is
warranted in order to avoid an imminent hazard to the public safety.
Because the Deputy Administrator hereby finds that it is necessary
to temporarily place these synthetic cannabinoids into Schedule I to
avoid an imminent hazard to the public safety, any subsequent final
order temporarily scheduling these substances will be effective on the
date of publication in the Federal Register, and will be in effect for
a period of two years, with a possible extension of one additional
year, pending completion of the regular (permanent) scheduling process.
21 U.S.C. 811(h)(1) and (2). It is the intention of the Deputy
Administrator to issue such a final order as soon as possible after the
expiration of 30 days from the date of publication of this notice. PB-
22, 5F-PB-22, AB-FUBINACA and ADB-PINACA will then be subject to the
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, possession, importation,
exportation, research, and conduct of instructional activities of a
Schedule I controlled substance.
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety.
[[Page 1780]]
As provided in this subsection, the Attorney General may, by order,
schedule a substance in Schedule I on a temporary basis. Such an order
may not be issued before the expiration of 30 days from (1) the
publication of a notice in the Federal Register of the intention to
issue such order and the grounds upon which such order is to be issued,
and (2) the date that notice of the proposed temporary scheduling order
is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of section 553 of the Administrative Procedure
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the
alternative, even assuming that this notice of intent might be subject
to section 553 of the APA, the Deputy 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 issuance of temporary
scheduling orders would be impracticable and contrary to the public
interest in view of the manifest urgency to avoid an imminent hazard to
the public safety.
Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Deputy Administrator will take
into consideration any comments submitted by the Assistant Secretary
with regard to the proposed temporary scheduling order.
Further, the DEA believes that this temporary scheduling action is
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, the DEA is not required by section 553 of the APA or any other
law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
Under the authority vested in the Attorney General by section
201(h) of the CSA, 21 U.S.C. 811(h), and delegated to the Deputy
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100, Appendix to Subpart R of Part 0), the Deputy Administrator
hereby proposes that 21 CFR part 1308 be 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. Section 1308.11 is amended by adding paragraphs (h)(15) through (18)
to read as follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
(15) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate, its optical,
positional, and geometric isomers, salts and salts of isomers--7222
(Other names: PB-22; QUPIC)
(16) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate, its
optical, positional, and geometric isomers, salts and salts of
isomers--7225 (Other names: 5-fluoro-PB-22; 5F-PB-22)
(17) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide, its optical, positional, and geometric isomers,
salts and salts of isomers--7012 (Other names: AB-FUBINACA)
(18) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-
3-carboxamide, its optical, positional, and geometric isomers, salts
and salts of isomers--7035 (Other names: ADB-PINACA)
Dated: January 6, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-00217 Filed 1-9-14; 8:45 am]
BILLING CODE 4410-09-P