Schedules of Controlled Substances: Temporary Placement of Four Synthetic Cannabinoids Into Schedule I, 1776-1780 [2014-00217]

Download as PDF 1776 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules Austro Engine GmbH Engines: Docket No. FAA–2013–0164; Directorate Identifier 2013–NE–10–AD. (a) Comments Due Date The FAA must receive comments on this AD action by March 11, 2014. (b) Affected ADs This AD supersedes AD 2013–14–08, Amendment 39–17513 (78 FR 42677, July 17, 2013). (c) Applicability This AD applies to all Austro Engine GmbH model E4 engines, with a waste gate controller, part number (P/N) E4A–41–120– 000, Revision 060, or lower revision; or a waste gate controller, P/N E4B–41–120–000, Revision 010, or lower revision, installed. (d) Unsafe Condition This AD was prompted by engine power loss events due to fracture of the waste gate controller lever. We are issuing this AD to prevent failure of the waste gate controller lever, which could lead to damage to one or more engines, loss of thrust control, and damage to the airplane. (e) Compliance (1) Comply with this AD within the compliance times specified, unless already done. (2) At the next maintenance action for any reason, or within 110 flight hours after the effective date of this AD, or within three months after the effective date of this AD, whichever occurs first, remove from service waste gate controller, P/N E4A–41–120–000, Revision 060, or lower revision, and waste gate controller, P/N E4B–41–120–000, Revision 010 or lower revision. (f) Installation Prohibition After the effective date of this AD, do not install any waste gate controller, P/N E4A– 41–120–000, Revision 060, or lower revision, or waste gate controller, P/N E4B–41–120– 000, Revision 010, or lower revision, onto any engine, nor approve for return to service any engine that has either waste gate controller installed. mstockstill on DSK4VPTVN1PROD with PROPOSALS (g) Alternative Methods of Compliance (AMOCs) The Manager, Engine Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. (h) Related Information (1) For more information about this AD, contact Frederick Zink, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7779; fax: 781–238–7199; email: frederick.zink@faa.gov. (2) Refer to MCAI European Aviation Safety Agency AD 2013–0213, dated September 13, 2013, for more information. You may examine the MCAI on the Internet at https://www.regulations.gov/ #!documentDetail;D=FAA-2013-0164-0002. (3) Austro Engine Mandatory Service Bulletin No. MSB–E4–007/6, Revision 6, VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 dated September 18, 2013, which is not incorporated by reference in this AD, can be obtained from Austro Engine GmbH, using the contact information in paragraph (h)(4) of this AD. (4) For service information identified in this AD, contact Austro Engine GmbH, Rudolf-Diesel-Strasse 11, A–2700 Weiner Neustadt, Austria; phone: +43 2622 23000; fax: +43 2622 23000–2711; Internet: www.austroengine.at. (5) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125. Issued in Burlington, Massachusetts, on December 31, 2013. Colleen M. D’Alessandro, Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft Certification Service. [FR Doc. 2014–00169 Filed 1–9–14; 8:45 am] BILLING CODE 4910–13–P 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 Drug Enforcement Administration, Department of Justice. ACTION: Notice of Intent. AGENCY: 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 1pentyl-1H-indole-3-carboxylate (PB–22; QUPIC); quinolin-8-yl 1-(5fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB–22; 5F–PB–22); N-(1amino-3-methyl-1-oxobutan-2-yl)-1-(4fluorobenzyl)-1H-indazole-3carboxamide (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, SUMMARY: PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 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– 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. E:\FR\FM\10JAP1.SGM 10JAP1 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS 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). 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- VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 1777 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-9tetrahydrocannabinol (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 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. E:\FR\FM\10JAP1.SGM 10JAP1 1778 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS (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. 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 preclinical 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– VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 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, PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 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 E:\FR\FM\10JAP1.SGM 10JAP1 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 nonresponsiveness. Medical examiner and postmortem toxicology reports demonstrate the involvement of 5F–PB–22 in the death of at least five individuals. These VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 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- PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 1779 pentyl-1H-indole-3-carboxylate (PB–22; QUPIC); quinolin-8-yl 1-(5fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB–22; 5F–PB–22); N-(1amino-3-methyl-1-oxobutan-2-yl)-1-(4fluorobenzyl)-1H-indazole-3carboxamide (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. E:\FR\FM\10JAP1.SGM 10JAP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS 1780 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules 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 VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 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. DEPARTMENT OF HOMELAND SECURITY List of Subjects in 21 CFR Part 1308 [Docket No. USCG–2013–1057] Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. RIN 1625–AB99 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 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. Section 1308.11 is amended by adding paragraphs (h)(15) through (18) to read as follows: ■ § 1308.11 Schedule I * * * * * (h) * * * (15) quinolin-8-yl 1-pentyl-1H-indole3-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-oxobutan2-yl)-1-(4-fluorobenzyl)-1H-indazole-3carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers—7012 (Other names: AB– FUBINACA) (18) N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-pentyl-1H-indazole-3carboxamide, 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 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 Coast Guard 33 CFR Parts 140 and 146 46 CFR Parts 4 and 109 Marine Casualty Reporting on the Outer Continental Shelf Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: ACTION: The Coast Guard proposes broadening the regulatory requirements for reporting marine casualties that occur on the U.S. Outer Continental Shelf (OCS). The limited reporting requirements currently applicable to foreign-flag OCS units in those waters would be replaced with the broader requirements currently applicable to U.S.-flag OCS units and to marine casualties occurring elsewhere in U.S. waters. The proposed changes would improve the Coast Guard’s ability to collect and analyze casualty data for incidents on the OCS, in the interest of maintaining and improving safety on the OCS. This proposed rule would support the Coast Guard’s maritime safety and stewardship missions. DATES: Comments and related material must either be submitted to our online docket via https://www.regulations.gov on or before April 10, 2014 or reach the Docket Management Facility by that date. Comments sent to the Office of Management and Budget (OMB) on collection of information must reach OMB on or before April 10, 2014. ADDRESSES: You may submit comments identified by docket number USCG– 2013–1057 using any one of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov. (2) Fax: 202–493–2251. (3) Mail: Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590– 0001. (4) Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366–9329. To avoid duplication, please use only one of these four methods. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section SUMMARY: E:\FR\FM\10JAP1.SGM 10JAP1

Agencies

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Proposed Rules]
[Pages 1776-1780]
From the Federal Register Online via the Government Printing 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).
---------------------------------------------------------------------------

    \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

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