Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cannabinoids Into Schedule I, 28735-28739 [2013-11593]

Download as PDF Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations § 880.6305 Ingestible event marker. (a) Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions. [FR Doc. 2013–11628 Filed 5–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–373] Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cannabinoids Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule three synthetic cannabinoids under the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are (1pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone (5- erowe on DSK2VPTVN1PROD with RULES VerDate Mar<15>2010 17:26 May 15, 2013 Jkt 229001 Effective Date: This Final Order is effective on May 16, 2013. DATES: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; telephone (202) 307–7165. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background Dated: May 10, 2013. Leslie Kux, Assistant Commissioner for Policy. SUMMARY: fluoro-UR-144, XLR11) and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (APINACA, AKB48). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cannabinoids and their salts, isomers and salts of isomers into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the full effect of the CSA and the Controlled Substances Import and Export Act (CSIEA) and their implementing regulations including criminal, civil and administrative penalties, sanctions and regulatory controls of Schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic cannabinoids. 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 up to one year. 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 under section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355) for the substance (21 U.S.C. 811 (h)(1)). The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of DEA, who in turn has delegated her authority to the Deputy Administrator of DEA. 28 CFR 0.100, Appendix to Subpart R. 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 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 28735 Schedule I of the CSA.1 The Deputy Administrator has transmitted notice of his intent to place UR-144, XLR11 and AKB48 in Schedule I on a temporary basis to the Assistant Secretary by letter dated February 14, 2013. The Assistant Secretary responded to this notice by letter dated March 14, 2013 (received by DEA on March 21, 2013), and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for UR-144, XLR11 or AKB48. The Assistant Secretary also stated that HHS has no objection to the temporary placement of UR-144, XLR11 or AKB48 into Schedule I of the CSA. DEA has taken into consideration the Assistant Secretary’s comments (21 U.S.C. 811(h)(4)). As UR-144, XLR11 and AKB48 are not currently listed in any schedule under the CSA, and as no exemptions or approvals are in effect for UR-144, XLR11 and AKB48 under Section 505 of the FD&C Act (21 U.S.C. 355), DEA believes that the conditions of 21 U.S.C. 811(h)(1) have been satisfied. On April 12, 2013, a Notice of Intent to temporarily schedule these three synthetic cannabinoids was published in the Federal Register (78 FR 21858). 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(h)(3)). These factors are as follows: 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(c)(4)–(6). 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 (21 U.S.C. 811(h)) may only be placed in Schedule I. Substances in Schedule I are those that have a high potential for 1 Because the Secretary of the Department of Health and Human Services (HHS) has delegated to the Assistant Secretary for Health of the Department of Health and Human Services the authority to make domestic drug scheduling recommendations, for purposes of this Final Order, 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 Secretary’s scheduling responsibilities under the Controlled Substance Act (CSA), with the concurrence of NIDA. 50 FR 9518. E:\FR\FM\16MYR1.SGM 16MYR1 28736 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations abuse, no currently accepted medical use in treatment in the United States (U.S.), and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for UR-144, XLR11 and AKB48 indicate that these three synthetic cannabinoids have a high potential for abuse, no currently accepted medical use in treatment in the U.S., and a lack of accepted safety for use under medical supervision. erowe on DSK2VPTVN1PROD with RULES Synthetic Cannabinoids While synthetic cannabinoids have been developed over the last 30 years for research purposes to investigate the cannabinoid system, no scientific literature referring to UR-144, XLR11 or AKB48 was available prior to these drugs’ identification in the illicit market. In addition, no legitimate nonresearch uses have been identified for these synthetic cannabinoids nor have they been approved by FDA for human consumption. Synthetic cannabinoids, of which (1-pentyl-1H-indol-3yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone (5fluoro-UR-144, XLR11), and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (APINACA, AKB48) are representative, are so-termed for their D9-tetrahydrocannabinol (THC)-like pharmacological properties. Numerous herbal products have been analyzed, and UR-144, XLR11 and AKB48 have been identified, in varying mixture profiles and amounts, spiked on plant material. As of April 3, 2013, according to the System to Retrieve Information from Drug Evidence (STRIDE) data, there are 1,510 reports involving 179 total cases for UR-144, 1,194 reports involving 186 total cases for XLR11 and 112 reports involving 40 total cases for AKB48. From January 2010 to March 2013, the National Forensic Laboratory Information System (NFLIS) registered 14,831 reports containing these synthetic cannabinoids (UR-144—5,465 reports; XLR11—8,837 reports; AKB48—529 reports) from at least 32 states. No instances regarding UR-144, XLR11 or AKB48 were reported in NFLIS prior to March of 2010. For the period January 2010 through March 2013, NFLIS and STRIDE reports 2 for 2 National Forensic Laboratory Information System (NFLIS) is a program sponsored by the Drug Enforcement Administration’s (DEA), Office of Diversion Control which compiles information on exhibits analyzed in State and local law enforcement forensic laboratories. System to Retrieve Information from Drug Evidence (STRIDE) VerDate Mar<15>2010 14:43 May 15, 2013 Jkt 229001 the three synthetic cannabinoids UR144, XLR11 and AKB48 (16,014 total reports) exceeded the number of reports for the five synthetic cannabinoids JWH–018, JWH–073, JWH–200, CP– 47,497 and CP–47,497 C8 (7,555 total reports). JWH–018, JWH–200, JWH–073, CP–47,497 and CP–47,497 C8 homologue were temporarily scheduled on March 1, 2011, and later placed in Schedule I by Section 1152 of Food and Drug Administration Safety and Innovation Act (FDASIA), Pub. L. 112– 144, on July 9, 2012. Section 1152 of the FDASIA 3 amended the CSA by placing cannabimimetic agents and 26 specific substances (including 15 synthetic cannabinoids, 2 synthetic cathinones, and 9 phenethylamines of the 2C-series) in Schedule I. UR-144, XLR11 and AKB48 were not included among the 15 specific named synthetic cannabinoids, and do not fall under the definition of cannabimimetic agents, under FDASIA. Factor 4. History and Current Pattern of Abuse Synthetic cannabinoids (JWH–018) laced on plant material were first reported in the U.S. in December 2008, when a shipment of ‘‘Spice’’ was seized and analyzed by U.S. Customs and Border Patrol in Dayton, Ohio. Also in December 2008, JWH–018 and cannabicyclohexanol were identified by German forensic laboratories. Since the initial identification of JWH–018 (December 2008), many additional synthetic cannabinoids with purported psychotropic effects have been found laced on plant material or related products. The popularity of these synthetic cannabinoids and their associated products appears to have increased since January 2010 in the U.S. based on seizure exhibits and media reports. This trend appears to mirror that experienced in Europe since 2008. Synthetic cannabinoids are being encountered in several regions of the U.S. with the substances primarily found as adulterants on plant material products as self-reported on internet discussion boards. Since then, numerous other synthetic cannabinoids including UR-144, XLR11 and AKB48 have been identified as product adulterants. Data gathered from published studies, supplemented by discussions on Internet Web sites and personal communications with toxicological is a DEA database which compiles information on exhibits analyzed in DEA laboratories. 3 Subtitle D of Title XI of the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes Sections 1151–1153 of Pub. L. 112–144, is also known as the ‘‘Synthetic Drug Abuse Prevention Act of 2012,’’ or ‘‘SDAPA.’’ PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 testing laboratories, demonstrate that products laced with UR-144, XLR11 and/or AKB48 are being abused mainly by smoking for their psychoactive properties. The adulterated products are marketed as ‘legal’ alternatives to marijuana. This characterization, along with their reputation as potent herbal intoxicants, has increased their popularity. Several synthetic cannabinoids, including UR-144, XLR11 and AKB48, have been shown to display higher potency in scientific studies when compared to THC. Smoking mixtures of these substances for the purpose of achieving intoxication has been identified as a reason for numerous emergency room visits and calls to poison control centers. Abuse of these synthetic cannabinoids and their products has been characterized with both acute and long term public health and safety issues. In addition, numerous states, local jurisdictions, and the international community have controlled these substances. Factor 5. Scope, Duration and Significance of Abuse According to forensic laboratory reports, the first appearance of synthetic cannabinoids in the U.S. occurred in December 2008, when U.S. Customs and Border Protection analyzed ‘‘Spice’’ products. NFLIS has reported 14,831 exhibits (January 2010 to March 2013) related to UR-144, XLR11 and AKB48 from various states including Alaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Indiana, Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, New Mexico, North Dakota, Nebraska, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming. STRIDE has reported 2,816 records involving UR-144, XLR11 and/or AKB48 from January 2010 through April 3, 2013. From January 1 through December 31, 2012, the American Association of Poison Control Centers 4 has reported receiving in excess of 5,200 calls relating to products purportedly laced with synthetic cannabinoids. Although the center does not identify specific cannabinoid substances, the data does indicate the magnitude of adverse exposure to synthetic cannabinoids. Factor 6. What, If Any, Risk There Is to the Public Health UR-144, XLR11 and AKB48 are pharmacologically similar to Schedule I 4 American Association of Poison Control Centers (AAPCC) is a non-profit, national organization that represents the poison centers of the United States. E:\FR\FM\16MYR1.SGM 16MYR1 erowe on DSK2VPTVN1PROD with RULES Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations substances THC and JWH–018, as well as other synthetic cannabinoids. By sharing pharmacological similarities with the Schedule I substances (THC and JWH–018), synthetic cannabinoids pose a risk to the abuser. In addition, the chronic abuse of products laced with synthetic cannabinoids has also been linked to addiction and withdrawal. Law enforcement, military and public health officials have reported exposure incidents that demonstrate the dangers associated with abuse of synthetic cannabinoids to both the individual abusers and other affected individuals since these substances were never intended for human use. Warnings regarding the dangers associated with abuse of synthetic cannabinoids and their products have been issued by numerous state public health departments, poison control centers and private organizations. In a 2012 report, the Substance Abuse and Mental Health Services Administration (SAMHSA) reported 11,406 emergency department visits involving a synthetic cannabinoid product during 2010. In a 2013 report, SAMHSA reported the number of emergency department visits in 2011 involving a synthetic cannabinoid product had increased 2.5 times to 28,531. Detailed product analyses have detected variations in the amount and type of synthetic cannabinoid laced on plant material even within samplings of the same product. Since abusers obtain these drugs through unknown sources, purity of these drugs is uncertain, thus posing significant adverse health risk to these users. Submissions to DEA laboratories from January 2012 through February 11, 2013, have documented over 142 distinct packaging examples containing a mixture of UR-144, XLR11 and/or AKB48. These unknown factors present a significant risk of danger to the abuser. Some of the adverse health effects reported in response to the abuse of synthetic cannabinoids include vomiting, anxiety, agitation, irritability, seizures, hallucinations, tachycardia, elevated blood pressure, and loss of consciousness. As mentioned above, there are reported instances of emergency department admissions in association with the abuse of these THClike substances. There are no recognized therapeutic uses of these substances in the U.S. In February 2013, the Centers for Disease Control and Prevention published a report by Murphy et al. describing unexplained cases of acute kidney injury in 16 patients, all of whom had reported recent smoking of synthetic cannabinoids. Upon further investigation, it was determined that of VerDate Mar<15>2010 14:43 May 15, 2013 Jkt 229001 the 16 patients, 7 of the subjects had smoked substances that were positive for XLR11 or its metabolite. Cases were reported from Wyoming (4 cases), Rhode Island (1 case), New York (2 cases), Oregon (6 cases), Kansas (1 case) and Oklahoma (2 cases). Finding of Necessity of Schedule I Scheduling To Avoid Imminent Hazard to Public Safety Based on the available data and information, the continued uncontrolled manufacture, distribution, importation, exportation and abuse of UR-144, XLR11 and AKB48 pose an imminent hazard to the public safety. DEA is not aware of any currently accepted medical uses for these synthetic cannabinoids in the U.S. A substance meeting the statutory requirements for temporary scheduling (21 U.S.C. 811(h)) 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 U.S., and a lack of accepted safety for use under medical supervision. Available data and information for UR144, XLR11 and AKB48 indicate that these three synthetic cannabinoids have a high potential for abuse, no currently accepted medical use in treatment in the U.S., and a lack of accepted safety for use under medical supervision. Conclusion In accordance with the provisions of section 201(h) of the CSA (21 U.S.C. 811(h)), the Deputy Administrator has considered available data and information and has set forth herein the grounds for his determination that it is necessary to temporarily schedule three synthetic cannabinoids, (1-pentyl-1Hindol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (APINACA, AKB48) 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, the 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 up to three years pending PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 28737 completion of the permanent or regular scheduling process. 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. The CSA sets forth specific criteria for scheduling a drug or other substance. While temporary scheduling orders are not subject to judicial review (21 U.S.C. 811(h)(6)), 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 permanent scheduling determination. Final decisions which conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Regulatory Requirements With the issuance of this final order, UR-144, XLR11 and AKB48 become subject to the regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, possession, importation and exportation of a Schedule I controlled substance under the CSA and the CSIEA. 1. Registration. Any person who manufactures, distributes, imports, exports, or possesses UR-144, XLR11 or AKB48, or who engages in research or conducts instructional activities with respect to UR-144, XLR11 or AKB48, or who proposes to engage in such activities, must be registered to conduct such activities in accordance with 21 U.S.C. 822 and 957. Any person who is currently engaged in any of the above activities and is not registered with DEA must submit an application for registration and may not continue their activities until DEA has approved that application. Retail sales of Schedule I controlled substances to the general public are not allowed under the CSA. Possession of any of these substances in a manner not authorized by the CSA on or after May 16, 2013 is unlawful and may subject those in possession of any of these substances to prosecution pursuant to the Controlled Substances Act. 2. Security. UR-144, XLR11 and AKB48 are subject to Schedule I security requirements. Accordingly, appropriately registered DEA registrants must manufacture, distribute and store these substances in accordance with 1301.71; 1301.72(a), (c) and (d); 1301.73; 1301.74; 1301.75(a) and (c); and 1301.76 of Title 21 of the Code of Federal Regulations as of May 16, 2013. E:\FR\FM\16MYR1.SGM 16MYR1 erowe on DSK2VPTVN1PROD with RULES 28738 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 3. Labeling and packaging. All labeling and packaging requirements for controlled substances set forth in Part 1302 of Title 21 of the Code of Federal Regulations shall apply to commercial containers of UR-144, XLR11 and AKB48. Current DEA registrants authorized to handle UR-144, XLR11 and AKB48 shall comply with Part 1302 of Title 21 of the Code of Federal Regulations within thirty (30) calendar days of May 16, 2013. 4. Quotas. Every manufacturer authorized to manufacture UR-144, XLR11 and AKB48 must apply for and be granted a quota to manufacture such substance(s) pursuant to Part 1303 of Title 21 of the Code of Federal Regulations. No authorized manufacturer may manufacture UR-144, XLR11 or AKB48 in excess of a quota assigned to him as of May 16, 2013. 5. Inventory. Every DEA registrant authorized to possess any quantity of UR-144, XLR11 or AKB48 is required to keep inventory of all stocks of these substances on hand pursuant to 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every authorized DEA registrant shall comply with all inventory requirements within thirty (30) calendar days of May 16, 2013. 6. Records. All registrants who are authorized to handle UR-144, XLR11 or AKB48 are required to keep records pursuant to 1304.03, 1304.04, 1304.21, 1304.22 and 1304.23 of Title 21 of the Code of Federal Regulations. Current DEA registrants authorized to handle UR-144, XLR11 or AKB48 shall comply with all recordkeeping requirements within thirty (30) calendar days of May 16, 2013. 7. Reports. All registrants are required to submit reports in accordance with 1304.33 of Title 21 of the Code of Federal Regulations. Registrants who manufacture or distribute UR-144, XLR11 or AKB48 are required to comply with these reporting requirements and shall do so as of May 16, 2013. 8. Order Forms. All registrants involved in the distribution of UR-144, XLR11 or AKB48 must comply with order form requirements of Part 1305 of Title 21 of the Code of Federal Regulations as of May 16, 2013. 9. Importation and Exportation. All importation and exportation of UR-144, XLR11 or AKB48 must be conducted by appropriately registered DEA registrants in compliance with Part 1312 of Title 21 of the Code of Federal Regulations on or after May 16, 2013. 10. Criminal Liability. The manufacture, distribution or possession with the intent to conduct these activities; as well as possession, VerDate Mar<15>2010 17:26 May 15, 2013 Jkt 229001 importation or exportation of UR-144, XLR11 or AKB48 not authorized by, or in violation of the CSA or the Controlled Substances Import and Export Act occurring as of May 16, 2013 is unlawful. 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. 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 a proposed temporary scheduling order is transmitted to the Secretary of HHS. 21 U.S.C. 811(h)(1). In as much 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, 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 final order. In the alternative, even assuming that this final order might be deemed to 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 of the temporary scheduling action to avoid an imminent hazard to the public safety. Further, DEA believes that this temporary scheduling action Final Order is not a ‘‘rule’’ as defined by 5 U.S.C. 601(2), and, accordingly, not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where (as here) the agency 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. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 This action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on 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. Pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801–808), DEA has submitted a copy of this Final Order to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. 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), the Deputy Administrator hereby orders 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 new paragraphs (h)(9), (10), and (11) to read as follows: ■ § 1308.11 Schedule I. * * * * * (h) * * * (9) (1-pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone, its optical, positional, and geometric isomers, salts and salts of isomers— 7144 (Other names: UR–144, 1-pentyl-3(2,2,3,3-tetramethylcyclopropoyl)indole) (10) [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone, its optical, positional, and geometric isomers, salts and salts of isomers— 7011 (Other names: 5-fluoro-UR-144, 5F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3(2,2,3,3-tetramethylcyclopropoyl)indole) (11) N-(1-adamantyl)-1-pentyl-1Hindazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers—7048 (Other names: APINACA, AKB48) E:\FR\FM\16MYR1.SGM 16MYR1 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations Dated: May 10, 2013. Thomas M. Harrigan, Deputy Administrator. [FR Doc. 2013–11593 Filed 5–15–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 5 [Docket No. TTB–2012–0001; T.D. TTB–113; Re: Notice No. 126] RIN 1513–AB91 Standards of Identity for Pisco and Cognac Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Final rule; Treasury decision. AGENCY: This final rule amends the Alcohol and Tobacco Tax and Trade Bureau regulations setting forth the standards of identity for distilled spirits to include Pisco as a type of brandy that must be manufactured in accordance with the laws and regulations of either Peru or Chile, as appropriate, governing the manufacture of those products. This final rule also removes ‘‘Pisco brandy’’ from the list of examples of geographical designations in the distilled spirits standards of identity, and it includes a technical correction to remove ‘‘Cognac’’ from the same list of examples. These changes provide greater clarity in distilled spirits labeling. SUMMARY: Effective Date: This final rule is effective July 15, 2013. FOR FURTHER INFORMATION CONTACT: Karen Welch, Alcohol and Tobacco Tax and Trade Bureau, Regulations and Rulings Division; telephone 202–453– 1039, ext. 046; email ITD@ttb.gov. SUPPLEMENTARY INFORMATION: DATES: Background erowe on DSK2VPTVN1PROD with RULES TTB Authority Section 105(e) of the Federal Alcohol Administration Act (FAA Act), codified in the United States Code at 27 U.S.C. 205(e), authorizes the Secretary of the Treasury (Secretary) to prescribe regulations relating to the packaging, marking, branding, labeling, and size and fill of containers of alcohol beverages that will prohibit consumer deception and provide the consumer with adequate information as to the identity and quality of the product. Section 105(e) of the FAA Act also generally requires bottlers and importers VerDate Mar<15>2010 14:43 May 15, 2013 Jkt 229001 of alcohol beverages to obtain certificates of label approval prior to bottling or importing alcohol beverages for sale in interstate commerce. Regulations implementing those provisions of section 105(e) as they relate to distilled spirits are set forth in part 5 of title 27 of the Code of Federal Regulations (27 CFR part 5). The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120–01 (Revised), dated January 21, 2003, to the TTB Administrator to perform the functions and duties in the administration and enforcement of this law. Certificates of Label Approval TTB’s regulations prohibit the release of bottled distilled spirits from customs custody for consumption unless an approved Certificate of Label Approval (COLA) covering the product has been deposited with the appropriate Customs officer at the port of entry. See 27 CFR 5.51. The TTB regulations also generally prohibit the bottling or removal from a plant of distilled spirits unless the proprietor possesses a COLA covering the labels on the bottle. See 27 CFR 5.55. Classes and Types of Spirits The TTB labeling regulations require that the class and type of distilled spirits appear on the product’s brand label. See 27 CFR 5.32(a)(2) and 5.35. Those regulations provide that the class and type must be stated in conformity with § 5.22 of the TTB regulations (27 CFR 5.22) if defined therein. Otherwise, the product must be designated in accordance with trade and consumer understanding thereof, or, if no such understanding exists, by a distinctive or fanciful name, and in either case (with limited exceptions), followed by a truthful and adequate statement of composition (see 27 CFR 5.35). Section 5.22 establishes standards of identity for distilled spirits products and categorizes these products according to various classes and types. As used in § 5.22, the term ‘‘class’’ refers to a general category of spirits, such as ‘‘whisky’’ or ‘‘brandy.’’ Currently, there are 12 different classes of distilled spirits recognized in § 5.22, including whisky, rum, and brandy. The term ‘‘type’’ refers to a subcategory within a class of spirits. For example, ‘‘Cognac’’ is a type of brandy, and ‘‘Canadian whisky’’ is a type of whisky. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 28739 Brandy and Pisco Brandy is Class 4 in the standards of identity, where it is defined in § 5.22(d) as ‘‘an alcoholic distillate from the fermented juice, mash, or wine of fruit, or from the residue thereof, produced at less than 190° proof in such manner that the distillate possesses the taste, aroma, and characteristics generally attributed to the product, and bottled at not less than 80° proof.’’ ‘‘Pisco’’ is a term recognized by both the governments of Peru and Chile as a designation for a distilled spirits product made from grapes. Generally, Pisco is classified as brandy under the terms of TTB’s current labeling regulations. However, Pisco is not currently listed as a type of brandy in Class 4. Rather, ‘‘Pisco brandy’’ has been included in Class 11, at § 5.22(k)(3), as an example of a geographical name that is not a name for a distinctive type of distilled spirits, and that has not become generic. International Agreements Pursuant to the United States-Peru Trade Promotion Agreement, the United ´ States recognized Pisco Peru as a distinctive product of Peru (Article 2.12(2) of the Agreement). Accordingly, the United States agreed not to permit ´ the sale of any product as Pisco Peru unless it has been manufactured in Peru in accordance with the laws and regulations of Peru governing Pisco. In addition, pursuant to the United States-Chile Free Trade Agreement, the United States recognized Pisco Chileno (Chilean Pisco) as a distinctive product of Chile (Article 3.15(2) of the Agreement). Accordingly, the United States agreed not to permit the sale of any product as Pisco Chileno (Chilean Pisco) unless it has been manufactured in Chile in accordance with the laws and regulations of Chile governing the manufacture of Pisco. In like manner, Peru and Chile agreed, respectively, to recognize Bourbon Whiskey and Tennessee Whiskey (which is defined in both Agreements as a straight Bourbon Whiskey authorized to be produced only in the State of Tennessee), as distinctive products of the United States, and not to permit the sale of any product as Bourbon Whiskey or Tennessee Whiskey unless it has been manufactured in the United States in accordance with the laws and regulations of the United States governing the manufacture of Bourbon Whiskey and Tennessee Whiskey. (TTB notes that there are alternative spellings for the same term—‘‘whisky’’ in the TTB regulations in 27 CFR part 5 and ‘‘whiskey’’ in the Agreements with Peru and Chile.) E:\FR\FM\16MYR1.SGM 16MYR1

Agencies

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Rules and Regulations]
[Pages 28735-28739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11593]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-373]


Schedules of Controlled Substances: Temporary Placement of Three 
Synthetic Cannabinoids Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Deputy Administrator of the Drug Enforcement 
Administration (DEA) is issuing this final order to temporarily 
schedule three synthetic cannabinoids under the Controlled Substances 
Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). The substances are (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, 
AKB48). This action is based on a finding by the Deputy Administrator 
that the placement of these synthetic cannabinoids and their salts, 
isomers and salts of isomers into Schedule I of the CSA is necessary to 
avoid an imminent hazard to the public safety. As a result of this 
order, the full effect of the CSA and the Controlled Substances Import 
and Export Act (CSIEA) and their implementing regulations including 
criminal, civil and administrative penalties, sanctions and regulatory 
controls of Schedule I substances will be imposed on the manufacture, 
distribution, possession, importation, and exportation of these 
synthetic cannabinoids.

DATES: Effective Date: This Final Order is effective on May 16, 2013.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; telephone (202) 307-7165.

SUPPLEMENTARY INFORMATION:

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 up 
to one year.
    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 under section 505 of the Federal Food, Drug and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355) for the substance (21 U.S.C. 
811 (h)(1)). The Attorney General has delegated his authority under 21 
U.S.C. 811 to the Administrator of DEA, who in turn has delegated her 
authority to the Deputy Administrator of DEA. 28 CFR 0.100, Appendix to 
Subpart R.
    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\ The Deputy Administrator has 
transmitted notice of his intent to place UR-144, XLR11 and AKB48 in 
Schedule I on a temporary basis to the Assistant Secretary by letter 
dated February 14, 2013. The Assistant Secretary responded to this 
notice by letter dated March 14, 2013 (received by DEA on March 21, 
2013), and advised that based on review by the Food and Drug 
Administration (FDA), there are currently no investigational new drug 
applications or approved new drug applications for UR-144, XLR11 or 
AKB48. The Assistant Secretary also stated that HHS has no objection to 
the temporary placement of UR-144, XLR11 or AKB48 into Schedule I of 
the CSA. DEA has taken into consideration the Assistant Secretary's 
comments (21 U.S.C. 811(h)(4)). As UR-144, XLR11 and AKB48 are not 
currently listed in any schedule under the CSA, and as no exemptions or 
approvals are in effect for UR-144, XLR11 and AKB48 under Section 505 
of the FD&C Act (21 U.S.C. 355), DEA believes that the conditions of 21 
U.S.C. 811(h)(1) have been satisfied. On April 12, 2013, a Notice of 
Intent to temporarily schedule these three synthetic cannabinoids was 
published in the Federal Register (78 FR 21858).
---------------------------------------------------------------------------

    \1\ Because the Secretary of the Department of Health and Human 
Services (HHS) has delegated to the Assistant Secretary for Health 
of the Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this Final 
Order, 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 Secretary's 
scheduling responsibilities under the Controlled Substance Act 
(CSA), with the concurrence of NIDA. 50 FR 9518.
---------------------------------------------------------------------------

    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(h)(3)). These factors are as follows: 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(c)(4)-(6). 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 (21 U.S.C. 811(h)) may only be placed in Schedule I. 
Substances in Schedule I are those that have a high potential for

[[Page 28736]]

abuse, no currently accepted medical use in treatment in the United 
States (U.S.), and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1). Available data and information for 
UR-144, XLR11 and AKB48 indicate that these three synthetic 
cannabinoids have a high potential for abuse, no currently accepted 
medical use in treatment in the U.S., and a lack of accepted safety for 
use under medical supervision.

Synthetic Cannabinoids

    While synthetic cannabinoids have been developed over the last 30 
years for research purposes to investigate the cannabinoid system, no 
scientific literature referring to UR-144, XLR11 or AKB48 was available 
prior to these drugs' identification in the illicit market. In 
addition, no legitimate non-research uses have been identified for 
these synthetic cannabinoids nor have they been approved by FDA for 
human consumption. Synthetic cannabinoids, of which (1-pentyl-1H-indol-
3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-
pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-
fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48) are representative, are so-termed for 
their [Delta]9-tetrahydrocannabinol (THC)-like pharmacological 
properties. Numerous herbal products have been analyzed, and UR-144, 
XLR11 and AKB48 have been identified, in varying mixture profiles and 
amounts, spiked on plant material.
    As of April 3, 2013, according to the System to Retrieve 
Information from Drug Evidence (STRIDE) data, there are 1,510 reports 
involving 179 total cases for UR-144, 1,194 reports involving 186 total 
cases for XLR11 and 112 reports involving 40 total cases for AKB48. 
From January 2010 to March 2013, the National Forensic Laboratory 
Information System (NFLIS) registered 14,831 reports containing these 
synthetic cannabinoids (UR-144--5,465 reports; XLR11--8,837 reports; 
AKB48--529 reports) from at least 32 states. No instances regarding UR-
144, XLR11 or AKB48 were reported in NFLIS prior to March of 2010. For 
the period January 2010 through March 2013, NFLIS and STRIDE reports 
\2\ for the three synthetic cannabinoids UR-144, XLR11 and AKB48 
(16,014 total reports) exceeded the number of reports for the five 
synthetic cannabinoids JWH-018, JWH-073, JWH-200, CP-47,497 and CP-
47,497 C8 (7,555 total reports). JWH-018, JWH-200, JWH-073, CP-47,497 
and CP-47,497 C8 homologue were temporarily scheduled on March 1, 2011, 
and later placed in Schedule I by Section 1152 of Food and Drug 
Administration Safety and Innovation Act (FDASIA), Pub. L. 112-144, on 
July 9, 2012. Section 1152 of the FDASIA \3\ amended the CSA by placing 
cannabimimetic agents and 26 specific substances (including 15 
synthetic cannabinoids, 2 synthetic cathinones, and 9 phenethylamines 
of the 2C-series) in Schedule I. UR-144, XLR11 and AKB48 were not 
included among the 15 specific named synthetic cannabinoids, and do not 
fall under the definition of cannabimimetic agents, under FDASIA.
---------------------------------------------------------------------------

    \2\ National Forensic Laboratory Information System (NFLIS) is a 
program sponsored by the Drug Enforcement Administration's (DEA), 
Office of Diversion Control which compiles information on exhibits 
analyzed in State and local law enforcement forensic laboratories. 
System to Retrieve Information from Drug Evidence (STRIDE) is a DEA 
database which compiles information on exhibits analyzed in DEA 
laboratories.
    \3\ Subtitle D of Title XI of the Food and Drug Administration 
Safety and Innovation Act (FDASIA), which includes Sections 1151-
1153 of Pub. L. 112-144, is also known as the ``Synthetic Drug Abuse 
Prevention Act of 2012,'' or ``SDAPA.''
---------------------------------------------------------------------------

Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids (JWH-018) laced on plant material were first 
reported in the U.S. in December 2008, when a shipment of ``Spice'' was 
seized and analyzed by U.S. Customs and Border Patrol in Dayton, Ohio. 
Also in December 2008, JWH-018 and cannabicyclohexanol were identified 
by German forensic laboratories.
    Since the initial identification of JWH-018 (December 2008), many 
additional synthetic cannabinoids with purported psychotropic effects 
have been found laced on plant material or related products. The 
popularity of these synthetic cannabinoids and their associated 
products appears to have increased since January 2010 in the U.S. based 
on seizure exhibits and media reports. This trend appears to mirror 
that experienced in Europe since 2008. Synthetic cannabinoids are being 
encountered in several regions of the U.S. with the substances 
primarily found as adulterants on plant material products as self-
reported on internet discussion boards. Since then, numerous other 
synthetic cannabinoids including UR-144, XLR11 and AKB48 have been 
identified as product adulterants.
    Data gathered from published studies, supplemented by discussions 
on Internet Web sites and personal communications with toxicological 
testing laboratories, demonstrate that products laced with UR-144, 
XLR11 and/or AKB48 are being abused mainly by smoking for their 
psychoactive properties. The adulterated products are marketed as 
`legal' alternatives to marijuana. This characterization, along with 
their reputation as potent herbal intoxicants, has increased their 
popularity. Several synthetic cannabinoids, including UR-144, XLR11 and 
AKB48, have been shown to display higher potency in scientific studies 
when compared to THC. Smoking mixtures of these substances for the 
purpose of achieving intoxication has been identified as a reason for 
numerous emergency room visits and calls to poison control centers. 
Abuse of these synthetic cannabinoids and their products has been 
characterized with both acute and long term public health and safety 
issues. In addition, numerous states, local jurisdictions, and the 
international community have controlled these substances.

Factor 5. Scope, Duration and Significance of Abuse

    According to forensic laboratory reports, the first appearance of 
synthetic cannabinoids in the U.S. occurred in December 2008, when U.S. 
Customs and Border Protection analyzed ``Spice'' products. NFLIS has 
reported 14,831 exhibits (January 2010 to March 2013) related to UR-
144, XLR11 and AKB48 from various states including Alaska, Alabama, 
Arkansas, California, Colorado, Florida, Georgia, Iowa, Indiana, 
Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, 
New Hampshire, New Jersey, New Mexico, North Dakota, Nebraska, Nevada, 
Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, 
Virginia, Wisconsin and Wyoming. STRIDE has reported 2,816 records 
involving UR-144, XLR11 and/or AKB48 from January 2010 through April 3, 
2013. From January 1 through December 31, 2012, the American 
Association of Poison Control Centers \4\ has reported receiving in 
excess of 5,200 calls relating to products purportedly laced with 
synthetic cannabinoids. Although the center does not identify specific 
cannabinoid substances, the data does indicate the magnitude of adverse 
exposure to synthetic cannabinoids.
---------------------------------------------------------------------------

    \4\ American Association of Poison Control Centers (AAPCC) is a 
non-profit, national organization that represents the poison centers 
of the United States.
---------------------------------------------------------------------------

Factor 6. What, If Any, Risk There Is to the Public Health

    UR-144, XLR11 and AKB48 are pharmacologically similar to Schedule I

[[Page 28737]]

substances THC and JWH-018, as well as other synthetic cannabinoids. By 
sharing pharmacological similarities with the Schedule I substances 
(THC and JWH-018), synthetic cannabinoids pose a risk to the abuser. In 
addition, the chronic abuse of products laced with synthetic 
cannabinoids has also been linked to addiction and withdrawal. Law 
enforcement, military and public health officials have reported 
exposure incidents that demonstrate the dangers associated with abuse 
of synthetic cannabinoids to both the individual abusers and other 
affected individuals since these substances were never intended for 
human use. Warnings regarding the dangers associated with abuse of 
synthetic cannabinoids and their products have been issued by numerous 
state public health departments, poison control centers and private 
organizations. In a 2012 report, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) reported 11,406 emergency department 
visits involving a synthetic cannabinoid product during 2010. In a 2013 
report, SAMHSA reported the number of emergency department visits in 
2011 involving a synthetic cannabinoid product had increased 2.5 times 
to 28,531.
    Detailed product analyses have detected variations in the amount 
and type of synthetic cannabinoid laced on plant material even within 
samplings of the same product. Since abusers obtain these drugs through 
unknown sources, purity of these drugs is uncertain, thus posing 
significant adverse health risk to these users. Submissions to DEA 
laboratories from January 2012 through February 11, 2013, have 
documented over 142 distinct packaging examples containing a mixture of 
UR-144, XLR11 and/or AKB48. These unknown factors present a significant 
risk of danger to the abuser. Some of the adverse health effects 
reported in response to the abuse of synthetic cannabinoids include 
vomiting, anxiety, agitation, irritability, seizures, hallucinations, 
tachycardia, elevated blood pressure, and loss of consciousness. As 
mentioned above, there are reported instances of emergency department 
admissions in association with the abuse of these THC-like substances. 
There are no recognized therapeutic uses of these substances in the 
U.S.
    In February 2013, the Centers for Disease Control and Prevention 
published a report by Murphy et al. describing unexplained cases of 
acute kidney injury in 16 patients, all of whom had reported recent 
smoking of synthetic cannabinoids. Upon further investigation, it was 
determined that of the 16 patients, 7 of the subjects had smoked 
substances that were positive for XLR11 or its metabolite. Cases were 
reported from Wyoming (4 cases), Rhode Island (1 case), New York (2 
cases), Oregon (6 cases), Kansas (1 case) and Oklahoma (2 cases).

Finding of Necessity of Schedule I Scheduling To Avoid Imminent Hazard 
to Public Safety

    Based on the available data and information, the continued 
uncontrolled manufacture, distribution, importation, exportation and 
abuse of UR-144, XLR11 and AKB48 pose an imminent hazard to the public 
safety. DEA is not aware of any currently accepted medical uses for 
these synthetic cannabinoids in the U.S. A substance meeting the 
statutory requirements for temporary scheduling (21 U.S.C. 811(h)) 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 U.S., and a lack of accepted safety for use under 
medical supervision. Available data and information for UR-144, XLR11 
and AKB48 indicate that these three synthetic cannabinoids have a high 
potential for abuse, no currently accepted medical use in treatment in 
the U.S., and a lack of accepted safety for use under medical 
supervision.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA (21 
U.S.C. 811(h)), the Deputy Administrator has considered available data 
and information and has set forth herein the grounds for his 
determination that it is necessary to temporarily schedule three 
synthetic cannabinoids, (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, 
AKB48) 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, the 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 up to three years pending completion of the permanent or 
regular scheduling process.
    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. The CSA sets forth specific criteria for scheduling 
a drug or other substance. While temporary scheduling orders are not 
subject to judicial review (21 U.S.C. 811(h)(6)), 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 permanent scheduling determination. Final 
decisions which conclude the regular scheduling process of formal 
rulemaking are subject to judicial review. 21 U.S.C. 877.

Regulatory Requirements

    With the issuance of this final order, UR-144, XLR11 and AKB48 
become subject to the regulatory controls and administrative, civil and 
criminal sanctions applicable to the manufacture, distribution, 
possession, importation and exportation of a Schedule I controlled 
substance under the CSA and the CSIEA.
    1. Registration. Any person who manufactures, distributes, imports, 
exports, or possesses UR-144, XLR11 or AKB48, or who engages in 
research or conducts instructional activities with respect to UR-144, 
XLR11 or AKB48, or who proposes to engage in such activities, must be 
registered to conduct such activities in accordance with 21 U.S.C. 822 
and 957. Any person who is currently engaged in any of the above 
activities and is not registered with DEA must submit an application 
for registration and may not continue their activities until DEA has 
approved that application. Retail sales of Schedule I controlled 
substances to the general public are not allowed under the CSA. 
Possession of any of these substances in a manner not authorized by the 
CSA on or after May 16, 2013 is unlawful and may subject those in 
possession of any of these substances to prosecution pursuant to the 
Controlled Substances Act.
    2. Security. UR-144, XLR11 and AKB48 are subject to Schedule I 
security requirements. Accordingly, appropriately registered DEA 
registrants must manufacture, distribute and store these substances in 
accordance with 1301.71; 1301.72(a), (c) and (d); 1301.73; 1301.74; 
1301.75(a) and (c); and 1301.76 of Title 21 of the Code of Federal 
Regulations as of May 16, 2013.

[[Page 28738]]

    3. Labeling and packaging. All labeling and packaging requirements 
for controlled substances set forth in Part 1302 of Title 21 of the 
Code of Federal Regulations shall apply to commercial containers of UR-
144, XLR11 and AKB48. Current DEA registrants authorized to handle UR-
144, XLR11 and AKB48 shall comply with Part 1302 of Title 21 of the 
Code of Federal Regulations within thirty (30) calendar days of May 16, 
2013.
    4. Quotas. Every manufacturer authorized to manufacture UR-144, 
XLR11 and AKB48 must apply for and be granted a quota to manufacture 
such substance(s) pursuant to Part 1303 of Title 21 of the Code of 
Federal Regulations. No authorized manufacturer may manufacture UR-144, 
XLR11 or AKB48 in excess of a quota assigned to him as of May 16, 2013.
    5. Inventory. Every DEA registrant authorized to possess any 
quantity of UR-144, XLR11 or AKB48 is required to keep inventory of all 
stocks of these substances on hand pursuant to 1304.03, 1304.04 and 
1304.11 of Title 21 of the Code of Federal Regulations. Every 
authorized DEA registrant shall comply with all inventory requirements 
within thirty (30) calendar days of May 16, 2013.
    6. Records. All registrants who are authorized to handle UR-144, 
XLR11 or AKB48 are required to keep records pursuant to 1304.03, 
1304.04, 1304.21, 1304.22 and 1304.23 of Title 21 of the Code of 
Federal Regulations. Current DEA registrants authorized to handle UR-
144, XLR11 or AKB48 shall comply with all recordkeeping requirements 
within thirty (30) calendar days of May 16, 2013.
    7. Reports. All registrants are required to submit reports in 
accordance with 1304.33 of Title 21 of the Code of Federal Regulations. 
Registrants who manufacture or distribute UR-144, XLR11 or AKB48 are 
required to comply with these reporting requirements and shall do so as 
of May 16, 2013.
    8. Order Forms. All registrants involved in the distribution of UR-
144, XLR11 or AKB48 must comply with order form requirements of Part 
1305 of Title 21 of the Code of Federal Regulations as of May 16, 2013.
    9. Importation and Exportation. All importation and exportation of 
UR-144, XLR11 or AKB48 must be conducted by appropriately registered 
DEA registrants in compliance with Part 1312 of Title 21 of the Code of 
Federal Regulations on or after May 16, 2013.
    10. Criminal Liability. The manufacture, distribution or possession 
with the intent to conduct these activities; as well as possession, 
importation or exportation of UR-144, XLR11 or AKB48 not authorized by, 
or in violation of the CSA or the Controlled Substances Import and 
Export Act occurring as of May 16, 2013 is unlawful.

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. 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 
a proposed temporary scheduling order is transmitted to the Secretary 
of HHS. 21 U.S.C. 811(h)(1).
    In as much 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, 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 final order. In the 
alternative, even assuming that this final order might be deemed to 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 of the temporary 
scheduling action to avoid an imminent hazard to the public safety.
    Further, DEA believes that this temporary scheduling action Final 
Order is not a ``rule'' as defined by 5 U.S.C. 601(2), and, 
accordingly, not subject to the requirements of the Regulatory 
Flexibility Act. The requirements for the preparation of an initial 
regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable 
where (as here) the agency 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.
    This action will not have substantial direct effects on the states, 
on the relationship between the national government and the states, or 
on 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.
    Pursuant to the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Congressional Review Act) (5 U.S.C. 801-808), DEA has 
submitted a copy of this Final Order to both Houses of Congress and to 
the Comptroller General.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    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), the Deputy Administrator hereby orders 
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 new paragraphs (h)(9), (10), 
and (11) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (9) (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7144 (Other names: UR-
144, 1-pentyl-3-(2,2,3,3-tetramethylcyclopropoyl)indole)
    (10) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7011 (Other names: 5-
fluoro-UR-144, 5- F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3-(2,2,3,3-
tetramethylcyclopropoyl)indole)
    (11) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide, its 
optical, positional, and geometric isomers, salts and salts of 
isomers--7048 (Other names: APINACA, AKB48)


[[Page 28739]]


    Dated: May 10, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-11593 Filed 5-15-13; 8:45 am]
BILLING CODE 4410-09-P