Schedules of Controlled Substances: Temporary Placement of Three Synthetic Phenethylamines Into Schedule I, 68716-68719 [2013-27315]

Download as PDF 68716 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–382] Schedules of Controlled Substances: Temporary Placement of Three Synthetic Phenethylamines 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 phenethylamines into the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are 2-(4iodo-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25I– NBOMe; 2C–I–NBOMe; 25I; Cimbi-5), 2(4-chloro-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25C– NBOMe; 2C–C–NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)N-(2-methoxybenzyl)ethanamine (25B– NBOMe; 2C–B–NBOMe; 25B; Cimbi-36) [hereinafter 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe]. This action is based on a finding by the Deputy Administrator that the placement of these synthetic phenethylamines and their optical, positional, and geometric isomers, salts and salts of isomers in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, and possess), or propose to handle these synthetic phenethylamines. DATES: This final order is effective November 15, 2013. FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, 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: emcdonald on DSK67QTVN1PROD with RULES SUMMARY: Legal Authority The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, but they are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. 21 U.S.C. 801– 971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, controlled substances are classified into one of five schedules based upon their potential for abuse, their currently accepted medical use, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308. 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 an 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 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). Pursuant to 21 U.S.C. 871(a), the Attorney General has delegated his scheduling 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. Background 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 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Services (HHS) of his intention to temporarily place a substance in schedule I of the CSA.1 The Deputy Administrator transmitted notice of his intent to place 25I–NBOMe, 25C– NBOMe, and 25B–NBOMe in schedule I on a temporary basis to the Assistant Secretary by letter dated September 3, 2013. The Assistant Secretary responded to this notice by letter dated October 1, 2013 (received by the DEA on October 8, 2013), and advised that based on review by the FDA, there are currently no investigational new drug applications or approved new drug applications for 25I–NBOMe, 25C– NBOMe, or 25B–NBOMe. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of 25I–NBOMe, 25C–NBOMe, or 25B– NBOMe in schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary’s comments as required by 21 U.S.C. 811(h)(4). As 25I– NBOMe, 25C–NBOMe, and 25B– NBOMe are not currently listed in any schedule under the CSA, and as no exemptions or approvals are in effect for 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe under section 505 of the FD&C Act, 21 U.S.C. 355, the conditions of 21 U.S.C. 811(h)(1) have been satisfied. As required by 21 U.S.C. 811(h)(1)(a), a notice of intent to temporarily schedule these three synthetic phenethylamines was published in the Federal Register on October 10, 2013. 78 FR 61991. To make a finding that placing a substance temporarily in 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(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 may only be placed in schedule I. 21 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 Final Order, all subsequent references to ‘‘Secretary’’ have been replaced with ‘‘Assistant Secretary.’’ As set forth in a memorandum of understanding entered into by the HHS, the Food and Drug Administration (FDA), and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Assistant Secretary’s scheduling responsibilities under the CSA, with the concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985. E:\FR\FM\15NOR1.SGM 15NOR1 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations emcdonald on DSK67QTVN1PROD with RULES 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 25I–NBOMe, 25C– NBOMe, and 25B–NBOMe indicate that these three synthetic phenethylamines 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 Phenethylamines The 2-methoxybenzyl series of 2C phenethylamine substances, such as 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe, has been developed over the last 10 years for use in mapping and investigating the serotonin receptors in the mammalian brain. 25I–NBOMe and 25B–NBOMe were first described by legitimate research laboratories in 2003. Subsequent studies involving these two substances appeared in the scientific literature starting in 2006. 25C–NBOMe first appeared in the scientific literature in 2011. No approved medical use has been identified for these synthetic phenethylamines, nor have they been approved by the FDA for human consumption. Synthetic 2C phenethylamine substances, of which 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe are representative, are sotermed for the two-carbon ethylene group between the phenyl ring and the amino group of the phenethylamine and are substituted with methoxy groups at the 2 and 5 positions of the phenyl ring. Numerous blotter papers and food items have been analyzed, and combinations of one or more of 25I–NBOMe, 25C– NBOMe, and 25B–NBOMe have been identified as adulterants. Bulk quantities of these substances have been encountered as powders and liquid solutions. From November 2011 through June 2013, according to the System to Retrieve Information from Drug Evidence 2 (STRIDE) data, there are 54 exhibits involving 27 cases for 25I– NBOMe; 27 exhibits involving 12 cases for 25C–NBOMe; and 4 exhibits involving 4 cases for 25B–NBOMe. From June 2011 through June 2013, the National Forensic Laboratory Information System 3 (NFLIS) registered 959 reports containing these synthetic phenethylamines (25I–NBOMe—795 2 STRIDE includes data on analyzed samples from DEA laboratories. 3 NFLIS is a database that collects scientifically verified data on analyzed samples in State and local forensic laboratories. VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 reports; 25C–NBOMe—144 reports; 25B–NBOMe—20 reports) across 35 States. No instances involving 25I– NBOMe, 25C–NBOMe, or 25B–NBOMe were reported in NFLIS prior to June 2011. Factor 4. History and Current Pattern of Abuse One or more 2-methoxybenzyl analogues of the 2C compounds described here have been available over the Internet since 2010. The first identified domestic law enforcement encounter with 25I–NBOMe occurred in June 2011 in Milwaukee, Wisconsin. Information from published studies and law enforcement reports, supplemented with discussions on Internet Web sites and personal communications, document abuse of 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe by nasal insufflation of powders, intravenous injection or nasal absorption of liquid solutions, sublingual or buccal administration of blotter papers, and consumption of food items laced with these substances. These sources also report that 25I– NBOMe, 25C–NBOMe, and 25B– NBOMe are often purported to be schedule I hallucinogens like lysergic acid diethylamide (LSD). Reports document that the abuse of these substances can cause severe toxic reactions, including death. According to United States Customs and Border Protection data, bulk quantities of powdered 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe have been seized from shipments originating overseas, particularly from Asia. Given the relatively small quantity of these substances predicted to produce a hallucinogenic effect in humans, single seizures of these substances are capable of producing hundreds of thousands to millions of dosage units. Large seizures of these substances prepared on blotter papers have also been reported. Abuse of 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe has been characterized with acute public health and safety issues domestically and abroad. In response, a number of States and foreign governments have controlled these substances. Factor 5. Scope, Duration, and Significance of Abuse According to forensic laboratory reports, the first law enforcement encounter with 25I–NBOMe in the United States occurred in June 2011. According to NFLIS, 959 exhibits involving 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe were submitted to forensic laboratories between June 2011 and June 2013 from a number of States PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 68717 including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming. The number of reports submitted to NFLIS involving 25I–NBOMe, 25C–NBOMe, and 25B– NBOMe has increased in each of the last five quarters where complete data is available. According to STRIDE, there are 85 records that identify 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe in evidence submitted to DEA laboratories between November 2011 and June 2013. Factor 6. What, If Any, Risk There Is to the Public Health In 2012 and 2013, emergency department physicians and toxicologists published and presented numerous case reports of patients treated for exposure to 25I–NBOMe. The adverse health effects reported include tachycardia, hypertension, agitation, aggression, visual and auditory hallucinations, seizures, hyperpyrexia, clonus, elevated white cell count, elevated creatine kinase, metabolic acidosis, rhabdomyolysis, and acute kidney injury. Medical examiner and postmortem toxicology reports from 11 States implicate some combination of 25I– NBOMe, 25C–NBOMe, and 25B– NBOMe in the death of at least 17 individuals. These reports suggest that 14 individuals died of acute toxicity, and 3 individuals died of unpredictable or violent behavior due to 25I–NBOMe toxicity. 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe have each been detected in postmortem blood toxicology for cases of acute toxicity. 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 for these substances in the United States and possible deadly drug interactions between 25I–NBOMe and FDA-approved medications have been noted. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety Based on the above data and information, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe pose an E:\FR\FM\15NOR1.SGM 15NOR1 68718 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations emcdonald on DSK67QTVN1PROD with RULES imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these synthetic phenethylamines 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 25I–NBOMe, 25C– NBOMe, and 25B–NBOMe indicate that these three synthetic phenethylamines 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)(4), the Deputy Administrator through a letter dated September 3, 2013, notified the Assistant Secretary of the intention to temporarily place these three synthetic phenethylamines in schedule I. Conclusion 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 three synthetic phenethylamines, 2-(4-iodo2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25I– NBOMe; 2C–I–NBOMe; 25I; Cimbi-5), 2(4-chloro-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25C– NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) and 2-(4-bromo-2,5-dimethoxyphenyl)N-(2-methoxybenzyl)ethanamine (25B– NBOMe; 2C–B–NBOMe; 25B; Cimbi-36), in schedule I of the CSA, and finds that placement of these synthetic phenethylamines in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Deputy Administrator hereby finds it necessary to temporarily place these synthetic phenethylamines in 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 two years, with a possible extension of one additional year, pending completion of the permanent or regular scheduling process. 21 U.S.C. 811(h)(1)–(2). The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 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 Requirements Upon the effective date of this Final Order, 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe will become subject to the CSA’s schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional activities, and possession including the following: 1. Registration. Any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, conducts instructional activities, or possesses), or desires to handle, 25I–NBOMe, 25C–NBOMe, or 25B–NBOMe must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. Any person who currently handles 25I–NBOMe, 25C– NBOMe, or 25B–NBOMe, and is not registered with the DEA must submit an application for registration and may not continue his/her activities until the DEA has approved that application. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. 2. Security. 25I–NBOMe, 25C– NBOMe, and 25B–NBOMe are subject to schedule I security requirements and must be handled and stored in accordance with 21 CFR 1301.71– 1301.93, pursuant to 21 U.S.C. 821, 823, 871(b), as of November 15, 2013. 3. Labeling and packaging. All labeling and packaging requirements for controlled substances set forth in part 1302 of title 21 of the CFR shall apply to commercial containers of 25I– NBOMe, 25C–NBOMe, and 25B– NBOMe. Current DEA registrants shall have 30 calendar days from November 15, 2013 to comply with all labeling and packaging requirements. 4. Quotas. Quotas for 25I–NBOMe, 25C–NBOMe, and 25B–NBOMe will be established based on registrations PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 granted and quota applications received pursuant to part 1303 of title 21 of the CFR. 5. Inventory. Every DEA registrant who possesses any quantity of 25I– NBOMe, 25C–NBOMe, or 25B–NBOMe on the effective date of this order will be required to take an inventory of all stocks of these substances on hand as of the effective date of this order, pursuant to 21 U.S.C. 827, 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. 6. Records. All registrants who are authorized to handle 25I–NBOMe, 25C– NBOMe, or 25B–NBOMe are required to keep records pursuant to 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of title 21 of the CFR. Current DEA registrants authorized to handle 25I– NBOMe, 25C–NBOMe, or 25B–NBOMe shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 7. Reports. All registrants are required to submit reports in accordance with 1304.33 of title 21 of the CFR. DEA registrants who manufacture or distribute 25I–NBOMe, 25C–NBOMe, or 25B–NBOMe are required to comply with these reporting requirements and shall do so as of November 15, 2013. 8. Order Forms. All registrants involved in the distribution of 25I– NBOMe, 25C–NBOMe, or 25B–NBOMe must comply with order form requirements of part 1305 of title 21 of the CFR as of November 15, 2013. 9. Importation and Exportation. All importation and exportation of 25I– NBOMe, 25C–NBOMe, or 25B–NBOMe must be conducted by appropriately registered DEA registrants in compliance with part 1312 of title 21 of the CFR, pursuant to 21 U.S.C. 952, 953, 957, and 958, on or after November 15, 2013. 10. Criminal Liability. Any activity involving 25I–NBOMe, 25C–NBOMe, or 25B–NBOMe not authorized by, or in violation of the CSA, occurring as of November 15, 2013 is unlawful, and may subject the person to administrative, civil, and criminal proceedings. 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, E:\FR\FM\15NOR1.SGM 15NOR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations 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 Assistant Secretary of HHS. 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 temporary scheduling action. In the alternative, even assuming that this action 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. Further, the DEA believes that this temporary scheduling action final order 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. Pursuant to section 808(2) of the Congressional Review Act (CRA), ‘‘any rule for which an agency for good cause finds…that notice and public procedure thereon are impracticable, unnecessary, VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.’’ It is in the public interest to schedule these substances immediately because they pose a public health risk. This temporary scheduling action is taken pursuant to section 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety from new or designer drugs or abuse of those drugs. Section 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie section 811(h), that is, the DEA’s need to move quickly to place these substances into schedule I because they pose a threat to public health, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, in accordance with section 808(2) of the CRA, this order shall take effect immediately upon its publication. 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 intends to order 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)(12), (13), and (14) to read as follows: ■ § 1308.11 * Schedule I. * * * (h) * * * (12) 2-(4-iodo-2,5-dimethoxyphenyl)N-(2-methoxybenzyl)ethanamine, its optical, positional, and geometric isomers, salts and salts of isomers— 7538 (Other names: 25I–NBOMe; 2C–I– NBOMe; 25I; Cimbi-5) (13) 2-(4-chloro-2,5dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine, its optical, positional, and geometric isomers, salts and salts of isomers—7537 (Other PO 00000 * Frm 00033 Fmt 4700 Sfmt 4700 68719 names: 25C–NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) (14) 2-(4-bromo-2,5dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine, its optical, positional, and geometric isomers, salts and salts of isomers—7536 (Other names: 25B–NBOMe; 2C–B– NBOMe; 25B; Cimbi-36) Dated: November 7, 2013. Thomas M. Harrigan, Deputy Administrator. [FR Doc. 2013–27315 Filed 11–14–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 50, 55, and 58 [Docket No. FR–5423–F–02] RIN 2501–AD51 Floodplain Management and Protection of Wetlands Office of the Secretary, HUD. Final rule. AGENCY: ACTION: This final rule revises HUD’s regulations governing the protection of wetlands and floodplains. With respect to wetlands, the rule codifies existing procedures for Executive Order 11990 (E.O. 11990), Protection of Wetlands. HUD’s policy has been to require the use of the 8-Step Process for floodplains for wetlands actions performed by HUD or actions performed with HUD financial assistance. This rule codifies this wetlands policy and improves consistency and increases transparency by placing the E.O. 11990 requirements in regulation. In certain instances, the new wetlands procedures will allow recipients of HUD assistance to use individual permits issued under section 404 of the Clean Water Act (Section 404 permits) in lieu of 5 steps of the E.O. 11990’s 8-Step Process, streamlining the wetlands decisionmaking processes. With respect to floodplains, with some exceptions, the rule prohibits HUD funding (e.g., Community Development Block Grants, HOME Investment Partnerships Program, Choice Neighborhoods, and others) or Federal Housing Administration (FHA) mortgage insurance for construction in Coastal High Hazard Areas. In order to ensure maximum protection for communities and wise investment of Federal resources in the face of current and future risk, this final rule also requires the use of preliminary flood maps and advisory base flood elevations where the Federal Emergency SUMMARY: E:\FR\FM\15NOR1.SGM 15NOR1

Agencies

[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68716-68719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27315]



[[Page 68716]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-382]


Schedules of Controlled Substances: Temporary Placement of Three 
Synthetic Phenethylamines 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 phenethylamines into the Controlled Substances 
Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). The substances are 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-
chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 
2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 
[hereinafter 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe]. This action is based 
on a finding by the Deputy Administrator that the placement of these 
synthetic phenethylamines and their optical, positional, and geometric 
isomers, salts and salts of isomers in schedule I of the CSA is 
necessary to avoid an imminent hazard to the public safety. As a result 
of this order, the regulatory controls and administrative, civil, and 
criminal sanctions applicable to schedule I controlled substances will 
be imposed on persons who handle (manufacture, distribute, dispense, 
import, export, engage in research, conduct instructional activities, 
and possess), or propose to handle these synthetic phenethylamines.

DATES: This final order is effective November 15, 2013.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, 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: 

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. Titles II and III are referred to as the ``Controlled 
Substances Act'' and the ``Controlled Substances Import and Export 
Act,'' respectively, but they are collectively referred to as the 
``Controlled Substances Act'' or the ``CSA'' for the purpose of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use, and the degree of dependence the substance may 
cause. 21 U.S.C. 812. The initial schedules of controlled substances 
established by Congress are found at 21 U.S.C. 812(c), and the current 
list of all scheduled substances is published at 21 CFR part 1308.
    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 
an 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 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). Pursuant to 21 U.S.C. 871(a), the Attorney General has 
delegated his scheduling 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.

Background

    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 in schedule I of the CSA.\1\ The Deputy Administrator 
transmitted notice of his intent to place 25I-NBOMe, 25C-NBOMe, and 
25B-NBOMe in schedule I on a temporary basis to the Assistant Secretary 
by letter dated September 3, 2013. The Assistant Secretary responded to 
this notice by letter dated October 1, 2013 (received by the DEA on 
October 8, 2013), and advised that based on review by the FDA, there 
are currently no investigational new drug applications or approved new 
drug applications for 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. The Assistant 
Secretary also stated that the HHS has no objection to the temporary 
placement of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe in schedule I of the 
CSA. The DEA has taken into consideration the Assistant Secretary's 
comments as required by 21 U.S.C. 811(h)(4). As 25I-NBOMe, 25C-NBOMe, 
and 25B-NBOMe are not currently listed in any schedule under the CSA, 
and as no exemptions or approvals are in effect for 25I-NBOMe, 25C-
NBOMe, and 25B-NBOMe under section 505 of the FD&C Act, 21 U.S.C. 355, 
the conditions of 21 U.S.C. 811(h)(1) have been satisfied. As required 
by 21 U.S.C. 811(h)(1)(a), a notice of intent to temporarily schedule 
these three synthetic phenethylamines was published in the Federal 
Register on October 10, 2013. 78 FR 61991.
---------------------------------------------------------------------------

    \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 Final 
Order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.'' As set forth in a memorandum of 
understanding entered into by the HHS, the Food and Drug 
Administration (FDA), and the National Institute on Drug Abuse 
(NIDA), the FDA acts as the lead agency within the HHS in carrying 
out the Assistant Secretary's scheduling responsibilities under the 
CSA, with the concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985.
---------------------------------------------------------------------------

    To make a finding that placing a substance temporarily in 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(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 may only be placed in schedule I. 21

[[Page 68717]]

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 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe indicate that these three synthetic 
phenethylamines 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 Phenethylamines

    The 2-methoxybenzyl series of 2C phenethylamine substances, such as 
25I-NBOMe, 25C-NBOMe, and 25B-NBOMe, has been developed over the last 
10 years for use in mapping and investigating the serotonin receptors 
in the mammalian brain. 25I-NBOMe and 25B-NBOMe were first described by 
legitimate research laboratories in 2003. Subsequent studies involving 
these two substances appeared in the scientific literature starting in 
2006. 25C-NBOMe first appeared in the scientific literature in 2011. No 
approved medical use has been identified for these synthetic 
phenethylamines, nor have they been approved by the FDA for human 
consumption. Synthetic 2C phenethylamine substances, of which 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe are representative, are so-termed for 
the two-carbon ethylene group between the phenyl ring and the amino 
group of the phenethylamine and are substituted with methoxy groups at 
the 2 and 5 positions of the phenyl ring. Numerous blotter papers and 
food items have been analyzed, and combinations of one or more of 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe have been identified as adulterants. 
Bulk quantities of these substances have been encountered as powders 
and liquid solutions.
    From November 2011 through June 2013, according to the System to 
Retrieve Information from Drug Evidence \2\ (STRIDE) data, there are 54 
exhibits involving 27 cases for 25I-NBOMe; 27 exhibits involving 12 
cases for 25C-NBOMe; and 4 exhibits involving 4 cases for 25B-NBOMe. 
From June 2011 through June 2013, the National Forensic Laboratory 
Information System \3\ (NFLIS) registered 959 reports containing these 
synthetic phenethylamines (25I-NBOMe--795 reports; 25C-NBOMe--144 
reports; 25B-NBOMe--20 reports) across 35 States. No instances 
involving 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe were reported in NFLIS 
prior to June 2011.
---------------------------------------------------------------------------

    \2\ STRIDE includes data on analyzed samples from DEA 
laboratories.
    \3\ NFLIS is a database that collects scientifically verified 
data on analyzed samples in State and local forensic laboratories.
---------------------------------------------------------------------------

Factor 4. History and Current Pattern of Abuse

    One or more 2-methoxybenzyl analogues of the 2C compounds described 
here have been available over the Internet since 2010. The first 
identified domestic law enforcement encounter with 25I-NBOMe occurred 
in June 2011 in Milwaukee, Wisconsin.
    Information from published studies and law enforcement reports, 
supplemented with discussions on Internet Web sites and personal 
communications, document abuse of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe 
by nasal insufflation of powders, intravenous injection or nasal 
absorption of liquid solutions, sublingual or buccal administration of 
blotter papers, and consumption of food items laced with these 
substances. These sources also report that 25I-NBOMe, 25C-NBOMe, and 
25B-NBOMe are often purported to be schedule I hallucinogens like 
lysergic acid diethylamide (LSD). Reports document that the abuse of 
these substances can cause severe toxic reactions, including death.
    According to United States Customs and Border Protection data, bulk 
quantities of powdered 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have been 
seized from shipments originating overseas, particularly from Asia. 
Given the relatively small quantity of these substances predicted to 
produce a hallucinogenic effect in humans, single seizures of these 
substances are capable of producing hundreds of thousands to millions 
of dosage units. Large seizures of these substances prepared on blotter 
papers have also been reported. Abuse of 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe has been characterized with acute public health and safety issues 
domestically and abroad. In response, a number of States and foreign 
governments have controlled these substances.

Factor 5. Scope, Duration, and Significance of Abuse

    According to forensic laboratory reports, the first law enforcement 
encounter with 25I-NBOMe in the United States occurred in June 2011. 
According to NFLIS, 959 exhibits involving 25I-NBOMe, 25C-NBOMe, and 
25B-NBOMe were submitted to forensic laboratories between June 2011 and 
June 2013 from a number of States including Alabama, Arizona, Arkansas, 
California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, 
Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, 
Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New 
Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, 
Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming. The number of 
reports submitted to NFLIS involving 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe has increased in each of the last five quarters where complete 
data is available. According to STRIDE, there are 85 records that 
identify 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in evidence submitted to 
DEA laboratories between November 2011 and June 2013.

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

    In 2012 and 2013, emergency department physicians and toxicologists 
published and presented numerous case reports of patients treated for 
exposure to 25I-NBOMe. The adverse health effects reported include 
tachycardia, hypertension, agitation, aggression, visual and auditory 
hallucinations, seizures, hyperpyrexia, clonus, elevated white cell 
count, elevated creatine kinase, metabolic acidosis, rhabdomyolysis, 
and acute kidney injury.
    Medical examiner and postmortem toxicology reports from 11 States 
implicate some combination of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in 
the death of at least 17 individuals. These reports suggest that 14 
individuals died of acute toxicity, and 3 individuals died of 
unpredictable or violent behavior due to 25I-NBOMe toxicity. 25I-NBOMe, 
25C-NBOMe, and 25B-NBOMe have each been detected in postmortem blood 
toxicology for cases of acute toxicity.
    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 for these substances in the 
United States and possible deadly drug interactions between 25I-NBOMe 
and FDA-approved medications have been noted.

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

    Based on the above data and information, the continued uncontrolled 
manufacture, distribution, importation, exportation, and abuse of 25I-
NBOMe, 25C-NBOMe, and 25B-NBOMe pose an

[[Page 68718]]

imminent hazard to the public safety. The DEA is not aware of any 
currently accepted medical uses for these synthetic phenethylamines 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 25I-NBOMe, 25C-NBOMe, 
and 25B-NBOMe indicate that these three synthetic phenethylamines 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)(4), the Deputy Administrator through a letter dated 
September 3, 2013, notified the Assistant Secretary of the intention to 
temporarily place these three synthetic phenethylamines in schedule I.

Conclusion

    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 three synthetic phenethylamines, 
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-
NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N-
(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) and 
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-
NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), in schedule I of the CSA, and finds 
that placement of these synthetic phenethylamines in schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety.
    Because the Deputy Administrator hereby finds it necessary to 
temporarily place these synthetic phenethylamines in 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 two years, with a possible extension of one additional year, 
pending completion of the permanent or regular scheduling process. 21 
U.S.C. 811(h)(1)-(2).
    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 Requirements

    Upon the effective date of this Final Order, 25I-NBOMe, 25C-NBOMe, 
and 25B-NBOMe will become subject to the CSA's schedule I regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, importation, exportation, research, 
conduct of instructional activities, and possession including the 
following:
    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, conducts 
instructional activities, or possesses), or desires to handle, 25I-
NBOMe, 25C-NBOMe, or 25B-NBOMe must be registered with the DEA to 
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, 
and in accordance with 21 CFR parts 1301 and 1312. Any person who 
currently handles 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe, and is not 
registered with the DEA must submit an application for registration and 
may not continue his/her activities until the DEA has approved that 
application. Retail sales of schedule I controlled substances to the 
general public are not allowed under the CSA.
    2. Security. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are subject to 
schedule I security requirements and must be handled and stored in 
accordance with 21 CFR 1301.71-1301.93, pursuant to 21 U.S.C. 821, 823, 
871(b), as of November 15, 2013.
    3. Labeling and packaging. All labeling and packaging requirements 
for controlled substances set forth in part 1302 of title 21 of the CFR 
shall apply to commercial containers of 25I-NBOMe, 25C-NBOMe, and 25B-
NBOMe. Current DEA registrants shall have 30 calendar days from 
November 15, 2013 to comply with all labeling and packaging 
requirements.
    4. Quotas. Quotas for 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe will be 
established based on registrations granted and quota applications 
received pursuant to part 1303 of title 21 of the CFR.
    5. Inventory. Every DEA registrant who possesses any quantity of 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe on the effective date of this order 
will be required to take an inventory of all stocks of these substances 
on hand as of the effective date of this order, pursuant to 21 U.S.C. 
827, 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11. Current DEA registrants shall have 30 calendar days from the 
effective date of this order to be in compliance with all inventory 
requirements.
    6. Records. All registrants who are authorized to handle 25I-NBOMe, 
25C-NBOMe, or 25B-NBOMe are required to keep records pursuant to 
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of title 21 of the CFR. 
Current DEA registrants authorized to handle 25I-NBOMe, 25C-NBOMe, or 
25B-NBOMe shall have 30 calendar days from the effective date of this 
order to be in compliance with all recordkeeping requirements.
    7. Reports. All registrants are required to submit reports in 
accordance with 1304.33 of title 21 of the CFR. DEA registrants who 
manufacture or distribute 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe are 
required to comply with these reporting requirements and shall do so as 
of November 15, 2013.
    8. Order Forms. All registrants involved in the distribution of 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must comply with order form 
requirements of part 1305 of title 21 of the CFR as of November 15, 
2013.
    9. Importation and Exportation. All importation and exportation of 
25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be conducted by appropriately 
registered DEA registrants in compliance with part 1312 of title 21 of 
the CFR, pursuant to 21 U.S.C. 952, 953, 957, and 958, on or after 
November 15, 2013.
    10. Criminal Liability. Any activity involving 25I-NBOMe, 25C-
NBOMe, or 25B-NBOMe not authorized by, or in violation of the CSA, 
occurring as of November 15, 2013 is unlawful, and may subject the 
person to administrative, civil, and criminal proceedings.

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,

[[Page 68719]]

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 Assistant Secretary of HHS. 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 temporary scheduling 
action. In the alternative, even assuming that this action 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.
    Further, the DEA believes that this temporary scheduling action 
final order 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.
    Pursuant to section 808(2) of the Congressional Review Act (CRA), 
``any rule for which an agency for good cause finds[hellip]that notice 
and public procedure thereon are impracticable, unnecessary, or 
contrary to the public interest, shall take effect at such time as the 
Federal agency promulgating the rule determines.'' It is in the public 
interest to schedule these substances immediately because they pose a 
public health risk. This temporary scheduling action is taken pursuant 
to section 811(h), which is specifically designed to enable the DEA to 
act in an expeditious manner to avoid an imminent hazard to the public 
safety from new or designer drugs or abuse of those drugs. Section 
811(h) exempts the temporary scheduling order from standard notice and 
comment rulemaking procedures to ensure that the process moves swiftly. 
For the same reasons that underlie section 811(h), that is, the DEA's 
need to move quickly to place these substances into schedule I because 
they pose a threat to public health, it would be contrary to the public 
interest to delay implementation of the temporary scheduling order. 
Therefore, in accordance with section 808(2) of the CRA, this order 
shall take effect immediately upon its publication.

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 intends 
to order 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)(12), (13), and 
(14) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (12) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7538 (Other names: 25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
    (13) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine, its optical, positional, and geometric 
isomers, salts and salts of isomers--7537 (Other names: 25C-NBOMe; 2C-
C-NBOMe; 25C; Cimbi-82)
    (14) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7536
    (Other names: 25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)

    Dated: November 7, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-27315 Filed 11-14-13; 8:45 am]
BILLING CODE 4410-09-P