Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I, 93595-93599 [2016-30595]

Download as PDF Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations Service Bulletin 670BA–32–041, dated March 28, 2013, the installation required by paragraph (m) of this AD may be delayed until the MLG door is reinstalled in accordance with paragraph (l) of this AD. When the removed MLG door is reinstalled, the installation required by paragraph (m) of this AD must be done at the time specified in paragraph (m) of this AD or before further flight after reinstallation of the removed MLG door, whichever occurs later. 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.govfxsp0;/federalregisterfxsp0;/cfr/ibr-locations.htmlfxsp0;. (o) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE–170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516–228–7300; fax 516–794–5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE–170, FAA; or TCCA; or Bombardier, Inc.’s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature. Issued in Renton, Washington, on December 1, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. asabaliauskas on DSK3SPTVN1PROD with RULES (p) Related Information Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF–2015–30, dated December 30, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA–2016–8847. (q) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise. (i) Bombardier Service Bulletin 670BA–32– 041, dated March 28, 2013. (ii) Bombardier Service Bulletin 670BA– 32–049, dated May 26, 2015. (3) For service information identified in ˆ this AD, contact Bombardier, Inc., 400 Cote´ Vertu Road West, Dorval, Quebec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1– 866–538–1247 or direct-dial telephone 1– 514–855–2999; fax 514–855–7401; email ac.yul@aero.bombardier.com; Internet http:// www.bombardier.com. (4) You may view this service information at the FAA, Transport Airplane Directorate, VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 [FR Doc. 2016–29513 Filed 12–20–16; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–446] Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F–ADB, 5F–AMB, 5F– APINACA, ADB–FUBINACA, MDMB– CHMICA and MDMB–FUBINACA) Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Notice of intent. AGENCY: The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule six synthetic cannabinoids: methyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [5F-ADB; 5F-MDMBPINACA]; methyl 2-(1-(5-fluoropentyl)1H-indazole-3-carboxamido)-3methylbutanoate [5F-AMB]; N(adamantan-1-yl)-1-(5-fluoropentyl)-1Hindazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADBFUBINACA]; methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMBFUBINACA], into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final SUMMARY: PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 93595 order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of these synthetic cannabinoids. DATES: December 21, 2016. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: Any final order will be published in the Federal Register and may not be effective prior to January 20, 2017. Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801–971. Titles II and III are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, and are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. 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 the 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, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other 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 she E:\FR\FM\21DER1.SGM 21DER1 93596 Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2). Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. asabaliauskas on DSK3SPTVN1PROD with RULES Background Section 201(h)(4) of the CSA 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of any intention to temporarily place a substance into schedule I of the CSA.1 The Acting Administrator transmitted notice of his intent to place 5F-ADB, 5FAMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMBFUBINACA in schedule I on a temporary basis to the Assistant Secretary by letter dated April 22, 2016. The Assistant Secretary responded to this notice by letter dated May 2, 2016, and advised that based on a review by the Food and Drug Administration (FDA), there were no investigational new drug applications or approved new drug applications for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA. The Assistant Secretary also stated that the HHS had no objection to the temporary placement of 5F-ADB, 5FAMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA into schedule I of the CSA. 5F-ADB, 5FAMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA are not currently listed in any schedule under the CSA. To find that placing a substance temporarily into schedule I of the CSA 1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the Department of Health and Human Service (HHS) in carrying out the Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance’s history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). 5F-ADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA Available data and information for 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these synthetic cannabinoids (SCs) have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Synthetic Cannabinoids SCs are substances synthesized in laboratories that mimic the biological effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. It is believed that SCs were first introduced on the designer drug market in several European countries as ‘‘herbal incense’’ before the initial encounter in the United States by U.S. Customs and Border Protection (CBP) in November 2008. From 2009 to the present, misuse and abuse of SCs has increased in the United States with law enforcement encounters describing SCs applied onto plant material and in designer drug products intended for human consumption. It has been demonstrated that the substances and the associated designer drug products are abused for their psychoactive properties. With many generations of SCs having been encountered since 2009, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are some of the latest, and the abuse of these substances is negatively impacting communities. As observed by the DEA and CBP, SCs originate from foreign sources, such as PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. According to online discussion boards and law enforcement encounters, applying by spraying or mixing the SCs with plant material provides a vehicle for the most common route of administration—smoking (using a pipe, a water pipe, or rolling the drug-laced plant material in cigarette papers). 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA have no accepted medical use in the United States. Use of these specific SCs has been reported to result in adverse effects in humans including deaths (see 3-Factor document in ‘‘Supporting and Related Material’’ section). Use of other SCs has resulted in signs of addiction and withdrawal, and based on the similar pharmacological profile of these six substances, it is believed that there will be similar observed adverse effects. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are SCs that have pharmacological effects similar to the schedule I hallucinogen delta-Dtetrahydrocannabinol (THC) and temporarily and permanently controlled schedule I synthetic cannabinoid substances. In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have been associated with either overdoses requiring emergency medical intervention or death (see factor 6). With no approved medical use and limited safety or toxicological information, 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, and the abuse of these substances for their psychoactive properties is concerning. The DEA’s analysis is available in its entirety under ‘‘Supporting and Related Material’’ of the public docket for this action at www.regulations.gov under docket number DEA–443. Factor 4. History and Current Pattern of Abuse Synthetic cannabinoids have been developed over the last 30 years as tools for investigating the endocannabinoid system (e.g. determining CB1 and CB2 receptor activity). The first encounter of SCs within the United States occurred in November 2008 by CBP. Since then the popularity of SCs and their E:\FR\FM\21DER1.SGM 21DER1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations associated products has increased steadily as evidenced by law enforcement seizures, public health information, and media reports. 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA are SCs that have been recently encountered (see ‘‘Supporting and Related Material,’’ Factor 5). Multiple overdoses involving emergency medical intervention or deaths have been associated with 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA. Research and clinical reports have demonstrated that SCs are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and/or psychoactive ‘‘high,’’ believed to be similar to marijuana. Data gathered from published studies, supplemented by discussions on Internet discussion Web sites, demonstrate that these products are being abused mainly by smoking for their psychoactive properties. The adulterated products are marketed as ‘‘legal’’ alternatives to marijuana. In recent overdoses, 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMBCHMICA and MDMB-FUBINACA have been shown to be applied onto plant material, similar to the SCs that have been previously available. Law enforcement personnel have encountered various application methods including buckets or cement mixers in which plant material and one or more SCs (including 5F-ADB, 5FAMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMBFUBINACA) are mixed together, as well as large areas where the plant material is spread out so that a dissolved SC mixture can be applied directly. Once mixed, the SC plant material is then allowed to dry before manufacturers package the product for distribution, ignoring any control mechanisms to prevent contamination or to ensure a consistent, uniform concentration of the substance in each package. Adverse health consequences may also occur from directly ingesting the substance(s) during the manufacturing process. 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA, similar to other SCs, have been encountered in form of dried leaves or herbal blends. The designer drug products laced with SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMBFUBINACA, are often sold under the guise of ‘‘herbal incense’’ or ‘‘potpourri,’’ use various product names, and are routinely labeled ‘‘not for VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 human consumption.’’ Additionally, these products are marketed as a ‘‘legal high’’ or ‘‘legal alternative to marijuana’’ and are readily available over the Internet, in head shops, or sold in convenience stores. There is an incorrect assumption that these products are safe, that they are a synthetic form of marijuana, and that labeling these products as ‘‘not for human consumption’’ is a legal defense to criminal prosecution. A major concern, as reiterated by public health officials and medical professionals, is the targeting and direct marketing of SCs and SC-containing products to adolescents and youth. This is supported by law enforcement encounters and reports from emergency departments; however, all age groups have been reported by media as abusing these substances and related products. Individuals, including minors, are purchasing SCs from Internet Web sites, gas stations, convenience stores, and head shops. Factor 5. Scope, Duration and Significance of Abuse SCs, including 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMBCHMICA and MDMB-FUBINACA, continue to be encountered on the illicit market regardless of scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Numerous substances are encountered each month, differing only by small modifications intended to avoid prosecution while maintaining the pharmacological effects. Law enforcement and health care professionals continue to report abuse of these substances and their associated products. As described by the National Institute on Drug Abuse (NIDA), many substances being encountered in the illicit market, specifically SCs, have been available for years but have reentered the marketplace due to a renewed popularity. The threat of serious injury to the individual following the ingestion of 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA and other SCs persists. Numerous calls have been received by poison centers regarding the abuse of products potentially laced with SCs that have resulted in visits to emergency departments. Law enforcement continues to encounter novel SCs on the illicit market, including 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMBCHMICA and MDMB-FUBINACA (see PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 93597 factor 5 in ‘‘Supporting and Related Material’’). The following information details information obtained through NFLIS 2 (queried on November 7, 2016), including dates of first encounter, exhibits/reports, and locations. 5F-ADB: NFLIS—2,311 reports, first encountered in September 2014, locations include: Arizona, Arkansas, California, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Missouri, New Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, and Wisconsin. 5F-AMB: NFLIS—3,349 reports, first encountered in January 2014, locations include: Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming. 5F-APINACA: NFLIS—1,936 reports, first encountered in August 2012, locations include: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin, and Wyoming. ADB-FUBINACA: NFLIS—942 reports, first encountered in March 2014, locations include: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Mississippi, Missouri, New Jersey, New Mexico, New York, North Dakota, Ohio, Pennsylvania, Texas, Utah, Virginia, and Wyoming. MDMB-CHMICA: NFLIS—227 reports, first encountered in March 2015, locations include: Arkansas, Georgia, Indiana, Kentucky, Louisiana, Nevada, Ohio, Oklahoma, South Carolina, and Texas. MDMB-FUBINACA: NFLIS—507 reports, first encountered in July 2015, locations include: Arkansas, California, Colorado, Connecticut, Georgia, Idaho, 2 The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories in the United States. E:\FR\FM\21DER1.SGM 21DER1 93598 Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations Indiana, Kansas, Kentucky, Louisiana, Missouri, Nevada, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Wisconsin, and West Virginia. asabaliauskas on DSK3SPTVN1PROD with RULES Factor 6. What, if Any, Risk There Is to the Public Health 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have all been identified in overdose and/or cases involving death attributed to their abuse. Adverse health effects reported from these incidents involving 5F-ADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have included: Nausea, persistent vomiting, agitation, altered mental status, seizures, convulsions, loss of consciousness and/ or cardio toxicity. Large clusters of overdoses requiring medical care have been reported involving 5F-AMB, MDMB-FUBINACA, MDMB-CHMICA and 5F-ADB. Reported deaths involving these SCs have included 5F-ADB (8); 5F-AMB (6); 5F-APINACA (1); ADBFUBINACA (2); MDMB-CHMICA (4), European Monitoring Centre for Drugs and Drug Addiction has reported an additional 12 deaths involving MDMBCHMICA; and MDMB-FUBINACA (1) (see factor 6 in ‘‘Supporting and Related Material’’). Finding of Necessity of Schedule I Placement to Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C. 811 (h)(3), based on the available data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these substances 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 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMBCHMICA and MDMB-FUBINACA indicate that these SCs have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 22, 2016, notified the Assistant Secretary of the DEA’s intention to temporarily place these six substances in schedule I. Conclusion This notice of intent initiates a temporary scheduling action and provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h). In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule methyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [5F-ADB; 5F-MDMBPINACA]; methyl 2-(1-(5-fluoropentyl)1H-indazole-3-carboxamido)-3methylbutanoate [5F-AMB]; N(adamantan-1-yl)-1-(5-fluoropentyl)-1Hindazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADBFUBINACA]; methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMB-FUBINACA] in schedule I of the CSA, and finds that the placement of these substances into schedule I of the CSA on a temporary basis is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds that it is necessary to temporarily place these SCs into schedule I to avoid an imminent hazard to the public safety, any subsequent final order temporarily scheduling these substances will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the intention of the Administrator to issue such a final order as soon as possible after the expiration of 30 days from the date of publication of this notice. 5FADB, 5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA and MDMB-FUBINACA will then be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 activities, and chemical analysis and possession of a schedule I controlled substance. The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done ‘‘on the record after opportunity for a hearing’’ conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Regulatory Matters Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1). Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes E:\FR\FM\21DER1.SGM 21DER1 Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations that in accordance with 21 U.S.C. 811(h)(4), the Administrator will take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order. Further, the DEA believes that this temporary scheduling action is not a ‘‘rule’’ as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking. Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget. This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 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. In § 1308.11, add paragraphs (h)(23) through (28) to read as follows: ■ § 1308.11 * Schedule I * * (h) * * * * * (23) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F–ADB; 5F–MDMB–PINACA) ........................................................................... (24) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F–AMB) ....................................................................................................................... (25) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F–APINACA, 5F–AKB48) ............................................................................................................ (26) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: ADB–FUBINACA) ................................................................................ (27) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB–CHMICA, MMB–CHMINACA) ................................................................ (28) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB–FUBINACA) ............................................................................................ Dated: December 13, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016–30595 Filed 12–20–16; 8:45 am] BILLING CODE 4410–09–P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4044 Allocation of Assets in SingleEmployer Plans; Interest Assumptions for Valuing Benefits Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: This final rule amends the Pension Benefit Guaranty Corporation’s regulation on Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the asset allocation regulation for valuation dates in the first quarter of 2017. The interest assumptions are used for valuing benefits under terminating singleemployer plans covered by the pension insurance system administered by PBGC. As discussed below, PBGC has published a separate final rule document dealing with interest asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 assumptions under its regulation on Benefits Payable in Terminated SingleEmployer Plans for January 2017. DATES: Effective January 1, 2017. FOR FURTHER INFORMATION CONTACT: Deborah C. Murphy (Murphy.Deborah@ PBGC.gov), Assistant General Counsel for Regulatory Affairs, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202–326– 4400 ext. 3451. (TTY/TDD users may call the Federal relay service toll free at 1–800–877–8339 and ask to be connected to 202–326–4400 ext. 3451.) SUPPLEMENTARY INFORMATION: PBGC’s regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes actuarial assumptions—including interest assumptions—for valuing plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC’s Web site (http://www.pbgc.gov). The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. Assumptions under the asset allocation regulation are updated quarterly and are intended to reflect PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 93599 (7034) (7033) (7049) (7010) (7042) (7020) current conditions in the financial and annuity markets. This final rule updates the asset allocation interest assumptions for the first quarter (January through March) of 2017. The first quarter 2017 interest assumptions under the allocation regulation will be 1.87 percent for the first 20 years following the valuation date and 2.37 percent thereafter. In comparison with the interest assumptions in effect for the fourth quarter of 2016, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.11 percent in the select rate, and a decrease of 0.30 percent in the ultimate rate (the final rate). PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible. Because of the need to provide immediate guidance for the valuation of benefits under plans with valuation dates during the first quarter of 2017, PBGC finds that good cause exists for E:\FR\FM\21DER1.SGM 21DER1

Agencies

[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Rules and Regulations]
[Pages 93595-93599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30595]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-446]


Schedules of Controlled Substances: Temporary Placement of Six 
Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA) Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule six synthetic 
cannabinoids: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate 
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], into 
schedule I pursuant to the temporary scheduling provisions of the 
Controlled Substances Act (CSA). This action is based on a finding by 
the Administrator that the placement of these synthetic cannabinoids 
into schedule I of the Controlled Substances Act is necessary to avoid 
an imminent hazard to the public safety. Any final order will impose 
the administrative, civil, and criminal sanctions and regulatory 
controls applicable to schedule I substances under the Controlled 
Substances Act on the manufacture, distribution, possession, 
importation, exportation of, and research and conduct with, 
instructional activities of these synthetic cannabinoids.

DATES: December 21, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: Any final order will be published in the 
Federal Register and may not be effective prior to January 20, 2017.

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. 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 the 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, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other 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 she

[[Page 93596]]

finds that such action is necessary to avoid an imminent hazard to the 
public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to 
control a substance are initiated under 21 U.S.C. 811(a)(1), the 
Attorney General may extend the temporary scheduling for up to one 
year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1); 21 CFR part 1308. The Attorney General has delegated 
scheduling authority under 21 U.S.C. 811 to the Administrator of the 
DEA. 28 CFR 0.100.

Background

    Section 201(h)(4) of the CSA 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of any intention to temporarily place a substance 
into schedule I of the CSA.\1\ The Acting Administrator transmitted 
notice of his intent to place 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA in schedule I on a temporary basis to the 
Assistant Secretary by letter dated April 22, 2016. The Assistant 
Secretary responded to this notice by letter dated May 2, 2016, and 
advised that based on a review by the Food and Drug Administration 
(FDA), there were no investigational new drug applications or approved 
new drug applications for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA or MDMB-FUBINACA. The Assistant Secretary also stated that 
the HHS had no objection to the temporary placement of 5F-ADB, 5F-AMB, 
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA into schedule I 
of the CSA. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or 
MDMB-FUBINACA are not currently listed in any schedule under the CSA.
---------------------------------------------------------------------------

    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the 
Department of Health and Human Service (HHS) in carrying out the 
Secretary's scheduling responsibilities under the CSA, with the 
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the 
HHS has delegated to the Assistant Secretary for Health of the HHS 
the authority to make domestic drug scheduling recommendations. 58 
FR 35460, July 1, 1993.
---------------------------------------------------------------------------

    To find that placing a substance temporarily into schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in 21 U.S.C. 811(c): The substance's history and current pattern 
of abuse; the scope, duration and significance of abuse; and what, if 
any, risk there is to the public health. 21 U.S.C. 811(h)(3). 
Consideration of these factors includes actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).

5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA

    Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these synthetic 
cannabinoids (SCs) have a high potential for abuse, no currently 
accepted medical use in treatment in the United States, and a lack of 
accepted safety for use under medical supervision.

Synthetic Cannabinoids

    SCs are substances synthesized in laboratories that mimic the 
biological effects of delta-9-tetrahydrocannabinol (THC), the main 
psychoactive ingredient in marijuana. It is believed that SCs were 
first introduced on the designer drug market in several European 
countries as ``herbal incense'' before the initial encounter in the 
United States by U.S. Customs and Border Protection (CBP) in November 
2008. From 2009 to the present, misuse and abuse of SCs has increased 
in the United States with law enforcement encounters describing SCs 
applied onto plant material and in designer drug products intended for 
human consumption. It has been demonstrated that the substances and the 
associated designer drug products are abused for their psychoactive 
properties. With many generations of SCs having been encountered since 
2009, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA are some of the latest, and the abuse of these substances is 
negatively impacting communities.
    As observed by the DEA and CBP, SCs originate from foreign sources, 
such as China. Bulk powder substances are smuggled via common carrier 
into the United States and find their way to clandestine designer drug 
product manufacturing operations located in residential neighborhoods, 
garages, warehouses, and other similar destinations throughout the 
country. According to online discussion boards and law enforcement 
encounters, applying by spraying or mixing the SCs with plant material 
provides a vehicle for the most common route of administration--smoking 
(using a pipe, a water pipe, or rolling the drug-laced plant material 
in cigarette papers).
    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-
FUBINACA have no accepted medical use in the United States. Use of 
these specific SCs has been reported to result in adverse effects in 
humans including deaths (see 3-Factor document in ``Supporting and 
Related Material'' section). Use of other SCs has resulted in signs of 
addiction and withdrawal, and based on the similar pharmacological 
profile of these six substances, it is believed that there will be 
similar observed adverse effects.
    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA are SCs that have pharmacological effects similar to the 
schedule I hallucinogen delta-[Delta]-tetrahydrocannabinol (THC) and 
temporarily and permanently controlled schedule I synthetic cannabinoid 
substances. In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have been associated with 
either overdoses requiring emergency medical intervention or death (see 
factor 6). With no approved medical use and limited safety or 
toxicological information, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, 
and the abuse of these substances for their psychoactive properties is 
concerning. The DEA's analysis is available in its entirety under 
``Supporting and Related Material'' of the public docket for this 
action at www.regulations.gov under docket number DEA-443.

Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids have been developed over the last 30 years 
as tools for investigating the endocannabinoid system (e.g. determining 
CB1 and CB2 receptor activity). The first encounter of SCs within the 
United States occurred in November 2008 by CBP. Since then the 
popularity of SCs and their

[[Page 93597]]

associated products has increased steadily as evidenced by law 
enforcement seizures, public health information, and media reports. 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 
are SCs that have been recently encountered (see ``Supporting and 
Related Material,'' Factor 5). Multiple overdoses involving emergency 
medical intervention or deaths have been associated with 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.
    Research and clinical reports have demonstrated that SCs are 
applied onto plant material so that the material may be smoked as users 
attempt to obtain a euphoric and/or psychoactive ``high,'' believed to 
be similar to marijuana. Data gathered from published studies, 
supplemented by discussions on Internet discussion Web sites, 
demonstrate that these products are being abused mainly by smoking for 
their psychoactive properties. The adulterated products are marketed as 
``legal'' alternatives to marijuana. In recent overdoses, 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been 
shown to be applied onto plant material, similar to the SCs that have 
been previously available.
    Law enforcement personnel have encountered various application 
methods including buckets or cement mixers in which plant material and 
one or more SCs (including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA) are mixed together, as well as large 
areas where the plant material is spread out so that a dissolved SC 
mixture can be applied directly. Once mixed, the SC plant material is 
then allowed to dry before manufacturers package the product for 
distribution, ignoring any control mechanisms to prevent contamination 
or to ensure a consistent, uniform concentration of the substance in 
each package. Adverse health consequences may also occur from directly 
ingesting the substance(s) during the manufacturing process. 5F-ADB, 
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, 
similar to other SCs, have been encountered in form of dried leaves or 
herbal blends.
    The designer drug products laced with SCs, including 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, are often 
sold under the guise of ``herbal incense'' or ``potpourri,'' use 
various product names, and are routinely labeled ``not for human 
consumption.'' Additionally, these products are marketed as a ``legal 
high'' or ``legal alternative to marijuana'' and are readily available 
over the Internet, in head shops, or sold in convenience stores. There 
is an incorrect assumption that these products are safe, that they are 
a synthetic form of marijuana, and that labeling these products as 
``not for human consumption'' is a legal defense to criminal 
prosecution.
    A major concern, as reiterated by public health officials and 
medical professionals, is the targeting and direct marketing of SCs and 
SC-containing products to adolescents and youth. This is supported by 
law enforcement encounters and reports from emergency departments; 
however, all age groups have been reported by media as abusing these 
substances and related products. Individuals, including minors, are 
purchasing SCs from Internet Web sites, gas stations, convenience 
stores, and head shops.

Factor 5. Scope, Duration and Significance of Abuse

    SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA, continue to be encountered on the illicit 
market regardless of scheduling actions that attempt to safeguard the 
public from the adverse effects and safety issues associated with these 
substances. Numerous substances are encountered each month, differing 
only by small modifications intended to avoid prosecution while 
maintaining the pharmacological effects. Law enforcement and health 
care professionals continue to report abuse of these substances and 
their associated products.
    As described by the National Institute on Drug Abuse (NIDA), many 
substances being encountered in the illicit market, specifically SCs, 
have been available for years but have reentered the marketplace due to 
a renewed popularity.
    The threat of serious injury to the individual following the 
ingestion of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and 
MDMB-FUBINACA and other SCs persists. Numerous calls have been received 
by poison centers regarding the abuse of products potentially laced 
with SCs that have resulted in visits to emergency departments. Law 
enforcement continues to encounter novel SCs on the illicit market, 
including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and 
MDMB-FUBINACA (see factor 5 in ``Supporting and Related Material'').
    The following information details information obtained through 
NFLIS \2\ (queried on November 7, 2016), including dates of first 
encounter, exhibits/reports, and locations.
---------------------------------------------------------------------------

    \2\ The National Forensic Laboratory Information System (NFLIS) 
is a national drug forensic laboratory reporting system that 
systematically collects results from drug chemistry analyses 
conducted by state and local forensic laboratories in the United 
States.
---------------------------------------------------------------------------

    5F-ADB: NFLIS--2,311 reports, first encountered in September 2014, 
locations include: Arizona, Arkansas, California, Florida, Georgia, 
Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Missouri, New 
Jersey, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, 
Texas, Virginia, and Wisconsin.
    5F-AMB: NFLIS--3,349 reports, first encountered in January 2014, 
locations include: Arizona, Arkansas, California, Colorado, Florida, 
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, 
Nebraska, New Hampshire, New Jersey, New Mexico, New York, North 
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, 
Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming.
    5F-APINACA: NFLIS--1,936 reports, first encountered in August 2012, 
locations include: Alabama, Arizona, Arkansas, California, Colorado, 
Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, 
Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, 
Nebraska, New Hampshire, New Jersey, North Dakota, Ohio, Oklahoma, 
Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, 
Virginia, West Virginia, Wisconsin, and Wyoming.
    ADB-FUBINACA: NFLIS--942 reports, first encountered in March 2014, 
locations include: Arkansas, California, Colorado, Florida, Georgia, 
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, 
Mississippi, Missouri, New Jersey, New Mexico, New York, North Dakota, 
Ohio, Pennsylvania, Texas, Utah, Virginia, and Wyoming.
    MDMB-CHMICA: NFLIS--227 reports, first encountered in March 2015, 
locations include: Arkansas, Georgia, Indiana, Kentucky, Louisiana, 
Nevada, Ohio, Oklahoma, South Carolina, and Texas.
    MDMB-FUBINACA: NFLIS--507 reports, first encountered in July 2015, 
locations include: Arkansas, California, Colorado, Connecticut, 
Georgia, Idaho,

[[Page 93598]]

Indiana, Kansas, Kentucky, Louisiana, Missouri, Nevada, New Jersey, New 
Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, 
Wisconsin, and West Virginia.

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

    5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA have all been identified in overdose and/or cases involving 
death attributed to their abuse. Adverse health effects reported from 
these incidents involving 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and/or MDMB-FUBINACA have included: Nausea, persistent 
vomiting, agitation, altered mental status, seizures, convulsions, loss 
of consciousness and/or cardio toxicity. Large clusters of overdoses 
requiring medical care have been reported involving 5F-AMB, MDMB-
FUBINACA, MDMB-CHMICA and 5F-ADB. Reported deaths involving these SCs 
have included 5F-ADB (8); 5F-AMB (6); 5F-APINACA (1); ADB-FUBINACA (2); 
MDMB-CHMICA (4), European Monitoring Centre for Drugs and Drug 
Addiction has reported an additional 12 deaths involving MDMB-CHMICA; 
and MDMB-FUBINACA (1) (see factor 6 in ``Supporting and Related 
Material'').
Finding of Necessity of Schedule I Placement to Avoid Imminent Hazard 
to Public Safety
    In accordance with 21 U.S.C. 811 (h)(3), based on the available 
data and information summarized above, the continued uncontrolled 
manufacture, distribution, importation, exportation, conduct of 
research and chemical analysis, possession, and abuse of 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA pose an 
imminent hazard to the public safety. The DEA is not aware of any 
currently accepted medical uses for these substances 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that 
these SCs 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 Administrator, through a 
letter dated April 22, 2016, notified the Assistant Secretary of the 
DEA's intention to temporarily place these six substances in schedule 
I.
Conclusion
    This notice of intent initiates a temporary scheduling action and 
provides the 30-day notice pursuant to section 201(h) of the CSA, 21 
U.S.C. 811(h). In accordance with the provisions of section 201(h) of 
the CSA, 21 U.S.C. 811(h), the Administrator considered available data 
and information, herein sets forth the grounds for his determination 
that it is necessary to temporarily schedule methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 
5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and 
methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [MDMB-FUBINACA] in schedule I of the CSA, and finds 
that the placement of these substances into schedule I of the CSA on a 
temporary basis is necessary to avoid an imminent hazard to the public 
safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place these SCs into schedule I to avoid an imminent hazard 
to the public safety, any subsequent final order temporarily scheduling 
these substances will be effective on the date of publication in the 
Federal Register, and will be in effect for a period of two years, with 
a possible extension of one additional year, pending completion of the 
regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It 
is the intention of the Administrator to issue such a final order as 
soon as possible after the expiration of 30 days from the date of 
publication of this notice. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, 
MDMB-CHMICA and MDMB-FUBINACA will then be subject to the regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, importation, exportation, research, 
conduct of instructional activities, and chemical analysis and 
possession of a schedule I controlled substance.
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).
Regulatory Matters
    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an 
expedited temporary scheduling action where such action is necessary to 
avoid an imminent hazard to the public safety. As provided in this 
subsection, the Attorney General may, by order, schedule a substance in 
schedule I on a temporary basis. Such an order may not be issued before 
the expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary. 21 U.S.C. 811(h)(1).
    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued, the DEA believes that the notice 
and comment requirements of section 553 of the Administrative Procedure 
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the 
alternative, even assuming that this notice of intent might be subject 
to section 553 of the APA, the Administrator finds that there is good 
cause to forgo the notice and comment requirements of section 553, as 
any further delays in the process for issuance of temporary scheduling 
orders would be impracticable and contrary to the public interest in 
view of the manifest urgency to avoid an imminent hazard to the public 
safety.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of section 553 of the APA, the DEA notes

[[Page 93599]]

that in accordance with 21 U.S.C. 811(h)(4), the Administrator will 
take into consideration any comments submitted by the Assistant 
Secretary with regard to the proposed temporary scheduling order.
    Further, the DEA believes that this temporary scheduling action is 
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act (RFA). 
The requirements for the preparation of an initial regulatory 
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as 
here, the DEA is not required by section 553 of the APA or any other 
law to publish a general notice of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget.
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

List of Subjects in 21 CFR Part 1308

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

    For the reasons set out above, the DEA amends 21 CFR part 1308 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. In Sec.  1308.11, add paragraphs (h)(23) through (28) to read as 
follows:


Sec.  1308.11   Schedule I

* * * * *
    (h) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
(23) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                  (7034)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: 5F-ADB; 5F-MDMB-PINACA)..........
(24) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                  (7033)
 carboxamido)-3-methylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: 5F-AMB)..........................
(25) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-         (7049)
 carboxamide, its optical, positional, and geometric
 isomers, salts and salts of isomers (Other names: 5F-
 APINACA, 5F-AKB48).....................................
(26) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-               (7010)
 fluorobenzyl)-1H-indazole-3-carboxamide, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: ADB-FUBINACA)....................
(27) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-                  (7042)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: MDMB-CHMICA, MMB-CHMINACA).......
(28) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-                  (7020)
 carboxamido)-3,3-dimethylbutanoate, its optical,
 positional, and geometric isomers, salts and salts of
 isomers (Other names: MDMB-FUBINACA)...................
------------------------------------------------------------------------


    Dated: December 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-30595 Filed 12-20-16; 8:45 am]
BILLING CODE 4410-09-P