Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I, 51154-51158 [2017-24010]

Download as PDF 51154 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations (2) The merits of the proceeding if all parties known to be interested in the proceeding have been given notice and an opportunity to participate. A memorandum of any such discussion shall be included in the record of the proceeding. (c) No interested person outside the Department shall make or knowingly cause to be made to an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding, an ex parte communication relevant to the merits of the proceeding except as provided in paragraph (a) of this section. (d) If an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding receives or makes or knowingly causes to be made a communication prohibited by this section, the Department shall place on the public record of the proceeding: (1) All such written communications; (2) Memoranda stating the substance of all such oral communications; and (3) All written responses, and memoranda, stating the substance of all oral responses thereto. (e) Upon receipt of a communication knowingly made or knowingly caused to be made by a party in violation of this section, the Department may, to the extent consistent with the interest of justice and the policy of the underlying statute, require the party to show cause why his claim or interest in the proceeding should not be dismissed, denied, disregarded, or otherwise adversely affected on account of such violation. (f) This section does not constitute authority to withhold information from Congress. after due consideration of the record, issue the final decision in the proceeding. (b) The Secretary may issue a tentative decision in which event the parties shall be afforded an opportunity to file exceptions before the issuance of the final decision. Stephen Alexander Vaden, Principal Deputy General Counsel, Office of the General Counsel. [FR Doc. 2017–23877 Filed 11–2–17; 8:45 am] BILLING CODE 3410–90–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–472] Schedules of Controlled Substances: Temporary Placement of FUB–AMB Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Temporary amendment; temporary scheduling order. AGENCY: In addition to the documents or papers required or authorized by the foregoing provisions of this subpart to be filed with the hearing clerk, the hearing clerk shall receive for filing and shall have custody of all papers, reports, records, orders, and other documents which relate to the administration of any order and which the Secretary is required to issue or to approve. The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoid, methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3methylbutanoate [FUB–AMB, MMB– FUBINACA, AMB–FUBINACA], and its optical, positional, and geometric isomers, salts, and salts of isomers into schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into schedule I of the Controlled Substances Act 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, FUB– AMB. § 1.819 DATES: jstallworth on DSKBBY8HB2PROD with RULES § 1.818 Additional documents to be filed with hearing clerk. Hearing before Secretary. (a) The Secretary may act in the place and stead of a Judge in any proceeding herein. When the Secretary so acts, the hearing clerk shall transmit the record to the Secretary at the expiration of the period provided for the filing of proposed findings of fact, conclusions, and orders, and the Secretary shall then, VerDate Sep<11>2014 15:05 Nov 02, 2017 Jkt 244001 SUMMARY: This temporary scheduling order is effective November 3, 2017, until November 4, 2019. If this order is extended or made permanent, the DEA will publish a document in the Federal Register. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: Legal Authority Section 201 of the Controlled Substances Act (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)(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 1 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). 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 his intention to temporarily place a substance into schedule I of the CSA.2 The Acting Administrator transmitted notice of his intent to place FUB–AMB into schedule I on a temporary basis to the Assistant Secretary for Health by letter dated May 19, 2017. The Assistant Secretary responded to this notice by letter dated June 9, 2017, and advised that based on a review by the Food and Drug Administration (FDA), there were no active investigational new drug applications or approved new drug 1 Though DEA has used the term ‘‘final order’’ with respect to temporary scheduling orders in the past, this notification adheres to the statutory language of 21 U.S.C. 811(h), which refers to a ‘‘temporary scheduling order.’’ No substantive change is intended. 2 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. E:\FR\FM\03NOR1.SGM 03NOR1 jstallworth on DSKBBY8HB2PROD with RULES Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations applications for FUB–AMB. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of FUB–AMB into 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). FUB–AMB is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for FUB–AMB under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of FUB–AMB in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule FUB–AMB was published in the Federal Register on September 11, 2017. 82 FR 42624. 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 section 201(c) of the CSA, 21 U.S.C. 811(c): The substance’s history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for FUB–AMB, summarized below, indicate that this synthetic cannabinoid (SC) has 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. The DEA’s three-factor analysis and the Assistant Secretary’s June 9, 2017 letter are available in their entirety under the tab ‘‘Supporting Documents’’ of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA–2017–0010 (Docket Number DEA–472). FUB–AMB The illicit use of the synthetic cannabinoid (SC) methyl 2-(1-(4fluorobenzyl)-1H-indazole-3carboxamido)-3-methylbutanoate (Street names: FUB–AMB, MMB–FUBINACA, VerDate Sep<11>2014 15:05 Nov 02, 2017 Jkt 244001 51155 AMB–FUBINACA) has dramatically increased over the past 12 months posing an imminent threat to public safety. FUB–AMB has emerged on the designer drug market, and the abuse of this substance for its psychoactive properties is concerning. 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, FUB–AMB is one 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). FUB–AMB has no accepted medical use in the United States. Use of this specific SC has been reported (see factor 6) to result in adverse effects in humans. Use of other SCs has resulted in signs of addiction and withdrawal and based on the similar pharmacological profile of FUB–AMB, it is believed that there will be similar observed adverse effects. FUB–AMB is a SC that has pharmacological effects similar to the Schedule I hallucinogen THC and other temporarily and permanently controlled Schedule I synthetic cannabinoid substances. In addition, the misuse of FUB–AMB has been associated with multiple overdoses requiring emergency medical intervention (see factor 6). With no approved medical use and limited safety or toxicological information, Factor 4. History and Current Pattern of Abuse Synthetic cannabinoids have been developed by researchers 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 associated products has increased steadily as evidenced by law enforcement seizures, public health information, and media reports. FUB–AMB was originally encountered in 2014, but has since seen a large increase in its illicit use. The misuse of FUB–AMB has been associated with multiple overdoses involving emergency medical intervention. 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 a published study, and supplemented by discussions on Internet 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, FUB– AMB has been encountered in the form of herbal products, similar to the SCs that have been previously available. The powder form of SCs is typically dissolved in solvents (e.g., acetone) before being applied to plant material or dissolved in a propellant intended for use in electronic cigarette devices. Law enforcement personnel have encountered various application methods including buckets or cement mixers in which plant material and one or more SCs 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 drug during the manufacturing process. FUB–AMB, similar to other SCs, has been encountered in the form of dried leave or herbal blends. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\03NOR1.SGM 03NOR1 51156 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations jstallworth on DSKBBY8HB2PROD with RULES The designer drug products laced with SCs, including FUB–AMB, 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. It is believed most abusers of SCs or SC-related products are smoking the product following application to plant material. Law enforcement has also begun to encounter new variations of SCs in liquid form. It is believed abusers have been applying the liquid to hookahs or ‘‘e-cigarettes,’’ which allows the user to administer a vaporized liquid that can be inhaled. Factor 5. Scope, Duration and Significance of Abuse SCs including FUB–AMB 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. Novel 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 the 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 FUB–AMB and other SCs persists. The following information details information obtained through NFLIS 3 (queried on May 16, 2017), including dates of first encounter, exhibits/reports, and locations. FUB–AMB: NFLIS–6,522 reports, first encountered in June 2014, locations include: Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, 3 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. VerDate Sep<11>2014 15:05 Nov 02, 2017 Jkt 244001 Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming. Factor 6. What, if Any, Risk There Is to the Public Health FUB–AMB has been identified in overdose cases attributed to its abuse. Adverse health effects reported from these incidents involving FUB–AMB have included: Nausea, persistent vomiting, agitation, altered mental status, seizures, convulsions, loss of consciousness, and cardiotoxicity. By sharing pharmacological similarities with Schedule I substances (D9–THC, JWH–018 and other temporarily and permanently controlled schedule I SCs), SCs pose a risk to the abuser. While these adverse effects have been shown by a variety of SCs, similar concerns remain regarding the welfare of the user as it relates to abuse of products laced with FUB–AMB. The risk of adverse health effects is further increased by the fact that similar products vary in the composition and concentration of SCs applied on the plant 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 FUB– AMB poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for FUB–AMB 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 FUB–AMB indicate that this SC has 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 May 19, 2017, notified the Assistant Secretary of the PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 DEA’s intention to temporarily place FUB–AMB in Schedule I. A notice of intent was subsequently published in the Federal Register on September 11, 2017. 82 FR 42624. Conclusion 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, and herein set forth the grounds for his determination that it is necessary to temporarily schedule methyl 2-(1-(4fluorobenzyl)-1H-indazole-3carboxamido)-3-methylbutanoate [FUB– AMB, MMB–FUBINACA, AMB– FUBINACA] into schedule I of the CSA to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this SC into schedule I of the CSA to avoid an imminent hazard to the public safety, this temporary order scheduling this substance is effective on the date of publication in the Federal Register, and is 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). The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent 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 permanent 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 permanent 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). Requirements for Handling Upon the effective date of this final order, FUB–AMB will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, E:\FR\FM\03NOR1.SGM 03NOR1 jstallworth on DSKBBY8HB2PROD with RULES Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, FUB–AMB 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, as of November 3, 2017. Any person who currently handles FUB–AMB and is not registered with the DEA, must submit an application for registration and may not continue to handle FUB–AMB as of November 3, 2017, unless the DEA has approved that application for registration. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after November 3, 2017 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA. 2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle FUB– AMB must surrender all quantities of currently held FUB–AMB. 3. Security. FUB–AMB is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71– 1301.93, as of November 3, 2017. 4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of FUB–AMB must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from November 3, 2017, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of FUB– AMB on the effective date of this order, must take an inventory of all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, 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. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including FUB– AMB) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records. All DEA registrants must maintain records with respect to FUB– AMB pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312, 1317 and § 1307.11. Current DEA registrants VerDate Sep<11>2014 15:05 Nov 02, 2017 Jkt 244001 authorized to handle FUB–AMB shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 7. Reports. All DEA registrants who manufacture or distribute FUB–AMB must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of November 3, 2017. 8. Order Forms. All DEA registrants who distribute FUB–AMB must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of November 3, 2017. 9. Importation and Exportation. All importation and exportation of FUB– AMB must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of November 3, 2017. 10. Quota. Only DEA registered manufacturers may manufacture FUB– AMB in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of November 3, 2017. 11. Liability. Any activity involving FUB–AMB not authorized by, or in violation of the CSA, occurring as of November 3, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Matters Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 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 the Administrative Procedure Act (APA) at 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 5 U.S.C. 553, 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 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 51157 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 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 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. As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the CRA, ‘‘any rule for which an agency for good cause finds 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.’’ 5 U.S.C. 808(2). It is in the public interest to schedule this substance immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 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. 21 U.S.C. 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 21 U.S.C. 811(h), that is, the need to move quickly to place this substance into schedule I because it poses an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order E:\FR\FM\03NOR1.SGM 03NOR1 51158 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Rules and Regulations shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801–808, because as noted above, this action is an order, not a rule. 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), 956(b), unless otherwise noted. 2. Amend § 1308.11 by adding paragraph (h)(18) to read as follows: ■ § 1308.11 Schedule I. * * * * * (h) * * * (18) methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: FUB–AMB, MMB–FUBINACA, AMB–FUBINACA) (7021) * * * * * Dated: October 27, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017–24010 Filed 11–2–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG–2017–0979] Drawbridge Operation Regulation; Kent Island Narrows, Grasonville, MD Coast Guard, DHS. Notice of deviation from drawbridge regulation. jstallworth on DSKBBY8HB2PROD with RULES AGENCY: ACTION: The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. Route 50/ 301 (Kent Narrows) Bridge across the Kent Island Narrows, mile 1.0, at SUMMARY: VerDate Sep<11>2014 15:05 Nov 02, 2017 Jkt 244001 Grasonville, MD. The deviation is necessary to facilitate a routine inspection. This deviation allows the bridge to remain in the closed-tonavigation position. DATES: This deviation is effective from 9 a.m. on November 7, 2017, to 3 p.m. on November 9, 2017. ADDRESSES: The docket for this deviation [USCG–2017–0979] is available at https://www.regulations.gov. Type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH’’. Click on Open Docket Folder on the line associated with this deviation. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary deviation, call or email Mr. Mickey Sanders, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398–6587, email Mickey.D.Sanders2@uscg.mil. SUPPLEMENTARY INFORMATION: The Maryland State Highway Administration, owner and operator of the U.S. Route 50/301 (Kent Narrows) Bridge across the Kent Island Narrows, mile 1.0, at Grasonville, MD, has requested a temporary deviation from the current operating schedule to accommodate a routine inspection. The bridge has a vertical clearance of 18 feet above mean high water (MHW) in the closed position. The current operating schedule is set out in 33 CFR 117.561. Under this temporary deviation, the bridge will require 30 minutes advanced notice to open from 9 a.m. on November 7, 2017, to 3 p.m. on November 9, 2017. The Kent Island Narrows is used by a variety of vessels including small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with waterway users in publishing this temporary deviation. Vessels able to pass through the bridge in the closed position may do so if at least 15 minutes notice is given. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by this temporary deviation. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of this effective period of this temporary deviation. This deviation PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 from the operating regulations is authorized under 33 CFR 117.35. Dated: October 31, 2017. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District. [FR Doc. 2017–24028 Filed 11–2–17; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Parts 61 and 62 RIN 2900–AQ07 Homeless Veterans Department of Veterans Affairs. Final rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) is amending its regulations that govern homeless veterans to conform to recent statutory requirements. VA is amending the definition of homeless veterans by including veterans who would otherwise be ineligible to receive certain benefits because of their length of service or type of discharge from the Armed Forces. This rule will also increase the payment of per diem in cases where homeless veterans are placed in transitional housing that will become permanent housing. This final rule is an essential part of VA’s attempts to eliminate homelessness among the veteran population. DATES: This final rule is effective December 4, 2017. FOR FURTHER INFORMATION CONTACT: Guy Liedke, guy.liedke@va.gov, Program Analyst, Grant/Per Diem Program, (673/ GPD), VA National Grant and Per Diem Program Office, 10770 N. 46th Street, Suite C–200, Tampa, FL 33617, (877) 332–0334. (This is a toll-free number.) SUPPLEMENTARY INFORMATION: In an effort to reduce homelessness in the veteran population, Congress has required VA to expand its definition of veteran as it applies to benefits for homeless veterans. See Public Law 114– 315, sec. 701, 702, and 703 (Dec. 16, 2016). This new definition will remove restrictions on length of military service for a homeless veteran receiving certain benefits from VA, as well as authorize certain benefits for veterans with types of discharges from the Armed Forces that would normally bar an individual from receiving VA benefits. Congress also required VA to increase the per diem payments for transitional housing assistance that will become permanent housing for homeless veterans. See Public Law 114–315, sec. 711 (Dec. 16, SUMMARY: E:\FR\FM\03NOR1.SGM 03NOR1

Agencies

[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Rules and Regulations]
[Pages 51154-51158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24010]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-472]


Schedules of Controlled Substances: Temporary Placement of FUB-
AMB Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary amendment; temporary scheduling order.

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

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to schedule the synthetic 
cannabinoid, methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], and its optical, 
positional, and geometric isomers, salts, and salts of isomers into 
schedule I. This action is based on a finding by the Administrator that 
the placement of this synthetic cannabinoid into schedule I of the 
Controlled Substances Act 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, reverse distribute, import, export, engage in 
research, conduct instructional activities or chemical analysis, or 
possess), or propose to handle, FUB-AMB.

DATES: This temporary scheduling order is effective November 3, 2017, 
until November 4, 2019. If this order is extended or made permanent, 
the DEA will publish a document in the Federal Register.

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

SUPPLEMENTARY INFORMATION: 

Legal Authority

    Section 201 of the Controlled Substances Act (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)(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 \1\ for up to one year. 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------

    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notification adheres 
to the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
---------------------------------------------------------------------------

    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). 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 his intention to temporarily place a substance 
into schedule I of the CSA.\2\ The Acting Administrator transmitted 
notice of his intent to place FUB-AMB into schedule I on a temporary 
basis to the Assistant Secretary for Health by letter dated May 19, 
2017. The Assistant Secretary responded to this notice by letter dated 
June 9, 2017, and advised that based on a review by the Food and Drug 
Administration (FDA), there were no active investigational new drug 
applications or approved new drug

[[Page 51155]]

applications for FUB-AMB. The Assistant Secretary also stated that the 
HHS has no objection to the temporary placement of FUB-AMB into 
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). FUB-
AMB is not currently listed in any schedule under the CSA, and no 
exemptions or approvals are in effect for FUB-AMB under section 505 of 
the FDCA, 21 U.S.C. 355. The DEA has found that the control of FUB-AMB 
in schedule I on a temporary basis is necessary to avoid an imminent 
hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), 
a notice of intent to temporarily schedule FUB-AMB was published in the 
Federal Register on September 11, 2017. 82 FR 42624.
---------------------------------------------------------------------------

    \2\ 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 section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's 
history and current pattern of abuse; the scope, duration and 
significance of abuse; and what, if any, risk there is to the public 
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes 
actual abuse, diversion from legitimate channels, and clandestine 
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).
    Available data and information for FUB-AMB, summarized below, 
indicate that this synthetic cannabinoid (SC) has 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. The DEA's three-factor analysis and the Assistant 
Secretary's June 9, 2017 letter are available in their entirety under 
the tab ``Supporting Documents'' of the public docket of this action at 
www.regulations.gov under FDMS Docket ID: DEA-2017-0010 (Docket Number 
DEA-472).

FUB-AMB

    The illicit use of the synthetic cannabinoid (SC) methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (Street 
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) has dramatically increased 
over the past 12 months posing an imminent threat to public safety.

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, FUB-AMB is one 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).
    FUB-AMB has no accepted medical use in the United States. Use of 
this specific SC has been reported (see factor 6) to result in adverse 
effects in humans. Use of other SCs has resulted in signs of addiction 
and withdrawal and based on the similar pharmacological profile of FUB-
AMB, it is believed that there will be similar observed adverse 
effects.
    FUB-AMB is a SC that has pharmacological effects similar to the 
Schedule I hallucinogen THC and other temporarily and permanently 
controlled Schedule I synthetic cannabinoid substances. In addition, 
the misuse of FUB-AMB has been associated with multiple overdoses 
requiring emergency medical intervention (see factor 6). With no 
approved medical use and limited safety or toxicological information, 
FUB-AMB has emerged on the designer drug market, and the abuse of this 
substance for its psychoactive properties is concerning.

Factor 4. History and Current Pattern of Abuse

    Synthetic cannabinoids have been developed by researchers 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 associated products has increased 
steadily as evidenced by law enforcement seizures, public health 
information, and media reports. FUB-AMB was originally encountered in 
2014, but has since seen a large increase in its illicit use. The 
misuse of FUB-AMB has been associated with multiple overdoses involving 
emergency medical intervention.
    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 a published study, and 
supplemented by discussions on Internet 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, FUB-AMB has 
been encountered in the form of herbal products, similar to the SCs 
that have been previously available.
    The powder form of SCs is typically dissolved in solvents (e.g., 
acetone) before being applied to plant material or dissolved in a 
propellant intended for use in electronic cigarette devices. Law 
enforcement personnel have encountered various application methods 
including buckets or cement mixers in which plant material and one or 
more SCs 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 drug during the 
manufacturing process. FUB-AMB, similar to other SCs, has been 
encountered in the form of dried leave or herbal blends.

[[Page 51156]]

    The designer drug products laced with SCs, including FUB-AMB, 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.
    It is believed most abusers of SCs or SC-related products are 
smoking the product following application to plant material. Law 
enforcement has also begun to encounter new variations of SCs in liquid 
form. It is believed abusers have been applying the liquid to hookahs 
or ``e-cigarettes,'' which allows the user to administer a vaporized 
liquid that can be inhaled.

Factor 5. Scope, Duration and Significance of Abuse

    SCs including FUB-AMB 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. Novel 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 the 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 FUB-AMB and other SCs persists.
    The following information details information obtained through 
NFLIS \3\ (queried on May 16, 2017), including dates of first 
encounter, exhibits/reports, and locations.
---------------------------------------------------------------------------

    \3\ 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.
---------------------------------------------------------------------------

    FUB-AMB: NFLIS-6,522 reports, first encountered in June 2014, 
locations include: Arizona, Arkansas, California, Colorado, Florida, 
Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, 
Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New 
Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, 
Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, 
Utah, Virginia, Wisconsin and Wyoming.

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

    FUB-AMB has been identified in overdose cases attributed to its 
abuse. Adverse health effects reported from these incidents involving 
FUB-AMB have included: Nausea, persistent vomiting, agitation, altered 
mental status, seizures, convulsions, loss of consciousness, and 
cardiotoxicity. By sharing pharmacological similarities with Schedule I 
substances ([Delta]9-THC, JWH-018 and other temporarily and permanently 
controlled schedule I SCs), SCs pose a risk to the abuser. While these 
adverse effects have been shown by a variety of SCs, similar concerns 
remain regarding the welfare of the user as it relates to abuse of 
products laced with FUB-AMB. The risk of adverse health effects is 
further increased by the fact that similar products vary in the 
composition and concentration of SCs applied on the plant 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 FUB-AMB poses 
an imminent hazard to the public safety. The DEA is not aware of any 
currently accepted medical uses for FUB-AMB 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 FUB-AMB indicate that this SC has 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 May 19, 2017, 
notified the Assistant Secretary of the DEA's intention to temporarily 
place FUB-AMB in Schedule I.
    A notice of intent was subsequently published in the Federal 
Register on September 11, 2017. 82 FR 42624.

Conclusion

    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, and herein set forth the grounds for his determination 
that it is necessary to temporarily schedule methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [FUB-AMB, 
MMB-FUBINACA, AMB-FUBINACA] into schedule I of the CSA to avoid an 
imminent hazard to the public safety.
    Because the Administrator hereby finds it necessary to temporarily 
place this SC into schedule I of the CSA to avoid an imminent hazard to 
the public safety, this temporary order scheduling this substance is 
effective on the date of publication in the Federal Register, and is 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).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Permanent 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 permanent 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 permanent 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).

Requirements for Handling

    Upon the effective date of this final order, FUB-AMB will be 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, engagement in research, and 
conduct of instructional activities or chemical analysis with, and 
possession of schedule I controlled substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports,

[[Page 51157]]

engages in research, or conducts instructional activities or chemical 
analysis with, or possesses), or who desires to handle, FUB-AMB 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, as of November 3, 2017. Any person who currently handles FUB-
AMB and is not registered with the DEA, must submit an application for 
registration and may not continue to handle FUB-AMB as of November 3, 
2017, unless the DEA has approved that application for registration. 
Retail sales of schedule I controlled substances to the general public 
are not allowed under the CSA. Possession of any quantity of this 
substance in a manner not authorized by the CSA on or after November 3, 
2017 is unlawful and those in possession of any quantity of this 
substance may be subject to prosecution pursuant to the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle FUB-AMB must 
surrender all quantities of currently held FUB-AMB.
    3. Security. FUB-AMB is subject to schedule I security requirements 
and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), 
and in accordance with 21 CFR 1301.71-1301.93, as of November 3, 2017.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of FUB-AMB must be in compliance with 21 U.S.C. 
825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA 
registrants shall have 30 calendar days from November 3, 2017, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
FUB-AMB on the effective date of this order, must take an inventory of 
all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 
958, 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. 
After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including FUB-AMB) on hand on a 
biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to FUB-AMB pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 
21 CFR parts 1304 and 1312, 1317 and Sec.  1307.11. Current DEA 
registrants authorized to handle FUB-AMB shall have 30 calendar days 
from the effective date of this order to be in compliance with all 
recordkeeping requirements.
    7. Reports. All DEA registrants who manufacture or distribute FUB-
AMB must submit reports pursuant to 21 U.S.C. 827 and in accordance 
with 21 CFR parts 1304 and 1312 as of November 3, 2017.
    8. Order Forms. All DEA registrants who distribute FUB-AMB must 
comply with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of November 3, 2017.
    9. Importation and Exportation. All importation and exportation of 
FUB-AMB must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in 
accordance with 21 CFR part 1312 as of November 3, 2017.
    10. Quota. Only DEA registered manufacturers may manufacture FUB-
AMB in accordance with a quota assigned pursuant to 21 U.S.C. 826 and 
in accordance with 21 CFR part 1303 as of November 3, 2017.
    11. Liability. Any activity involving FUB-AMB not authorized by, or 
in violation of the CSA, occurring as of November 3, 2017, is unlawful, 
and may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 
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 the Administrative Procedure Act (APA) at 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 5 
U.S.C. 553, 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.
    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 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.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the CRA, ``any rule 
for which an agency for good cause finds 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.'' 5 U.S.C. 808(2). It is in the 
public interest to schedule this substance immediately to avoid an 
imminent hazard to the public safety. This temporary scheduling action 
is taken pursuant to 21 U.S.C. 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. 21 U.S.C. 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 21 U.S.C. 811(h), that is, the need to move quickly to place 
this substance into schedule I because it poses an imminent hazard to 
public safety, it would be contrary to the public interest to delay 
implementation of the temporary scheduling order. Therefore, this order

[[Page 51158]]

shall take effect immediately upon its publication.
    The DEA has submitted a copy of this temporary order to both Houses 
of Congress and to the Comptroller General, although such filing is not 
required under the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Congressional Review Act), 5 U.S.C. 801-808, because as noted 
above, this action is an order, not a rule.

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), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.11 by adding paragraph (h)(18) to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (h) * * *
    (18) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-
methylbutanoate, its optical, positional, and geometric isomers, salts 
and salts of isomers (Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) 
(7021)
* * * * *


    Dated: October 27, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-24010 Filed 11-2-17; 8:45 am]
BILLING CODE 4410-09-P
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