Schedules of Controlled Substances: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I, 49504-49508 [2017-23206]

Download as PDF 49504 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations years, must justify such requests, for example by proposing development, environmental, and recreation enhancements in a license amendment application accompanied by a request that the Commission extend their license term.21 III. Document Availability 21. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC’s Home Page (http:// www.ferc.gov) and in FERC’s Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC 20426. 22. From FERC’s Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. User assistance is available for eLibrary and the Commission’s Web site during normal business hours from FERC Online Support at 202–502–6652 (toll free at 1–866–208–3676) or email at ferconlinesupport@ferc.gov, or the Public Reference Room at (202) 502– 8371, TTY (202)502–8659. Email the Public Reference Room at public.referenceroom@ferc.gov. By the Commission. Issued: October 19, 2017. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2017–23286 Filed 10–25–17; 8:45 am] ethrower on DSK3G9T082PROD with RULES BILLING CODE 6717–01–P 21 See, e.g., Idaho Power Co., 132 FERC ¶ 62,001 (2010) (10-year extension of the license term due to the costs of replacing the project’s existing powerhouse and increasing generating capacity); PPL Holtwood, LLC, 129 FERC ¶ 62,092 (2009) (16year extension of license term due to costs associated with the constructing a new powerhouse, installing two turbine generating units at the existing powerhouse, and various environmental measures). VerDate Sep<11>2014 18:08 Oct 25, 2017 Jkt 244001 DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–473] Schedules of Controlled Substances: Temporary Placement of orthoFluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Temporary amendment; temporary scheduling order. AGENCY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioids, N-(2fluorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1phenethylpiperidin-4-yl)-Nphenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2methoxy-N-(1-phenethylpiperidin-4-yl)N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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, orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl. DATES: This temporary scheduling order is effective October 26, 2017, until October 28, 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: SUMMARY: Legal Authority Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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 Administrator transmitted notice of his intent to place ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in Schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter. Notice for these actions was transmitted on the following dates: May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl). The Assistant Secretary responded by letters dated June 9, 2017 (ortho-fluorofentanyl) and July 14, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for ortho1 Though DEA has used the term ‘‘final order’’ with respect to temporary scheduling orders in the past, this document 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 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\26OCR1.SGM 26OCR1 ethrower on DSK3G9T082PROD with RULES Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl 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). ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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 issue a temporary order to schedule orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl was published in the Federal Register on September 12, 2017. 82 FR 42754. 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 into 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, summarized below, indicate that these synthetic opioids 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. The DEA’s three-factor analysis, and the Assistant VerDate Sep<11>2014 18:08 Oct 25, 2017 Jkt 244001 Secretary’s June 9, 2017 and July 14, 2017 letters 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–2017–0005 (Docket Number DEA–473). Factor 4. History and Current Pattern of Abuse The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. orthoFluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have recently been encountered by law enforcement and public health officials. Adverse health effects and outcomes are demonstrated by fatal overdose cases involving these substances. The documented adverse health effects of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are consistent with those of other opioids. On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on June 19, 2017. STARLiMS registered four reports containing ortho-fluorofentanyl from California and five reports containing tetrahydrofuranyl fentanyl from Florida and Missouri. According to STARLiMS, the first laboratory submissions of orthofluorofentanyl and tetrahydrofuranyl fentanyl occurred in April 2016, and March 2017, respectively. 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 other federal, state, and local forensic laboratories across the country. Data from NFLIS was queried on June 20, 2017. NFLIS registered three reports containing ortho-fluorofentanyl from state or local forensic laboratories in Virginia.3 According to NFLIS, the first report of ortho-fluorofentanyl was reported in September 2016. NFLIS registered two reports containing tetrahydrofuranyl fentanyl from state or local forensic laboratories in New Jersey and was first 3 Data are still being collected for March 2017– June 2017 due to the normal lag period for labs reporting to NFLIS. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 49505 reported in January 2017. The identification of methoxyacetyl fentanyl in drug evidence submitted in April 2017 was reported to DEA from a local laboratory in Ohio.4 The DEA is not aware of any laboratory identifications of ortho-fluorofentanyl prior to 2016 or identifications of tetrahydrofuranyl fentanyl or methoxyacetyl fentanyl prior to 2017. Evidence suggests that the pattern of abuse of fentanyl analogues, including ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been encountered in powder form similar to fentanyl and heroin and have been connected to fatal overdoses. Factor 5. Scope, Duration and Significance of Abuse Reports collected by the DEA demonstrate ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are being abused for their opioid properties. Abuse of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have resulted in mortality (see DEA 3-Factor Analysis for full discussion). The DEA collected post-mortem toxicology and medical examiner reports on 13 confirmed fatalities associated with orthofluorofentanyl which occurred in Georgia (1), North Carolina (11), and Texas (1), two confirmed fatalities associated with tetrahydrofuranyl fentanyl which occurred in New Jersey (1) and Wisconsin (1), and two confirmed fatalities associated with methoxyacetyl fentanyl which occurred in Pennsylvania. It is likely that the prevalence of these substances in opioid related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate fentanyl analogues from fentanyl. ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been identified in drug evidence collected by law enforcement. NFLIS and STARLiMS have a total of seven drug reports in which ortho-fluorofentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 from law enforcement encounters in California and Virginia and seven drug reports in which tetrahydrofuranyl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2017 from law 4 Email from Cuyahoga County Medical Examiner’s Office, to DEA (May 8, 2017 02:29 p.m. EST) (on file with DEA). E:\FR\FM\26OCR1.SGM 26OCR1 49506 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations ethrower on DSK3G9T082PROD with RULES enforcement encounters in Florida, Missouri, and New Jersey. The identification of methoxyacetyl fentanyl in drug evidence submitted in April 2017 was reported to DEA from Ohio. The population likely to abuse orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl, and other fentanyl-related substances. This is evidenced by the routes of drug administration and drug use history documented in orthofluorofentanyl and tetrahydrofuranyl fentanyl fatal overdose cases. Because abusers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are likely to obtain these substances through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e. use a drug for the first time) ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.). Factor 6. What, if Any, Risk There Is to the Public Health ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl exhibit pharmacological profiles similar to that of fentanyl and other m-opioid receptor agonists. The toxic effects of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in humans are demonstrated by overdose fatalities involving these substances. Abusers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl may not know the origin, identity, or purity of these substances, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on information received by the DEA, the misuse and abuse of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl lead to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are high. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. VerDate Sep<11>2014 18:08 Oct 25, 2017 Jkt 244001 ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been associated with numerous fatalities. At least 13 confirmed overdose deaths involving ortho-fluorofentanyl abuse have been reported from Georgia (1), North Carolina (11), and Texas (1). At least two confirmed overdose deaths involving tetrahydrofuranyl fentanyl have been reported from New Jersey (1) and Wisconsin (1). At least two confirmed overdose deaths involving methoxyacetyl fentanyl have been repored from Pennsylvania. As the data demonstrate, the potential for fatal and non-fatal overdoses exists for orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl and these substances pose an imminent hazard to the public safety. 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, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl indicate that these substances 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 letters dated May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), notified the Assistant Secretary of the DEA’s intention to temporarily place these substances in Schedule I. A notice of intent was subsequently published in PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 the Federal Register on September 12, 2017. 82 FR 42754. 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, herein sets forth the grounds for his determination that it is necessary to temporarily schedule orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I of the CSA, and finds that placement of these synthetic opioids into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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 temporary order, ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl will become 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: E:\FR\FM\26OCR1.SGM 26OCR1 ethrower on DSK3G9T082PROD with RULES Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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 October 26, 2017. Any person who currently handles ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl as of October 26, 2017, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of Schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of these substances in a manner not authorized by the CSA on or after October 26, 2017 is unlawful and those in possession of any quantity of these substances 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, must surrender all quantities of currently held ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl. 3. Security. ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are 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 October 26, 2017. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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 October 26, 2017, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl on the effective date of this order must take VerDate Sep<11>2014 18:08 Oct 25, 2017 Jkt 244001 an inventory of all stocks of these substances 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 orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl) 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 orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and § 1307.11. Current DEA registrants 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 orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of October 26, 2017. 8. Order Forms. All DEA registrants who distribute ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of October 26, 2017. 9. Importation and Exportation. All importation and exportation of orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of October 26, 2017. 10. Quota. Only DEA registered manufacturers may manufacture orthofluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of October 26, 2017. 11. Liability. Any activity involving ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl not authorized by, or in violation of the CSA, occurring as of October 26, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 49507 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 5 U.S.C. 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. 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 E:\FR\FM\26OCR1.SGM 26OCR1 49508 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations 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 Congressional Review Act, ‘‘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 these substances 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 DEA’s need to move quickly to place these substances into Schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order 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. In § 1308.11, add reserved paragraphs (h)(15) through (18) and paragraphs (h)(19), (20), and (21) to read as follows: ■ § 1308.11 * Schedule I. * * (h) * * * * * (19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl) ..................................................................................................... (20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: tetrahydrofuranyl fentanyl) .................................................................................................... (21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: methoxyacetyl fentanyl) .............................................................................................................................. Dated: October 17, 2017. Robert W. Patterson, Acting Administrator. Applicability Date: The corrections to §§ 1.1.871–15, 1.871–15T, 1.1441– 1(e)(5)(v)(B)(4), (e)(6), and (f)(5), 1.1441– 2, 1.1441–7, and 1.1461–1 are applicable on January 19, 2017. FOR FURTHER INFORMATION CONTACT: D. Peter Merkel or Karen Walny at 202– 317–6938 (not a toll-free number). SUPPLEMENTARY INFORMATION: [FR Doc. 2017–23206 Filed 10–25–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9815] RIN 1545–BM33 Dividend Equivalents From Sources Within the United States; Correction Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and temporary regulations; Correcting amendments. AGENCY: This document contains corrections to final and temporary regulations (TD TD 9815), which were published in the Federal Register on Tuesday, January 24, 2017. DATES: Effective Date: These corrections are effective October 26, 2017. ethrower on DSK3G9T082PROD with RULES SUMMARY: Need for Correction As published, TD 9815 contains errors that may prove to be misleading and are in need of clarification. § 1.871–15(a)(14)(ii)(B) ...................................... § 1.871–15(l)(1), second sentence ..................... § 1.871–15(q)(1) ELI.More ........................................................... described in this paragraph (l) ......................... qualified intermediary agreement .................... Income taxes, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments: Paragraph 1. The authority citation for part 1 continues to read in part as follows: ■ Authority: 26 U.S.C. 7805 * * * § 1.871–15 [Amended] Par. 2. Section 1.871–15 is amended by: ■ 1. Removing paragraph (r)(2). ■ 2. Redesignating paragraphs (r)(3), (4), and (5), as (r)(2), (3), and (4), respectively. ■ § 1.871–15 [Amended] Par. 3. For each section listed in the table, remove the language in the ‘‘Remove’’ column and add in its place the language in the ‘‘Add’’ column as set forth below: ■ Remove 18:08 Oct 25, 2017 Jkt 244001 (9825) PART 1—INCOME TAXES Section VerDate Sep<11>2014 (9843) List of Subjects in 26 CFR Part 1 Background The final and temporary regulations that are the subject of these corrections are §§ 1.871–15, 1.871–15T, 1.1441–1, 1.1441–2, 1.1441–7, and 1.1461–1, promulgated under sections 871(m) and 7805 of the Internal Revenue Code. These regulations affect foreign persons that hold certain financial products providing for payments that are contingent upon or determined by reference to U.S. source dividends, as well withholding agents with respect to dividend equivalents and certain other parties to section 871(m) transactions and their agents. (9816) PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 Add ELI. More described in this paragraph (l)(1) qualified intermediary withholding agreement E:\FR\FM\26OCR1.SGM 26OCR1

Agencies

[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Rules and Regulations]
[Pages 49504-49508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23206]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-473]


Schedules of Controlled Substances: Temporary Placement of ortho-
Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl 
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 
opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide 
(ortho-fluorofentanyl or 2-fluorofentanyl), N-(1-phenethylpiperidin-4-
yl)-N-phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), 
and 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 
(methoxyacetyl fentanyl), into Schedule I. This action is based on a 
finding by the Administrator that the placement of ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
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, ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.

DATES: This temporary scheduling order is effective October 26, 2017, 
until October 28, 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 document 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 Administrator transmitted notice of 
his intent to place ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, 
and methoxyacetyl fentanyl in Schedule I on a temporary basis to the 
Assistant Secretary for Health of HHS by letter. Notice for these 
actions was transmitted on the following dates: May 19, 2017 (ortho-
fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and 
methoxyacetyl fentanyl). The Assistant Secretary responded by letters 
dated June 9, 2017 (ortho-fluorofentanyl) and July 14, 2017 
(tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), and advised 
that based on review by the Food and Drug Administration (FDA), there 
are currently no investigational new drug applications or approved new 
drug applications for ortho-

[[Page 49505]]

fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl. 
The Assistant Secretary also stated that the HHS has no objection to 
the temporary placement of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, or methoxyacetyl fentanyl 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). ortho-Fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are not 
currently listed in any schedule under the CSA, and no exemptions or 
approvals are in effect for ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl under section 505 of the FDCA, 21 
U.S.C. 355. The DEA has found that the control of ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 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 issue a temporary order to schedule ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl was published in 
the Federal Register on September 12, 2017. 82 FR 42754.
---------------------------------------------------------------------------

    \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 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 into 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 ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, summarized 
below, indicate that these synthetic opioids 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. The DEA's three-factor analysis, and the Assistant 
Secretary's June 9, 2017 and July 14, 2017 letters 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-
2017-0005 (Docket Number DEA-473).

Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-like substances continues to be 
a significant concern. These substances are distributed to users, often 
with unpredictable outcomes. ortho-Fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl have recently been encountered by 
law enforcement and public health officials. Adverse health effects and 
outcomes are demonstrated by fatal overdose cases involving these 
substances. The documented adverse health effects of ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
are consistent with those of other opioids.
    On October 1, 2014, the DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) to replace the 
System to Retrieve Information from Drug Evidence (STRIDE) as its 
laboratory drug evidence data system of record. DEA laboratory data 
submitted after September 30, 2014, are reposited in STARLiMS. Data 
from STRIDE and STARLiMS were queried on June 19, 2017. STARLiMS 
registered four reports containing ortho-fluorofentanyl from California 
and five reports containing tetrahydrofuranyl fentanyl from Florida and 
Missouri. According to STARLiMS, the first laboratory submissions of 
ortho-fluorofentanyl and tetrahydrofuranyl fentanyl occurred in April 
2016, and March 2017, respectively.
    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 other 
federal, state, and local forensic laboratories across the country. 
Data from NFLIS was queried on June 20, 2017. NFLIS registered three 
reports containing ortho-fluorofentanyl from state or local forensic 
laboratories in Virginia.\3\ According to NFLIS, the first report of 
ortho-fluorofentanyl was reported in September 2016. NFLIS registered 
two reports containing tetrahydrofuranyl fentanyl from state or local 
forensic laboratories in New Jersey and was first reported in January 
2017. The identification of methoxyacetyl fentanyl in drug evidence 
submitted in April 2017 was reported to DEA from a local laboratory in 
Ohio.\4\ The DEA is not aware of any laboratory identifications of 
ortho-fluorofentanyl prior to 2016 or identifications of 
tetrahydrofuranyl fentanyl or methoxyacetyl fentanyl prior to 2017.
---------------------------------------------------------------------------

    \3\ Data are still being collected for March 2017-June 2017 due 
to the normal lag period for labs reporting to NFLIS.
    \4\ Email from Cuyahoga County Medical Examiner's Office, to DEA 
(May 8, 2017 02:29 p.m. EST) (on file with DEA).
---------------------------------------------------------------------------

    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl have been encountered in powder 
form similar to fentanyl and heroin and have been connected to fatal 
overdoses.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are being abused 
for their opioid properties. Abuse of ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have resulted in 
mortality (see DEA 3-Factor Analysis for full discussion). The DEA 
collected post-mortem toxicology and medical examiner reports on 13 
confirmed fatalities associated with ortho-fluorofentanyl which 
occurred in Georgia (1), North Carolina (11), and Texas (1), two 
confirmed fatalities associated with tetrahydrofuranyl fentanyl which 
occurred in New Jersey (1) and Wisconsin (1), and two confirmed 
fatalities associated with methoxyacetyl fentanyl which occurred in 
Pennsylvania. It is likely that the prevalence of these substances in 
opioid related emergency room admissions and deaths is underreported as 
standard immunoassays may not differentiate fentanyl analogues from 
fentanyl.
    ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl have been identified in drug evidence collected by law 
enforcement. NFLIS and STARLiMS have a total of seven drug reports in 
which ortho-fluorofentanyl was identified in drug exhibits submitted to 
forensic laboratories in 2016 from law enforcement encounters in 
California and Virginia and seven drug reports in which 
tetrahydrofuranyl fentanyl was identified in drug exhibits submitted to 
forensic laboratories in 2017 from law

[[Page 49506]]

enforcement encounters in Florida, Missouri, and New Jersey. The 
identification of methoxyacetyl fentanyl in drug evidence submitted in 
April 2017 was reported to DEA from Ohio.
    The population likely to abuse ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl overlaps with 
the population abusing prescription opioid analgesics, heroin, 
fentanyl, and other fentanyl-related substances. This is evidenced by 
the routes of drug administration and drug use history documented in 
ortho-fluorofentanyl and tetrahydrofuranyl fentanyl fatal overdose 
cases. Because abusers of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl are likely to obtain these 
substances through unregulated sources, the identity, purity, and 
quantity are uncertain and inconsistent, thus posing significant 
adverse health risks to the end user. Individuals who initiate (i.e. 
use a drug for the first time) ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, or methoxyacetyl fentanyl abuse are likely to be at risk of 
developing substance use disorder, overdose, and death similar to that 
of other opioid analgesics (e.g., fentanyl, morphine, etc.).

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

    ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl exhibit pharmacological profiles similar to that of fentanyl 
and other [micro]-opioid receptor agonists. The toxic effects of ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
in humans are demonstrated by overdose fatalities involving these 
substances. Abusers of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl may not know the origin, identity, 
or purity of these substances, thus posing significant adverse health 
risks when compared to abuse of pharmaceutical preparations of opioid 
analgesics, such as morphine and oxycodone.
    Based on information received by the DEA, the misuse and abuse of 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl lead to the same qualitative public health risks as heroin, 
fentanyl and other opioid analgesic substances. As with any non-
medically approved opioid, the health and safety risks for users are 
high. The public health risks attendant to the abuse of heroin and 
opioid analgesics are well established and have resulted in large 
numbers of drug treatment admissions, emergency department visits, and 
fatal overdoses.
    ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl have been associated with numerous fatalities. At least 13 
confirmed overdose deaths involving ortho-fluorofentanyl abuse have 
been reported from Georgia (1), North Carolina (11), and Texas (1). At 
least two confirmed overdose deaths involving tetrahydrofuranyl 
fentanyl have been reported from New Jersey (1) and Wisconsin (1). At 
least two confirmed overdose deaths involving methoxyacetyl fentanyl 
have been repored from Pennsylvania. As the data demonstrate, the 
potential for fatal and non-fatal overdoses exists for ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
and these substances pose an imminent hazard to the public safety.

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, reverse distribution, importation, 
exportation, conduct of research and chemical analysis, possession, and 
abuse of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl poses an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl 
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 ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl indicate that 
these substances 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 
letters dated May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 
(tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), notified the 
Assistant Secretary of the DEA's intention to temporarily place these 
substances in Schedule I. A notice of intent was subsequently published 
in the Federal Register on September 12, 2017. 82 FR 42754.

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, herein sets forth the grounds for his determination that 
it is necessary to temporarily schedule ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I 
of the CSA, and finds that placement of these synthetic opioids into 
Schedule I of the CSA is necessary to avoid an imminent hazard to the 
public safety.
    Because the Administrator hereby finds it necessary to temporarily 
place these synthetic opioids into Schedule I to avoid an imminent 
hazard to the public safety, this temporary order scheduling ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
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 temporary order, ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
will become 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:

[[Page 49507]]

    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl 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 October 26, 
2017. Any person who currently handles ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, and is not 
registered with the DEA, must submit an application for registration 
and may not continue to handle ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl as of October 26, 2017, unless the 
DEA has approved that application for registration pursuant to 21 
U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 
1312. Retail sales of Schedule I controlled substances to the general 
public are not allowed under the CSA. Possession of any quantity of 
these substances in a manner not authorized by the CSA on or after 
October 26, 2017 is unlawful and those in possession of any quantity of 
these substances 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 ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, 
must surrender all quantities of currently held ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.
    3. Security. ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl are 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 October 26, 2017.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl 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 October 26, 2017, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl on the effective date of this order must take an inventory of 
all stocks of these substances 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 ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl) 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR parts 1304, and 1312, 1317 and Sec.  1307.11. Current DEA 
registrants 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 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312 as of October 26, 2017.
    8. Order Forms. All DEA registrants who distribute ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of October 26, 2017.
    9. Importation and Exportation. All importation and exportation of 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and 
in accordance with 21 CFR part 1312 as of October 26, 2017.
    10. Quota. Only DEA registered manufacturers may manufacture ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 as of October 26, 2017.
    11. Liability. Any activity involving ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl not authorized 
by, or in violation of the CSA, occurring as of October 26, 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 5 U.S.C. 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. 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

[[Page 49508]]

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 Congressional 
Review Act, ``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 these substances 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 DEA's need to 
move quickly to place these substances into Schedule I because it poses 
an imminent hazard to the public safety, it would be contrary to the 
public interest to delay implementation of the temporary scheduling 
order. Therefore, this order 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. In Sec.  1308.11, add reserved paragraphs (h)(15) through (18) and 
paragraphs (h)(19), (20), and (21) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-                (9816)
 yl)propionamide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other names: ortho-
 fluorofentanyl, 2-fluorofentanyl)..........................
(20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-     (9843)
 carboxamide, its isomers, esters, ethers, salts and salts
 of isomers, esters and ethers (Other name:
 tetrahydrofuranyl fentanyl)................................
(21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-                   (9825)
 phenylacetamide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other name:
 methoxyacetyl fentanyl)....................................
 


    Dated: October 17, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-23206 Filed 10-25-17; 8:45 am]
BILLING CODE 4410-09-P