Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I, 32453-32457 [2017-14880]

Download as PDF Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the initial agreement still pertain and no cause for suspension of the agreement exists. (19 CFR 12.104g(a)). On July 12, 2016, the Department of State received a request by the Republic of Cyprus to extend the Agreement. The Department of State proposed to extend the import restrictions for an additional five years in a notice published in the Federal Register (81 FR 52946) on August 10, 2016. On March 22, 2017, the Assistant Secretary for Educational and Cultural Affairs, State Department, after consultation with and recommendations by the Cultural Property Advisory Committee, determined that the cultural heritage of Cyprus continues to be in jeopardy from pillage of certain archaeological objects and certain ethnological materials and that the import restrictions should be extended for an additional five-year period to July 16, 2022. Diplomatic notes have been exchanged reflecting the extension of those restrictions for an additional five-year period. Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions. The Amended Designated List of archaeological objects and Byzantine and post-Byzantine ecclesiastical and ritual ethnological materials is set forth in CBP Dec. 12–13. The herein mentioned Agreements and the Designated List and amended Designated Lists may be found at the following Web site address: https:// eca.state.gov/cultural-heritage-center/ cultural-property-protection/bilateralagreements by clicking on ‘‘Cyprus.’’ The restrictions on the importation of these archaeological, and ecclesiastical and ritual ethnological materials from Cyprus are to continue in effect through July 16, 2022. Importation of such materials from Cyprus continues to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met. Inapplicability of Notice and Delayed Effective Date This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). In addition, CBP has determined that such notice or public procedure would be impracticable and contrary to the public interest because the action being taken is essential to avoid interruption of the application of the existing import restrictions (5 U.S.C. VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 553(b)(B)). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3). DEPARTMENT OF JUSTICE Regulatory Flexibility Act 21 CFR Part 1308 Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. 32453 [Docket No. DEA–460] Executive Orders 12866 and 13771 Because this rule involves a foreign affairs function of the United States, it is not subject to either Executive Order 12866 or Executive Order 13771. Signing Authority This regulation is being issued in accordance with 19 CFR 0.1(a)(1). List of Subjects in 19 CFR Part 12 Cultural property, Customs duties and inspection, Imports, Prohibited merchandise. Amendment to CBP Regulations For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below: PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general authority citation for part 12 and the specific authority citation for § 12.104g continue to read as follows: ■ Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624; * * * * * Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612; * * § 12.104g * * * [Amended] 2. In § 12.104g, paragraph (a), the table is amended in the entry for ‘‘Cyprus’’ by adding the words ‘‘extended by CBP Dec. 17–07’’ after the words ‘‘CBP Dec. 12–13’’ in the column headed ‘‘Decision No.’’. ■ Kevin K. McAleenan, Acting Commissioner, U.S. Customs and Border Protection. Approved: July 11, 2017. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. 2017–14822 Filed 7–13–17; 8:45 am] BILLING CODE 9111–14–P PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 Drug Enforcement Administration Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Temporary scheduling order. AGENCY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl 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, acryl fentanyl. DATES: This temporary scheduling order is effective July 14, 2017, until July 15, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence. 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 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 E:\FR\FM\14JYR1.SGM 14JYR1 32454 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations 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. mstockstill on DSK30JT082PROD with RULES Background Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.2 The Administrator transmitted the notice of intent to place acryl fentanyl into Schedule I on a temporary basis to the Assistant Secretary by letter dated April 17, 2017. The Assistant Secretary responded to this notice by letter dated May 2, 2017, 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 acryl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acryl 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). Acryl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of acryl 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. 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. 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. VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 811(h)(1)(A), a notice of intent to issue a temporary order to schedule acryl fentanyl was published in the Federal Register on June 2, 2017. 82 FR 25564. 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 acryl fentanyl, summarized below, indicate that this synthetic opioid 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 May 2, 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–2017–0005 (Docket Number DEA–460). 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. Acryl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. The documented negative effects of acryl 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 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on May 5, 2017. STARLiMS registered 36 reports containing acryl fentanyl, from Alabama, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, South Carolina, Tennessee, Texas, and West Virginia. According to STARLiMS, the first laboratory submission of acryl fentanyl occurred in July 2016 in Texas. 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. NFLIS registered 74 reports containing acryl fentanyl from state or local forensic laboratories in Arkansas, California, Connecticut, Iowa, Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin (query date: May 5, 2017).3 The first report of acryl fentanyl was reported in Wisconsin in May 2016. The DEA is not aware of any laboratory identifications of acryl fentanyl prior to 2016. Evidence suggests that the pattern of abuse of fentanyl analogues, including acryl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of acryl fentanyl have been encountered in powder form, in solution, and packaged similar to that of heroin. Acryl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, 4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has been connected to fatal overdoses, in which insufflation and intravenous routes of administration were documented. Factor 5. Scope, Duration and Significance of Abuse Reports collected by the DEA demonstrate acryl fentanyl is being abused for its opioid properties. This abuse of acryl fentanyl has resulted in morbidity and mortality (see DEA 3Factor Analysis for full discussion). The DEA has received reports for at least 83 confirmed fatalities associated with acryl fentanyl. Information on these deaths, occurring as early as September 2016, was collected by the DEA from post-mortem toxicology and medical examiner reports. These deaths were reported from, and occurred in, Illinois (27), Maryland (22), New Jersey (1), 3 Data are still being collected for February 2017– April 2017 due to the normal lag period for labs reporting to NFLIS. E:\FR\FM\14JYR1.SGM 14JYR1 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a total of 110 drug reports in which acryl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 and 2017 from law enforcement encounters in Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, and Wisconsin. It is likely that the prevalence of acryl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this substance from fentanyl. The population likely to abuse acryl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl, and other fentanylrelated substances. This is evidenced by the routes of drug administration and drug use history documented in acryl fentanyl fatal overdose cases and encounters of the substance by law enforcement officials. Because abusers of acryl fentanyl are likely to obtain this substance 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) acryl 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.). mstockstill on DSK30JT082PROD with RULES Factor 6. What, if Any, Risk There Is to the Public Health Acryl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other m-opioid receptor agonists. The toxic effects of acryl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of acryl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on information reviewed by the DEA, the misuse and abuse of acryl fentanyl leads 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 VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 drug treatment admissions, emergency department visits, and fatal overdoses. Acryl fentanyl has been associated with numerous fatalities. At least 83 confirmed overdose deaths involving acryl fentanyl abuse have been reported from Illinois, Maryland, New Jersey, Ohio, and Pennsylvania in 2016 and 2017. As the data demonstrates, the potential for fatal and non-fatal overdoses exists for acryl fentanyl; thus, acryl fentanyl poses 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 data and information summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of acryl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into 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 acryl fentanyl indicate that this substance 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 April 17, 2017, notified the Assistant Secretary of the DEA’s intention to temporarily place this substance into Schedule I. A notice of intent was subsequently published in the Federal Register on June 2, 2017. 82 FR 25564. 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 acryl fentanyl into Schedule I of the CSA, and finds that placement of this synthetic opioid into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 32455 Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling acryl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). 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, acryl 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: 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, acryl 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 July 14, 2017. Any person who currently handles acryl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acryl fentanyl as of July 14, 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 E:\FR\FM\14JYR1.SGM 14JYR1 mstockstill on DSK30JT082PROD with RULES 32456 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations 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 July 14, 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 acryl fentanyl, must surrender all quantities of currently held acryl fentanyl. 3. Security. Acryl fentanyl 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 July 14, 2017. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acryl 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 July 14, 2017, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of acryl fentanyl 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 acryl 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 acryl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 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 acryl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of July 14, 2017. 8. Order Forms. All DEA registrants who distribute acryl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of July 14, 2017. VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 9. Importation and Exportation. All importation and exportation of acryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of July 14, 2017. 10. Quota. Only DEA registered manufacturers may manufacture acryl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of July 14, 2017. 11. Liability. Any activity involving acryl fentanyl not authorized by, or in violation of the CSA, occurring as of July 14, 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. PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. 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 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 DEA’s need to move quickly to place this substance 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, E:\FR\FM\14JYR1.SGM 14JYR1 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations Reporting and recordkeeping requirements. PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES ■ For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: ■ 1. The authority citation for part 1308 continues to read as follows: § 1308.11 Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Amend § 1308.11 by adding paragraph (h)(17) to read as follows: * Schedule I * * (h) * * * * * (17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: acryl fentanyl, acryloylfentanyl) ................................................................................................................ * * * * those mixtures that do not qualify for automatic exemption. DATES: Effective date: August 14, 2017. 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: * Dated: July 10, 2017. Chuck Rosenberg Acting Administrator. [FR Doc. 2017–14880 Filed 7–13–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA–379] RIN 1117–ZA04 Designation of AlphaPhenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: The Drug Enforcement Administration (DEA) is finalizing the designation of the chemical alphaphenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2propanone or P2P), methamphetamine, and amphetamine. This rulemaking finalizes, without change, the control of APAAN as a list I chemical. This action does not establish a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, shall be regulated. In addition, chemical mixtures containing APAAN are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of APAAN shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for SUMMARY: mstockstill on DSK30JT082PROD with RULES 32457 VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 Legal Authority The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I or list II chemicals. 21 U.S.C. 802 (34) and (35). A ‘‘list I chemical’’ is a chemical that is used in manufacturing a controlled substance in violation of title II of the CSA, and is important to the manufacture of the controlled substance. 21 U.S.C. 802(34). A ‘‘list II chemical’’ is a chemical (other than a list I chemical) that is used in manufacturing a controlled substance in violation of title II of the CSA. 21 U.S.C. 802(35). The current list of all listed chemicals is published at 21 CFR 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to designate list I and list II chemicals to the Administrator of the Drug Enforcement Administration. In addition, the United States is a Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention). When the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention pursuant to article 12, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion. In addition, the 1988 Convention requires the United States to take other specified measures related to that chemical, including measures related to its international trade. Background By a letter dated April 9, 2014, the Secretary-General of the United Nations informed the United States Government that the chemical alpha- PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 (9811) phenylacetoacetonitrile (APAAN) was added to Table I of the 1988 Convention. This letter was prompted by a March 19, 2014, decision at the 57th Session of the United Nations Commission on Narcotic Drugs (CND) to add APAAN to Table I. As a Party to the 1988 Convention, the United States is obligated, pursuant to article 12, to take measures it deems appropriate to monitor the manufacture and distribution of APAAN within the United States and to prevent its diversion. Article 12 also obligates the United States to take other specified measures related to APAAN, including measures related to its international trade. By designating APAAN, which is a primary precursor for the manufacture of phenylacetone (also known as phenyl-2-propanone (P2P) or benzyl methyl ketone), methamphetamine, and amphetamine, as a list I chemical, the United States will fulfill its obligations under the 1988 Convention. Designation of APAAN and Its Salts, Optical Isomers, and Salts of Optical Isomers as a List I Chemical On December 12, 2016, DEA published a Notice of Proposed Rulemaking (NPRM) proposing control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2propanone or P2P), methamphetamine, and amphetamine. 81 FR 89402. In response to the NPRM, only one comment was received. This comment was supportive of the DEA’s proposed control of APAAN. As such, this rulemaking finalizes the control of APAAN as a list I chemical. On the effective date of this final rule, handlers of APAAN shall be subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of APAAN can make a significant amount of P2P, this action does not establish a threshold for domestic and import transactions of APAAN in accordance with the provisions of 21 CFR 1310.04(g). Therefore, all APAAN transactions, regardless of size, will be regulated E:\FR\FM\14JYR1.SGM 14JYR1

Agencies

[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Rules and Regulations]
[Pages 32453-32457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14880]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-460]


Schedules of Controlled Substances: Temporary Placement of Acryl 
Fentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary scheduling order.

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

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to schedule the synthetic 
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl 
fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts 
and salts of isomers, esters, and ethers, into Schedule I. This action 
is based on a finding by the Administrator that the placement of acryl 
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, 
acryl fentanyl.

DATES: This temporary scheduling order is effective July 14, 2017, 
until July 15, 2019, unless it is extended for an additional year or a 
permanent scheduling proceeding is completed. The DEA will publish a 
document in the Federal Register announcing an extension or permanence.

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

[[Page 32454]]

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 the notice 
of intent to place acryl fentanyl into Schedule I on a temporary basis 
to the Assistant Secretary by letter dated April 17, 2017. The 
Assistant Secretary responded to this notice by letter dated May 2, 
2017, 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 acryl fentanyl. The 
Assistant Secretary also stated that the HHS has no objection to the 
temporary placement of acryl 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). Acryl fentanyl is not currently listed 
in any schedule under the CSA, and no exemptions or approvals are in 
effect for acryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. 
The DEA has found that the control of acryl 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 acryl fentanyl was published in 
the Federal Register on June 2, 2017. 82 FR 25564.
---------------------------------------------------------------------------

    \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 acryl fentanyl, summarized 
below, indicate that this synthetic opioid 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 May 2, 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-2017-0005 (Docket Number 
DEA-460).

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. Acryl fentanyl has recently been 
encountered by law enforcement and public health officials and the 
adverse health effects and outcomes are demonstrated by fatal overdose 
cases. The documented negative effects of acryl 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 May 5, 2017. STARLiMS 
registered 36 reports containing acryl fentanyl, from Alabama, 
Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, 
Missouri, North Carolina, South Carolina, Tennessee, Texas, and West 
Virginia. According to STARLiMS, the first laboratory submission of 
acryl fentanyl occurred in July 2016 in Texas.
    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. 
NFLIS registered 74 reports containing acryl fentanyl from state or 
local forensic laboratories in Arkansas, California, Connecticut, Iowa, 
Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin 
(query date: May 5, 2017).\3\ The first report of acryl fentanyl was 
reported in Wisconsin in May 2016. The DEA is not aware of any 
laboratory identifications of acryl fentanyl prior to 2016.
---------------------------------------------------------------------------

    \3\ Data are still being collected for February 2017-April 2017 
due to the normal lag period for labs reporting to NFLIS.
---------------------------------------------------------------------------

    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including acryl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of acryl fentanyl have been encountered in 
powder form, in solution, and packaged similar to that of heroin. Acryl 
fentanyl has been encountered as a single substance as well as in 
combination with other substances of abuse, including heroin, fentanyl, 
4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has 
been connected to fatal overdoses, in which insufflation and 
intravenous routes of administration were documented.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate acryl fentanyl is being 
abused for its opioid properties. This abuse of acryl fentanyl has 
resulted in morbidity and mortality (see DEA 3-Factor Analysis for full 
discussion). The DEA has received reports for at least 83 confirmed 
fatalities associated with acryl fentanyl. Information on these deaths, 
occurring as early as September 2016, was collected by the DEA from 
post-mortem toxicology and medical examiner reports. These deaths were 
reported from, and occurred in, Illinois (27), Maryland (22), New 
Jersey (1),

[[Page 32455]]

Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a total of 110 
drug reports in which acryl fentanyl was identified in drug exhibits 
submitted to forensic laboratories in 2016 and 2017 from law 
enforcement encounters in Alabama, Arkansas, California, Connecticut, 
Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Missouri, 
North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, 
West Virginia, and Wisconsin. It is likely that the prevalence of acryl 
fentanyl in opioid analgesic-related emergency room admissions and 
deaths is underreported as standard immunoassays may not differentiate 
this substance from fentanyl.
    The population likely to abuse acryl 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 acryl 
fentanyl fatal overdose cases and encounters of the substance by law 
enforcement officials. Because abusers of acryl fentanyl are likely to 
obtain this substance 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) acryl 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

    Acryl fentanyl exhibits pharmacological profiles similar to that of 
fentanyl and other [micro]-opioid receptor agonists. The toxic effects 
of acryl fentanyl in humans are demonstrated by overdose fatalities 
involving this substance. Abusers of acryl fentanyl may not know the 
origin, identity, or purity of this substance, thus posing significant 
adverse health risks when compared to abuse of pharmaceutical 
preparations of opioid analgesics, such as morphine and oxycodone.
    Based on information reviewed by the DEA, the misuse and abuse of 
acryl fentanyl leads 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.
    Acryl fentanyl has been associated with numerous fatalities. At 
least 83 confirmed overdose deaths involving acryl fentanyl abuse have 
been reported from Illinois, Maryland, New Jersey, Ohio, and 
Pennsylvania in 2016 and 2017. As the data demonstrates, the potential 
for fatal and non-fatal overdoses exists for acryl fentanyl; thus, 
acryl fentanyl poses 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 data and 
information summarized above, the continued uncontrolled manufacture, 
distribution, reverse distribution, importation, exportation, conduct 
of research and chemical analysis, possession, and abuse of acryl 
fentanyl pose an imminent hazard to the public safety. The DEA is not 
aware of any currently accepted medical uses for this substance in 
treatment in the United States. A substance meeting the statutory 
requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be 
placed into 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 acryl 
fentanyl indicate that this substance 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 April 17, 2017, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance into Schedule I. A notice of intent was subsequently 
published in the Federal Register on June 2, 2017. 82 FR 25564.

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 acryl fentanyl into Schedule I 
of the CSA, and finds that placement of this synthetic opioid 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 this synthetic opioid into Schedule I to avoid an imminent hazard 
to the public safety, this temporary order scheduling acryl fentanyl 
will be effective on the date of publication in the Federal Register, 
and will be in effect for a period of two years, with a possible 
extension of one additional year, pending completion of the regular 
(permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
    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, acryl 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:
    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, acryl 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 July 14, 2017. 
Any person who currently handles acryl fentanyl, and is not registered 
with the DEA, must submit an application for registration and may not 
continue to handle acryl fentanyl as of July 14, 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

[[Page 32456]]

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 July 14, 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 acryl fentanyl, must 
surrender all quantities of currently held acryl fentanyl.
    3. Security. Acryl fentanyl 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 July 
14, 2017.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of acryl 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 July 14, 2017, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
acryl fentanyl 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 acryl 
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 acryl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR parts 1304, 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 acryl 
fentanyl must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312 as of July 14, 2017.
    8. Order Forms. All DEA registrants who distribute acryl fentanyl 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of July 14, 2017.
    9. Importation and Exportation. All importation and exportation of 
acryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, 
and in accordance with 21 CFR part 1312 as of July 14, 2017.
    10. Quota. Only DEA registered manufacturers may manufacture acryl 
fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 
and in accordance with 21 CFR part 1303 as of July 14, 2017.
    11. Liability. Any activity involving acryl fentanyl not authorized 
by, or in violation of the CSA, occurring as of July 14, 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 (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    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 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 DEA's need to 
move quickly to place this substance 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,

[[Page 32457]]

Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

0
2. Amend Sec.  1308.11 by adding paragraph (h)(17) to read as follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *

(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide,            (9811)
 its isomers, esters, ethers, salts and salts of
 isomers, esters and ethers (Other names: acryl
 fentanyl, acryloylfentanyl)............................
 

* * * * *

    Dated: July 10, 2017.
Chuck Rosenberg
Acting Administrator.
[FR Doc. 2017-14880 Filed 7-13-17; 8:45 am]
 BILLING CODE 4410-09-P