83 FR 4580 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 22 (February 1, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 22 (February 1, 2018)
| Page Range | 4580-4585 | |
| FR Document | 2018-02008 |
[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)] [Rules and Regulations] [Pages 4580-4585] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02008] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-475] Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in 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 seven fentanyl- related substances in schedule I. These seven substances are: N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide (valeryl fentanyl), N-(4- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide (para- fluorobutyryl fentanyl), N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4- yl)butyramide (para-methoxybutyryl fentanyl), N-(4-chlorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide (para-chloroisobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide (isobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in 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 [[Page 4581]] 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, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil. DATES: This temporary scheduling order is effective February 1, 2018, until February 1, 2020. 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 in 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 in schedule I of the CSA.\2\ The Administrator transmitted notice of his intent to place valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter dated October 20, 2017. The Assistant Secretary responded to this notice of intent by letter dated November 8, 2017, and advised that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of these seven substances in schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for these seven substances under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil was published in the Federal Register on December 13, 2017. 82 FR 58575. --------------------------------------------------------------------------- \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 in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil, 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 November 8, 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-2017-0016- 0001 (Docket Number DEA-475). Factor 4. History and Current Pattern of Abuse The recreational abuse of fentanyl-related substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Evidence suggests that the pattern of abuse of these fentanyl-related substances parallels that of heroin and prescription opioid analgesics. Valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are fentanyl-related substances that have been encountered by law enforcement and/or reported in the scientific literature by public health officials. Adverse health effects and outcomes related to the abuse of fentanyl-related substances have been documented in previous temporary [[Page 4582]] scheduling actions (see DEA 3-Factor Analysis). 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 November 2, 2017. STARLiMS registered the following reports: valeryl fentanyl (15), para- fluorobutyryl fentanyl (5), isobutyryl fentanyl (116), and cyclopentyl fentanyl (1). These identifications were made beginning in 2015. 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 was queried on November 3, 2017 \3\ and the following substances (number of drug reports) were identified from state and local forensic laboratories since 2015: valeryl fentanyl (69), para-fluorobutyryl fentanyl (220), para-methoxybutyryl fentanyl (1), and isobutyryl fentanyl (4). The identification in other countries of para- fluorobutyryl fentanyl (Poland and Sweden), para-methoxybutyryl fentanyl (Sweden), ocfentanil (Belgium and Switzerland), cylcopentyl fentanyl (Sweden), and para-chloroisobutyryl fentanyl (Sweden) in toxicological samples associated with fatal and non-fatal overdoses was reported in the scientific literature. --------------------------------------------------------------------------- \3\ Data are still being collected for July 2017-October 2017 due to the normal lag period for labs reporting to NFLIS. --------------------------------------------------------------------------- Factor 5. Scope, Duration and Significance of Abuse Fentanyl-related substances have recently re-emerged on the illicit market (see DEA 3-Factor Analysis for full discussion). Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have been identified in evidence submitted to law enforcement and/or reported in the scientific literature by public health forensic laboratories. The identification of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in forensic evidence indicates that these substances are intended to be replacements for controlled synthetic opioids, heroin, and/or prescription opioids. Because abusers of these fentanyl-related substances 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) abuse of these substances 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). Factor 6. What, if Any, Risk There Is to the Public Health With no legitimate medical use in the United States, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have emerged on the illicit drug market. Substances within this chemical structural class have demonstrated pharmacological profiles similar to that of fentanyl and other [micro]- opioid receptor agonists (see DEA 3-Factor Analysis). The abuse of these fentanyl-related substances poses significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. The toxic effects of substances within this structural class in humans are demonstrated by overdose fatalities described in previous scheduling actions. Based on information received by the DEA, the misuse and abuse of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil lead to, at least, 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. 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these seven substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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, by letter dated October 20, 2017, 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 December 13, 2017. 82 FR 58575. Conclusion In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, and herein sets forth the grounds for his determination that it is necessary to temporarily schedule valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I of the CSA to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids in schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil is effective on [[Page 4583]] 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, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil 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 February 1, 2018. Any person who currently handles valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil, and is not registered with the DEA, must submit an application for registration and may not continue to handle valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil as of February 1, 2018, 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 February 1, 2018, 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil, must surrender all currently held quantities of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil. 3. Security. Valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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 February 1, 2018. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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 February 1, 2018, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil) 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil must submit reports pursuant to 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312, as of February 1, 2018. 8. Order Forms. All DEA registrants who distribute valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil must comply with order form requirements pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305, as of February 1, 2018. 9. Importation and Exportation. All importation and exportation of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312, as of February 1, 2018. 10. Quota. Only DEA registered manufacturers may manufacture valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil in accordance with a quota assigned pursuant to 21 U.S.C. 826, and [[Page 4584]] in accordance with 21 CFR part 1303, as of February 1, 2018. 11. Liability. Any activity involving valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil not authorized by, or in violation of, the CSA, occurring as of February 1, 2018, 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 CRA, ``any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the public interest to schedule 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 in schedule I because they pose 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 paragraphs (h)(23) through (29) to read as follows: Sec. 1308.11 Schedule I. * * * * * (h) * * * ------------------------------------------------------------------------ ------------------------------------------------------------------------ (23) N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its (9804) isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: valeryl fentanyl).......... (24) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4- (9823) yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para- fluorobutyryl fentanyl)................................... (25) N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4- (9837) yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para- methoxybutyryl fentanyl).................................. (26) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- (9826) yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para- chloroisobutyryl fentanyl)................................ (27) N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, (9827) its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: isobutyryl fentanyl)....... (28) N-(1-phenethylpiperidin-4-yl)-N- (9847) phenylcyclopentanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl)........................ (29) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4- (9832) yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: ocfentanil).... ------------------------------------------------------------------------ [[Page 4585]] Dated: January 26, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-02008 Filed 1-31-18; 8:45 am] BILLING CODE 4410-09-P
![4580 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Rules and Regulations
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CPSC National Product Testing and (if any) additional cost. The * * * * *
Evaluation Center, 5 Research Place, Commission did not receive any public (c) * * *
Rockville, MD 20850; www.cpsc.gov. comments that addressed the potential (3) * * *
The test method is also available on the impact on small entities, nor has the (i) CPSC–CH–C1001–9.4, ‘‘Standard
CPSC website. https://cpsc.gov/ Commission staff become aware of any Operating Procedure for Determination
Business-Manufacturing/Testing- new information that would change its of Phthalates’’, January 17, 2018;
Certification/Lab-Accreditation/Test- previous determination regarding the * * * * *
Methods/. A copy of the test method can impact on small entities.
also be inspected at CPSC’s Office of the Alberta E. Mills,
Secretary, U.S. Consumer Product H. Environmental Considerations Acting Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330 The Commission’s regulations Safety Commission.
East-West Highway, Bethesda, MD provide a categorical exclusion for the [FR Doc. 2018–01452 Filed 1–31–18; 8:45 am]
20814, telephone 301–504–7923. Commission’s rules from any BILLING CODE 6355–01–P
requirement to prepare an
F. Effective Date
environmental assessment or an
The APA generally requires that a environmental impact statement DEPARTMENT OF JUSTICE
substantive rule must be published not because they ‘‘have little or no potential
less than 30 days before its effective for affecting the human environment.’’ Drug Enforcement Administration
date. 5 U.S.C. 553(d)(1). The NPR 16 CFR 1021.5(c)(2). This rule falls
proposed a 30-day effective date within the categorical exclusion, so no 21 CFR Part 1308
because the rule allows testing to environmental assessment or [Docket No. DEA–475]
continue under the existing testing environmental impact statement is
method by testing laboratories that meet required. Schedules of Controlled Substances:
certain criteria for a period of up to two Temporary Placement of Seven
years after the publication of a final List of Subjects in 16 CFR Part 1112
Fentanyl-Related Substances in
rule. However, to avoid possible Administrative practice and Schedule I
confusion if the effective date for this procedure, Audit, Consumer protection,
rule differed from the effective date for Incorporation by reference, Reporting AGENCY: Drug Enforcement
the underlying phthalates rule, we are and recordkeeping requirements, Third Administration, Department of Justice.
setting the effective date for the rule on party conformity assessment body. ACTION: Temporary amendment;
April 25, 2018, the same date the For the reasons discussed in the temporary scheduling order.
phthalates rule takes effect. This is preamble, the Commission amends title
consistent with past practice setting the SUMMARY: The Administrator of the Drug
16 CFR chapter II, as follows: Enforcement Administration is issuing
effective date for NORs for durable
nursery products under section 104 of PART 1112—REQUIREMENTS this temporary scheduling order to
the CPSIA and updates to the PERTAINING TO THIRD PARTY schedule seven fentanyl-related
mandatory toy standard ASTM F963 on CONFORMITY ASSESSMENT BODIES substances in schedule I. These seven
the same date the underlying rule takes substances are: N-(1-
effect. ■ 1. The authority citation for part 1112 phenethylpiperidin-4-yl)-N-
continues to read as follows: phenylpentanamide (valeryl fentanyl),
G. Regulatory Flexibility Act N-(4-fluorophenyl)-N-(1-
Authority: 15 U.S.C. 2063; Pub. L. 110–
The Regulatory Flexibility Act (RFA) 314, section 3, 122 Stat. 3016, 3017 (2008).
phenethylpiperidin-4-yl)butyramide
requires an agency to prepare a (para-fluorobutyryl fentanyl), N-(4-
regulatory flexibility analysis for any ■ 2. Amend § 1112.15 by: methoxyphenyl)-N-(1-
rule subject to notice and comment ■ a. Revising the introductory text to phenethylpiperidin-4-yl)butyramide
rulemaking requirements under the paragraph (b)(31); (para-methoxybutyryl fentanyl), N-(4-
■ b. Revising paragraph (b)(31)(i); and chlorophenyl)-N-(1-phenethylpiperidin-
APA, or any other statute, unless the
■ c. Revising paragraph (c)(3)(i).
agency certifies that the rulemaking will 4-yl)isobutyramide (para-
The revisions read as follows: chloroisobutyryl fentanyl), N-(1-
not have a significant economic impact
on a substantial number of small § 1112.15 When can a third party phenethylpiperidin-4-yl)-N-
entities. 5 U.S.C. 603 and 605. Small conformity assessment body apply for phenylisobutyramide (isobutyryl
entities include small businesses, small CPSC acceptance for a particular CPSC rule fentanyl), N-(1-phenethylpiperidin-4-
organizations, and small governmental or test method? yl)-N-phenylcyclopentanecarboxamide
jurisdictions. * * * * * (cyclopentyl fentanyl), and N-(2-
The Commission certified, in the (b) * * * fluorophenyl)-2-methoxy-N-(1-
NPR, that the rule would not have a (31) 16 CFR part 1307, Prohibition of phenethylpiperidin-4-yl)acetamide
significant impact on a substantial Children’s Toys and Child Care Articles (ocfentanil). This action is based on a
number of small entities because the Containing Specified Phthalates. For its finding by the Administrator that the
revised testing method is substantially accreditation to be accepted by the placement of these seven synthetic
daltland on DSKBBV9HB2PROD with RULES
the same as the method that laboratories Commission to test for phthalates in opioids in schedule I of the Controlled
are already using, qualified testing children’s toys and child care articles, a Substances Act is necessary to avoid an
laboratories should be able to adopt the third party conformity assessment body imminent hazard to the public safety.
new method without difficulty, and the must have one or more of the following As a result of this order, the regulatory
2-year window allowed to amend the test methods referenced in its statement controls and administrative, civil, and
accreditation scope documents would of scope: criminal sanctions applicable to
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![Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Rules and Regulations 4585
Dated: January 26, 2018. position. The current operating IV. Ordering Paragraphs
Robert W. Patterson, schedule is set out in 33 CFR 117.5. I. Introduction
Acting Administrator. Under this temporary deviation, the
[FR Doc. 2018–02008 Filed 1–31–18; 8:45 am] bridge will be in the closed-to- In this Order, the Commission adopts
BILLING CODE 4410–09–P
navigation position between 7 a.m. on a final rule concerning mail preparation
February 26, 2018, through 7 p.m. on changes. The final rule adopted by this
March 12, 2018. Order amends an existing Commission
DEPARTMENT OF HOMELAND The Beach Thorofare is used by a rule located at 39 CFR part 3010.1 The
SECURITY variety of vessels including recreational rule as adopted incorporates suggestions
vessels. The Coast Guard has carefully presented by commenters that include
Coast Guard coordinated the restrictions with slight modifications to the rule as
waterway users in publishing this proposed, but do not materially affect its
33 CFR Part 117 temporary deviation. substance.
Vessels able to pass through the
[Docket No. USCG–2018–0033] bridge in the closed-to-navigation II. Background
position may do so at any time. The The Commission is charged with
Drawbridge Operation Regulation; New
bridge will not be able to open for enforcing its price cap rules, which
Jersey Intracoastal Waterway, Beach
emergencies and there is no immediate require that the Postal Service make
Thorofare, Margate City, NJ
alternative route for vessels unable to reasonable adjustments to its billing
AGENCY: Coast Guard, DHS. pass through the bridge in the closed determinants to account for the effects
ACTION:Notice of deviation from position. The Coast Guard will also of classification changes such as the
drawbridge regulation. inform the users of the waterway introduction, deletion, or redefinition of
through our Local and Broadcast rate cells. See 39 CFR 3010.23(d)(2).
SUMMARY: The Coast Guard has issued a Notices to Mariners of the change in
temporary deviation from the operating Under § 3010.23(d)(2), these
operating schedule for the bridge, so classification changes can include
schedule that governs the Margate that vessel operators can arrange their
Boulevard/Margate Bridge which carries changes to mail preparation
transits to minimize any impact caused requirements made by the Postal
Margate Boulevard across the New by the temporary deviation.
Jersey Intracoastal Waterway, Beach Service. In Docket No. R2013–10R, the
In accordance with 33 CFR 117.35(e),
Thorofare, mile 74.0, at Margate City, Commission articulated a standard
the drawbridge must return to its regular
NJ. The deviation is necessary to governing when mail preparation
operating schedule immediately at the
facilitate bridge maintenance. This changes result in the deletion or
end of the effective period of this
deviation allows the bridge to remain in redefinition of rate cells under
temporary deviation. This deviation
the closed-to-navigation position. § 3010.23(d)(2) of the price cap rules.2
from the operating regulations is
DATES: The deviation is effective from 7 authorized under 33 CFR 117.35. After setting forth the standard
a.m. on Monday, February 26, 2018, applied to mail preparation
Dated: January 26, 2018.
through 7 p.m. on Monday, March 12, requirements, the Commission
Hal R. Pitts, instituted the present rulemaking ‘‘to
2018.
Bridge Program Manager, Fifth Coast Guard create rules for the process and
ADDRESSES: The docket for this District.
deviation, [USCG–2018–0033] is timeframes for the regulation of mail
[FR Doc. 2018–01981 Filed 1–31–18; 8:45 am] preparation requirement changes.’’ 3 As
available at http://www.regulations.gov.
Type the docket number in the BILLING CODE 9110–04–P discussed below, the Commission
‘‘SEARCH’’ box and click ‘‘SEARCH’’. issued an initial proposed rule that was
Click on Open Docket Folder on the line
associated with this deviation. POSTAL REGULATORY COMMISSION 1 On December 1, 2017, the Commission issued a
Notice of Proposed Rulemaking in Docket No.
FOR FURTHER INFORMATION CONTACT: If 39 CFR Part 3010 RM2017–3 that proposed replacing provisions of 39
you have questions on this temporary CFR part 3010 with new rules in new subparts. The
deviation, call or email Mr. Michael [Docket No. RM2016–6; Order No. 4393] Commission issues this rule in part 3010 and any
Thorogood, Bridge Administration changes to the rule’s location in the CFR will be
Branch Fifth District, Coast Guard, Mail Preparation Changes made in the Docket No. RM2017–3 rulemaking. See
Docket No. RM2017–3, Notice of Proposed
telephone 757–398–6557, email AGENCY: Postal Regulatory Commission. Rulemaking for the System for Regulating Rates and
Michael.R.Thorogood@uscg.mil. ACTION: Final rule. Classes for Market Dominant Products, December 1,
2017 (Order No. 4258). The notice of proposed
SUPPLEMENTARY INFORMATION: The Ole
rulemaking was published in the Federal Register
Hansen and Sons, Inc., owner and SUMMARY: The Commission adopts a on December 11, 2017. See 82 FR 58280.
operator of the Margate Boulevard/ final rule concerning mail preparation 2 Docket No. R2013–10R, Order Resolving Issues
Margate Bridge that carries Margate changes. This Order amends an existing on Remand, January 22, 2016 (Order No. 3047). For
Boulevard across the New Jersey Commission rule. a complete history of the underlying proceedings
and the facts regarding the change to Full Service
Intracoastal Waterway, Beach Thorofare, DATES: Effective March 5, 2018. Intelligent Mail barcoding (IMb) which precipitated
mile 74.0, at Margate City, NJ, has FOR FURTHER INFORMATION CONTACT: the need for a standard, see Docket No. R2013–10,
requested a temporary deviation from David A. Trissell, General Counsel, at Order on Price Adjustments for Market Dominant
the current operating schedule to Products and Related Mail Classification Changes,
202–789–6820. November 21, 2013, at 5–35 (Order No. 1890); Order
facilitate maintenance of the structural
daltland on DSKBBV9HB2PROD with RULES
SUPPLEMENTARY INFORMATION: No. 3047; Docket No. R2013–10R, Order Resolving
steel and replacement of the structural Motion for Reconsideration of Commission Order
steel support column of the double Table of Contents No. 3047, July 20, 2016 (Order No. 3441).
3 Order No. 3047 at 21. See also id. at 59 (‘‘The
bascule drawbridge. The bridge has a I. Introduction Commission intends to also issue a rulemaking to
vertical clearance of 14 feet above mean II. Background establish procedural rules setting forth the process
high water in the closed position and III. Review of Proposed Rule and Analysis of governing mail preparation changes that require
unlimited clearance in the open Comments price cap compliance.’’).
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Document Created: 2018-10-26 13:45:56
Document Modified: 2018-10-26 13:45:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Temporary amendment; temporary scheduling order. | |
| Dates | This temporary scheduling order is effective February 1, 2018, until February 1, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 83 FR 4580 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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