83 FR 469 - Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 3 (January 4, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 3 (January 4, 2018)
| Page Range | 469-472 | |
| FR Document | 2017-28470 |
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)] [Rules and Regulations] [Pages 469-472] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28470] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-474] Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl 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 the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of cyclopropyl fentanyl 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 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, cyclopropyl fentanyl. DATES: This temporary scheduling order is effective January 4, 2018, until January 4, 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 cyclopropyl fentanyl in schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter dated August 28, 2017. The Assistant Secretary responded by letter dated September 6, 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 cyclopropyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of cyclopropyl fentanyl 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). Cyclopropyl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for cyclopropyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of cyclopropyl 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 temporarily schedule cyclopropyl fentanyl was published in the Federal Register on November 21, 2017. 82 FR 55333. --------------------------------------------------------------------------- \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 [[Page 470]] 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 cyclopropyl 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 September 6, 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-474). 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. Cyclopropyl fentanyl has been encountered by law enforcement and public health officials beginning as early as May 2017. The DEA is not aware of any laboratory identifications of this substance prior to 2017. Adverse health effects and outcomes of cyclopropyl fentanyl abuse are consistent with those of other opioids and are demonstrated by fatal overdose cases involving this substance. 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 August 25, 2017. STARLiMS registered a total of three reports containing cyclopropyl fentanyl from California, Connecticut, and New York. Of these three exhibits, one had a net weight of approximately one kilogram. According to STARLiMS, the first laboratory submission of cyclopropyl fentanyl occurred in Connecticut in June 2017. 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 10 reports containing cyclopropyl fentanyl from state or local forensic laboratories in Oklahoma in July 2017 (query date: August 29, 2017).\3\ --------------------------------------------------------------------------- \3\ Data are still being collected for May 2017-August 2017 due to the normal lag period for labs reporting to NFLIS. --------------------------------------------------------------------------- In addition to data recorded in NFLIS and STARLiMS, cyclopropyl fentanyl was identified in drug evidence submitted to state and local forensic laboratories in Georgia and Pennsylvania. Cyclopropyl fentanyl was confirmed in combination with U-47700, another synthetic opioid temporarily controlled in schedule I of the CSA, in 24 glassine paper packets submitted to a law enforcement forensic laboratory in Pennsylvania.\4\ A law enforcement forensic laboratory in Georgia confirmed \5\ the presence of cyclopropyl fentanyl in counterfeit oxycodone tablets which also contained U-47700. The distribution of cyclopropyl fentanyl in these forms, and in combination with another synthetic opioid, suggests that this substance was marketed as heroin or prescription opioids in the illicit market. --------------------------------------------------------------------------- \4\ Email from Philadelphia Police Department-Office of Forensic Science, to DEA (August 18, 2017 11:09 a.m.) (on file with DEA). \5\ Laboratory report obtained from Division of Forensic Science, Georgia Bureau of Investigation. --------------------------------------------------------------------------- Evidence suggests that the pattern of abuse of fentanyl analogues, including cyclopropyl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of cyclopropyl fentanyl have been encountered in powder form, similar to fentanyl and heroin, and in counterfeit prescription opioid analgesics (i.e. counterfeit oxycodone tablets). Cyclopropyl fentanyl was also confirmed in toxicology samples from fatal overdose cases. Factor 5. Scope, Duration and Significance of Abuse Reports collected by the DEA demonstrate that cyclopropyl fentanyl is being abused for its opioid effects. Abuse of cyclopropyl fentanyl has resulted in mortality (see DEA 3-Factor Analysis for full discussion). The DEA collected post-mortem toxicology and medical examiner reports on 115 confirmed fatalities associated with cyclopropyl fentanyl which occurred in Georgia (1), Maryland (24), Mississippi (1), North Carolina (75), and Wisconsin (14). It is likely that the prevalence of this substance in opioid related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this fentanyl analogue from fentanyl. NFLIS and STARLiMS have a total of 13 drug reports in which cyclopropyl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2017 from law enforcement encounters in California, Connecticut, New York, and Oklahoma. In addition to the data collected in these databases, cyclopropyl fentanyl was identified in drug evidence submitted to forensic laboratories in Georgia (counterfeit oxycodone preparation) and Pennsylvania (24 glassine paper packets). The population likely to abuse cyclopropyl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl and other fentanyl-related substances. This is supported by cyclopropyl fentanyl being identified in powder contained within glassine paper packets and counterfeit prescription opioid products. This is also demonstrated by routes of drug administration and drug use history documented in cyclopropyl fentanyl fatal overdose cases. Because abusers of cyclopropyl fentanyl 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) cyclopropyl 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 With no legitimate medical use, cyclopropyl fentanyl has emerged on the illicit drug market and is being misused and abused for its opioid properties. Cyclopropyl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other [micro]-opioid receptor agonists. The abuse of cyclopropyl fentanyl poses significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. The toxic effects of cyclopropyl fentanyl in humans are demonstrated by overdose fatalities involving this substance. [[Page 471]] Based on information received by the DEA, the misuse and abuse of cyclopropyl fentanyl 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 agonist, 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. Cyclopropyl fentanyl has been associated with numerous fatalities. At least 115 confirmed overdose deaths involving cyclopropyl fentanyl abuse have been reported from Georgia (1), Maryland (24), Mississippi (1), North Carolina (75), and Wisconsin (14) in 2017. As the data demonstrate, the potential for fatal and non-fatal overdoses exists for cyclopropyl fentanyl and this substance 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 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 cyclopropyl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for cyclopropyl fentanyl in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for cyclopropyl 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, by letter dated August 28, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place this substance in schedule I. A notice of intent was subsequently published in the Federal Register on November 21, 2017. 82 FR 55333. 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 cyclopropyl fentanyl 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 this synthetic opioid in schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling cyclopropyl fentanyl is effective on the date of publication in the Federal Register, and is in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done ``on the record after opportunity for a hearing'' conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Requirements for Handling Upon the effective date of this temporary order, cyclopropyl fentanyl 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, cyclopropyl 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 January 4, 2018. Any person who currently handles cyclopropyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle cyclopropyl fentanyl as of January 4, 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 this substance in a manner not authorized by the CSA on or after January 4, 2018 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 cyclopropyl fentanyl must surrender all currently held quantities of cyclopropyl fentanyl. 3. Security. Cyclopropyl 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 January 4, 2018. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of cyclopropyl 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 January 4, 2018, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of cyclopropyl 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 cyclopropyl 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 cyclopropyl 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 [[Page 472]] date of this order to be in compliance with all recordkeeping requirements. 7. Reports. All DEA registrants who manufacture or distribute cyclopropyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of January 4, 2018. 8. Order Forms. All DEA registrants who distribute cyclopropyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of January 4, 2018. 9. Importation and Exportation. All importation and exportation of cyclopropyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of January 4, 2018. 10. Quota. Only DEA registered manufacturers may manufacture cyclopropyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of January 4, 2018. 11. Liability. Any activity involving cyclopropyl fentanyl not authorized by, or in violation of, the CSA, occurring as of January 4, 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 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 in schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. 0 2. In Sec. 1308.11, add paragraph (h)(22) to read as follows: Sec. 1308.11 Schedule I. * * * * * (h) * * * (22) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopropyl fentanyl). . . . . . . . . . . .(9845) Dated: December 28, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017-28470 Filed 1-3-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations 469
List of Subjects in 18 CFR Part 381 ACTION:Temporary amendment; 21 U.S.C. 812, or if there is no
Electric power plants, Electric temporary scheduling order. exemption or approval in effect for the
utilities, Natural gas, reporting and substance under section 505 of the
SUMMARY: The Administrator of the Drug Federal Food, Drug, and Cosmetic Act
recordkeeping requirements. Enforcement Administration is issuing (FDCA), 21 U.S.C. 355. 21 U.S.C.
Anton C. Porter, this temporary scheduling order to 811(h)(1). The Attorney General has
Executive Director. schedule the synthetic opioid, N-(1- delegated scheduling authority under 21
In consideration of the foregoing, the phenethylpiperidin-4-yl)-N- U.S.C. 811 to the Administrator of the
Commission amends Part 381, Chapter I, phenylcyclopropanecarboxamide DEA. 28 CFR 0.100.
Title 18, Code of Federal Regulations, as (cyclopropyl fentanyl), and its isomers,
esters, ethers, salts, and salts of isomers, Background
set forth below.
esters, and ethers in schedule I. This Section 201(h)(4) of the CSA, 21
PART 381—FEES action is based on a finding by the U.S.C. 811(h)(4), requires the
Administrator that the placement of Administrator to notify the Secretary of
■ 1. The authority citation for Part 381 cyclopropyl fentanyl in schedule I of the the Department of Health and Human
continues to read as follows: Controlled Substances Act is necessary Services (HHS) of his intention to
Authority: 15 U.S.C. 717–717w; 16 U.S.C. to avoid an imminent hazard to the temporarily place a substance in
791–828c, 2601–2645; 31 U.S.C. 9701; 42 public safety. As a result of this order, schedule I of the CSA.2 The
U.S.C. 7101–7352; 49 U.S.C. 60502; 49 App. the regulatory controls and Administrator transmitted notice of his
U.S.C. 1–85. administrative, civil, and criminal intent to place cyclopropyl fentanyl in
sanctions applicable to schedule I schedule I on a temporary basis to the
§ 381.302 [Amended]
controlled substances will be imposed Assistant Secretary for Health of HHS by
■ 2. In 381.302, paragraph (a) is on persons who handle (manufacture, letter dated August 28, 2017. The
amended by removing ‘‘$25,640’’ and distribute, reverse distribute, import, Assistant Secretary responded by letter
adding ‘‘$27,130’’ in its place. export, engage in research, conduct dated September 6, 2017, and advised
instructional activities or chemical that based on review by the Food and
§ 381.303 [Amended]
analysis, or possess), or propose to Drug Administration (FDA), there are
■ 3. In 381.303, paragraph (a) is handle, cyclopropyl fentanyl. currently no investigational new drug
amended by removing ‘‘$37,430’’ and applications or approved new drug
DATES: This temporary scheduling order
adding ‘‘$39,610’’ in its place. applications for cyclopropyl fentanyl.
is effective January 4, 2018, until
January 4, 2020. If this order is extended The Assistant Secretary also stated that
§ 381.304 [Amended]
or made permanent, the DEA will the HHS has no objection to the
■ 4. In 381.304, paragraph (a) is temporary placement of cyclopropyl
publish a document in the Federal
amended by removing ‘‘$19,630’’ and fentanyl in schedule I of the CSA. The
Register.
adding ‘‘$20,770’’ in its place. DEA has taken into consideration the
FOR FURTHER INFORMATION CONTACT: Assistant Secretary’s comments as
§ 381.305 [Amended] Michael J. Lewis, Diversion Control required by 21 U.S.C. 811(h)(4).
■ 5. In 381.305, paragraph (a) is Division, Drug Enforcement Cyclopropyl fentanyl is not currently
amended by removing ‘‘$7,350’’ and Administration; Mailing Address: 8701 listed in any schedule under the CSA,
adding ‘‘$7,780’’ in its place. Morrissette Drive, Springfield, Virginia and no exemptions or approvals are in
22152; Telephone: (202) 598–6812. effect for cyclopropyl fentanyl under
§ 381.403 [Amended]
SUPPLEMENTARY INFORMATION: section 505 of the FDCA, 21 U.S.C. 355.
■ 6. Section 381.403 is amended by The DEA has found that the control of
removing ‘‘$12,760’’ and adding Legal Authority
cyclopropyl fentanyl in schedule I on a
‘‘$13,500’’ in its place. Section 201 of the Controlled temporary basis is necessary to avoid an
Substances Act (CSA), 21 U.S.C. 811, imminent hazard to the public safety,
§ 381.505 [Amended]
provides the Attorney General with the and as required by 21 U.S.C.
■ 7. In 381.505, paragraph (a) is authority to temporarily place a 811(h)(1)(A), a notice of intent to
amended by removing ‘‘$22,050’’ and substance in schedule I of the CSA for temporarily schedule cyclopropyl
adding ‘‘$23,330’’ in its place and by two years without regard to the fentanyl was published in the Federal
removing ‘‘$24,960’’ and adding requirements of 21 U.S.C. 811(b) if he Register on November 21, 2017. 82 FR
‘‘$26,410’’ in its place. finds that such action is necessary to 55333.
[FR Doc. 2017–28466 Filed 1–3–18; 8:45 am] avoid an imminent hazard to the public To find that placing a substance
BILLING CODE 6717–01–P safety. 21 U.S.C. 811(h)(1). In addition, temporarily in schedule I of the CSA is
if proceedings to control a substance are necessary to avoid an imminent hazard
initiated under 21 U.S.C. 811(a)(1), the to the public safety, the Administrator is
DEPARTMENT OF JUSTICE Attorney General may extend the required to consider three of the eight
temporary scheduling 1 for up to one factors set forth in section 201(c) of the
Drug Enforcement Administration year. 21 U.S.C. 811(h)(2). CSA, 21 U.S.C. 811(c): The substance’s
Where the necessary findings are
21 CFR Part 1308 made, a substance may be temporarily 2 As discussed in a memorandum of
scheduled if it is not listed in any other understanding entered into by the Food and Drug
[Docket No. DEA–474] Administration (FDA) and the National Institute on
rmajette on DSKBCKNHB2PROD with RULES
schedule under section 202 of the CSA, Drug Abuse (NIDA), the FDA acts as the lead agency
Schedules of Controlled Substances: within the HHS in carrying out the Secretary’s
1 Though DEA has used the term ‘‘final order’’ scheduling responsibilities under the CSA, with the
Temporary Placement of Cyclopropyl with respect to temporary scheduling orders in the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
Fentanyl in Schedule I past, this document adheres to the statutory The Secretary of the HHS has delegated to the
language of 21 U.S.C. 811(h), which refers to a Assistant Secretary for Health of the HHS the
AGENCY:Drug Enforcement ‘‘temporary scheduling order.’’ No substantive authority to make domestic drug scheduling
Administration, Department of Justice. change is intended. recommendations. 58 FR 35460, July 1, 1993.
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date of this order to be in compliance in view of the manifest urgency to avoid copy of this temporary order to both
with all recordkeeping requirements. an imminent hazard to the public safety. Houses of Congress and to the
7. Reports. All DEA registrants who Further, the DEA believes that this Comptroller General, although such
manufacture or distribute cyclopropyl temporary scheduling action is not a filing is not required under the Small
fentanyl must submit reports pursuant ‘‘rule’’ as defined by 5 U.S.C. 601(2), Business Regulatory Enforcement
to 21 U.S.C. 827 and in accordance with and, accordingly, is not subject to the Fairness Act of 1996 (Congressional
21 CFR parts 1304 and 1312 as of requirements of the Regulatory Review Act), 5 U.S.C. 801–808 because,
January 4, 2018. Flexibility Act. The requirements for the as noted above, this action is an order,
8. Order Forms. All DEA registrants preparation of an initial regulatory not a rule.
who distribute cyclopropyl fentanyl flexibility analysis in 5 U.S.C. 603(a) are
not applicable where, as here, the DEA List of Subjects in 21 CFR Part 1308
must comply with order form
requirements pursuant to 21 U.S.C. 828 is not required by the APA or any other Administrative practice and
and in accordance with 21 CFR part law to publish a general notice of procedure, Drug traffic control,
1305 as of January 4, 2018. proposed rulemaking. Reporting and recordkeeping
9. Importation and Exportation. All Additionally, this action is not a requirements.
importation and exportation of significant regulatory action as defined For the reasons set out above, the DEA
cyclopropyl fentanyl must be in by Executive Order 12866 (Regulatory amends 21 CFR part 1308 as follows:
Planning and Review), section 3(f), and,
compliance with 21 U.S.C. 952, 953,
accordingly, this action has not been PART 1308—SCHEDULES OF
957, 958, and in accordance with 21
reviewed by the Office of Management CONTROLLED SUBSTANCES
CFR part 1312 as of January 4, 2018.
and Budget (OMB).
10. Quota. Only DEA registered This action will not have substantial ■ 1. The authority citation for part 1308
manufacturers may manufacture direct effects on the States, on the continues to read as follows:
cyclopropyl fentanyl in accordance with relationship between the national
a quota assigned pursuant to 21 U.S.C. Authority: 21 U.S.C. 811, 812, 871(b),
government and the States, or on the 956(b), unless otherwise noted.
826 and in accordance with 21 CFR part distribution of power and
1303 as of January 4, 2018. ■ 2. In § 1308.11, add paragraph (h)(22)
responsibilities among the various
11. Liability. Any activity involving to read as follows:
levels of government. Therefore, in
cyclopropyl fentanyl not authorized by, accordance with Executive Order 13132 § 1308.11 Schedule I.
or in violation of, the CSA, occurring as (Federalism) it is determined that this
of January 4, 2018, is unlawful, and may * * * * *
action does not have sufficient (h) * * *
subject the person to administrative, federalism implications to warrant the (22) N-(1-phenethylpiperidin-4-yl)-N-
civil, and/or criminal sanctions. preparation of a Federalism Assessment. phenylcyclopropanecarboxamide, its
Regulatory Matters As noted above, this action is an isomers, esters, ethers, salts and salts of
order, not a rule. Accordingly, the isomers, esters and ethers (Other name:
Section 201(h) of the CSA, 21 U.S.C. Congressional Review Act (CRA) is
811(h), provides for a temporary cyclopropyl fentanyl). . . . . . . . . . . .(9845)
inapplicable, as it applies only to rules.
scheduling action where such action is However, if this were a rule, pursuant Dated: December 28, 2017.
necessary to avoid an imminent hazard to the Congressional Review Act, ‘‘any Robert W. Patterson,
to the public safety. As provided in this rule for which an agency for good cause Acting Administrator.
subsection, the Attorney General may, finds that notice and public procedure [FR Doc. 2017–28470 Filed 1–3–18; 8:45 am]
by order, schedule a substance in thereon are impracticable, unnecessary, BILLING CODE 4410–09–P
schedule I on a temporary basis. Such or contrary to the public interest, shall
an order may not be issued before the take effect at such time as the federal
expiration of 30 days from (1) the agency promulgating the rule DEPARTMENT OF HOMELAND
publication of a notice in the Federal determines.’’ 5 U.S.C. 808(2). It is in the SECURITY
Register of the intention to issue such public interest to schedule this
order and the grounds upon which such substance immediately to avoid an Federal Emergency Management
order is to be issued, and (2) the date imminent hazard to the public safety. Agency
that notice of the proposed temporary This temporary scheduling action is
scheduling order is transmitted to the taken pursuant to 21 U.S.C. 811(h), 44 CFR Chapter I
Assistant Secretary. 21 U.S.C. 811(h)(1). which is specifically designed to enable
[Docket ID FEMA–2016–0022]
Inasmuch as section 201(h) of the the DEA to act in an expeditious manner
CSA directs that temporary scheduling to avoid an imminent hazard to the Revisions to the Public Assistance
actions be issued by order and sets forth public safety. 21 U.S.C. 811(h) exempts Program and Policy Guide
the procedures by which such orders are the temporary scheduling order from
to be issued, the DEA believes that the standard notice and comment AGENCY: Federal Emergency
notice and comment requirements of the rulemaking procedures to ensure that Management Agency, DHS.
Administrative Procedure Act (APA) at the process moves swiftly. For the same ACTION: Notification of availability.
5 U.S.C. 553, do not apply to this reasons that underlie 21 U.S.C. 811(h),
temporary scheduling action. In the that is, the DEA’s need to move quickly SUMMARY: This document provides
alternative, even assuming that this to place this substance in schedule I notice of the availability of the final
policy Public Assistance Program and
rmajette on DSKBCKNHB2PROD with RULES
action might be subject to 5 U.S.C. 553, because it poses an imminent hazard to
the Administrator finds that there is the public safety, it would be contrary Policy Guide (PAPPG).
good cause to forgo the notice and to the public interest to delay DATES: FEMA applies the revisions in
comment requirements of 5 U.S.C. 553, implementation of the temporary this policy to incidents declared on or
as any further delays in the process for scheduling order. Therefore, this order after August 23, 2017, or to any
issuance of temporary scheduling orders shall take effect immediately upon its application for assistance that, as of
would be contrary to the public interest publication. The DEA has submitted a January 1, 2018 is pending before
VerDate Sep<11>2014 14:53 Jan 03, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\04JAR1.SGM 04JAR1](https://thefederalregister.org/doc/83_FR_472/page/4.svg)
Document Created: 2018-01-04 02:01:57
Document Modified: 2018-01-04 02:01:57
| 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 January 4, 2018, until January 4, 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 469 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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