Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I, 29492-29496 [2016-11219]

Download as PDF 29492 Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Rules and Regulations (1) Brivaracetam ((2S)-2-[(4R)-2oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB–34714; Briviact) (including its salts) ........................... * * * * * Dated: May 6, 2016. Chuck Rosenberg, Acting Administrator. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 2710 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–11245 Filed 5–11–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–434F] Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioids, N-(1phenethylpiperidin-4-yl)-Nphenylbutyramide, also known as N-(1phenethylpiperidin-4-yl)-Nphenylbutanamide, (butyryl fentanyl) and N-[1-[2-hydroxy-2-(thiophen-2yl)ethyl]piperidin-4-yl]-Nphenylpropionamide, also known as N[1-[2-hydroxy-2-(2-thienyl)ethyl]-4piperidinyl]-N-phenylpropanamide, (beta-hydroxythiofentanyl), and their isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of butyryl fentanyl and betahydroxythiofentanyl 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, butyryl fentanyl and betahydroxythiofentanyl. jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: This final order is effective on May 12, 2016. DATES: VerDate Sep<11>2014 13:18 May 11, 2016 Jkt 238001 Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801–971. Titles II and III are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, and are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308. Section 201 of the 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 she 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 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 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 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 her 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.1 The Administrator transmitted the notice of intent to place butyryl fentanyl and beta-hydroxythiofentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated December 21, 2015. The Assistant Secretary responded to this notice by letter dated January 13, 2016, 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 butryl fentanyl or betahydroxythiofentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of butryl fentanyl or betahydroxythiofentanyl 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). Neither butryl fentanyl nor beta-hydroxythiofentanyl is currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for butryl fentanyl or betahydroxythiofentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of butryl fentanyl and beta-hydroxythiofentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule butryl fentanyl and beta-hydroxythiofentanyl was published in the Federal Register on March 23, 2016. 81 FR 15485. 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 1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. E:\FR\FM\12MYR1.SGM 12MYR1 Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Rules and Regulations 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 butryl fentanyl and betahydroxythiofentanyl, 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 threefactor analysis, and the Assistant Secretary’s January 13, 2016, 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–2016–0005 (Docket Number DEA–434). jstallworth on DSK7TPTVN1PROD with RULES Factor 4. History and Current Pattern of Abuse Clandestinely produced substances structurally related to the schedule II opioid analgesic fentanyl were trafficked and abused on the West Coast in the late 1970s and 1980s. These clandestinely produced fentanyl-like substances were commonly known as designer drugs, and recently there has been a reemergence in the trafficking and abuse of designer drug substances, including fentanyl-like substances. Alpha-methylfentanyl, the first fentanyl analogue identified in California, was placed into schedule I of the CSA in September 1981. 46 FR 46799. Following the control of alphamethylfentanyl, the DEA identified several other fentanyl analogues (3methylthiofentanyl, acetyl-alphamethylfentanyl, beta-hydroxy-3methylfentanyl, alphamethylthiofentanyl, thiofentanyl, betahydroxyfentanyl, para-fluorofentanyl, and 3-methylfentanyl) in submissions to forensic laboratories. These substances VerDate Sep<11>2014 13:18 May 11, 2016 Jkt 238001 were temporarily controlled 2 in 1985– 1987 under schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed in schedule I of the CSA. On July 17, 2015, acetyl fentanyl was temporarily controlled under schedule I of the CSA after a finding by the Administrator that it posed an imminent hazard to public safety. 80 FR 42381. Prior to October 1, 2014, the System to Retrieve Information from Drug Evidence (STRIDE) collected the results of drug evidence analyzed at DEA laboratories and reflected evidence submitted by the DEA, other federal law enforcement agencies, and some local law enforcement agencies. STRIDE data were queried through September 30, 2014, by date submitted to federal forensic laboratories. Since October 1, 2014, STARLiMS (a web-based, commercial laboratory information management system) has replaced STRIDE as the DEA 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 December 21, 2015. The National Forensic Laboratory Information System (NFLIS) is a program of the DEA that collects drug identification results from drug cases analyzed by other federal, state, and local forensic laboratories. NFLIS reports from other federal, state, and local forensic laboratories were queried on December 22, 2015.3 The first laboratory submission of butyryl fentanyl was recorded in Kansas in March 2014 according to NFLIS. STRIDE, STARLiMS, and NFLIS registered seven reports containing butyryl fentanyl in 2014 in Illinois, Kansas, Minnesota, and Pennsylvania; 81 reports of butyryl fentanyl were recorded in 2015 in California, Connecticut, Florida, Indiana, North Dakota, New York, Ohio, Oregon, Tennessee, Virginia, and Wisconsin. A total of three reports of betahydroxythiofentanyl were recorded by STARLiMS, all of which were reported in 2015 from Florida. As of December 22, 2015, beta-hydroxythiofentanyl had not been reported in NFLIS; however, this substance was identified in June 2015 by a forensic laboratory in Oregon. Evidence also suggests that the pattern of abuse of fentanyl analogues, 2 50 FR 43698, 51 FR 42834, 50 FR 11690, 51 FR 15474, and 51 FR 4722. [The temporary scheduling of para-fluorofentanyl was extended in 1987, at 52 FR 7270. 3 Data are still being reported for September– November 2015 due to normal lag time for laboratories to report to NFLIS. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 29493 including butyryl fentanyl and betahydroxythiofentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of butyryl fentanyl have been encountered in tablet and powder form. Butyryl fentanyl was identified on bottle caps and spoons and residue was detected within glassine bags, on digital scales, and on sifters which demonstrates the abuse of this substance as a replacement for heroin or other opioids, either knowingly or unknowingly. Butyryl fentanyl has been encountered as a single substance as well as in combination with other illicit substances, such as acetyl fentanyl, heroin, cocaine, or methamphetamine. Like butyryl fentanyl, betahydroxythiofentanyl has been encountered in both tablet and powder form. Both butyryl fentanyl and betahydroxythiofentanyl have caused fatal overdoses, in which intravenous routes of administration are documented. Factor 5. Scope, Duration and Significance of Abuse The DEA is currently aware of at least 40 confirmed fatalities associated with butyryl fentanyl and 7 confirmed fatalities associated with betahydroxythiofentanyl. The information on these deaths occurring in 2015 was collected from toxicology and medical examiner reports and was reported from four states—Florida (7, betahydroxythiofentanyl), Maryland (1, butyryl fentanyl), New York (38, butyryl fentanyl), and Oregon (1, butyryl fentanyl). STRIDE, STARLiMS, and NFLIS have a total of 88 drug reports in which butyryl fentanyl was identified in drug exhibits submitted in 2014 and 2015 from California, Connecticut, Florida, Illinois, Indiana, Kansas, Minnesota, North Dakota, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, and Wisconsin. STARLiMS has a total of three drug reports in which beta-hydroxythiofentanyl was identified in drug exhibits submitted in 2015 from Florida. It is likely that the prevalence of butyryl fentanyl and betahydroxythiofentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays cannot differentiate these substances from fentanyl. The population likely to abuse butyryl fentanyl and beta-hydroxythiofentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use history documented in butyryl fentanyl and beta-hydroxythiofentanyl fatal overdose cases. Because abusers of these fentanyl analogues are likely to obtain these E:\FR\FM\12MYR1.SGM 12MYR1 29494 Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Rules and Regulations substances through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to abusers of butyryl fentanyl and betahydroxythiofentanyl. Individuals who initiate (i.e., use an illicit drug for the first time) butyryl fentanyl or betahydroxythiofentanyl 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.). jstallworth on DSK7TPTVN1PROD with RULES Factor 6. What, if Any, Risk There Is to the Public Health Butyryl fentanyl and betahydroxythiofentanyl exhibit pharmacological profiles similar to that of fentanyl and other mu-opioid receptor agonists. Due to limited scientific data, their potency and toxicity are not known; however, the toxic effects of both butyryl fentanyl and beta-hydroxythiofentanyl in humans are demonstrated by overdose fatalities involving these substances. Abusers of these fentanyl analogues may not know the origin, identity, or purity of these substances, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on the documented case reports of overdose fatalities, the abuse of butyryl fentanyl and betahydroxythiofentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. 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. Butyryl fentanyl and betahydroxythiofentanyl have been associated with numerous fatalities. At least 40 confirmed overdose deaths involving butyryl fentanyl abuse have been reported in Maryland (1), New York (38), and Oregon (1) in 2015. At least seven confirmed overdose fatalities involving beta-hydroxythiofentanyl have been reported in Florida in 2015. This indicates that both butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent hazard to the public safety. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of butyryl fentanyl and beta- VerDate Sep<11>2014 13:18 May 11, 2016 Jkt 238001 hydroxythiofentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these 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 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 butyryl fentanyl and beta-hydroxythiofentanyl indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated December 21, 2015, notified the Assistant Secretary of the DEA’s intention to temporarily place these substances into schedule I. 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 butyryl fentanyl and beta-hydroxythiofentanyl into schedule I of the CSA, and finds that placement of these synthetic opioids into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids into schedule I to avoid an imminent hazard to the public safety, this final order temporarily scheduling butyryl fentanyl and beta-hydroxythiofentanyl 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 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Requirements for Handling Upon the effective date of this final order, butyryl fentanyl and betahydroxythiofentanyl 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, butyryl fentanyl and beta-hydroxythiofentanyl 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 May 12, 2016. Any person who currently handles butyryl fentanyl and beta-hydroxythiofentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle butyryl fentanyl or beta-hydroxythiofentanyl as of May 12, 2016, 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 May 12, 2016 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 butyryl fentanyl and betahydroxythiofentanyl, must surrender all quantities of currently held butyryl fentanyl and beta-hydroxythiofentanyl. 3. Security. Butyryl fentanyl and betahydroxythiofentanyl 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 May 12, 2016. E:\FR\FM\12MYR1.SGM 12MYR1 jstallworth on DSK7TPTVN1PROD with RULES Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Rules and Regulations 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of butyryl fentanyl and betahydroxythiofentanyl 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 May 12, 2016, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of butyryl fentanyl and beta-hydroxythiofentanyl 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 butyryl fentanyl and beta-hydroxythiofentanyl) 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 butyryl fentanyl and beta-hydroxythiofentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and § 1307.11. Current DEA registrants authorized to handle butyryl fentanyl and betahydroxythiofentanyl 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 butyryl fentanyl and beta-hydroxythiofentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 1312 as of May 12, 2016. 8. Order Forms. All DEA registrants who distribute butyryl fentanyl and beta-hydroxythiofentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of May 12, 2016. 9. Importation and Exportation. All importation and exportation of butyryl fentanyl and beta-hydroxythiofentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of May 12, 2016. 10. Quota. Only DEA registered manufacturers may manufacture butyryl fentanyl and beta-hydroxythiofentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of May 12, 2016. VerDate Sep<11>2014 13:18 May 11, 2016 Jkt 238001 11. Liability. Any activity involving butyryl fentanyl and betahydroxythiofentanyl not authorized by, or in violation of the CSA, occurring as of May 12, 2016, 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 an expedited 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 29495 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 these substances immediately because they pose a public health risk. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA’s need to move quickly to place these substances into schedule I because they pose an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801–808 because, as noted above, this action is an order, not a rule. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: ■ Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. E:\FR\FM\12MYR1.SGM 12MYR1 29496 Federal Register / Vol. 81, No. 92 / Thursday, May 12, 2016 / Rules and Regulations mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High § 1308.11 Schedule I. Water in the closed-to-navigation * * * * * position. The draw operates as required (h) * * * by 33 CFR 117.189(a). Navigation on the (26) N-(1-phenethylpiperidin-4-yl)waterway is commercial and N-phenylbutyramide, its isomers, recreational. esters, ethers, salts and salts of The drawspan will be secured in the isomers, esters and ethers (Other closed-to-navigation position from 7:30 names: Butyryl fentanyl) ............. (9822) a.m. to 11 a.m. on May 15, 2016, to (27) N-[1-[2-hydroxy-2-(thiophen-2allow the community to participate in yl)ethyl]piperidin-4-yl]-Nthe Capital City Classic Run. This phenylpropionamide, its isotemporary deviation has been mers, esters, ethers, salts and coordinated with the waterway users. salts of isomers, esters and ethers (Other names: betaNo objections to the proposed hydroxythiofentanyl) ................... (9836) temporary deviation were raised. Vessels able to pass through the Dated: May 6, 2016. bridge in the closed position may do so Chuck Rosenberg, at any time. The bridge will be able to Acting Administrator. open for emergencies and there is no [FR Doc. 2016–11219 Filed 5–11–16; 8:45 am] immediate alternate route for vessels to BILLING CODE 4410–09–P pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for DEPARTMENT OF HOMELAND the bridge so that vessels can arrange SECURITY their transits to minimize any impact Coast Guard caused by the temporary deviation. In accordance with 33 CFR 117.35(e), 33 CFR Part 117 the drawbridge must return to its regular operating schedule immediately at the [Docket No. USCG–2016–0348] end of the effective period of this temporary deviation. This deviation Drawbridge Operation Regulation; from the operating regulations is Sacramento River, Sacramento, CA authorized under 33 CFR 117.35. AGENCY: Coast Guard, DHS. Dated: May 3, 2016. ACTION: Notice of deviation from D.H. Sulouff, drawbridge regulation. 2. Amend § 1308.11 by adding paragraphs (h)(26) and (27) to read as follows: ■ The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the Capital City Classic Run. This deviation allows the bridge to remain in the closed-tonavigation position during the deviation period. DATES: This deviation is effective from 7:30 a.m. to 11 a.m. on May 15, 2016. ADDRESSES: The docket for this deviation, [USCG–2016–0348] is available at https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510– 437–3516, email David.H.Sulouff@ uscg.mil. jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 13:18 May 11, 2016 Jkt 238001 District Bridge Chief, Eleventh Coast Guard District. [FR Doc. 2016–11266 Filed 5–11–16; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2016–0215] RIN 1625–AA87 Security Zone; Port of New York, Moving Security Zone; Canadian Naval Vessels Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing a temporary moving security zone around all Canadian Naval Ships in the New York Harbor, New York, NY. The moving security zone will extend 100 yards on all sides of the ships. The security zone is needed to SUMMARY: PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 protect the vessels and their respective crews from potential security threats. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port New York. DATES: This rule is effective from May 25, 2016 through May 31, 2016. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2016– 0215 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email MST1 R. J. Sampert, Waterways Management Division, U.S. Coast Guard; telephone 718–354–4197, email ronald.j.sampert@uscg.mil. SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because the specifics associated with the entry and transit of the foreign naval vessels in the harbor were not received in time to publish an NPRM. Publishing an NPRM and delaying the effective date of this rule to await public comments would be impracticable and contrary to the public interest since it would inhibit the Coast Guard’s ability to fulfill its statutory missions to protect and secure the ports and waterways of the United States. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest because immediate action is E:\FR\FM\12MYR1.SGM 12MYR1

Agencies

[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Rules and Regulations]
[Pages 29492-29496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11219]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-434F]


Schedules of Controlled Substances: Temporary Placement of 
Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to temporarily schedule the synthetic opioids, 
N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, also known as N-(1-
phenethylpiperidin-4-yl)-N-phenylbutanamide, (butyryl fentanyl) and N-
[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-
phenylpropionamide, also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-
4-piperidinyl]-N-phenylpropanamide, (beta-hydroxythiofentanyl), and 
their isomers, esters, ethers, salts and salts of isomers, esters and 
ethers, into schedule I pursuant to the temporary scheduling provisions 
of the Controlled Substances Act. This action is based on a finding by 
the Administrator that the placement of butyryl fentanyl and beta-
hydroxythiofentanyl 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, 
butyryl fentanyl and beta-hydroxythiofentanyl.

DATES: This final order is effective on May 12, 2016.

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

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while ensuring an adequate supply is available for the 
legitimate medical, scientific, research, and industrial needs of the 
United States. Controlled substances have the potential for abuse and 
dependence and are controlled to protect the public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the 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 she 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 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 her 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.\1\ The Administrator transmitted the notice 
of intent to place butyryl fentanyl and beta-hydroxythiofentanyl into 
schedule I on a temporary basis to the Assistant Secretary by letter 
dated December 21, 2015. The Assistant Secretary responded to this 
notice by letter dated January 13, 2016, 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 butryl fentanyl or beta-hydroxythiofentanyl. The 
Assistant Secretary also stated that the HHS has no objection to the 
temporary placement of butryl fentanyl or beta-hydroxythiofentanyl 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). 
Neither butryl fentanyl nor beta-hydroxythiofentanyl is currently 
listed in any schedule under the CSA, and no exemptions or approvals 
are in effect for butryl fentanyl or beta-hydroxythiofentanyl under 
section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the 
control of butryl fentanyl and beta-hydroxythiofentanyl in schedule I 
on a temporary basis is necessary to avoid an imminent hazard to public 
safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent 
to temporarily schedule butryl fentanyl and beta-hydroxythiofentanyl 
was published in the Federal Register on March 23, 2016. 81 FR 15485.
---------------------------------------------------------------------------

    \1\ 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

[[Page 29493]]

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 
butryl fentanyl and beta-hydroxythiofentanyl, 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 January 13, 
2016, 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-2016-0005 (Docket Number 
DEA-434).

Factor 4. History and Current Pattern of Abuse

    Clandestinely produced substances structurally related to the 
schedule II opioid analgesic fentanyl were trafficked and abused on the 
West Coast in the late 1970s and 1980s. These clandestinely produced 
fentanyl-like substances were commonly known as designer drugs, and 
recently there has been a reemergence in the trafficking and abuse of 
designer drug substances, including fentanyl-like substances. Alpha-
methylfentanyl, the first fentanyl analogue identified in California, 
was placed into schedule I of the CSA in September 1981. 46 FR 46799. 
Following the control of alpha-methylfentanyl, the DEA identified 
several other fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-
methylfentanyl, beta-hydroxy-3-methylfentanyl, alpha-
methylthiofentanyl, thiofentanyl, beta-hydroxyfentanyl, para-
fluorofentanyl, and 3-methylfentanyl) in submissions to forensic 
laboratories. These substances were temporarily controlled \2\ in 1985-
1987 under schedule I of the CSA after finding that they posed an 
imminent hazard to public safety and were subsequently permanently 
placed in schedule I of the CSA. On July 17, 2015, acetyl fentanyl was 
temporarily controlled under schedule I of the CSA after a finding by 
the Administrator that it posed an imminent hazard to public safety. 80 
FR 42381.
---------------------------------------------------------------------------

    \2\ 50 FR 43698, 51 FR 42834, 50 FR 11690, 51 FR 15474, and 51 
FR 4722. [The temporary scheduling of para-fluorofentanyl was 
extended in 1987, at 52 FR 7270.
---------------------------------------------------------------------------

    Prior to October 1, 2014, the System to Retrieve Information from 
Drug Evidence (STRIDE) collected the results of drug evidence analyzed 
at DEA laboratories and reflected evidence submitted by the DEA, other 
federal law enforcement agencies, and some local law enforcement 
agencies. STRIDE data were queried through September 30, 2014, by date 
submitted to federal forensic laboratories. Since October 1, 2014, 
STARLiMS (a web-based, commercial laboratory information management 
system) has replaced STRIDE as the DEA 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 December 21, 2015. The National Forensic Laboratory 
Information System (NFLIS) is a program of the DEA that collects drug 
identification results from drug cases analyzed by other federal, 
state, and local forensic laboratories. NFLIS reports from other 
federal, state, and local forensic laboratories were queried on 
December 22, 2015.\3\
---------------------------------------------------------------------------

    \3\ Data are still being reported for September-November 2015 
due to normal lag time for laboratories to report to NFLIS.
---------------------------------------------------------------------------

    The first laboratory submission of butyryl fentanyl was recorded in 
Kansas in March 2014 according to NFLIS. STRIDE, STARLiMS, and NFLIS 
registered seven reports containing butyryl fentanyl in 2014 in 
Illinois, Kansas, Minnesota, and Pennsylvania; 81 reports of butyryl 
fentanyl were recorded in 2015 in California, Connecticut, Florida, 
Indiana, North Dakota, New York, Ohio, Oregon, Tennessee, Virginia, and 
Wisconsin. A total of three reports of beta-hydroxythiofentanyl were 
recorded by STARLiMS, all of which were reported in 2015 from Florida. 
As of December 22, 2015, beta-hydroxythiofentanyl had not been reported 
in NFLIS; however, this substance was identified in June 2015 by a 
forensic laboratory in Oregon.
    Evidence also suggests that the pattern of abuse of fentanyl 
analogues, including butyryl fentanyl and beta-hydroxythiofentanyl, 
parallels that of heroin and prescription opioid analgesics. Seizures 
of butyryl fentanyl have been encountered in tablet and powder form. 
Butyryl fentanyl was identified on bottle caps and spoons and residue 
was detected within glassine bags, on digital scales, and on sifters 
which demonstrates the abuse of this substance as a replacement for 
heroin or other opioids, either knowingly or unknowingly. Butyryl 
fentanyl has been encountered as a single substance as well as in 
combination with other illicit substances, such as acetyl fentanyl, 
heroin, cocaine, or methamphetamine. Like butyryl fentanyl, beta-
hydroxythiofentanyl has been encountered in both tablet and powder 
form. Both butyryl fentanyl and beta-hydroxythiofentanyl have caused 
fatal overdoses, in which intravenous routes of administration are 
documented.

Factor 5. Scope, Duration and Significance of Abuse

    The DEA is currently aware of at least 40 confirmed fatalities 
associated with butyryl fentanyl and 7 confirmed fatalities associated 
with beta-hydroxythiofentanyl. The information on these deaths 
occurring in 2015 was collected from toxicology and medical examiner 
reports and was reported from four states--Florida (7, beta-
hydroxythiofentanyl), Maryland (1, butyryl fentanyl), New York (38, 
butyryl fentanyl), and Oregon (1, butyryl fentanyl). STRIDE, STARLiMS, 
and NFLIS have a total of 88 drug reports in which butyryl fentanyl was 
identified in drug exhibits submitted in 2014 and 2015 from California, 
Connecticut, Florida, Illinois, Indiana, Kansas, Minnesota, North 
Dakota, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, and 
Wisconsin. STARLiMS has a total of three drug reports in which beta-
hydroxythiofentanyl was identified in drug exhibits submitted in 2015 
from Florida. It is likely that the prevalence of butyryl fentanyl and 
beta-hydroxythiofentanyl in opioid analgesic-related emergency room 
admissions and deaths is underreported as standard immunoassays cannot 
differentiate these substances from fentanyl.
    The population likely to abuse butyryl fentanyl and beta-
hydroxythiofentanyl overlaps with the populations abusing prescription 
opioid analgesics and heroin. This is evidenced by the routes of 
administration and drug use history documented in butyryl fentanyl and 
beta-hydroxythiofentanyl fatal overdose cases. Because abusers of these 
fentanyl analogues are likely to obtain these

[[Page 29494]]

substances through illicit sources, the identity, purity, and quantity 
is uncertain and inconsistent, thus posing significant adverse health 
risks to abusers of butyryl fentanyl and beta-hydroxythiofentanyl. 
Individuals who initiate (i.e., use an illicit drug for the first time) 
butyryl fentanyl or beta-hydroxythiofentanyl 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

    Butyryl fentanyl and beta-hydroxythiofentanyl exhibit 
pharmacological profiles similar to that of fentanyl and other mu-
opioid receptor agonists. Due to limited scientific data, their potency 
and toxicity are not known; however, the toxic effects of both butyryl 
fentanyl and beta-hydroxythiofentanyl in humans are demonstrated by 
overdose fatalities involving these substances. Abusers of these 
fentanyl analogues may not know the origin, identity, or purity of 
these substances, thus posing significant adverse health risks when 
compared to abuse of pharmaceutical preparations of opioid analgesics, 
such as morphine and oxycodone.
    Based on the documented case reports of overdose fatalities, the 
abuse of butyryl fentanyl and beta-hydroxythiofentanyl leads to the 
same qualitative public health risks as heroin, fentanyl and other 
opioid analgesic substances. 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.
    Butyryl fentanyl and beta-hydroxythiofentanyl have been associated 
with numerous fatalities. At least 40 confirmed overdose deaths 
involving butyryl fentanyl abuse have been reported in Maryland (1), 
New York (38), and Oregon (1) in 2015. At least seven confirmed 
overdose fatalities involving beta-hydroxythiofentanyl have been 
reported in Florida in 2015. This indicates that both butyryl fentanyl 
and beta-hydroxythiofentanyl pose an imminent hazard to the public 
safety.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard 
to Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the data and 
information summarized above, the continued uncontrolled manufacture, 
distribution, importation, exportation, and abuse of butyryl fentanyl 
and beta-hydroxythiofentanyl pose an imminent hazard to the public 
safety. The DEA is not aware of any currently accepted medical uses for 
these 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 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 
butyryl fentanyl and beta-hydroxythiofentanyl indicate that these 
substances have a high potential for abuse, no currently accepted 
medical use in treatment in the United States, and a lack of accepted 
safety for use under medical supervision. As required by section 
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a 
letter dated December 21, 2015, notified the Assistant Secretary of the 
DEA's intention to temporarily place these substances into schedule I.

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 butyryl fentanyl and beta-
hydroxythiofentanyl into schedule I of the CSA, and finds that 
placement of these synthetic opioids into schedule I of the CSA is 
necessary to avoid an imminent hazard to the public safety. Because the 
Administrator hereby finds it necessary to temporarily place these 
synthetic opioids into schedule I to avoid an imminent hazard to the 
public safety, this final order temporarily scheduling butyryl fentanyl 
and beta-hydroxythiofentanyl 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 final order, butyryl fentanyl and 
beta-hydroxythiofentanyl 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, butyryl fentanyl and beta-hydroxythiofentanyl 
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 May 12, 2016. Any person who currently handles 
butyryl fentanyl and beta-hydroxythiofentanyl, and is not registered 
with the DEA, must submit an application for registration and may not 
continue to handle butyryl fentanyl or beta-hydroxythiofentanyl as of 
May 12, 2016, 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 May 12, 2016 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 butyryl fentanyl and 
beta-hydroxythiofentanyl, must surrender all quantities of currently 
held butyryl fentanyl and beta-hydroxythiofentanyl.
    3. Security. Butyryl fentanyl and beta-hydroxythiofentanyl 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 May 12, 2016.

[[Page 29495]]

    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of butyryl fentanyl and beta-hydroxythiofentanyl 
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 May 12, 2016, to comply with all labeling and packaging 
requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
butyryl fentanyl and beta-hydroxythiofentanyl 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 butyryl fentanyl and beta-hydroxythiofentanyl) 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 butyryl fentanyl and beta-hydroxythiofentanyl pursuant to 21 U.S.C. 
827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 
and Sec.  1307.11. Current DEA registrants authorized to handle butyryl 
fentanyl and beta-hydroxythiofentanyl 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 
butyryl fentanyl and beta-hydroxythiofentanyl must submit reports 
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 
1312 as of May 12, 2016.
    8. Order Forms. All DEA registrants who distribute butyryl fentanyl 
and beta-hydroxythiofentanyl must comply with order form requirements 
pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of 
May 12, 2016.
    9. Importation and Exportation. All importation and exportation of 
butyryl fentanyl and beta-hydroxythiofentanyl must be in compliance 
with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 
1312 as of May 12, 2016.
    10. Quota. Only DEA registered manufacturers may manufacture 
butyryl fentanyl and beta-hydroxythiofentanyl in accordance with a 
quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR 
part 1303 as of May 12, 2016.
    11. Liability. Any activity involving butyryl fentanyl and beta-
hydroxythiofentanyl not authorized by, or in violation of the CSA, 
occurring as of May 12, 2016, 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 an 
expedited 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 these substances immediately 
because they pose a public health risk. This temporary scheduling 
action is taken pursuant to 21 U.S.C. 811(h), which is specifically 
designed to enable the DEA to act in an expeditious manner to avoid an 
imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the 
temporary scheduling order from standard notice and comment rulemaking 
procedures to ensure that the process moves swiftly. For the same 
reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move 
quickly to place these substances into schedule I because they pose an 
imminent hazard to public safety, it would be contrary to the public 
interest to delay implementation of the temporary scheduling order. 
Therefore, this order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this final 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), unless otherwise noted.


[[Page 29496]]



0
2. Amend Sec.  1308.11 by adding paragraphs (h)(26) and (27) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(26) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its        (9822)
 isomers, esters, ethers, salts and salts of isomers, esters
 and ethers (Other names: Butyryl fentanyl)....................
(27) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-    (9836)
 phenylpropionamide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other names: beta-
 hydroxythiofentanyl)..........................................
 


    Dated: May 6, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-11219 Filed 5-11-16; 8:45 am]
 BILLING CODE 4410-09-P
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