Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl Into Schedule I, 42381-42385 [2015-17563]

Download as PDF Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations untreated wood components. Therefore this rule would be expected to impact only a small number of manufacturers and importers or at most, a small portion of the toys in the market. Second, manufacturers of toys containing unfinished and untreated wood components still would be required to test to other aspects of the ASTM toy standard, so the impact of this rule relative to production costs for most firms should be small. Due to the small number of entities affected and the limited scope of the impact, the Commission certifies that this rule will not have a significant impact on a substantial number of small entities pursuant to section 605(b) of the RFA, 5 U.S.C. 605(b). G. Environmental Considerations The Commission’s regulations provide a categorical exclusion for Commission rules from any requirement to prepare an environmental assessment or an environmental impact statement because they ‘‘have little or no potential for affecting the human environment.’’ 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. The Commission’s regulations state that safety standards for products normally have little or no potential for affecting the human environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that expectation. List of Subjects Business and industry, Infants and children, Consumer protection, Imports, Product testing and certification, Toys. Accordingly, 16 CFR part 1251 is added to read as follows: ingested, must comply with solubility limits that the toy standard establishes for eight heavy elements. Materials used in toys subject to section 4.3.5 of the toy standard must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (‘‘CPSA’’), unless listed in § 1251.2. § 1251.2 Wood. (a) Unfinished and untreated wood does not exceed the limits for the heavy elements established in section 4.3.5 of the toy standard with a high degree of assurance as that term is defined in 16 CFR part 1107, provided that the material has been neither treated nor adulterated with materials that could result in the addition of any of the heavy elements listed in the toy standard at levels above their respective solubility limits. (b) For purposes of this section, unfinished and untreated wood means wood harvested from the trunks of trees with no added surface coatings (such as, varnish, paint, shellac, or polyurethane) and no materials added to the wood substrate (such as, stains, dyes, preservatives, antifungals, or insecticides). Unfinished and untreated wood does not include manufactured or engineered woods (such as pressed wood, plywood, particle board, or fiberboard). Dated: July 13, 2015. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2015–17413 Filed 7–16–15; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF JUSTICE PART 1251—TOYS: DETERMINATIONS REGARDING HEAVY ELEMENTS LIMITS FOR CERTAIN MATERIALS Drug Enforcement Administration Sec. 1251.1 The toy standard and testing requirements. 1251.2 Wood. [Docket No. DEA–413F] Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl Into Schedule I Authority: Sec. 3, Pub. L. 110–314, 122 Stat. 3016; 15 U.S.C. 2063(d)(3)(B). asabaliauskas on DSK5VPTVN1PROD with RULES The Consumer Product Safety Improvement Act of 2008 (‘‘CPSIA’’) made provisions of ASTM F963, Consumer Product Safety Specifications for Toy Safety (‘‘toy standard’’), a mandatory consumer product safety standard. Among the mandated provisions is section 4.3.5 of ASTM F963 which requires that surface coating materials and accessible substrates of toys that can be sucked, mouthed, or 17:58 Jul 16, 2015 Jkt 235001 Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: § 1251.1 The toy standard and testing requirements. VerDate Sep<11>2014 21 CFR Part 1308 The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylacetamide (acetyl fentanyl), and its optical, positional, and geometric isomers, salts and salts of isomers, into schedule I pursuant to the temporary scheduling provisions of the Controlled SUMMARY: PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 42381 Substances Act. This action is based on a finding by the Administrator that the placement of this opioid substance 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, import, export, engage in research, or possess), or propose to handle, acetyl fentanyl. DATES: This final order is effective on July 17, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, 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. 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. 21 U.S.C. 801–971. 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 E:\FR\FM\17JYR1.SGM 17JYR1 42382 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 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. asabaliauskas on DSK5VPTVN1PROD with RULES Background Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of the Administrator’s intention to temporarily place a substance into schedule I of the CSA.1 The Administrator transmitted the notice of intent to place acetyl fentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated April 7, 2015. The Assistant Secretary responded to this notice by letter dated April 29, 2015 (received by the DEA on May 05, 2015), and advised that based on review by the FDA, there are currently no investigational new drug applications or approved new drug applications for acetyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acetyl fentanyl into schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary’s comments as required by 21 U.S.C. 811(h)(4). Acetyl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acetyl fentanyl under section 505 of the FDCA, 1 Because the Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations, for purposes of this final order, all subsequent references to ‘‘Secretary’’ have been replaced with ‘‘Assistant Secretary.’’ As set forth in a memorandum of understanding entered into by HHS, 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 Assistant Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. VerDate Sep<11>2014 17:58 Jul 16, 2015 Jkt 235001 21 U.S.C. 355. The DEA has found that the scheduling of acetyl fentanyl 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 acetyl fentanyl was published in the Federal Register on May 21, 2015. 80 FR 29227. To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): the substance’s history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for acetyl 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 analysis is available in its entirety under the tab ‘‘Supporting and Related Material’’ of the public docket of this action at www.regulations.gov under Docket Number DEA–413F. 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. Following the control of alpha-methylfentanyl, the DEA identified several other fentanyl analogues (3-methylthiofentanyl, acetyl- PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 alpha-methylfentanyl, beta-hydroxy-3methylfentanyl, alphamethylthiofentanyl, thiofentanyl, betahydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in submissions to forensic laboratories. These substances were temporarily controlled under schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed into schedule I of the CSA. 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 State and local forensic laboratories across the country. The first laboratory submission of acetyl fentanyl was recorded in Maine in April 2013 according to NFLIS. NFLIS registered eight reports containing acetyl fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio, Oregon, Pennsylvania, and Virginia. The System to Retrieve Information from Drug Evidence (STRIDE) is a database of drug exhibits sent to DEA laboratories for analysis. Exhibits from this database are from the DEA, other Federal agencies, and some local law enforcement agencies. Acetyl fentanyl was first reported to STRIDE in September 2013 from exhibits obtained through a controlled purchase in Louisiana. In October 2013, an exhibit collected from a controlled purchase of suspected oxycodone tablets in Rhode Island contained acetyl fentanyl as the primary substance. In 2014, STARLiMS (a Web-based, commercial laboratory information management system that is in transition to replace STRIDE) and STRIDE reported eight additional seizures in Colorado, Florida, Georgia, and Washington. In August 2013, the Centers for Disease Control and Prevention published an article in its Morbidity and Mortality Weekly Report documenting a series of 14 fatalities related to acetyl fentanyl that occurred between March and May 2013. In December 2013, another fatality associated with acetyl fentanyl was reported in Rhode Island for a total of 15 fatalities. In February 2014, the North Carolina Department of Health and Human Services issued a health advisory related to acetyl fentanyl following at least three deaths related to this synthetic drug. Toxicologists at the North Carolina Office of the Chief Medical Examiner detected acetyl fentanyl in specimens associated with deaths that occurred in January 2014 in Sampson, Person, and E:\FR\FM\17JYR1.SGM 17JYR1 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations asabaliauskas on DSK5VPTVN1PROD with RULES Transylvania counties. In July and August 2014, four additional fatalities involving acetyl fentanyl were reported for a total of seven fatalities in North Carolina. Deaths involving acetyl fentanyl have also been reported in California (1), Louisiana (14), Oregon (1) and Pennsylvania (1). A significant seizure of acetyl fentanyl occurred in April 2013 during a law enforcement investigation in Montreal, Canada. Approximately three kilograms of acetyl fentanyl in powder form and approximately 11,000 tablets containing acetyl fentanyl were seized. Given that a typical dose of acetyl fentanyl is in the microgram range, a three kilogram quantity could potentially produce millions of dosage units. In the United States, tablets that mimic pharmaceutical opioid products have been reported in multiple states, including Colorado, Florida, Georgia, Rhode Island, and Washington. Recent reports indicate that acetyl fentanyl in powder form is available over the Internet and has been imported to addresses within the United States. Evidence also suggests that the pattern of abuse of fentanyl analogues, including acetyl fentanyl, parallels that of heroin and prescription opioid analgesics. For example, seizures of acetyl fentanyl have been encountered both in powder and in tablet form. It is also known to have caused many fatal overdoses, in which intravenous routes of administration and histories of drug abuse are documented. Factor 5. Scope, Duration and Significance of Abuse The DEA is currently aware of at least 39 fatalities associated with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six states including California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases capturing drug evidence information from DEA forensic laboratories, have a total of 10 drug reports in which acetyl fentanyl was identified in six cases for analyzed drugs submitted from January 2010— December 2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and Washington. It is likely that the prevalence of acetyl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported since standard immunoassays cannot differentiate acetyl fentanyl from fentanyl. The population likely to abuse acetyl fentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use VerDate Sep<11>2014 17:58 Jul 16, 2015 Jkt 235001 history documented in acetyl fentanyl fatal overdose cases. Because abusers of acetyl fentanyl are likely to obtain the drug through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to its abusers. This risk is particularly heightened by the fact that acetyl fentanyl is a highly potent opioid (15.7 fold more potent than that of morphine as tested in mice using an acetic acid writhing method). Thus small changes in the amount and purity of the substance could potentially lead to overdose and death. Factor 6. What, if Any, Risk There Is to the Public Health Acetyl fentanyl exhibits a pharmacological profile similar to that of fentanyl and other opioid analgesic compounds, and it is a potent opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7 times as potent as morphine in mice tested in an acetic acid writhing method. In addition, studies also showed that the range between the effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is narrower than that of morphine and fentanyl, increasing the risk of fatal overdose. Thus, its abuse is likely to pose quantitatively greater risks to the public health and safety than abuse of traditional opioid analgesics such as morphine. Based on the above pharmacological data, the abuse of acetyl fentanyl at least leads to the same qualitative public health risks as heroin, fentanyl, and other opioid analgesic compounds. The public health risks attendant to the abuse of heroin and opioid analgesics are well established. The abuse of opioid analgesics has resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. Acetyl fentanyl has been associated with numerous fatalities. At least 39 overdose deaths due to acetyl fentanyl abuse have been reported in six states in 2013 and 2014, California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that acetyl fentanyl poses an imminent hazard to public safety. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety Based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of acetyl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in the PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 42383 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 acetyl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 7, 2015, notified the Assistant Secretary of the DEA’s intention to temporarily place this substance 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 N-(1phenethylpiperidin-4-yl)-Nphenylacetamide (acetyl fentanyl), into schedule I of the CSA, and finds that placement of this synthetic opioid into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into schedule I to avoid an imminent hazard to the public safety, this final order temporarily scheduling acetyl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The CSA sets forth specific criteria for scheduling a drug or other substance. Regular 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 regular 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 regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary E:\FR\FM\17JYR1.SGM 17JYR1 42384 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations asabaliauskas on DSK5VPTVN1PROD with RULES 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, acetyl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional activities, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, conducts instructional activities with, or possesses), or who desires to handle, acetyl fentanyl must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of July 17, 2015. Any person who currently handles acetyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acetyl fentanyl as of July 17, 2015, 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 July 17, 2015 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA. 2. Security. Acetyl fentanyl is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71– 1301.93, as of July 17, 2015. 3. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acetyl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of July 17, 2015. Current DEA registrants shall have 30 calendar days from July 17, 2015, to comply with all labeling and packaging requirements. 4. Inventory. Every DEA registrant who possesses any quantity of acetyl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand as of July 17, 2015, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with VerDate Sep<11>2014 17:58 Jul 16, 2015 Jkt 235001 all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including acetyl 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. 5. Records. All DEA registrants must maintain records with respect to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA registrants authorized to handle acetyl fentanyl shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 6. Reports. All DEA registrants who manufacture or distribute acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. 7. Order Forms. All DEA registrants who distribute acetyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of July 17, 2015. 8. Importation and Exportation. All importation and exportation of acetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of July 17, 2015. 9. Quota. Only DEA registered manufacturers may manufacture acetyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of July 17, 2015. 10. Liability. Any activity involving acetyl fentanyl not authorized by, or in violation of the CSA, occurring as of July 17, 2015, 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). PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 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 final order 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. 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 E:\FR\FM\17JYR1.SGM 17JYR1 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations Big Foot Tension Leg Platform construction site, located in Walker Ridge Block 29 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. The purpose of this interim rule is to include the construction area and protect the facility and all operations during the construction phase from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Placing a safety zone around the facility while under construction that includes the construction site will List of Subjects in 21 CFR Part 1308 significantly reduce the threat of Administrative practice and allisions, collisions, security breaches, procedure, Drug traffic control, oil spills, releases of natural gas, and Reporting and recordkeeping thereby protect the safety of life, requirements. property, and the environment. For the reasons set out above, the DEA DATES: This rule is effective without amends 21 CFR part 1308 as follows: actual notice July 17, 2015. For the purposes of enforcement, actual notice PART 1308—SCHEDULES OF will be used from June 3, 2015 until July CONTROLLED SUBSTANCES 17, 2015. Comments and related material must be received by the Coast ■ 1. The authority citation for part 1308 Guard on or before August 3, 2015. continues to read as follows: ADDRESSES: Documents mentioned in Authority: 21 U.S.C. 811, 812, 871(b), this preamble are part of Docket Number unless otherwise noted. USCG–2014–0863. To view documents ■ 2. Amend § 1308.11 by adding mentioned in this preamble as being paragraph (h)(24) to read as follows: available in the docket, go to http:// www.regulations.gov, type the docket § 1308.11 Schedule I. number in the ‘‘SEARCH’’ box and click * * * * * ‘‘SEARCH.’’ Click on ‘‘Open Docket (h) * * * Folder’’ on the line associated with this (24) N-(1-phenethylpiperidinrulemaking. You may also visit the 4-yl)-N-phenylacetamide, its Docket Management Facility in Room optical, positional, and geoW12–140 on the ground floor of the metric isomers, salts and Department of Transportation West salts of isomers (Other names: acetyl fentanyl) ........ (9821). Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. * * * * * and 5 p.m., Monday through Friday, Dated: July 13, 2015. except Federal holidays. Chuck Rosenberg, You may submit comments, identified Acting Administrator. by docket number, using any one of the following methods: [FR Doc. 2015–17563 Filed 7–16–15; 8:45 am] (1) Federal eRulemaking Portal: BILLING CODE 4410–09–P http://www.regulations.gov. (2) Fax: (202) 493–2251. (3) Mail or Delivery: Docket DEPARTMENT OF HOMELAND Management Facility (M–30), U.S. SECURITY Department of Transportation, West Building Ground Floor, Room W12–140, Coast Guard 1200 New Jersey Avenue SE., Washington, DC 20590–0001. Deliveries 33 CFR Part 147 accepted between 9 a.m. and 5 p.m., [Docket Number USCG–2014–0863] Monday through Friday, except federal holidays. The telephone number is 202– RIN 1625–AA00 366–9329. Safety Zone; Big Foot TLP, Walker See the ‘‘Public Participation and Ridge 29, Outer Continental Shelf on Request for Comments’’ portion of the the Gulf of Mexico SUPPLEMENTARY INFORMATION section below for further instructions on AGENCY: Coast Guard, DHS. submitting comments. To avoid ACTION: Interim rule and request for duplication, please use only one of comments. these three methods. FOR FURTHER INFORMATION CONTACT: If SUMMARY: The Coast Guard is you have questions on this rule, call or establishing a safety zone around the asabaliauskas on DSK5VPTVN1PROD with RULES from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA’s need to move quickly to place this substance into schedule I because it poses an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, in accordance with 5 U.S.C. 808(2), this order shall take effect immediately upon its publication. VerDate Sep<11>2014 17:58 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 42385 email Mr. Rusty Wright, U.S. Coast Guard, District Eight Waterways Management Branch; telephone 504– 671–2138, rusty.h.wright@uscg.mil. If you have questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: Table of Acronyms DHS Department of Homeland Security NPRM Notice of Proposed Rulemaking OCS Outer Continental Shelf A. Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http:// www.regulations.gov and will include any personal information you have provided. 1. Submitting Comments If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http:// www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission. To submit your comment online, go to http://www.regulations.gov, type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on ‘‘Submit a Comment’’ on the line associated with this rulemaking. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received E:\FR\FM\17JYR1.SGM 17JYR1

Agencies

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42381-42385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17563]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-413F]


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to temporarily schedule the synthetic opioid, 
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), and 
its optical, positional, and geometric isomers, salts and salts of 
isomers, 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 this opioid 
substance 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, import, export, 
engage in research, or possess), or propose to handle, acetyl fentanyl.

DATES: This final order is effective on July 17, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, 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. 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. 21 U.S.C. 801-971. 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

[[Page 42382]]

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 the Administrator's intention to temporarily 
place a substance into schedule I of the CSA.\1\ The Administrator 
transmitted the notice of intent to place acetyl fentanyl into schedule 
I on a temporary basis to the Assistant Secretary by letter dated April 
7, 2015. The Assistant Secretary responded to this notice by letter 
dated April 29, 2015 (received by the DEA on May 05, 2015), and advised 
that based on review by the FDA, there are currently no investigational 
new drug applications or approved new drug applications for acetyl 
fentanyl. The Assistant Secretary also stated that the HHS has no 
objection to the temporary placement of acetyl fentanyl into schedule I 
of the CSA. The DEA has taken into consideration the Assistant 
Secretary's comments as required by 21 U.S.C. 811(h)(4). Acetyl 
fentanyl is not currently listed in any schedule under the CSA, and no 
exemptions or approvals are in effect for acetyl fentanyl under section 
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the scheduling 
of acetyl fentanyl 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 acetyl 
fentanyl was published in the Federal Register on May 21, 2015. 80 FR 
29227.
---------------------------------------------------------------------------

    \1\ Because the Secretary of the HHS has delegated to the 
Assistant Secretary for Health of the HHS the authority to make 
domestic drug scheduling recommendations, for purposes of this final 
order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.'' As set forth in a memorandum of 
understanding entered into by HHS, 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 Assistant 
Secretary's scheduling responsibilities under the CSA, with the 
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
---------------------------------------------------------------------------

    To find that placing a substance temporarily into schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): the substance's 
history and current pattern of abuse; the scope, duration and 
significance of abuse; and what, if any, risk there is to the public 
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes 
actual abuse, diversion from legitimate channels, and clandestine 
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). 
Substances in schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1). Available data and information for 
acetyl 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 analysis is available in its 
entirety under the tab ``Supporting and Related Material'' of the 
public docket of this action at www.regulations.gov under Docket Number 
DEA-413F.

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. 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 under schedule I of the CSA after finding that they posed an 
imminent hazard to public safety and were subsequently permanently 
placed into schedule I of the CSA.
    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 State and 
local forensic laboratories across the country. The first laboratory 
submission of acetyl fentanyl was recorded in Maine in April 2013 
according to NFLIS. NFLIS registered eight reports containing acetyl 
fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports 
in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio, 
Oregon, Pennsylvania, and Virginia.
    The System to Retrieve Information from Drug Evidence (STRIDE) is a 
database of drug exhibits sent to DEA laboratories for analysis. 
Exhibits from this database are from the DEA, other Federal agencies, 
and some local law enforcement agencies. Acetyl fentanyl was first 
reported to STRIDE in September 2013 from exhibits obtained through a 
controlled purchase in Louisiana. In October 2013, an exhibit collected 
from a controlled purchase of suspected oxycodone tablets in Rhode 
Island contained acetyl fentanyl as the primary substance. In 2014, 
STARLiMS (a Web-based, commercial laboratory information management 
system that is in transition to replace STRIDE) and STRIDE reported 
eight additional seizures in Colorado, Florida, Georgia, and 
Washington.
    In August 2013, the Centers for Disease Control and Prevention 
published an article in its Morbidity and Mortality Weekly Report 
documenting a series of 14 fatalities related to acetyl fentanyl that 
occurred between March and May 2013. In December 2013, another fatality 
associated with acetyl fentanyl was reported in Rhode Island for a 
total of 15 fatalities. In February 2014, the North Carolina Department 
of Health and Human Services issued a health advisory related to acetyl 
fentanyl following at least three deaths related to this synthetic 
drug. Toxicologists at the North Carolina Office of the Chief Medical 
Examiner detected acetyl fentanyl in specimens associated with deaths 
that occurred in January 2014 in Sampson, Person, and

[[Page 42383]]

Transylvania counties. In July and August 2014, four additional 
fatalities involving acetyl fentanyl were reported for a total of seven 
fatalities in North Carolina. Deaths involving acetyl fentanyl have 
also been reported in California (1), Louisiana (14), Oregon (1) and 
Pennsylvania (1).
    A significant seizure of acetyl fentanyl occurred in April 2013 
during a law enforcement investigation in Montreal, Canada. 
Approximately three kilograms of acetyl fentanyl in powder form and 
approximately 11,000 tablets containing acetyl fentanyl were seized. 
Given that a typical dose of acetyl fentanyl is in the microgram range, 
a three kilogram quantity could potentially produce millions of dosage 
units. In the United States, tablets that mimic pharmaceutical opioid 
products have been reported in multiple states, including Colorado, 
Florida, Georgia, Rhode Island, and Washington. Recent reports indicate 
that acetyl fentanyl in powder form is available over the Internet and 
has been imported to addresses within the United States.
    Evidence also suggests that the pattern of abuse of fentanyl 
analogues, including acetyl fentanyl, parallels that of heroin and 
prescription opioid analgesics. For example, seizures of acetyl 
fentanyl have been encountered both in powder and in tablet form. It is 
also known to have caused many fatal overdoses, in which intravenous 
routes of administration and histories of drug abuse are documented.

Factor 5. Scope, Duration and Significance of Abuse

    The DEA is currently aware of at least 39 fatalities associated 
with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six 
states including California, Louisiana, North Carolina, Oregon, 
Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases 
capturing drug evidence information from DEA forensic laboratories, 
have a total of 10 drug reports in which acetyl fentanyl was identified 
in six cases for analyzed drugs submitted from January 2010--December 
2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and 
Washington. It is likely that the prevalence of acetyl fentanyl in 
opioid analgesic-related emergency room admissions and deaths is 
underreported since standard immunoassays cannot differentiate acetyl 
fentanyl from fentanyl.
    The population likely to abuse acetyl fentanyl overlaps with the 
populations abusing prescription opioid analgesics and heroin. This is 
evidenced by the routes of administration and drug use history 
documented in acetyl fentanyl fatal overdose cases. Because abusers of 
acetyl fentanyl are likely to obtain the drug through illicit sources, 
the identity, purity, and quantity is uncertain and inconsistent, thus 
posing significant adverse health risks to its abusers. This risk is 
particularly heightened by the fact that acetyl fentanyl is a highly 
potent opioid (15.7 fold more potent than that of morphine as tested in 
mice using an acetic acid writhing method). Thus small changes in the 
amount and purity of the substance could potentially lead to overdose 
and death.

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

    Acetyl fentanyl exhibits a pharmacological profile similar to that 
of fentanyl and other opioid analgesic compounds, and it is a potent 
opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7 
times as potent as morphine in mice tested in an acetic acid writhing 
method. In addition, studies also showed that the range between the 
effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is 
narrower than that of morphine and fentanyl, increasing the risk of 
fatal overdose. Thus, its abuse is likely to pose quantitatively 
greater risks to the public health and safety than abuse of traditional 
opioid analgesics such as morphine.
    Based on the above pharmacological data, the abuse of acetyl 
fentanyl at least leads to the same qualitative public health risks as 
heroin, fentanyl, and other opioid analgesic compounds. The public 
health risks attendant to the abuse of heroin and opioid analgesics are 
well established. The abuse of opioid analgesics has resulted in large 
numbers of drug treatment admissions, emergency department visits, and 
fatal overdoses.
    Acetyl fentanyl has been associated with numerous fatalities. At 
least 39 overdose deaths due to acetyl fentanyl abuse have been 
reported in six states in 2013 and 2014, California, Louisiana, North 
Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that 
acetyl fentanyl poses an imminent hazard to public safety.

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

    Based on the data and information summarized above, the continued 
uncontrolled manufacture, distribution, importation, exportation, and 
abuse of acetyl fentanyl poses an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for this 
substance 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 acetyl 
fentanyl indicate that this substance has a high potential for abuse, 
no currently accepted medical use in treatment in the United States, 
and a lack of accepted safety for use under medical supervision. As 
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the 
Administrator, through a letter dated April 7, 2015, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance 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 N-(1-phenethylpiperidin-4-yl)-
N-phenylacetamide (acetyl fentanyl), into schedule I of the CSA, and 
finds that placement of this synthetic opioid into schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety. 
Because the Administrator hereby finds it necessary to temporarily 
place this synthetic opioid into schedule I to avoid an imminent hazard 
to the public safety, this final order temporarily scheduling acetyl 
fentanyl will be effective on the date of publication in the Federal 
Register, and will be in effect for a period of two years, with a 
possible extension of one additional year, pending completion of the 
regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular 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 regular 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 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary

[[Page 42384]]

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, acetyl fentanyl will 
become subject to the regulatory controls and administrative, civil, 
and criminal sanctions applicable to the manufacture, distribution, 
importation, exportation, research, conduct of instructional 
activities, and possession of schedule I controlled substances 
including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, conducts instructional 
activities with, or possesses), or who desires to handle, acetyl 
fentanyl must be registered with the DEA to conduct such activities 
pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 
CFR parts 1301 and 1312, as of July 17, 2015. Any person who currently 
handles acetyl fentanyl, and is not registered with the DEA, must 
submit an application for registration and may not continue to handle 
acetyl fentanyl as of July 17, 2015, 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 July 17, 2015 is unlawful and 
those in possession of any quantity of this substance may be subject to 
prosecution pursuant to the CSA.
    2. Security. Acetyl fentanyl is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July 
17, 2015.
    3. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of acetyl fentanyl must be in compliance with 21 
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of 
July 17, 2015. Current DEA registrants shall have 30 calendar days from 
July 17, 2015, to comply with all labeling and packaging requirements.
    4. Inventory. Every DEA registrant who possesses any quantity of 
acetyl fentanyl on the effective date of this order must take an 
inventory of all stocks of this substance on hand as of July 17, 2015, 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11(a) and (d). 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 acetyl 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.
    5. Records. All DEA registrants must maintain records with respect 
to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA 
registrants authorized to handle acetyl fentanyl shall have 30 calendar 
days from the effective date of this order to be in compliance with all 
recordkeeping requirements.
    6. Reports. All DEA registrants who manufacture or distribute 
acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015.
    7. Order Forms. All DEA registrants who distribute acetyl fentanyl 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of July 17, 2015.
    8. Importation and Exportation. All importation and exportation of 
acetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 
958, and in accordance with 21 CFR part 1312 as of July 17, 2015.
    9. Quota. Only DEA registered manufacturers may manufacture acetyl 
fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 
and in accordance with 21 CFR part 1303 as of July 17, 2015.
    10. Liability. Any activity involving acetyl fentanyl not 
authorized by, or in violation of the CSA, occurring as of July 17, 
2015, 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 
final order 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.
    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

[[Page 42385]]

from standard notice and comment rulemaking procedures to ensure that 
the process moves swiftly. For the same reasons that underlie 21 U.S.C. 
811(h), that is, the DEA's need to move quickly to place this substance 
into schedule I because it poses an imminent hazard to public safety, 
it would be contrary to the public interest to delay implementation of 
the temporary scheduling order. Therefore, in accordance with 5 U.S.C. 
808(2), this order shall take effect immediately upon its publication.

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.


0
2. Amend Sec.  1308.11 by adding paragraph (h)(24) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(24) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its        (9821).
 optical, positional, and geometric isomers, salts and
 salts of isomers (Other names: acetyl fentanyl)...........
 

* * * * *

    Dated: July 13, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-17563 Filed 7-16-15; 8:45 am]
 BILLING CODE 4410-09-P