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readily visible part of the outside of the in their place the words ‘‘floating of isomers in schedule I. This action is floating cabin. cabin’’. based on a finding by the Acting * * * * * ■ 10. Amend § 1304.412 by: Administrator that the placement of N- (c) A floating cabin moored at a ■ a. Adding in alphabetical order ethylpentylone in schedule I of the location approved pursuant to the definitions for ‘‘Existing floating cabin’’ Controlled Substances Act (CSA) is regulations in this subpart shall not be and ‘‘New floating cabin’’; necessary to avoid an imminent hazard relocated and moored at a different ■ b. Removing the definition of to the public safety. As a result of this location without prior approval by TVA, ‘‘Nonnavigable houseboat’’; and order, the regulatory controls and except for movement to a new location ■ c. Adding in alphabetical order administrative, civil, and criminal within the designated harbor limits of definitions for ‘‘Rebuilding’’ and sanctions applicable to schedule I the same commercial dock or marina. ‘‘Tennessee River System’’. controlled substances will be imposed The additions read as follows: on persons who handle (manufacture, § 1304.103 [Removed and Reserved] distribute, reverse distribute, import, ■ 7. Remove and reserve § 1304.103. § 1304.412 Definitions. export, engage in research, conduct ■ 8. Amend § 1304.204 by revising * * * * * instructional activities or chemical paragraphs (a), (b), and (n) to read as Existing floating cabin means a analysis, or possess), or propose to follows: floating cabin that was located or handle N-ethylpentylone. moored on the Tennessee River System DATES: This temporary scheduling order § 1304.204 Docks, piers, and boathouses. on or before December 16, 2016. is effective August 31, 2018, until * * * * * * * * * * August 31, 2020. If this order is (a) Docks, piers, boathouses, and all New floating cabin means a floating extended or made permanent, the DEA other residential water-use facilities cabin that was not located or moored on will publish a document in the Federal shall not exceed a total footprint area of the Tennessee River System on or before Register. greater than 1,000 square feet, unless the December 16, 2016. proposed water-use facility will be FOR FURTHER INFORMATION CONTACT: * * * * * located in an area of preexisting Thomas D. Sonnen, Diversion Control Rebuilding means replacement of all development. For the purpose of this Division, Drug Enforcement or a significant portion of an approved regulation, ‘‘preexisting development’’ Administration; Mailing Address: 8701 obstruction to the same configuration, means either: The water-use facility will Morrissette Drive, Springfield, Virginia total footprint, and dimensions (length, be located in a subdivision recorded 22152; Telephone: (202) 598–2896. width, and height) as the approved before November 1, 1999, and TVA SUPPLEMENTARY INFORMATION: plans, standards, and conditions of the permitted at least one water-use facility Section 26a permit. Legal Authority in the subdivision prior to November 1, 1999; or if there is no subdivision, * * * * * Section 201 of the CSA, 21 U.S.C. 811, where the water-use facility will be Tennessee River System means TVA provides the Attorney General with the located within a quarter-mile radius of reservoirs, the Tennessee River or any of authority to temporarily place a another water-use facility that TVA the Tennessee River’s tributaries. substance in schedule I of the CSA for permitted prior to November 1, 1999. * * * * * two years without regard to the TVA may allow even larger facilities David L. Bowling, requirements of 21 U.S.C. 811(b) if he where an applicant requests and Vice President, Land & River Management. finds that such action is necessary to justifies a waiver or variance, set forth avoid an imminent hazard to the public in §§ 1304.212 and 1304.408 [FR Doc. 2018–18887 Filed 8–30–18; 8:45 am] safety. 21 U.S.C. 811(h)(1). In addition, respectively, but such waivers or BILLING CODE 8120–08–P if proceedings to control a substance variances shall be made in TVA’s permanently are initiated under 21 discretion and on a case-by-case basis. U.S.C. 811(a)(1) while the substance is (b) Docks, boatslips, piers, and fixed DEPARTMENT OF JUSTICE temporarily controlled under section or floating boathouses are allowable. 811(h), the Attorney General may Drug Enforcement Administration These and other water-use facilities extend the temporary scheduling 1 for associated with a lot must be sited up to one year. 21 U.S.C. 811(h)(2). 21 CFR Part 1308 within a 1,000- or 1,800-square-foot Where the necessary findings are rectangular or square area as required by [Docket No. DEA–482] made, a substance may be temporarily § 1304.204(a) at the lakeward end of the scheduled if it is not listed in any other access walkway that extends from the Schedules of Controlled Substances: schedule under section 202 of the CSA, shore to the structure. Access walkways Temporary Placement of N- 21 U.S.C. 812, or if there is no to the water-use structure are not Ethylpentylone in Schedule I exemption or approval in effect for the included in calculating the 1,000- or AGENCY: Drug Enforcement substance under section 505 of the 1,800-square foot area. Administration, Department of Justice. Federal Food, Drug, and Cosmetic Act * * * * * ACTION: Temporary amendment; (FDCA), 21 U.S.C. 355. 21 U.S.C. (n) Except for floating cabins temporary scheduling order. 811(h)(1). The Attorney General has approved in accordance with subpart B delegated scheduling authority under 21 of this part, toilets and sinks are not SUMMARY: The Acting Administrator of U.S.C. 811 to the Administrator of the permitted on water-use facilities. the Drug Enforcement Administration is DEA. 28 CFR 0.100. * * * * * issuing this temporary scheduling order to schedule the synthetic cathinone, 1- 1 Though DEA has used the term ‘‘final order’’ § 1304.406 [Amended] (1,3-benzodioxol-5-yl)-2-(ethylamino)- with respect to temporary scheduling orders in the ■ past, this document adheres to the statutory 9. Amend § 1304.406 in the first pentan-1-one (N-ethylpentylone, language of 21 U.S.C. 811(h), which refers to a sentence by removing the words ephylone) and its optical, positional, ‘‘temporary scheduling order.’’ No substantive ‘‘nonnavigable houseboat’’ and adding and geometric isomers, salts, and salts change is intended.

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Background A substance meeting the statutory ethylpentylone reported in NFLIS for requirements for temporary scheduling 2013. N-Ethylpentylone was first Section 201(h)(4) of the CSA, 21 may only be placed in schedule I. 21 identified in NFLIS in May 2014. U.S.C. 811(h)(4), requires the U.S.C. 811(h)(1). Substances in schedule STRIDE/STARLiMS registered over 300 Administrator to notify the Secretary of I are those that have a high potential for reports from DEA forensic laboratories the Department of Health and Human abuse, no currently accepted medical from January 2013 to December 2017. Services (HHS) of his intention to use in treatment in the United States, There were no occurrences of N- temporarily place a substance in and a lack of accepted safety for use ethylpentylone reported in STRIDE/ schedule I of the CSA.2 The Acting under medical supervision. 21 U.S.C. STARLiMS for 2013. N-Ethylpentylone Administrator transmitted notice of his 812(b)(1). was first reported to STRIDE/ intent to place N-ethylpentylone in Available data and information for N- STARLiMS in December 2015. schedule I on a temporary basis to the ethylpentylone, summarized below, Additionally, U.S. Customs and Border Acting Assistant Secretary for Health of indicate that this synthetic cathinone Protection (CBP) encounters of N- HHS by letter dated November 22, 2017. has a high potential for abuse, no ethylpentylone have occurred. The Acting Assistant Secretary currently accepted medical use in N-Ethylpentylone, like other synthetic responded to this notice of intent by treatment in the United States, and a cathinones, is a designer drug of the letter dated December 13, 2017, and lack of accepted safety for use under phenethylamine class and it is advised that based on a review by the medical supervision. The DEA’s three- pharmacologically similar to schedule I Food and Drug Administration (FDA), factor analysis and the Assistant synthetic cathinones (e.g., cathinone, there are currently no active Secretary’s December 13, 2017 letter are methcathinone, mephedrone, investigational new drug applications or available in their entirety under the tab methylone, pentylone, and MDPV) and approved new drug applications for N- ‘‘Supporting Documents’’ of the public well-known schedule I and II ethylpentylone. The Acting Assistant docket of this action at sympathomimetic agents (e.g., Secretary also stated that HHS has no www.regulations.gov under FDMS methamphetamine, 3,4- objection to the temporary placement of Docket ID: DEA–2018–0011 (Docket methylenedioxymethamphetamine N-ethylpentylone in schedule I of the Number DEA–482). (MDMA), and cocaine). N- ethylpentylone, similar to these CSA. The DEA has taken into N-Ethylpentylone consideration the Assistant Secretary’s substances, causes stimulant related comments as required by 21 U.S.C. Around 2014, the synthetic cathinone, psychological and somatic effects. 811(h)(4). N-Ethylpentylone is not N-ethylpentylone, emerged in the Consequently, there have been currently listed in any schedule under United States’ illicit drug market after documented reports of emergency room the CSA, and no exemptions or the scheduling of other popular admissions and numerous deaths approvals are in effect for this substance synthetic cathinones (e.g., ethylone, 4- associated with the abuse of N- under section 505 of the FDCA, 21 methyl-N-ethylcathinone (4–MEC), ethylpentylone. No approved medical U.S.C. 355. The DEA has found that the mephedrone, methylone, pentylone, and use has been identified for this control of N-ethylpentylone in schedule 3,4-methylenedioxypyrovalerone substance, nor has it been approved by I on a temporary basis is necessary to (MDPV)). The identification of N- the FDA for human consumption. avoid an imminent hazard to the public ethylpentylone in forensic evidence and overdose deaths indicates that this Factor 4. History and Current Pattern of safety, and as required by 21 U.S.C. Abuse 811(h)(1)(A), a notice of intent to substance is being misused and abused. temporarily schedule N-ethylpentylone Law enforcement encounters include N-Ethylpentylone is a synthetic was published in the Federal Register those reported to the National Forensic cathinone of the phenethylamine class on June 13, 2018. 83 FR 27520. Laboratory Information System (NFLIS), and it is structurally and a DEA sponsored program that pharmacologically similar to cathinone, To find that placing a substance systematically collects drug methcathinone, mephedrone, temporarily in schedule I of the CSA is identification results and associated methylone, pentylone, MDPV, necessary to avoid an imminent hazard information from drug cases analyzed methamphetamine, MDMA, and other to the public safety, the Administrator is by Federal, State, and local forensic schedule I and II substances. Thus, it is required to consider three of the eight laboratories, the System to Retrieve highly likely that N-ethylpentylone is factors set forth in 21 U.S.C. 811(c): The Information from Drug Evidence abused in the same manner and by the substance’s history and current pattern (STRIDE), a federal database for the drug same users as these substances. That is, of abuse; the scope, duration and samples analyzed by DEA forensic N-ethylpentylone, like these substances, significance of abuse; and what, if any, laboratories, and STARLiMS (a web- is most likely ingested by swallowing risk there is to the public health. 21 based, commercial laboratory capsules or tablets or snorted by nasal U.S.C. 811(h)(3). Consideration of these information management system that insufflation of the powder tablets. factors includes actual abuse, diversion replaced STRIDE in 2014). Forensic Products containing N-ethylpentylone, from legitimate channels, and laboratories have analyzed drug exhibits similar to schedule I synthetic clandestine importation, manufacture, received from Federal, State, or local, cathinones, are likely to be falsely or distribution. 21 U.S.C. 811(h)(3). law enforcement agencies that were marketed as ‘‘research chemicals,’’ found to contain N-ethylpentylone.3 ‘‘jewelry cleaner,’’ ‘‘stain remover,’’ 2 As discussed in a memorandum of NFLIS registered over 6,000 reports ‘‘plant food or fertilizer,’’ ‘‘insect understanding entered into by the Food and Drug repellants’’ or ‘‘bath salts,’’ sold at Administration (FDA) and the National Institute on from state and local forensic laboratories Drug Abuse (NIDA), the FDA acts as the lead agency identifying this substance in drug- smoke shops, head shops, convenience within the HHS in carrying out the Secretary’s related exhibits for a period from stores, adult book stores, and gas scheduling responsibilities under the CSA, with the January 2013 to December 2017 from 41 stations, and purchased on the internet. concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. Like those seen with commercial The Secretary of the HHS has delegated to the states. There were no occurrences of N- Assistant Secretary for Health of the HHS the products that contain synthetic authority to make domestic drug scheduling 3 NFLIS and STRIDE/STARLiMS databases were cathinones, the packages of products recommendations. 58 FR 35460, July 1, 1993. queried on February 8, 2018. that contain N-ethylpentylone also

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probably contain the warning ‘‘not for reported to NFLIS in 2017. From and have resulted in large numbers of human consumption,’’ most likely in an January 2013 to December 2017, NFLIS ED visits and fatal overdoses. effort to circumvent statutory registered 6,035 reports from state and Finding of Necessity of Schedule I restrictions for these substances. local forensic laboratories identifying Placement To Avoid an Imminent Demographic data collected from this substance in drug-related exhibits Hazard to the Public Safety published reports and mortality records from 41 states. STRIDE/STARLiMS suggest that the main users of N- registered over 338 reports from DEA In accordance with 21 U.S.C. ethylpentylone, similar to schedule I forensic laboratories during January 811(h)(3), based on the available data synthetic cathinones and MDMA, are 2013 to December 2017. There were no and information, summarized above, the young adults. occurrences of N-ethylpentylone uncontrolled manufacture, distribution, Available evidence suggests that the reported in NFLIS or STRIDE/ reverse distribution, importation, history and pattern of abuse of N- STARLiMS for 2013. Additionally, exportation, conduct of research and ethylpentylone parallels that of MDMA, seizures of N-ethylpentylone have chemical analysis, possession, and/or methamphetamine, or cocaine and that occurred by the U.S. Customs and abuse of N-ethylpentylone poses an N-ethylpentylone has been marketed as Border Protection (CBP) beginning in imminent hazard to the public safety. a replacement for these substances. N- 2016. Concerns over the continuing The DEA is not aware of any currently Ethylpentylone has been identified in abuse of synthetic cathinones have led accepted medical uses for this substance law enforcement seizures that were to the control of many synthetic in the United States. A substance initially suspected to be MDMA. In cathinones. meeting the statutory requirements for addition, there are reports that abusers temporary scheduling, 21 U.S.C. of N-ethylpentylone thought they were Factor 6. What, if Any, Risk There Is to 811(h)(1), may only be placed in using the Public Health schedule I. Substances in schedule I are MDMA or another illicit substance The identification of N- those that have a high potential for but toxicological analysis revealed that ethylpentylone in toxicological samples abuse, no currently accepted medical the psychoactive substance was N- associated with fatal and non-fatal use in treatment in the United States, ethylpentylone. Toxicology reports also overdoses have been reported in and a lack of accepted safety for use revealed that N-ethylpentylone is being medical and scientific literature, under medical supervision. Available ingested with other substances forensic laboratory reports, and public data and information for N- including other synthetic cathinones, health documents. Like schedule I ethylpentylone indicate that this common cutting agents, or other synthetic cathinones, N-ethylpentylone synthetic cathinone has a high potential recreational substances. Consequently, has caused acute health problems for abuse, no currently accepted medical products containing synthetic leading to emergency department (ED) use in treatment in the United States, cathinones, including N-ethylpentylone, admissions, violent behaviors causing and a lack of accepted safety for use are distributed to users, often with harm to self or others, and/or death. under medical supervision. As required unpredictable outcomes. Thus, the Adverse health effects associated with by section 201(h)(4) of the CSA, 21 recreational abuse of synthetic the abuse of N-ethylpentylone include a U.S.C. 811(h)(4), the Acting cathinones, including N-ethylpentylone, number of stimulant-like adverse health Administrator, through a letter dated is a significant concern. effects such as diaphoresis, insomnia, November 22, 2017, notified the Acting mydriasis, hyperthermia, vomiting, Assistant Secretary of the DEA’s Factor 5. Scope, Duration and agitation, disorientation, paranoia, intention to temporarily place this Significance of Abuse abdominal pain, cardiac arrest, substance in schedule I. A notice of N-Ethylpentylone is a popular respiratory failure, and coma. In intent was subsequently published in recreational drug that emerged on the addition, N-ethylpentylone has been the Federal Register on June 13, 2018. United States’ illicit drug market after involved in deaths of many individuals. 83 FR 27520. the scheduling of other popular The DEA is aware of approximately 151 Conclusion synthetic cathinones (e.g., ethylone, overdose deaths involving N- mephedrone, methylone, pentylone, and ethylpentylone abuse reported in the In accordance with the provisions of MDPV) (see DEA 3-Factor Analysis for United States between 2014 and 2018. section 201(h) of the CSA, 21 U.S.C. a full discussion). Forensic laboratories Thus, the abuse of N-ethylpentylone, 811(h), the Acting Administrator have confirmed the presence of N- like that of the abuse of schedule I considered available data and ethylpentylone in drug exhibits received synthetic cathinones and stimulant information, herein set forth the from state, local, and federal law drugs, poses significant adverse health grounds for his determination that it is enforcement agencies. Law enforcement risks. Furthermore, because abusers of necessary to temporarily schedule N- data show that N-ethylpentylone first synthetic cathinones obtain these ethylpentylone in schedule I of the CSA, appeared in the illicit drug market in substances through unregulated sources, and finds that placement of N- 2014 with one encounter and began the identity, purity, and quantity are ethylpentylone in schedule I of the CSA increasing thereafter.4 In 2015, NFLIS uncertain and inconsistent. These is necessary in order to avoid an registered five reports from three states unknown factors pose an additional risk imminent hazard to the public safety. regarding N-ethylpentylone. However, for significant adverse health effects to Because the Acting Administrator in 2016, there were 2,074 reports from the end user. hereby finds that it is necessary to 39 states and, in 2017, there were 3,955 Based on information received by the temporarily place N-ethylpentylone in reports from 39 states related to this DEA, the misuse and abuse of N- schedule I to avoid an imminent hazard substance registered in NFLIS. N- ethylpentylone has led to, at least, the to the public safety, this temporary Ethylpentylone represented 60% of all same qualitative public health risks as order scheduling this substance is synthetic cathinones encountered by schedule I synthetic cathinones, effective on the date of publication in local law enforcement agencies and MDMA, and methamphetamine. The the Federal Register, and is in effect for public health risks attendant to the a period of two years, with a possible 4 NFLIS and STRIDE/STARLiMS databases were abuse of synthetic cathinones, including extension of one additional year, queried on February 8, 2018. N-ethylpentylone, are well established pending completion of the regular

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(permanent) scheduling process. 21 a schedule I registration to handle N- ethylpentylone in accordance with a U.S.C. 811(h)(1) and (2). ethylpentylone must surrender all quota assigned pursuant to 21 U.S.C. The CSA sets forth specific criteria for currently held quantities of N- 826 and in accordance with 21 CFR part scheduling a drug or other substance. ethylpentylone. 1303 as of August 31, 2018. Permanent scheduling actions in 3. Security. N-ethylpentylone is 11. Liability. Any activity involving accordance with 21 U.S.C. 811(a) are subject to schedule I security N-ethylpentylone not authorized by, or subject to formal rulemaking procedures requirements and must be handled and in violation of the CSA, occurring as of done ‘‘on the record after opportunity stored pursuant to 21 U.S.C. 821, 823, August 31, 2018, is unlawful, and may for a hearing’’ conducted pursuant to 871(b), and in accordance with 21 CFR subject the person to administrative, the provisions of 5 U.S.C. 556 and 557. 1301.71–1301.93, as of August 31, 2018. civil, and/or criminal sanctions. 21 U.S.C. 811. The permanent 4. Labeling and Packaging. All labels, Regulatory Matters scheduling process of formal labeling, and packaging for commercial rulemaking affords interested parties containers of N-ethylpentylone must be Section 201(h) of the CSA, 21 U.S.C. with appropriate process and the in compliance with 21 U.S.C. 825, 811(h), provides for a temporary government with any additional 958(e), and be in accordance with 21 scheduling action where such action is relevant information needed to make a CFR part 1302. Current DEA registrants necessary to avoid an imminent hazard determination. Final decisions that shall have 30 calendar days from August to the public safety. As provided in this conclude the permanent scheduling 31, 2018, to comply with all labeling subsection, the Attorney General may, process of formal rulemaking are subject and packaging requirements. by order, schedule a substance in to judicial review. 21 U.S.C. 877. 5. Inventory. Every DEA registrant schedule I on a temporary basis. Such Temporary scheduling orders are not who possesses any quantity of N- an order may not be issued before the subject to judicial review. 21 U.S.C. ethylpentylone on the effective date of expiration of 30 days from (1) the 811(h)(6). this order must take an inventory of all publication of a notice in the Federal stocks of this substance on hand, Register of the intention to issue such Requirements for Handling pursuant to 21 U.S.C. 827 and 958, and order and the grounds upon which such Upon the effective date of this in accordance with 21 CFR 1304.03, order is to be issued, and (2) the date temporary order, N-ethylpentylone will 1304.04, and 1304.11. Current DEA that notice of the proposed temporary be subject to the regulatory controls and registrants shall have 30 calendar days scheduling order is transmitted to the administrative, civil, and criminal from the effective date of this order to Assistant Secretary of HHS. 21 U.S.C. sanctions applicable to the manufacture, be in compliance with all inventory 811(h)(1). distribution, reverse distribution, requirements. After the initial Inasmuch as section 201(h) of the importation, exportation, engagement in inventory, every DEA registrant must CSA directs that temporary scheduling research, and conduct of instructional take an inventory of all controlled actions be issued by order and sets forth activities or chemical analysis with, and substances (including N-ethylpentylone) the procedures by which such orders are possession of schedule I controlled on hand on a biennial basis, pursuant to to be issued, the DEA believes that the substances including the following: 21 U.S.C. 827 and 958, and in notice and comment requirements of 1. Registration. Any person who accordance with 21 CFR 1304.03, section 553 of the Administrative handles (manufactures, distributes, 1304.04, and 1304.11. Procedure Act (APA), 5 U.S.C. 553, do reverse distributes, imports, exports, 6. Records. All DEA registrants must not apply to this notice of intent. In the engages in research, or conducts maintain records with respect to N- alternative, even assuming that this instructional activities or chemical ethylpentylone pursuant to 21 U.S.C. notice of intent might be subject to analysis with, or possesses), or who 827 and 958(e), and in accordance with section 553 of the APA, the Acting desires to handle, N-ethylpentylone 21 CFR parts 1304, 1312, 1317 and Administrator finds that there is good must be registered with the DEA to § 1307.11. Current DEA registrants cause to forgo the notice and comment conduct such activities pursuant to 21 authorized to handle N-ethylpentylone requirements of section 553, as any U.S.C. 822, 823, 957, and 958, and in shall have 30 calendar days from the further delays in the process for accordance with 21 CFR parts 1301 and effective date of this order to be in issuance of temporary scheduling orders 1312, as of August 31, 2018. Any person compliance with all recordkeeping would be impracticable and contrary to who currently handles N- requirements. the public interest in view of the ethylpentylone, and is not registered 7. Reports. All DEA registrants who manifest urgency to avoid an imminent with the DEA, must submit an manufacture or distribute N- hazard to the public safety. application for registration and may not ethylpentylone must submit reports Further, the DEA believes that this continue to handle N-ethylpentylone as pursuant to 21 U.S.C. 827 and in temporary scheduling action is not a of August 31, 2018, unless the DEA has accordance with 21 CFR parts 1304 and ‘‘rule’’ as defined by 5 U.S.C. 601(2), approved that application for 1312 as of August 31, 2018. and, accordingly, is not subject to the registration pursuant to 21 U.S.C. 822, 8. Order Forms. All DEA registrants requirements of the Regulatory 823, 957, and 958, and in accordance who distribute N-ethylpentylone must Flexibility Act (RFA). The requirements with 21 CFR parts 1301 and 1312. Retail comply with order form requirements for the preparation of an initial sales of schedule I controlled substances pursuant to 21 U.S.C. 828 and in regulatory flexibility analysis in 5 U.S.C. to the general public are not allowed accordance with 21 CFR part 1305 as of 603(a) are not applicable where, as here, under the CSA. Possession of any August 31, 2018. the DEA is not required by section 553 quantity of this substance in a manner 9. Importation and Exportation. All of the APA or any other law to publish not authorized by the CSA on or after importation and exportation of N- a general notice of proposed August 31, 2018 is unlawful and those ethylpentylone must be in compliance rulemaking. in possession of any quantity of this with 21 U.S.C. 952, 953, 957, 958, and Additionally, this action is not a substance may be subject to prosecution in accordance with 21 CFR part 1312 as significant regulatory action as defined pursuant to the CSA. of August 31, 2018. by Executive Order 12866 (Regulatory 2. Disposal of stocks. Any person who 10. Quota. Only DEA registered Planning and Review), section 3(f), and, does not desire or is not able to obtain manufacturers may manufacture N- accordingly, this action has not been

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reviewed by the Office of Management PART 1308—SCHEDULES OF SUPPLEMENTARY INFORMATION: The event and Budget. CONTROLLED SUBSTANCES director, Game On Inc., with approval This action will not have substantial from the North Carolina Department of ■ 1. The authority citation for part 1308 direct effects on the States, on the Transportation, who owns and operates continues to read as follows: relationship between the national the U.S. 70 (Alfred A. Cunningham) government and the States, or on the Authority: 21 U.S.C. 811, 812, 871(b), Bridge across the Trent River, mile 0.0, distribution of power and 956(b), unless otherwise noted. at New Bern, NC, has requested a responsibilities among the various ■ 2. In § 1308.11, add paragraph (h)(36) temporary deviation from the current levels of government. Therefore, in to read as follows: operating regulations. This temporary accordance with Executive Order 13132 deviation is necessary to accommodate (Federalism) it is determined that this § 1308.11 Schedule I. participation by cyclists during the 30th action does not have sufficient * * * * * Annual Bike MS: Historic New Bern federalism implications to warrant the (h) * * * Ride. The bridge is a double bascule preparation of a Federalism Assessment. (36) N-Ethylpentylone, its optical, bridge and has a vertical clearance in positional, and geometric isomers, salts As noted above, this action is an the closed position of 14 feet above and salts of isomers (Other names: mean high water. order, not a rule. Accordingly, the ephylone, 1-(1,3-benzodioxol-5-yl)-2- Congressional Review Act (CRA) is (ethylamino)-pentan-1-one)...... (7543) The current operating schedule is set inapplicable, as it applies only to rules. out in 33 CFR 117.843(a). Under this However, if this were a rule, pursuant Dated: August 24, 2018. temporary deviation, the bridge will be to the CRA, ‘‘any rule for which an Uttam Dhillon, maintained in the closed-to-navigation agency for good cause finds that notice Acting Administrator. position from 8:00 a.m. to 9:30 a.m. on and public procedure thereon are [FR Doc. 2018–18988 Filed 8–30–18; 8:45 am] September 8th and September 9th 2018. impracticable, unnecessary, or contrary BILLING CODE 4410–09–P The Trent River is used by a variety of to the public interest, shall take effect at vessels including small commercial such time as the federal agency vessels and recreational vessels. The promulgating the rule determines.’’ 5 DEPARTMENT OF HOMELAND Coast Guard has carefully coordinated U.S.C. 808(2). It is in the public interest SECURITY the restrictions with waterway users in to schedule this substance immediately publishing this temporary deviation. to avoid an imminent hazard to the Coast Guard public safety. This temporary Vessels able to pass through the scheduling action is taken pursuant to 33 CFR Part 117 bridge in the closed position may do so at anytime. There is no immediate 21 U.S.C. 811(h), which is specifically [Docket No. USCG–2018–0841] designed to enable the DEA to act in an alternate route for vessels unable to pass expeditious manner to avoid an Drawbridge Operation Regulation; through the bridge in the closed imminent hazard to the public safety. 21 Trent River, New Bern, NC position but the bridge will be able to U.S.C. 811(h) exempts the temporary open for emergencies. The Coast Guard AGENCY: scheduling order from standard notice Coast Guard, DHS. will also inform users of the waterways and comment rulemaking procedures to ACTION: Notice of deviation from through our Local and Broadcast Notice ensure that the process moves swiftly. drawbridge regulation. to Mariners of the change in operating For the same reasons that underlie 21 schedule for the bridge so that vessels SUMMARY: The Coast Guard has issued a can arrange their transits to minimize U.S.C. 811(h), that is, the DEA’s need to temporary deviation from the operating move quickly to place this substance in schedule that governs the U.S. 70 any impacts caused by this temporary schedule I because it poses an imminent (Alfred A. Cunningham) Bridge across deviation. hazard to the public safety, it would be the Trent River, mile 0.0, at New Bern, In accordance with 33 CFR 117.35(e), contrary to the public interest to delay NC. The deviation is necessary to the drawbridge must return to its regular implementation of the temporary accommodate the 30th Annual Bike MS: operating schedule immediately at the scheduling order. Therefore, this order Historic New Bern Ride. This deviation end of the effective period of this shall take effect immediately upon its allows the bridge to remain in the temporary deviation. This deviation publication. The DEA has submitted a closed-to-navigation position. from the operating regulations is copy of this temporary order to both DATES: This deviation is effective from authorized under 33 CFR 117.35. Houses of Congress and to the 8:00 a.m. on September 8, 2018 to 9:30 Comptroller General, although such Dated: August 27, 2018. a.m. on September 9, 2018. filing is not required under the Small Hal R. Pitts, ADDRESSES: The docket for this Business Regulatory Enforcement Bridge Program Manager, Fifth Coast Guard deviation, [USCG–2018–0841], is Fairness Act of 1996 (Congressional District. Review Act), 5 U.S.C. 801–808 because, available at http://www.regulations.gov. Type the docket number in the [FR Doc. 2018–18929 Filed 8–30–18; 8:45 am] as noted above, this action is an order, BILLING CODE 9110–04–P not a rule. ‘‘SEARCH’’ box and click ‘‘SEARCH’’. Click on Open Docket Folder on the line List of Subjects in 21 CFR Part 1308 associated with this deviation. FOR FURTHER INFORMATION CONTACT: Administrative practice and If procedure, Drug traffic control, you have questions on this temporary Reporting and recordkeeping deviation, call or email Ms. Kashanda Booker, Bridge Administration Branch requirements. Fifth District, Coast Guard, telephone For the reasons set out above, the DEA (757) 398–6227, email amends 21 CFR part 1308 as follows: [email protected].

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