Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Proposed Rules 52935

BIS does not seek to expand DATES: Comments must be submitted Drug Enforcement Administration, Attn: jurisdiction over technologies that are electronically or postmarked on or DEA Federal Register Representative/ not currently subject to the EAR, such before September 28, 2020. DPW, 8701 Morrissette Drive, as ‘‘fundamental research’’ described in Interested persons may file written Springfield, Virginia 22152. § 734.8 of the EAR. comments on this proposal in FOR FURTHER INFORMATION CONTACT: BIS will review public comments accordance with 21 CFR 1308.43(g). Scott A. Brinks, Regulatory Drafting and submitted in response to this ANPRM to Commenters should be aware that the Policy Support Section, Diversion help inform BIS and its interagency electronic Federal Docket Management Control Division, Drug Enforcement partners’ efforts to identify, reevaluate System will not accept comments after Administration; Mailing Address: 8701 and subsequently control foundational 11:59 p.m. Eastern Time on the last day Morrissette Drive, Springfield, Virginia technologies. This interagency process of the comment period. 22152; Telephone: (571) 362–8209. is expected to result in rules and Interested persons may file a request SUPPLEMENTARY INFORMATION: comment periods with new control for a hearing or waiver of hearing levels for items currently controlled for pursuant to 21 CFR 1308.44 and in Posting of Public Comments AT reasons on the CCL or new ECCNs accordance with 21 CFR 1316.45 and/or Please note that all comments on the CCL for technologies currently 1316.47, as applicable. Requests for a received in response to this docket are classified as EAR99. hearing and waivers of an opportunity considered part of the public record. OMB has determined that this action for a hearing or to participate in a They will, unless reasonable cause is is significant under Executive Order hearing must be received on or before given, be made available by the Drug 12866. September 28, 2020. Enforcement Administration (DEA) for Submission of Comments ADDRESSES: To ensure proper handling public inspection online at http:// of comments, please reference ‘‘Docket www.regulations.gov. Such information Comments should be submitted to BIS No. DEA–482’’ on all electronic and includes personal identifying as described in the ADDRESSES section of written correspondence, including any information (such as your name, this ANPRM by October 26, 2020. attachments. address, etc.) voluntarily submitted by Matthew S. Borman, • Electronic comments: The Drug the commenter. The Freedom of Deputy Assistant Secretary for Export Enforcement Administration (DEA) Information Act (FOIA) applies to all Administration. encourages that all comments be comments received. If you want to [FR Doc. 2020–18910 Filed 8–26–20; 8:45 am] submitted electronically through the submit personal identifying information Federal eRulemaking Portal which (such as your name, address, etc.) as BILLING CODE 3510–33–P provides the ability to type short part of your comment, but do not want comments directly into the comment it to be made publicly available, you field on the web page or attach a file for must include the phrase ‘‘PERSONAL DEPARTMENT OF JUSTICE lengthier comments. Please go to http:// IDENTIFYING INFORMATION’’ in the Drug Enforcement Administration www.regulations.gov and follow the first paragraph of your comment. You online instructions at that site for must also place all of the personal 21 CFR Part 1308 submitting comments. Upon completion identifying information you do not want of your submission you will receive a made publicly available in the first [Docket No. DEA–482] Comment Tracking Number for your paragraph of your comment and identify comment. Please be aware that what information you want redacted. Schedules of Controlled Substances: submitted comments are not If you want to submit confidential Placement of N-Ethylpentylone in instantaneously available for public business information as part of your Schedule I view on Regulations.gov. If you have comment, but do not want it to be made AGENCY: Drug Enforcement received a Comment Tracking Number, publicly available, you must include the Administration, Department of Justice. your comment has been successfully phrase ‘‘CONFIDENTIAL BUSINESS ACTION: Notice of proposed rulemaking. submitted and there is no need to INFORMATION’’ in the first paragraph resubmit the same comment. of your comment. You must also SUMMARY: The Drug Enforcement • Paper comments: Paper comments prominently identify the confidential Administration proposes placing 1-(1,3- that duplicate the electronic submission business information to be redacted benzodioxol-5-yl)-2- are not necessary. Should you wish to within the comment. (ethylamino)pentan-1-one (N- mail a paper comment, in lieu of an Comments containing personal ethylpentylone, ephylone) and its electronic comment, it should be sent identifying information or confidential optical, positional, and geometric via regular or express mail to: Drug business information identified as isomers, salts, and salts of isomers Enforcement Administration, Attn: DEA directed above will be made publicly whenever the existence of such salts, Federal Register Representative/DPW, available in redacted form. If a comment isomers, and salts of isomers is possible, 8701 Morrissette Drive, Springfield, has so much confidential business in schedule I of the Controlled Virginia 22152. information that it cannot be effectively Substances Act. If finalized, this action • Hearing requests: All requests for a redacted, all or part of that comment would make permanent the existing hearing and waivers of participation may not be made publicly available. regulatory controls and administrative, must be sent to: Drug Enforcement Comments posted to http:// civil, and criminal sanctions applicable Administration, Attn: Administrator, www.regulations.gov may include any to schedule I controlled substances on 8701 Morrissette Drive, Springfield, personal identifying information (such persons who handle (manufacture, Virginia 22152. All requests for hearing as name, address, and phone number) distribute, reverse distribute, import, and waivers of participation should also included in the text of your electronic export, engage in research, conduct be sent to: (1) Drug Enforcement submission that is not identified as instructional activities or chemical Administration, Attn: Hearing Clerk/ directed above as confidential. analysis, or possess), or propose to ALJ, 8701 Morrissette Drive, An electronic copy of this document handle N-ethylpentylone. Springfield, Virginia 22152; and (2) and supplemental information to this

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proposed rule are available at http:// who handles or proposes to handle N- medical evidence, on July 15, 2020, the www.regulations.gov for easy reference. ethylpentylone. Assistant Secretary submitted to the Acting Administrator HHS’s scientific Request for Hearing or Waiver of Background and medical evaluations for this Participation in Hearing On August 31, 2018, DEA published substance. Upon receipt of the scientific Pursuant to 21 U.S.C. 811(a), this an order in the Federal Register and medical evaluation and scheduling action is a formal rulemaking ‘‘on the amending 21 CFR 1308.11(h) to recommendation from HHS, DEA record after opportunity for a hearing.’’ temporarily place 1-(1,3-benzodioxol-5- reviewed the documents and all other Such proceedings are conducted yl)-2-(ethylamino)pentan-1-one (N- relevant data, and conducted its own pursuant to the provisions of the ethylpentylone, ephylone) in schedule I eight-factor analysis of the abuse Administrative Procedure Act, 5 U.S.C. of the CSA pursuant to the temporary potential of N-ethylpentylone in 551–559. 21 CFR 1308.41–1308.45; 21 scheduling provisions of 21 U.S.C. accordance with 21 U.S.C. 811(c). CFR part 1316, subpart D. Interested 811(h). 83 FR 44474. That temporary persons may file requests for hearing or scheduling order was effective on the Proposed Determination To Schedule notices of intent to participate in a date of publication, and was based on N-Ethylpentylone hearing in conformity with the findings by the former Acting As discussed in the background requirements of 21 CFR 1308.44(a) or Administrator of DEA that the section, the Acting Administrator is (b), and include a statement of interest temporary scheduling of this synthetic initiating proceedings, pursuant to 21 in the proceeding and the objections or cathinone was necessary to avoid an U.S.C. 811(a)(1), to add N- issues, if any, concerning which the imminent hazard to the public safety ethylpentylone permanently to schedule person desires to be heard. Any pursuant to section 811(h)(1). Section I. DEA has reviewed the scientific and interested person may file a waiver of an 811(h)(2) provides that the temporary medical evaluation and scheduling opportunity for a hearing or to control of this substance expire two recommendation, received from HHS, participate in a hearing together with a years from the effective date of the and all other relevant data and written statement regarding the scheduling order, which was August 31, conducted its own eight-factor analysis interested person’s position on the 2020. However, this same provision also of the abuse potential of N- matters of fact and law involved in any provides that, during the pendency of ethylpentylone pursuant to 21 U.S.C. hearing as set forth in 21 CFR proceedings under 21 U.S.C. 811(a)(1) 811(c). Included below is a brief 1308.44(c). for the permanent scheduling of the summary of each factor as analyzed by All requests for a hearing and waivers substance, the temporary scheduling of HHS and DEA, and as considered by of participation must be sent to DEA that substance can be extended for up to DEA in its proposed scheduling action. using the address information provided one year. Proceedings for the scheduling Please note that both the DEA and the above. of a substance under 21 U.S.C. 811(a) HHS 8-Factor analyses and the Assistant Legal Authority may be initiated by the Attorney Secretary’s July 15, 2020, letter are General (delegated to the Administrator available in their entirety under the tab The Controlled Substances Act (CSA) of DEA pursuant to 28 CFR 0.100) on his provides that proceedings for the ‘‘Supporting Documents’’ of the public own motion, at the request of the docket of this rulemaking action at issuance, amendment, or repeal of the Secretary of HHS,3 or on the petition of scheduling of any drug or other http://www.regulations.gov, under any interested party. An extension of Docket Number ‘‘DEA–482.’’ substance may be initiated by the the existing temporary order is being 1. The Drug’s Actual or Relative Attorney General (1) on his own motion; ordered by the Acting Administrator of Potential for Abuse: Both the DEA and (2) at the request of the Secretary of the DEA (Acting Administrator) in a the HHS 8-factor analyses found that N- Department of Health and Human separate action, and is being 1 ethylpentylone has abuse potential Services (HHS); or (3) on the petition simultaneously published elsewhere in associated with its abilities to produce of any interested party. 21 U.S.C. 811(a). this issue of the Federal Register. This proposed action is supported by a The Acting Administrator, on his own psychoactive effects that are similar to recommendation from the Assistant motion, is initiating proceedings under those produced by schedule I synthetic Secretary for Health of the HHS 21 U.S.C. 811(a)(1) to permanently cathinones such as pentylone, (Assistant Secretary) and an evaluation schedule N-ethylpentylone. DEA has mephedrone, methylone, and 3,4- of all other relevant data by DEA. If gathered and reviewed the available methylenedioxypyrovalerone (MDPV) finalized, this action would make information regarding the and schedule II stimulants such as permanent 2 the imposition of regulatory pharmacology, chemistry, trafficking, methamphetamine and cocaine that controls and administrative, civil, and actual abuse, pattern of abuse, and the have a high potential for abuse. In criminal sanctions of schedule I relative potential for abuse for this particular, the responses in humans to controlled substances on any person synthetic cathinone. On September 25, N-ethylpentylone are stimulant-like and 2019, the former Acting Administrator include paranoia, agitation, palpitations, 1 As discussed in a memorandum of submitted a request to the Assistant tachycardia, hypertension, and understanding entered into by the Food and Drug Secretary to provide DEA with a hyperthermia. Administration (FDA) and the National Institute on scientific and medical evaluation of N-Ethylpentylone has no approved Drug Abuse (NIDA), FDA acts as the lead agency medical uses in the United States 4 within HHS in carrying out the Secretary’s available information and a scheduling and scheduling responsibilities under the CSA, with the recommendation for N-ethylpentylone, has been encountered on the illicit concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. in accordance with 21 U.S.C. 811(b) and market with adverse outcomes on the The Secretary of HHS has delegated to the Assistant public health and safety. Because this Secretary for Health of HHS the authority to make (c). Upon evaluating the scientific and domestic drug scheduling recommendations. 58 FR substance is not an approved drug 35460, July 1, 1993. 3 Because the Secretary of HHS has delegated to product, a practitioner may not legally 2 N-ethylpentylone is currently subject to the Assistant Secretary for Health the authority to schedule I controls on a temporary basis, pursuant make domestic drug scheduling recommendations, 4 There are no legitimate drug channels for N- to a temporary scheduling order issued by DEA for purposes of this proposed rulemaking, all ethylpentylone as a marketed drug, but DEA notes under authority of 21 U.S.C. 811(h). 83 FR 44474, subsequent references to ‘‘Secretary’’ have been that this synthetic cathinone has been used in Aug. 31, 2018. replaced with ‘‘Assistant Secretary.’’ scientific research.

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prescribe it, and it cannot be dispensed pharmacological effects that are similar satisfies a five-part test. Specifically, to an individual. The use of this to those produced by schedule I and II with respect to a drug that has not been substance without medical advice leads substances such as methamphetamine approved by FDA, all of the following to the conclusion that this synthetic (II), cocaine (II), MDMA (I), mephedrone must be demonstrated: The drug’s cathinone is being abused for its (I), MDPV (I), and methylone (I). Similar chemistry is known and reproducible; psychoactive properties. to these schedule I and II substances, N- there are adequate safety studies; there Reports from public health and law ethylpentylone binds to monoamine are adequate and well-controlled studies enforcement state that this substance is transporters for dopamine, serotonin, or proving efficacy; the drug is accepted by being abused and taken in amounts norepinephrine, and blocks the uptake qualified experts; and the scientific sufficient to create a hazard to an of these neurotransmitters at their evidence is widely available. 57 FR individual’s health. This hazard is transporters, but does not promote the 10499 (1992). Based on this analysis, N- evidenced by emergency department release of these monoamines. ethylpentylone has no currently admissions and deaths, representing a Additionally, behavioral studies in accepted medical use in the United significant safety issue for those in the animals demonstrate that N- States. Furthermore, DEA has not found community. Further, from January 2014 ethylpentylone produces locomotor any references regarding clinical testing through December 2019 (query date: behavior and discriminative stimulus of N-ethylpentylone in the scientific and July 10, 2020), the System to Retrieve effects that are similar to those of medical literature. Although the Information from Drug Evidence MDMA, methamphetamine, and chemistry of synthetic cathinones, in (STRIDE), STARLiMS, and the National cocaine. Overall, these data indicate that general, is known and has been Forensic Laboratory Information System N-ethylpentylone produces reproduced, as mentioned above there (NFLIS) databases registered a total of pharmacological effects and stimulant- are no clinical studies involving N- 20,502 reports by participating DEA, like behaviors that are similar to those ethylpentylone. Taken together with the State, local, and other forensic of schedule I substances MDMA, HHS’s conclusion, DEA finds that there laboratories, as applicable, pertaining to mephedrone, MDPV, and methylone, as is no legitimate medical use for N- N-ethylpentylone.5 NFLIS registered well as schedule II stimulants ethylpentylone in the United States. more than 19,000 reports from state and methamphetamine and cocaine. 4. History and Current Pattern of local forensic laboratories identifying 3. The State of Current Scientific Abuse: As described by DEA and HHS, this substance in drug-related exhibits Knowledge Regarding the Drug or Other N-ethylpentylone is a synthetic for a period from January 2014 to Substance: N-Ethylpentylone, like other cathinone of the phenethylamine class December 2019 from 46 states. There synthetic cathinones, is a designer drug and it is structurally and were no occurrences of N- of the phenethylamine class and it is pharmacologically similar to schedule I ethylpentylone reported in NFLIS for structurally similar to schedule I and II substances such as pentylone (I), 2013. N-Ethylpentylone was first substances pentylone, mephedrone, mephedrone (I), methylone (I), MDPV identified in NFLIS in May 2014. methylone, MDMA, and MDPV, as well (I), methamphetamine (II), MDMA (I). STRIDE/STARLiMS registered more as schedule II substance Thus, it is likely that N-ethylpentylone than 700 reports from DEA forensic methamphetamine. N-Ethylpentylone is abused in the same manner and by laboratories from January 2015 to has an ethyl carbon chain (-CH2CH3) on the same users as these substances. That December 2019. There were no the nitrogen (N) atom, a propyl group is, N-ethylpentylone, like these occurrences of N-ethylpentylone (-CH2CH2CH3) on the a-carbon, and a substances, is most likely ingested by reported in STRIDE/STARLiMS for 2013 methylenedioxy group (-OCH2O-) on the swallowing capsules or tablets or and 2014. N-Ethylpentylone was first phenyl ring. snorted by nasal insufflation of the reported to STRIDE/STARLiMS in Pharmacokinetic studies show that N- powder tablets. Products containing N- December 2015. Consequently, the data ethylpentylone is rapidly absorbed and ethylpentylone, similar to schedule I indicate that N-ethylpentylone is being enters the brain within 20 minutes after synthetic cathinones, are likely to be abused, and it presents safety hazards to intraperitoneal administration, and at falsely marketed as ‘‘research the health of individuals who consume approximately 40 minutes reaches its chemicals,’’ ‘‘jewelry cleaner,’’ ‘‘stain it due to its stimulant properties, maximum concentration. N- remover,’’ ‘‘plant food or fertilizer,’’ making it a hazard to the safety of the Ethylpentylone was found to undergo ‘‘insect repellants,’’ or ‘‘bath salts’’; sold community. hydrogenation, deethylation, at smoke shops, head shops, 2. Scientific Evidence of the Drug’s demethylation, and hydroxylation in convenience stores, adult book stores, Pharmacological Effects, if Known: As human liver microsomes resulting in and gas stations; and purchased on the described by HHS, studies show that N- four different metabolites. These four internet. Like those seen with ethylpentylone produces metabolites of N-ethylpentylone have commercial products that contain been identified in blood and oral fluid synthetic cathinones, the packages of 5 STRIDE is a database of drug exhibits sent to specimens in humans. products that contain N-ethylpentylone DEA laboratories. Exhibits from the database are Neither DEA nor HHS is aware of any also probably contain the warning ‘‘not from DEA, other federal agencies, and some local currently accepted medical use for N- for human consumption,’’ most likely in law enforcement agencies. STARLiMS is a ethylpentylone. According to HHS’s an effort to circumvent statutory laboratory information management system that systematically collects results from drug chemistry July 2020 scientific and medical restrictions for these substances. analyses conducted by DEA laboratories, and it evaluation and scheduling Demographic data collected from replaced STRIDE in 2014. NFLIS is a national drug recommendation, FDA has not approved published reports and mortality records forensic laboratory reporting system that a marketing application for a drug suggest that the main users of N- systematically collects results from drug chemistry analyses conducted by state and local forensic product containing N-ethylpentylone for ethylpentylone, similar to schedule I laboratories across the country. The NFLIS any therapeutic indication, nor is HHS synthetic cathinones and MDMA, are participation rate, defined as the percentage of the aware of any reports of clinical studies young adults. national drug caseload represented by laboratories or claims of an accepted medical use for Available evidence suggests that the that have joined NFLIS, is over 97 percent. NFLIS includes drug chemistry results from completed N-ethylpentylone in the United States. history and pattern of abuse of N- analyses only. NFLIS and STRIDE/STARLiMS A drug has a ‘‘currently accepted ethylpentylone parallels that of MDMA, databases were queried on July 10, 2020. medical use’’ if DEA concludes that it methamphetamine, or cocaine and that

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N-ethylpentylone has been marketed as were no occurrences of N- HHS, the psychic or physiological a replacement for these substances. N- ethylpentylone reported to STRIDE/ dependence liability of N- Ethylpentylone has been identified in STARLiMS for 2014. Concerns over the ethylpentylone is demonstrated by its law enforcement seizures that were continuing abuse of synthetic positive abuse-related studies in initially suspected to be MDMA. In cathinones have led to the control of animals and reported stimulant effects addition, there are reports that abusers many synthetic cathinones. in humans. The results from two of N-ethylpentylone thought they were 6. What, if Any, Risk There Is to the behavioral studies (drug discrimination using MDMA or another illicit Public Health: HHS reported that the and locomotor studies) demonstrate that substance but toxicological analysis public health risks of N-ethylpentylone N-ethylpentylone produced behavioral revealed that the psychoactive result from its ability to induce effects that are similar to those of substance was N-ethylpentylone. stimulant-like responses, which may substances with stimulant effects such Toxicology reports also revealed that N- lead to adverse events that include as the schedule I cathinones pentylone ethylpentylone is being ingested with cognitive impairment and even death. and MDPV. Furthermore, N- other substances including other Adverse health effects associated with ethylpentylone has been reported to be synthetic cathinones, common cutting the abuse of N-ethylpentylone include a abused for its stimulant properties. In agents, or other recreational substances. number of stimulant-like adverse health addition, DEA notes that because N- Consequently, products containing effects such as diaphoresis, insomnia, ethylpentylone shares pharmacological synthetic cathinones, including N- mydriasis, hyperthermia, vomiting, properties with substances that have ethylpentylone, are distributed to users, agitation, disorientation, paranoia, stimulant properties, it is probable that often with unpredictable outcomes. abdominal pain, cardiac arrest, N-ethylpentylone has a dependence Thus, the recreational abuse of N- respiratory failure, and coma. In profile similar to these substances ethylpentylone is a significant concern. addition, N-ethylpentylone has been which are known to cause substance 5. Scope, Duration and Significance involved in deaths of many individuals. dependence. of Abuse: N-Ethylpentylone is a popular DEA is aware of approximately 154 In summary, data suggests that N- recreational drug that emerged on the overdose deaths involving N- ethylpentylone produces behavioral United States’ illicit drug market after ethylpentylone abuse reported in the effects in animals and humans that are the scheduling of other popular United States between 2014 and 2018. similar to those of schedule I and II synthetic cathinones (e.g., ethylone, Some of these deaths occurred in stimulants. Although there are no mephedrone, methylone, pentylone, and Alabama, Maryland, and Florida. clinical studies evaluating dependence MDPV) (see DEA’s Eight Factor Analysis Furthermore, the identification of N- liabilities specific for N-ethylpentylone, for a full discussion). Forensic ethylpentylone in toxicological samples the pharmacological profile of this laboratories have confirmed the associated with fatal and non-fatal substance strongly suggests that it presence of N-ethylpentylone in drug overdoses as reported in the medical possesses dependence liabilities that are exhibits received from state, local, and and scientific literature, forensic qualitatively similar to schedule I or II federal law enforcement agencies. Law laboratory reports, and public health substances such as pentylone (I), enforcement data show that N- documents confirms these adverse MDMA (I), methamphetamine (II), and ethylpentylone first appeared in the effects of N-ethylpentylone. Like cocaine (II). illicit drug market in 2014 with one schedule I synthetic cathinones, N- encounter and began increasing ethylpentylone has caused acute health 8. Whether the Substance is an thereafter.6 In 2015, NFLIS registered 6 problems leading to emergency Immediate Precursor of a Substance reports from 4 states regarding N- department admissions, violent Already Controlled Under the CSA: N- ethylpentylone. However, in 2016, there behaviors causing harm to self or others, Ethylpentylone is not an immediate were 2,252 reports from 40 states and, and/or death. Thus, the abuse of N- precursor of any controlled substance in 2017, there were 6,242 reports from ethylpentylone, like that of the abuse of under the CSA as defined by 21 U.S.C 44 states related to this substance schedule I synthetic cathinones and 802(23). registered in NFLIS. N-Ethylpentylone stimulant drugs, poses significant Conclusion: After considering the represented 61 percent of all synthetic adverse health risks including death. scientific and medical evaluation cathinones encountered by local law Furthermore, because abusers of conducted by HHS, HHS’s scheduling enforcement agencies and reported to synthetic cathinones obtain these recommendation, and DEA’s own eight- NFLIS in 2017. In 2018, there were substances through unregulated sources, factor analysis, DEA finds that the facts 9,680 reports from 41 states related to the identity, purity, and quantity are and all relevant data constitute this substance registered in NFLIS, and uncertain and inconsistent. These substantial evidence of the potential for in 2019, there were 1,598 reports from unknown factors pose an additional risk abuse of N-ethylpentylone. As such, 25 states. At its peak in 2018, N- for significant adverse health effects to DEA hereby proposes to permanently ethylpentylone represented 79 percent the end user. schedule N-ethylpentylone as a of all synthetic cathinones encountered Based on information received by controlled substance under the CSA. by local law enforcement agencies and DEA, the abuse of N-ethylpentylone has Proposed Determination of Appropriate reported to NFLIS. Overall, from led to, at least, the same qualitative Schedule January 2014 to December 2019, NFLIS public health risks as schedule I registered 19,779 reports from state and synthetic cathinones and MDMA, and The CSA establishes five schedules of local forensic laboratories identifying schedule II methamphetamine. The controlled substances known as this substance in drug-related exhibits public health risks attendant to the schedules I, II, III, IV, and V. The CSA from 46 states. STRIDE/STARLiMS abuse of synthetic cathinones, including also outlines the findings required to registered more than 700 reports from N-ethylpentylone, are well established place a drug or other substance in any DEA forensic laboratories during and have resulted in large numbers of particular schedule. 21 U.S.C. 812(b). January 2015 to December 2019. There emergency department visits and fatal After consideration of the analysis and overdoses. recommendation of the Assistant 6 NFLIS and STRIDE/STARLiMS databases were 7. Its Psychic or Physiological Secretary for HHS and review of all queried on July 10, 2020. Dependence Liability: According to other available data, the Acting

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Administrator of DEA, pursuant to 21 in compliance with 21 U.S.C. 825 and pursuant to section 3(d)(1) of Executive U.S.C. 811(a) and 812(b)(1), finds that: 958(e), and be in accordance with 21 Order 12866 and the principles 1. N-Ethylpentylone has a high CFR part 1302. reaffirmed in Executive Order (E.O.) potential for abuse; 4. Quota. Only registered 13563. 2. N-Ethylpentylone has no currently manufacturers are permitted to This proposed rule does not meet the accepted medical use in treatment in the manufacture N-ethylpentylone in definition of an E.O. 13771 regulatory United States; and accordance with a quota assigned action, and the repeal and cost offset 3. There is a lack of accepted safety pursuant to 21 U.S.C. 826 and in requirements of E.O. 13771 have not for use of N-ethylpentylone under accordance with 21 CFR part 1303. been triggered. OMB has previously medical supervision. 5. Inventory. Any person registered determined that formal rulemaking Based on these findings, the Acting with DEA to handle N-ethylpentylone actions concerning the scheduling of Administrator of DEA concludes that 1- must have an initial inventory of all controlled substances, such as this rule, (1,3-benzodioxol-5-yl)-2- stocks of controlled substances are not significant regulatory actions (ethylamino)pentan-1-one (N- (including N-ethylpentylone) on hand under Section 3(f) of E.O. 12866. on the date the registrant first engages ethylpentylone, ephylone) including its Executive Order 12988, Civil Justice in the handling of controlled substances salts, isomers, and salts of isomers, Reform whenever the existence of such salts, pursuant to 21 U.S.C. 827 and 958, and isomers, and salts of isomers is possible, in accordance with 21 CFR 1304.03, This proposed regulation meets the warrants continued control in schedule 1304.04, and 1304.11. applicable standards set forth in I of the CSA. 21 U.S.C. 812(b)(1). After the initial inventory, every DEA sections 3(a) and 3(b)(2) of E.O. 12988 registrant must take an inventory of all to eliminate drafting errors and Requirements for Handling controlled substances (including N- ambiguity, minimize litigation, provide N-Ethylpentylone ethylpentylone) on hand every two a clear legal standard for affected If this rule is finalized as proposed, N- years, pursuant to 21 U.S.C. 827 and conduct, and promote simplification ethylpentylone would continue 7 to be 958, and in accordance with 21 CFR and burden reduction. subject to the CSA’s schedule I 1304.03, 1304.04, and 1304.11. Executive Order 13132, Federalism regulatory controls and administrative, 6. Records and Reports. Every DEA civil, and criminal sanctions applicable registrant is required to maintain This proposed rulemaking does not to the manufacture, distribution, reverse records and submit reports with respect have federalism implications warranting distribution, importation, exportation, to N-ethylpentylone pursuant to 21 the application of E.O. 13132. The engagement in research, and conduct of U.S.C. 827 and 958(e), and in proposed rule does not have substantial instructional activities or chemical accordance with 21 CFR parts 1304 and direct effects on the States, on the analysis with, and possession of 1312. relationship between the national schedule I controlled substances 7. Order Forms. Every DEA registrant government and the States, or the including the following: who distributes N-ethylpentylone is distribution of power and 1. Registration. Any person who required to comply with the order form responsibilities among the various handles (manufactures, distributes, requirements, pursuant to 21 U.S.C. 828 levels of government. reverse distributes, imports, exports, and 21 CFR part 1305. Executive Order 13175, Consultation engages in research, or conducts 8. Importation and Exportation. All and Coordination With Indian Tribal instructional activities or chemical importation and exportation of N- Governments analysis with, or possesses) N- ethylpentylone must be in compliance This proposed rule does not have ethylpentylone, or who desires to with 21 U.S.C. 952, 953, 957, and 958, tribal implications warranting the handle N-ethylpentylone, is required to and in accordance with 21 CFR part application of E.O. 13175. It does not be registered with DEA to conduct such 1312. have substantial direct effects on one or activities pursuant to 21 U.S.C. 822, 9. Liability. Any activity involving N- more Indian tribes, on the relationship 823, 957, and 958, and in accordance ethylpentylone not authorized by, or in between the Federal government and with 21 CFR parts 1301 and 1312. violation of the CSA or its implementing Indian tribes, or on the distribution of 2. Security. N-Ethylpentylone is regulations is unlawful, and could power and responsibilities between the subject to schedule I security subject the person to administrative, Federal government and Indian tribes. requirements and must be handled and civil, and/or criminal sanctions. stored pursuant to 21 U.S.C. 821, 823, Regulatory Analyses Regulatory Flexibility Act 871(b), and in accordance with 21 CFR The Acting Administrator, in 1301.71–1301.93. Non-practitioners Executive Orders 12866, 13563, and accordance with the Regulatory handling N-ethylpentylone must also 13771, Regulatory Planning and Review, Flexibility Act (RFA), 5 U.S.C. 601–602, comply with the employee screening Improving Regulation and Regulatory has reviewed this proposed rule and by requirements of 21 CFR 1301.90– Review, and Reducing Regulation and approving it certifies that it will not 1301.93. Controlling Regulatory Costs have a significant economic impact on 3. Labeling and Packaging. All labels, In accordance with 21 U.S.C. 811(a), a substantial number of small entities. labeling, and packaging for commercial this proposed scheduling action is On August 31, 2018, DEA published an containers of N-ethylpentylone must be subject to formal rulemaking procedures order to temporarily place N- performed ‘‘on the record after ethylpentylone in schedule I of the CSA 7 N-Ethylpentylone is currently subject to pursuant to the temporary scheduling schedule I controls on a temporary basis, pursuant opportunity for a hearing,’’ which are to the temporary scheduling order issued by DEA conducted pursuant to the provisions of provisions of 21 U.S.C. 811(h). DEA under the authority of 21 U.S.C. 811(h). 83 FR 5 U.S.C. 556 and 557. The CSA sets estimates that all entities handling or 44474, August 31, 2018. An order extending the forth the criteria for scheduling a drug planning to handle this substance have temporary scheduling of N-ethylpentylone for one already established and implemented year is published elsewhere in this issue of the or other substance. Such actions are Federal Register, on the same day as this notice of exempt from review by the Office of the systems and processes required to proposed rulemaking. Management and Budget (OMB) handle N-ethylpentylone. There are

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currently 20 unique registrations List of Subjects in 21 CFR Part 1308 FOR FURTHER INFORMATION CONTACT: Lisa authorized to handle N-ethylpentylone Administrative practice and O. Wilson, (410) 786–8852. specifically, as well as a number of procedure, Drug traffic control, SUPPLEMENTARY INFORMATION: In the registered analytical labs that are Reporting and recordkeeping October 17, 2019 Federal Register (84 authorized to handle schedule I requirements. FR 55766), we published a proposed controlled substances generally. From For the reasons set out above, DEA rule that addressed undue regulatory review of entity names, DEA estimates proposes to amend 21 CFR part 1308 as impact and burden of the physician self- these 20 registrations represent 16 follows: referral law. The proposed rule was entities. Some of these entities are likely issued in conjunction with the Centers to be small entities. However, since DEA PART 1308—SCHEDULES OF for Medicare & Medicaid Services’ does not have information of registrant CONTROLLED SUBSTANCES (CMS) Patients over Paperwork size and the majority of DEA registrants initiative and the Department of Health ■ are small entities or are employed by 1. The authority citation for part 1308 and Human Services’ (the Department small entities, DEA estimates a continues to read as follows: or HHS) Regulatory Sprint to maximum of 16 entities are small Authority: 21 U.S.C. 811, 812, 871(b), Coordinated Care. In the proposed rule, entities. Therefore, DEA conservatively 956(b), unless otherwise noted. we proposed exceptions to the estimates as many as 16 small entities ■ 2. In § 1308.11, add paragraph (d)(86) physician self-referral law for certain are affected by this proposed rule. and remove and reserve paragraph value-based compensation arrangements between or among physicians, A review of the 20 registrations (h)(36). The addition reads as follows: providers, and suppliers; a new indicates that all entities that currently exception for certain arrangements handle N-ethylpentylone also handle § 1308.11 Schedule I. under which a physician receives other schedule I controlled substances, * * * * * limited remuneration for items or and thus they have established and (d) * * * services actually provided by the implemented (or maintain) the systems (86) N-Ethylpentylone (Other physician; a new exception for and processes required to handle N- names: ephylone, 1-(1,3- donations of cybersecurity technology ethylpentylone as a schedule I benzodioxol-5-yl)-2- and related services; and amendments substance. Therefore, DEA anticipates (ethylamino)pentan-1-one) ...... 7543 to the existing exception for electronic that this proposed rule will impose * * * * * health records (EHR) items and services. minimal or no economic impact on any The proposed rule also provides affected entities, and, thus, will not Dated: August 24, 2020. critically necessary guidance for have a significant economic impact on Timothy J. Shea, physicians and health care providers any of the 16 affected small entities. Acting Administrator. and suppliers whose financial Therefore, DEA has concluded that this [FR Doc. 2020–19007 Filed 8–26–20; 8:45 am] relationships are governed by the proposed rule will not have a significant BILLING CODE 4410–09–P physician self-referral statute and effect on a substantial number of small regulations. This notice announces an entities. extension of the timeline for publication DEPARTMENT OF HEALTH AND of the final rule and the continuation of Unfunded Mandates Reform Act of 1995 HUMAN SERVICES effectiveness of the proposed rule. In accordance with the Unfunded Section 1871(a)(3)(A) of the Social Mandates Reform Act (UMRA) of 1995, Centers for Medicare & Medicaid Security Act (the Act) requires us to Services 2 U.S.C. 1501 et seq., DEA has establish and publish a regular timeline determined and certifies that this action for the publication of final regulations 42 CFR Part 411 would not result in any Federal based on the previous publication of a mandate that may result ‘‘in the [CMS–1720–RCN] proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the expenditure by State, local, and tribal RIN 0938–AT64 governments, in the aggregate, or by the timeline may vary among different regulations based on differences in the private sector, of $100,000,000 or more Medicare Program; Modernizing and complexity of the regulation, the (adjusted annually for inflation) in any Clarifying the Physician Self-Referral number and scope of comments 1 year * * *.’’ Therefore, neither a Regulations Extension of Timeline for received, and other relevant factors, but Small Government Agency Plan nor any Publication of Final Rule may not be longer than 3 years except other action is required under UMRA of AGENCY: under exceptional circumstances. In 1995. Centers for Medicare & Medicaid Services (CMS), HHS. addition, in accordance with section Paperwork Reduction Act of 1995 ACTION: Extension of timeline for 1871(a)(3)(B) of the Act, the Secretary publication of final rule. may extend the initial targeted This action does not impose a new publication date of the final regulation collection of information under the SUMMARY: This notice announces an if the Secretary, no later than the Paperwork Reduction Act of 1995. 44 extension of the timeline for publication regulation’s previously established U.S.C. 3501–3521. This action would of a Medicare final rule in accordance proposed publication date, publishes a not impose recordkeeping or reporting with the Social Security Act, which notice with the new target date, and requirements on State or local allows us to extend the timeline for such notice includes a brief explanation governments, individuals, businesses, or publication of the final rule. of the justification for the variation. organizations. An agency may not DATES: As of August 26, 2020, the We announced in the Spring 2020 conduct or sponsor, and a person is not timeline for publication of the final rule Unified Agenda (June 30, 2020, required to respond to, a collection of to finalize the provisions of the October www.reginfo.gov) that we would issue information unless it displays a 17, 2019 proposed rule (84 FR 55766) is the final rule in August 2020. However, currently valid OMB control number. extended until August 31, 2021. we are still working through the

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