Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Proposed Rules 37719

Signed in Washington, DC, on July 9, 2021. online instructions at that site for MEAP, 2-(ethylamino)-1-(4- Treena V. Garrett, submitting comments. Upon completion methylphenyl)pentan-1-one), Federal Register Liaison Officer, U.S. of your submission you will receive a • 4′-methyl-alpha- Department of Energy. Comment Tracking Number for your pyrrolidinohexiophenone (other names: ′ ′ [FR Doc. 2021–14977 Filed 7–15–21; 8:45 am] comment. Please be aware that 4 -methyl-a-PHP, 4 -methyl PHP, PV4, BILLING CODE 6450–01–P submitted comments are not 4-MPHP, MPHP, 4-methyl-alpha- instantaneously available for public pyrrolidino hexanophenone, 1-(4- view on Regulations.gov. If you have methylphenyl)-2-(pyrrolidin-1-yl)hexan- received a Comment Tracking Number, 1-one), DEPARTMENT OF JUSTICE • your comment has been successfully alpha-pyrrolidinoheptaphenone Drug Enforcement Administration submitted and there is no need to (other names: alpha- resubmit the same comment. pyrrolidinoheptiophenone, alpha-PHpP, 21 CFR Part 1308 • Paper comments: Paper comments PV8, 1-phenyl-2-(pyrrolidin-1- that duplicate the electronic submission yl)heptan-1-one), and • ′ [Docket No. DEA–495] are not necessary. Should you wish to 4 -chloro-alpha- mail a paper comment, in lieu of an pyrrolidinovalerophenone (other names: Schedules of Controlled Substances: 4-chloro-a-pyrrolidinopentiophenone, Placement of N-Ethylhexedrone, alpha- electronic comment, it should be sent via regular or express mail to: Drug 4-chloro-a-PVP, 4-Cl-a-PVP, 4-chloro-2- Pyrrolidinohexanophenone, 4-Methyl- (1-pyrrolidinyl)-valerophenone, 1-(4- alpha-ethylaminopentiophenone, 4′- Enforcement Administration, Attn: DEA Federal Register Representative/DPW, chlorophenyl)-2-(pyrrolidin-1- Methyl-alpha- yl)pentan-1-one). pyrrolidinohexiophenone, alpha- 8701 Morrissette Drive, Springfield, Pyrrolidinoheptaphenone, and 4′- Virginia 22152. Posting of Public Comments • Hearing requests: All requests for a Chloro-alpha- Please note that all comments pyrrolidinovalerophenone in Schedule hearing and waivers of participation, received in response to this docket are I together with a written statement of considered part of the public record. position on the matters of fact and law They will, unless reasonable cause is AGENCY: Drug Enforcement asserted in the hearing, must be sent to: given, be made available by DEA for Administration, Department of Justice. Drug Enforcement Administration, Attn: public inspection online at http:// ACTION: Notice of proposed rulemaking. Administrator, 8701 Morrissette Drive, www.regulations.gov. Such information Springfield, Virginia 22152. All requests includes personal identifying SUMMARY: The Drug Enforcement for hearing and waivers of participation information (such as your name, Administration proposes placing six should also be sent to: (1) Drug address, etc.) voluntarily submitted by synthetic , as identified in Enforcement Administration, Attn: the commenter. The Freedom of this proposed rule, in schedule I of the Hearing Clerk/OALJ, 8701 Morrissette Information Act applies to all comments Controlled Substances Act. If finalized, Drive, Springfield, Virginia 22152; and received. If you want to submit personal this action would make permanent the (2) Drug Enforcement Administration, identifying information (such as your existing regulatory controls and Attn: DEA Federal Register name, address, etc.) as part of your administrative, civil, and criminal Representative/DPW, 8701 Morrissette comment, but do not want it to be made sanctions applicable to schedule I Drive, Springfield, Virginia 22152. publicly available, you must include the controlled substances on persons who FOR FURTHER INFORMATION CONTACT: phrase ‘‘PERSONAL IDENTIFYING handle (manufacture, distribute, reverse Terrence L. Boos, Ph.D., Drug and INFORMATION’’ in the first paragraph distribute, import, export, engage in Chemical Evaluation Section, Drug of your comment. You must also place research, conduct instructional Enforcement Administration; all of the personal identifying activities or chemical analysis, or Telephone: (571) 362–3249. information you do not want made possess), or propose to handle these six SUPPLEMENTARY INFORMATION: publicly available in the first paragraph specified controlled substances. In this proposed rule, the Drug of your comment and identify what DATES: Comments must be submitted Enforcement Administration (DEA) information you want redacted. electronically or postmarked on or proposes to permanently schedule the If you want to submit confidential before August 16, 2021. following six controlled substances in business information as part of your Requests for hearing and waivers of schedule I of the Controlled Substances comment, but do not want it to be made an opportunity for a hearing or to Act (CSA), including their salts, publicly available, you must include the participate in a hearing must be isomers, and salts of isomers whenever phrase ‘‘CONFIDENTIAL BUSINESS received on or before August 16, 2021. the existence of such salts, isomers, and INFORMATION’’ in the first paragraph ADDRESSES: To ensure proper handling salts of isomers is possible within the of your comment. You must also of comments, please reference ‘‘Docket specific chemical designation: prominently identify the confidential No. DEA–495’’ on all electronic and • N-ethylhexedrone (other names: a- business information to be redacted written correspondence, including any ethylaminohexanophenone, ethyl within the comment. attachments. hexedrone, HEXEN, 2-(ethylamino)-1- Comments containing personal • Electronic comments: The Drug phenylhexan-1-one), identifying information or confidential Enforcement Administration (DEA) • alpha-pyrrolidinohexanophenone business information identified as encourages that all comments be (other names: a-pyrrolidino- directed above will be made publicly submitted electronically through the hexanophenone, alpha-PHP, a-PHP, available in redacted form. If a comment Federal eRulemaking Portal which PV7, 1-phenyl-2-(pyrrolidin-1-yl)hexan- has so much confidential business provides the ability to type short 1-one), information that it cannot be effectively comments directly into the comment • 4-methyl-alpha- redacted, all or part of that comment field on the web page or attach a file for ethylaminopentiophenone (other names: may not be made publicly available. lengthier comments. Please go to http:// N-ethyl-4-methylnorpentedrone, 4- Comments posted to http:// www.regulations.gov and follow the methyl-a-ethylaminopentiophenone, 4- www.regulations.gov may include any

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personal identifying information (such Background the scientific and medical evidence, on as name, address, and phone number) On July 18, 2019, pursuant to 21 July 8, 2021, the Assistant Secretary included in the text of your electronic U.S.C. 811(h)(1), DEA published an submitted to the Acting Administrator submission that is not identified as order in the Federal Register (84 FR HHS’s scientific and medical evaluation directed above as confidential. 34291) temporarily placing N- and scheduling recommendation for An electronic copy of this document ethylhexedrone, alpha- these substances. Upon receipt of the scientific and medical evaluation and and supplemental information to this pyrrolidinohexanophenone (a-PHP), 4- scheduling recommendation from HHS, proposed rule are available at http:// methyl-alpha- DEA reviewed the document and all www.regulations.gov for easy reference. ethylaminopentiophenone (4-MEAP), 4′- methyl-alpha-pyrrolidinohexiophenone other relevant data, and conducted its Request for Hearing or Waiver of (MPHP), alpha- own eight-factor analysis of the abuse Particpation in Hearing pyrrolidinoheptaphenone (PV8), and 4′- potential of N-ethylhexedrone, a-PHP, chloro-alpha-pyrrolidinovalerophenone 4-MEAP, MPHP, PV8, and 4-chloro-a- Pursuant to 21 U.S.C. 811(a), this (4-chloro-a-PVP) in schedule I of the PVP in accordance with 21 U.S.C. action is a formal rulemaking ‘‘on the CSA upon finding that these synthetic 811(c). record after opportunity for a hearing.’’ cathinones pose an imminent hazard to Proposed Determination of Schedule Such proceedings are conducted the public safety. That temporary order N-Ethylhexedrone, a-PHP, 4-MEAP, pursuant to the provisions of the was effective on the date of publication. MPHP, PV8, and 4-Chloro-a-PVP Administrative Procedure Act, 5 U.S.C. Pursuant to 21 U.S.C. 811(h)(2), the As discussed in the background 551–559. 21 CFR 1308.41–1308.45; 21 temporary control of these substances is section, the Administrator is initiating CFR part 1316, subpart D. Interested set to expire on July 18, 2021. However, proceedings, pursuant to 21 U.S.C. persons may file requests for hearing or this same subsection also provides that, 811(a)(1), to add N-ethylhexedrone, a- notices of intent to participate in a during the pendency of proceedings PHP, 4-MEAP, MPHP, PV8, and 4- hearing in conformity with the under 21 U.S.C. 811(a)(1) with respect chloro-a-PVP permanently to schedule requirements of 21 CFR 1308.44(a) or to a substance, the temporary I. DEA has reviewed the scientific and (b), and include a statement of interest scheduling of that substance may be medical evaluation and scheduling in the proceeding and the objections or extended for up to one year. recommendation, received from HHS, issues, if any, concerning which the Proceedings for the scheduling of a and all other relevant data and person desires to be heard. Any substance under 21 U.S.C. 811(a) may conducted its own eight-factor analysis be initiated by the Attorney General interested person may file a waiver of an of the abuse potential of N- (delegated to the Administrator of DEA opportunity for a hearing or to ethylhexedrone, a-PHP, 4-MEAP, (Administrator) pursuant to 28 CFR participate in a hearing together with a MPHP, PV8, and 4-chloro-a-PVP 0.100) on his own motion, at the request written statement regarding the pursuant to 21 U.S.C. 811(c). Included of the Secretary of HHS,1 or on the interested person’s position on the below is a brief summary of each factor petition of any interested party. An matters of fact and law involved in any as analyzed by HHS and DEA, and as extension of the existing temporary hearing as set forth in 21 CFR considered by DEA in its proposed order is being ordered by the 1308.44(c). scheduling action. Please note that both Administrator in a separate action, and the DEA and the HHS 8-Factor analyses All requests for a hearing and waivers is being simultaneously published and the Assistant Secretary’s July 8, of participation, together with a written elsewhere in this issue of the Federal 2021 letter are available in their entirety statement of position on the matters of Register. fact and law involved in such hearing, The Administrator, on her own under the tab ‘‘Supporting Documents’’ must be sent to DEA using the address motion, is initiating proceedings under of the public docket of this rulemaking information provided above. 21 U.S.C. 811(a)(1) to permanently action at http://www.regulations.gov, schedule N-ethylhexedrone, a-PHP, 4- under Docket Number ‘‘DEA–495.’’ Legal Authority 1. The Drug’s Actual or Relative MEAP, MPHP, PV8, and 4-chloro-a- Potential for Abuse: Both the DEA and PVP. DEA has gathered and reviewed The CSA provides that proceedings the HHS 8-factor analyses found that N- the available information regarding the for the issuance, amendment, or repeal ethylhexedrone, a-PHP, 4-MEAP, pharmacology, chemistry, trafficking, of the scheduling of any drug or other MPHP, PV8, and 4-chloro-a-PVP have actual abuse, pattern of abuse, and the substance may be initiated by the abuse potential associated with its relative potential for abuse for these Attorney General on his own motion. 21 abilities to produce psychoactive effects synthetic cathinones. On October 22, U.S.C. 811(a). This proposed action is that are similar to those produced by 2020, the Acting Administrator of DEA supported by a recommendation from schedule I synthetic cathinones such as submitted a request to the Assistant the Assistant Secretary for Health of the , , Department of Health and Human Secretary for Health of HHS (Assistant Secretary) to provide DEA with a , , and 3,4- Services (HHS) and an evaluation of all methylenedioxypyrovalerone (MDPV) other relevant data by DEA. If finalized, scientific and medical evaluation of available information and a scheduling and schedule II such as this action would make permanent the and that existing temporary regulatory controls recommendation for N-ethylhexedrone, a have a high potential for abuse. In and administrative, civil, and criminal -PHP, 4-MEAP, MPHP, PV8, and 4- chloro-a-PVP, in accordance with 21 particular, the responses in humans to sanctions for schedule I controlled U.S.C. 811(b) and (c). Upon evaluating N-ethylhexedrone, a-PHP, 4-MEAP, substances on any person who handles MPHP, PV8, and 4-chloro-a-PVP are (manufactures, distributes, imports, 1 Because the Secretary of HHS has delegated to -like and include paranoia, exports, engages in research, conducts the Assistant Secretary for Health (Assistant agitation, palpitations, tachycardia, instructional activities or chemical Secretary) the authority to make domestic drug hypertension, and hyperthermia. analysis, or possesses) or proposes to scheduling recommendations, for purposes of this N-Ethylhexedrone, a-PHP, 4-MEAP, proposed rulemaking, all subsequent references to handle N-ethylhexedrone, a-PHP, 4- ‘‘Secretary’’ have been replaced with ‘‘Assistant MPHP, PV8, and 4-chloro-a-PVP have MEAP, MPHP, PV8, or 4-chloro-a-PVP. Secretary.’’ no approved medical uses in the United

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States but there have been reports of I and II substances, N-ethylhexedrone, A drug has a ‘‘currently accepted individuals experiencing adverse a-PHP, 4-MEAP, MPHP, PV8, and 4- medical use’’ if DEA concludes that it outcomes after taking these substances. chloro-a-PVP bind to monoamine satisfies a five-part test. Specifically, Because these substances are not transporters for and with respect to a drug that has not been approved drug products, a practitioner , and block the uptake of approved by FDA, all of the following may not legally prescribe them, and these neurotransmitters at their must be demonstrated: The drug’s they cannot be dispensed to an transporters. N-Ethylhexedrone, a-PHP, chemistry is known and reproducible; individual. The use of these substances and MPHP (4-MEAP, PV8, and 4-chloro- there are adequate safety studies; there without medical advice leads to the a-PVP were not tested in this assay) do are adequate and well-controlled studies conclusion that these synthetic not promote the release of these proving efficacy; the drug is accepted by cathinones are being abused for their monoamines. Additionally, behavioral qualified experts; and the scientific psychoactive properties. studies in animals demonstrate that N- evidence is widely available.3 Based on Reports from public health and law ethylhexedrone, a-PHP, 4-MEAP, this analysis, N-ethylhexedrone, a-PHP, enforcement state that these substances MPHP, PV8, and 4-chloro-a-PVP 4-MEAP, MPHP, PV8, and 4-chloro-a- are being abused and taken in amounts produce locomotor behavior and PVP have no currently accepted medical sufficient to create a hazard to an discriminative stimulus effects that are use in the United States. Furthermore, individual’s health. This hazard is similar to those of methamphetamine DEA has not found any references evidenced by emergency department and cocaine. Overall, these data indicate regarding clinical testing of these admissions or deaths, representing a that N-ethylhexedrone, a-PHP, 4-MEAP, substances in the scientific and medical significant safety issue for those in the MPHP, PV8, and 4-chloro-a-PVP literature. Although the chemistry of community. Further, from January 2012 produce pharmacological effects and synthetic cathinones, in general, is through December 2020 (query date: stimulant-like behaviors that are similar known and has been reproduced, as May 3, 2021), the National Forensic to those of other schedule I synthetic mentioned above there are no clinical Laboratory Information System (NFLIS) cathinones such as methcathinone, studies involving N-ethylhexedrone, a- databases registered a total of 2,289 mephedrone, MDPV, and methylone, as PHP, 4-MEAP, MPHP, PV8, and 4- reports by participating DEA, State, well as schedule II stimulants chloro-a-PVP. Taken together with local, and other forensic laboratories, as methamphetamine and cocaine. HHS’s conclusion, DEA finds that there applicable, pertaining to N- 3. The State of Current Scientific is no legitimate medical use for N- ethylhexedrone, a-PHP, 4-MEAP, Knowledge Regarding the Drug or Other ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP.2 Substance: N-Ethylhexedrone, a-PHP, 4- MPHP, PV8, and 4-chloro-a-PVP in the NFLIS registered these reports MEAP, MPHP, PV8, and 4-chloro-a-PVP United States. identifying these substances in drug- are designer drugs of the 4. History and Current Pattern of related exhibits from more than 40 class and they are Abuse: Available evidence suggests that States. MPHP was first identified in structurally similar to permanently the history and pattern of abuse of N- June 2012 in seized drug evidence controlled schedule I synthetic ethylhexedrone, a-PHP, 4-MEAP, (although MPHP was identified in blood cathinones and schedule II stimulants MPHP, PV8, and 4-chloro-a-PVP samples from a 27-year-old decedent in like methamphetamine. parallel that of permanently controlled 2011), followed by 4-MEAP and PV8 Pharmacokinetic studies show that schedule I stimulants. N- (August and December 2013, humans, in general, metabolize ethylhexedrone, a-PHP, 4-MEAP, synthetic cathinones to their respectively), alpha-PHP (May 2014), 4- MPHP, PV8, and 4-chloro-a-PVP are corresponding followed chloro-a-PVP (December 2015) and most synthetic cathinones of the by reduction of the beta-keto group to recently N-ethylhexedrone (August phenethylamine class and they are the corresponding alcohol which can 2016). Consequently, the data indicate structurally and pharmacologically involve hydrogenation, deethylation, that N-ethylhexedrone, a-PHP, 4-MEAP, similar to schedule I and II substances demethylation, or hydroxylation. Given MPHP, PV8, and 4-chloro-a-PVP are such as methcathinone (I) and that N-ethylhexedrone, a-PHP, 4-MEAP, being abused, and they present safety methamphetamine (II). Like these MPHP, PV8, and 4-chloro-a-PVP are hazards to the health of individuals who schedule I and II substances, N- synthetic cathinones, it is likely that consume them due to their stimulant ethylhexedrone, a-PHP, 4-MEAP, these six synthetic cathinones are also MPHP, PV8, and 4-chloro-a-PVP are properties. metabolized to their corresponding 2. Scientific Evidence of the Drug’s most likely ingested by swallowing amphetamines and alcohols. capsules or tablets or snorted by nasal Pharmacological Effects, if Known: As Neither DEA nor HHS is aware of any described by HHS, studies show that N- insufflation of the powder tablets. As currently accepted medical use for N- reported by DEA and HHS, products ethylhexedrone, a-PHP, 4-MEAP, ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP containing N-ethylhexedrone, a-PHP, 4- MPHP, PV8, and 4-chloro-a-PVP. MEAP, MPHP, PV8, or 4-chloro-a-PVP, produce pharmacological effects that are According to HHS’s 2021 scientific and similar to those produced by schedule I similar to schedule I synthetic medical evaluation and scheduling cathinones, are likely to be falsely and II substances such as recommendation, the Food and Drug methamphetamine (II), cocaine (II), marketed as ‘‘research chemicals,’’ Administration (FDA) has not approved ‘‘jewelry cleaner,’’ ‘‘stain remover,’’ mephedrone (I), MDPV (I), and marketing applications for drug ‘‘plant food or fertilizer,’’ ‘‘insect methylone (I). Similar to these schedule products containing N-ethylhexedrone, repellants,’’ or ‘‘;’’ sold at a-PHP, 4-MEAP, MPHP, PV8, and 4- 2 smoke shops, head shops, convenience NFLIS is a national drug forensic laboratory chloro-a-PVP for any therapeutic reporting system that systematically collects results stores, adult book stores, or gas stations; from drug chemistry analyses conducted by state indication, nor is HHS aware of any and purchased on the internet. Like and local forensic laboratories across the country. reports of clinical studies or claims of those seen with commercial products The NFLIS participation rate, defined as the accepted medical use for N- percentage of the national drug caseload a represented by laboratories that have joined NFLIS, ethylhexedrone, -PHP, 4-MEAP, 3 57 FR 10499 (1992), pet. for rev. denied, is over 97 percent. NFLIS includes drug chemistry MPHP, PV8, and 4-chloro-a-PVP in the Alliance for Cannabis Therapeutics v. DEA, 15 F.3d results from completed analyses only. United States. 1131, 1135 (D.C. Cir. 1994).

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that contain synthetic cathinones, the of 2,289 reports from forensic documents confirms these adverse packages of products that contain N- laboratories pertaining to the 6 synthetic effects of N-ethylhexedrone, a-PHP, 4- ethylhexedrone, a-PHP, 4-MEAP, cathinones (N-ethylhexedrone, 613 MEAP, MPHP, PV8, or 4-chloro-a-PVP. MPHP, PV8, or 4-chloro-a-PVP also reports; a-PHP—984 reports; 4-MEAP— Like schedule I synthetic cathinones, N- probably contain the warning ‘‘not for 131 reports; MPHP—92 reports; PV8— ethylhexedrone, a-PHP, 4-MEAP, human consumption,’’ most likely in an 174 reports; and 4-chloro-a-PVP—295 MPHP, PV8, and 4-chloro-a-PVP have effort to circumvent statutory reports). HHS reported that there were caused acute health problems leading to restrictions for these substances. Law 13,238 calls to United States poison emergency department (ED) admissions, enforcement data indicate that N- control centers (PCCs) 4 involving violent behaviors causing harm to self or ethylhexedrone, a-PHP, 4-MEAP, synthetic cathinones from 2010 to 2019 others, and/or death. Specifically, MPHP, PV8, and 4-chloro-a-PVP are and 39 mentions of cathinones of which evidence demonstrate that all six available for illicit use and are being 23 were for a-PHP on the Dashboard 5 synthetic cathinones have resulted in abused. Demographic data collected from July 2018 to July 2020. ED visits that required medical from published reports and mortality Accordingly, concerns over the attention, but only N-ethylhexedrone, a- records suggest that the main users of N- continuing abuse of synthetic PHP, MPHP, and PV8 abuse have been ethylhexedrone, a-PHP, 4-MEAP, cathinones have led to the control of associated with the deaths of MPHP, PV8, and 4-chloro-a-PVP, many synthetic cathinones. A full individuals. It remains highly likely that similar to other schedule I synthetic presentation of the NFLIS reports by additional cases of adverse health cathinones permanently placed in substance and year, PCC, and Dashboard effects involving N-ethylhexedrone, a- schedule I, are young adults. Toxicology data are available in both DEA’s and PHP, 4-MEAP, MPHP, PV8, and 4- reports also revealed that N- HHS’s eight-factor analyses within the chloro-a-PVP in the United States have ethylhexedrone, a-PHP, 4-MEAP, Supporting Documents section of the occurred and will continue to be under- MPHP, PV8, and 4-chloro-a-PVP are public docket available at http:// reported as these substances are not part being ingested with other substances www.regulations.gov. of standard panels for toxicological including other synthetic cathinones, 6. What, if Any, Risk There Is to the analyses of biological specimens. Thus, common cutting agents, or other Public Health: HHS reported that the the abuse of N-ethylhexedrone, a-PHP, recreational substances. Consequently, public health risks of N-ethylhexedrone, 4-MEAP, MPHP, PV8, and 4-chloro-a- products containing synthetic a-PHP, 4-MEAP, MPHP, PV8, and 4- PVP, like that of the abuse of schedule cathinones, including N- chloro-a-PVP result from their ability to I synthetic cathinones and stimulant ethylhexedrone, a-PHP, 4-MEAP, induce stimulant-like responses, which drugs, poses significant adverse health MPHP, PV8, or 4-chloro-a-PVP, are may lead to impaired judgement and risks including death. distributed to users, often with dangerous behavior. Adverse health Furthermore, because abusers of unpredictable outcomes. Thus, the effects associated with the abuse of N- synthetic cathinones obtain these recreational abuse of N-ethylhexedrone, ethylhexedrone, a-PHP, 4-MEAP, substances through unregulated sources, a-PHP, 4-MEAP, MPHP, PV8, and 4- MPHP, PV8, and 4-chloro-a-PVP the identity, purity, and quantity are chloro-a-PVP is a significant concern. include a number of stimulant-like uncertain and inconsistent. These These data indicate that N- adverse health effects such as unknown factors pose an additional risk ethylhexedrone, a-PHP, 4-MEAP, diaphoresis, insomnia, mydriasis, for significant adverse health effects to the end user. MPHP, PV8, and 4-chloro-a-PVP have a hyperthermia, vomiting, agitation, Based on information received by history and current pattern of abuse. disorientation, paranoia, and abdominal DEA, the abuse of N-ethylhexedrone, a- 5. Scope, Duration and Significance pain. Serious adverse events such as PHP, 4-MEAP, MPHP, PV8, and 4- of Abuse: N-ethylhexedrone, a-PHP, 4- acute kidney failure, cardiac arrest, chloro-a-PVP has led to, at least, the MEAP, MPHP, PV8, and 4-chloro-a-PVP rhabdomyolysis, and coma have been same qualitative public health risks as are recreational drugs that emerged on associated with the use of N- other schedule I synthetic cathinones the United States’ illicit drug market ethylhexedrone, a-PHP, 4-MEAP, and and the schedule II stimulant after the scheduling of other synthetic PV8. In addition, N-ethylhexedrone, a- methamphetamine. The public health cathinones (e.g., N-ethylpentylone, PHP, MPHP, and PV8 have been risks attendant to the abuse of synthetic , mephedrone, methylone, involved in the deaths of individuals. cathinones, including N- pentylone, and MDPV) (see DEA’s Eight The identification of N-ethylhexedrone, ethylhexedrone, a-PHP, 4-MEAP, Factor Analysis for a full discussion). a-PHP, 4-MEAP, MPHP, PV8, or 4- MPHP, PV8, or 4-chloro-a-PVP, are well Forensic laboratories have confirmed chloro-a-PVP in toxicological samples established and have resulted in large the presence of N-ethylhexedrone, a- associated with fatal and non-fatal numbers of ED visits and fatal PHP, 4-MEAP, MPHP, PV8, and 4- overdoses as reported in the medical overdoses. chloro-a-PVP in drug exhibits received and scientific literature, forensic 7. Its Psychic or Physiological from Federal, State, and local law laboratory reports, and public health Dependence Liability: According to enforcement agencies. MPHP was first HHS, the psychic or physiological identified in June 2012 in seized drug 4 PCC data are derived from the National Poison dependence liability of N- Data System, a database managed by the American evidence (although MPHP was Association of Poison Control Centers (AAPCC). ethylhexedrone, a-PHP, 4-MEAP, identified in blood samples from a 27- AAPCC is a nationwide network of PCCs that MPHP, PV8, and 4-chloro-a-PVP is year-old decedent in 2011—see Factor 6 receive calls from individuals, healthcare demonstrated by their positive abuse- for details), followed by 4-MEAP and professionals, and other interested persons in the related studies in animals and reported general U.S. population regarding exposures to PV8 (August and December 2013, prescription drugs and other substances. stimulant effects in humans. The results respectively), alpha-PHP (May 2014), 4- 5 The Dashboard is an online, interactive tool that from two behavioral studies (drug chloro-a-PVP (December 2015) and most reports on the identification of certain novel discrimination and locomotor studies) recently N-ethylhexedrone (August psychoactive substances in de-identified sample demonstrate that N-ethylhexedrone, a- extracts from forensic investigations, including 2016). From January 2012 through medicolegal death investigations and toxicology PHP, 4-MEAP, MPHP, PV8, or 4-chloro- December 2020 (query date: May 3, testing. The Dashboard was accessed on February a-PVP produced behavioral effects that 2021), NFLIS database registered a total 26, 2021. are similar to those of substances with

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stimulant effects such as the schedule II designation, warrant control in schedule a-PHP, 4-MEAP, MPHP, PV8, or 4- stimulants cocaine and I of the CSA. 21 U.S.C. 812(b)(1). chloro-a-PVP must have an initial methamphetamine. Thus, based on the inventory of all stocks of controlled Requirements for Handling structural and pharmacological substances (including N- N-Ethylhexedrone, a-PHP, 4-MEAP, similarities of N-ethylhexedrone, a-PHP, ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-Chloro-a-PVP 4-MEAP, MPHP, PV8, and 4-chloro-a- MPHP, PV8, and 4-chloro-a-PVP) on PVP to schedule II stimulant substances If this rule is finalized as proposed, N- hand on the date the registrant first that have demonstrated psychic or ethylhexedrone, a-PHP, 4-MEAP, engages in the handling of controlled physiological dependence liability, it is MPHP, PV8, or 4-chloro-a-PVP would substances pursuant to 21 U.S.C. 827 anticipated that the stimulant properties continue 6 to be subject to the CSA’s and in accordance with 21 CFR 1304.03, of N-ethylhexedrone, a-PHP, 4-MEAP, schedule I regulatory controls and 1304.04, and 1304.11. MPHP, PV8, and 4-chloro-a-PVP administrative, civil, and criminal After the initial inventory, every DEA produce psychic dependence liability. sanctions applicable to the manufacture, registrant must take an inventory of all 8. Whether the Substance is an distribution, reverse distribution, controlled substances (including N- Immediate Precursor of a Substance importation, exportation, research, and ethylhexedrone, a-PHP, 4-MEAP, Already Controlled Under the CSA: N- conduct of instructional activities MPHP, PV8, and 4-chloro-a-PVP) on Ethylhexedrone, a-PHP, 4-MEAP, involving the handling of schedule I hand every two years, pursuant to 21 MPHP, PV8, and 4-chloro-a-PVP are not controlled substances including the U.S.C. 827 and in accordance with 21 immediate precursors of any controlled following: CFR 1304.03, 1304.04, and 1304.11. substance under the CSA as defined by 1. Registration. Any person who 6. Records and Reports. Every DEA 21 U.S.C. 802(23). handles (manufactures, distributes, registrant is required to maintain Conclusion: After considering the reverse distributes, imports, exports, records and submit reports with respect scientific and medical evaluation engages in research, or conducts to N-ethylhexedrone, a-PHP, 4-MEAP, conducted by HHS, HHS’s scheduling instructional activities or chemical MPHP, PV8, or 4-chloro-a-PVP pursuant recommendation, and DEA’s own eight- analysis with, or possesses) or who to 21 U.S.C. 827, and in accordance factor analysis, DEA finds that the facts desires to handle N-ethylhexedrone, a- with 21 CFR 1301.74(b) and (c) and and all relevant data constitute PHP, 4-MEAP, MPHP, PV8, or 4-chloro- parts 1304, 1312, and 1317. substantial evidence of the potential for a-PVP is required to be registered with Manufacturers and distributors must abuse of N-ethylhexedrone, a-PHP, 4- DEA to conduct such activities pursuant submit reports regarding these MEAP, MPHP, PV8, and 4-chloro-a- to 21 U.S.C. 822, 823, 957, and 958, and substances to the Automation of Reports PVP. As such, DEA hereby proposes to in accordance with 21 CFR parts 1301 and Consolidated Order System permanently schedule N- and 1312. pursuant to 21 U.S.C. 827 and in ethylhexedrone, a-PHP, 4-MEAP, 2. Security. N-ethylhexedrone, a-PHP, accordance with 21 CFR parts 1304 and MPHP, PV8, and 4-chloro-a-PVP as 4-MEAP, MPHP, PV8, and 4-chloro-a- 1312. controlled substances under the CSA. PVP are subject to schedule I security 7. Order Forms. Every DEA registrant Proposed Determination of Appropriate requirements and must be handled and who distributes N-ethylhexedrone, a- Schedule stored pursuant to 21 U.S.C. 823 and in PHP, 4-MEAP, MPHP, PV8, or 4-chloro- accordance with 21 CFR 1301.71– a-PVP is required to comply with the The CSA establishes five schedules of 1301.76. Non-practitioners handling N- order form requirements, pursuant to 21 controlled substances known as ethylhexedrone, a-PHP, 4-MEAP, U.S.C. 828 and 21 CFR part 1305. schedules I, II, III, IV, and V. The CSA MPHP, PV8, or 4-chloro-a-PVP must 8. Importation and Exportation. All also outlines the findings required to also comply with the employee importation and exportation of N- place a drug or other substance in any screening requirements of 21 CFR ethylhexedrone, a-PHP, 4-MEAP, particular schedule. 21 U.S.C. 812(b). 1301.90–1301.93. MPHP, PV8, or 4-chloro-a-PVP must be After consideration of the analysis and 3. Labeling and Packaging. All labels, in compliance with 21 U.S.C. 952, 953, recommendation of the Assistant labeling, and packaging for commercial 957, and 958, and in accordance with 21 Secretary for Health of HHS and review containers of N-ethylhexedrone, a-PHP, CFR part 1312. of all other available data, the 4-MEAP, MPHP, PV8, and 4-chloro-a- 9. Liability. Any activity involving N- Administrator of DEA, pursuant to 21 PVP must be in compliance with 21 ethylhexedrone, a-PHP, 4-MEAP, U.S.C. 811(a) and 812(b)(1), finds that: U.S.C. 825, and be in accordance with MPHP, PV8, or 4-chloro-a-PVP not 1. N-ethylhexedrone, a-PHP, 4-MEAP, 21 CFR part 1302. authorized by, or in violation of the CSA MPHP, PV8, and 4-chloro-a-PVP have a 4. Quota. Only registered or its implementing regulations, is high potential for abuse; manufacturers are permitted to unlawful, and could subject the person 2. N-ethylhexedrone, a-PHP, 4-MEAP, manufacture N-ethylhexedrone, a-PHP, to administrative, civil, and/or criminal MPHP, PV8, and 4-chloro-a-PVP have 4-MEAP, MPHP, PV8, or 4-chloro-a-PVP sanctions. no currently accepted medical use in in accordance with a quota assigned treatment in the United States; and Regulatory Analyses 3. There is a lack of accepted safety pursuant to 21 U.S.C. 826 and in Executive Orders 12866 (Regulatory for use of N-ethylhexedrone, a-PHP, 4- accordance with 21 CFR part 1303. Planning and Review) and 13563 MEAP, MPHP, PV8, and 4-chloro-a-PVP 5. Inventory. Any person registered (Improving Regulation and Regulatory under medical supervision. with DEA to handle N-ethylhexedrone, Based on these findings, the Review) 6 N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, Administrator concludes that N- and 4-chloro-a-PVP are currently subject to In accordance with 21 U.S.C. 811(a), ethylhexedrone, a-PHP, 4-MEAP, schedule I controls on a temporary basis, pursuant this proposed scheduling action is MPHP, PV8, and 4-chloro-a-PVP, to 21 U.S.C. 811(h). 84 FR 34291, July 18, 2019. An subject to formal rulemaking procedures including their salts, isomers, and salts order extending the temporary scheduling of N- performed ‘‘on the record after ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and of isomers, whenever the existence of 4-chloro-a-PVP for one year is published elsewhere opportunity for a hearing,’’ which are such salts, isomers, and salts of isomers in this issue of the Federal Register, on the same conducted pursuant to the provisions of is possible within the specific chemical day as this notice of proposed rulemaking. 5 U.S.C. 556 and 557. The CSA sets

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forth the criteria for scheduling a drug chloro-a-PVP in schedule I of the CSA 2 U.S.C. 1501 et seq., DEA has or other substance. Such actions are pursuant to the temporary scheduling determined and certifies that this exempt from review by the Office of provisions of 21 U.S.C. 811(h). DEA proposed action would not result in any Management and Budget (OMB) estimates that all entities handling or Federal mandate that may result ‘‘in the pursuant to section 3(d)(1) of Executive planning to handle these substances expenditure by State, local, and tribal Order (E.O.) 12866 and the principles have already established and governments, in the aggregate, or by the reaffirmed in E.O. 13563. implemented the systems and processes private sector, of $100,000,000 or more Executive Order 12988, Civil Justice required to handle N-ethylhexedrone, a- (adjusted annually for inflation) in any Reform PHP, 4-MEAP, MPHP, PV8, or 4-chloro- 1 year * * * .’’ Therefore, neither a a-PVP. There are currently 34 unique Small Government Agency Plan nor any This proposed regulation meets the registrations authorized to handle N- other action is required under UMRA of applicable standards set forth in ethylhexedrone, a-PHP, 4-MEAP, 1995. sections 3(a) and 3(b)(2) of E.O. 12988 MPHP, PV8, or 4-chloro-a-PVP Paperwork Reduction Act of 1995 to eliminate drafting errors and specifically, as well as a number of ambiguity, minimize litigation, provide registered analytical labs that are This proposed action does not impose a clear legal standard for affected authorized to handle schedule I a new collection of information under conduct, and promote simplification controlled substances generally. From the Paperwork Reduction Act of 1995. and burden reduction. review of entity names, DEA estimates 44 U.S.C. 3501–3521. This proposed Executive Order 13132, Federalism these 34 registrations represent 29 action would not impose recordkeeping entities. Some of these entities are likely or reporting requirements on State or This proposed rulemaking does not to be large entities. However, since DEA local governments, individuals, have federalism implications warranting does not have information of registrant businesses, or organizations. An agency the application of E.O. 13132. The size and the majority of DEA registrants may not conduct or sponsor, and a proposed rule does not have substantial are small entities or are employed by person is not required to respond to, a direct effects on the States, on the small entities, DEA estimates a collection of information unless it relationship between the national maximum of 29 entities are small displays a currently valid OMB control government and the States, or the entities. Therefore, DEA conservatively number. distribution of power and estimates as many as 29 small entities responsibilities among the various List of Subjects in 21 CFR Part 1308 are affected by this proposed rule. levels of government. A review of the 34 registrations Administrative practice and Executive Order 13175, Consultation indicates that all entities that currently procedure, Drug traffic control, and Coordination With Indian Tribal handle N-ethylhexedrone, a-PHP, 4- Reporting and recordkeeping Governments MEAP, MPHP, PV8, or 4-chloro-a-PVP requirements. This proposed rule does not have also handle other schedule I controlled For the reasons set out above, DEA tribal implications warranting the substances, and thus they have proposes to amend 21 CFR part 1308 as application of E.O. 13175. It does not established and implemented (or follows: have substantial direct effects on one or maintain) the systems and processes PART 1308—SCHEDULES OF more Indian tribes, on the relationship required to handle N-ethylhexedrone, a- CONTROLLED SUBSTANCES between the Federal government and PHP, 4-MEAP, MPHP, PV8, and 4- a Indian tribes, or on the distribution of chloro- -PVP as a schedule I substance. ■ Therefore, DEA anticipates that this 1. The authority citation for part 1308 power and responsibilities between the continues to read as follows: Federal government and Indian tribes. proposed rule will impose minimal or no economic impact on any affected Authority: 21 U.S.C. 811, 812, 871(b), Regulatory Flexibility Act entities, and, thus, will not have a 956(b), unless otherwise noted. The Administrator, in accordance significant economic impact on any of ■ 2. Amend § 1308.11 by: with the Regulatory Flexibility Act, 5 the 29 affected small entities. Therefore, ■ a. Adding paragraphs (d)(94) through U.S.C. 601–612, has reviewed this DEA has concluded that this proposed (99); and proposed rule and by approving it rule will not have a significant ■ b. Removing and reserving paragraphs certifies that it will not have a economic impact on a substantial (h)(42) through (h)(47). significant economic impact on a number of small entities. The additions to read as follows: substantial number of small entities. On Unfunded Mandates Reform Act of 1995 July 18, 2019, DEA published an order § 1308.11 Schedule I. to temporarily place N-ethylhexedrone, In accordance with the Unfunded * * * * * a-PHP, 4-MEAP, MPHP, PV8, and 4- Mandates Reform Act (UMRA) of 1995, (d) * * *

(94) N-Ethylhexedrone (Other name: a-ethylaminohexanophenone) ...... 7246 (95) alpha-Pyrrolidinohexanophenone (Other names: a-PHP, a-pyrrolidino-hexanophenone, 1-phenyl-2-(pyrrolidin-1- yl)hexan-1-one) ...... 7544 (96) 4-Methyl-alpha-Ethylaminopentiophenone (Other names: 4-MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one) .... 7245 (97) 4′-Methyl-alpha-pyrrolidinohexiophenone (Other names: MPHP, 4′-methyl-alpha- pyrrolidino hexanophenone; 1-(4- methylphenyl)-2-(pyrrolidin-1-yl)hexan-1-one) ...... 7446 (98) alpha-Pyrrolidinoheptaphenone (Other names: PV8, 1-phenyl-2-(pyrrolidin-1-yl)heptan-1-one) ...... 7548 (99) 4′-Chloro-alpha-Pyrrolidinovalerophenone (Other names: 4-chloro-a-PVP, 4-chloro-a-pyrrolidinopentiophenone, 1-(4- chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one) ...... 7443

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* * * * * submissions received must include the Riverway near Cable, Wisconsin. The words ‘‘National Park Service’’ or trail would be designed for hiking, trail Anne Milgram, ‘‘NPS’’ and must include the docket running, and bicycle and electric Administrator. number or RIN (1024–AE64) for this bicycle (e-bike) use, and silent sports in [FR Doc. 2021–15114 Filed 7–15–21; 8:45 am] rulemaking. Comments received may be the winter such as fat-tire bicycling, BILLING CODE 4410–09–P posted without change to snowshoeing, and cross-country skiing. www.regulations.gov, including any It would be the first trail at the Riverway personal information provided. open to bicycle use. Construction of the DEPARTMENT OF THE INTERIOR Docket: For access to the docket to trail would respond to a specific read background documents or opportunity identified by the NPS and National Park Service comments received, go to local partners to create a link across www.regulations.gov and search for public land to provide direct access to 36 CFR Part 7 ‘‘1024–AE64’’. the Riverway and new recreational [NPS–SACN–31398; PPMWMWROW2/ FOR FURTHER INFORMATION CONTACT: Julie opportunities within the Riverway and PMP00UP05.YP0000] Galonska, Superintendent, St. Croix on the Chequamegon Area Mountain Bike Association (CAMBA) trail RIN 1024–AE64 National Scenic Riverway; (715) 483– 2270, [email protected]. network in Bayfield County, Wisconsin. St. Croix National Scenic Riverway, SUPPLEMENTARY INFORMATION: The trail would be built from the end of Bicycling a segment of CAMBA’s Wild River Trail Background on a former railroad grade near the AGENCY: National Park Service, Interior. The Namekagon and St. Croix Rivers Town of Cable, connecting to Parker ACTION: Proposed rule. flow through some of the most scenic Road. The trail would provide a critical and least developed country in the link to adjoining trails and would serve SUMMARY: The National Park Service Upper Midwest. The free-flowing an important role providing proposes to amend the special character and exceptional water quality connectivity for several local trail regulations for St. Croix National Scenic of these waterways serve as a unique running and biking events that start or Riverway to allow bicycle use on a 0.25- ecological corridor in northwest finish in the Cable area. The bare soil mile connector trail across National Wisconsin and eastern Minnesota that trail would be built using sustainable Park Service land near Cable, sustains a diversity of aquatic and trail construction techniques to protect Wisconsin. The new trail would provide terrestrial wildlife and habitats. natural and cultural resources. The trail direct access to the Riverway and new In 1968, to preserve, protect, and would utilize landforms and natural recreational opportunities within the enhance this unique national resource features exhibiting the natural beauty of Riverway and on the Chequamegon for the benefit and enjoyment of present the area and would feature a slight Area Mountain Bike Association trail and future generations, Congress crown, shallow grades, open sight lines, network in Bayfield County, Wisconsin. established the St. Croix National and gentle turns to support user safety, National Park Service regulations Scenic Riverway, a 230-mile long provide adequate drainage to minimize require promulgation of a special protected area that includes the braiding, seasonal muddiness, and regulation to designate new trails for Namekagon River, as one of the original erosion, and reduce the overall bicycle use off park roads and outside eight rivers protected under the national maintenance costs associated with more of developed areas. Wild and Scenic Rivers Act. In 1972, the complex trail features. Signage would DATES: Comments on the proposed rule Lower St. Croix National Scenic clearly indicate allowed uses on the must be received by 11:59 p.m. EDT on Riverway was added to the National trail. Equestrian and motorized use September 14, 2021. Wild and Scenic Rivers System. would not be allowed. ADDRESSES: You may submit comments, Together, these areas form the Riverway. On September 22, 2020, the NPS identified by Regulation Identifier Today, the rivers continue to flow published the Cable Connector Trail Number (RIN) 1024–AE64, by either of unimpeded for considerable distances Environmental Assessment (EA). The the following methods: as they have for millennia, through the EA describes one action alternative (the (1) Electronically: Go to the Federal river corridor, growing and changing in preferred alternative) and the no-action eRulemaking Portal: character from their headwaters to the alternative. Under the preferred www.regulations.gov. Follow the St. Croix’s confluence with the alternative, the NPS would construct the instructions for submitting comments. Mississippi. The Riverway offers 0.25 mile Cable Connector Trail to (2) By hard copy: Mail to: exceptional recreational opportunities accommodate bicycle and e-bike use. Superintendent, St. Croix National for visitors to paddle, boat, camp, hike, The EA evaluates (1) the suitability of Scenic Riverway, 401 North Hamilton fish, explore, and find solitude in a the Cable Connector Trail for bicycle Street, St. Croix Falls, WI 54024. natural setting close to the major and e-bike use; and (2) life cycle Document Availability: The Cable metropolitan area of Minneapolis-Saint maintenance costs, safety Connector Trail Environmental Paul. The National Park Service (NPS) considerations, methods to prevent or Assessment and Finding of No and state partners work with local minimize user conflict, and methods to Significant Impact provide information communities to maintain the aquatic, protect natural and cultural resources and context for this proposed rule and cultural, recreational, riparian, scenic– and mitigate impacts associated with are available online at https:// aesthetic, and geologic values of the bicycle and e-bike use on the trail. The parkplanning.nps.gov/sacn by clicking rivers for the benefit and enjoyment of EA contains a full description of the the link entitled ‘‘Cable Connector more than 600,000 annual visitors. purpose and need for taking action, the Trail’’ and then clicking the link alternatives considered, a map of the entitled ‘‘Document List.’’ Cable Connector Trail Environmental affected area, and the environmental Instructions: Comments will not be Assessment impacts associated with the project. accepted by fax, email, or in any way The NPS proposes to construct a 0.25- After a public review period, on other than those specified above. All mile connector trail through the February 1, 2021, the Regional Director

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