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DOE will provide a grace period of 180 requirements or otherwise violate the Administrator to notify the Secretary of days for the manufacturer to begin to CSA with respect to these substances. the Department of Health and Human use the DOE test procedure or the DATES: May 1, 2019. Services (HHS) of his intention to alternate test procedure specified in the FOR FURTHER INFORMATION CONTACT: temporarily place a substance in 2 decision and order on the petition to Lynnette M. Wingert, Regulatory schedule I of the CSA. The Acting make representations of energy Drafting and Policy Support Section Administrator transmitted notice of his efficiency. (DPW), Diversion Control Division, Drug intent to place N-ethylhexedrone, a- * * * * * Enforcement Administration; Mailing PHP, 4-MEAP, MPHP, PV8, and 4- (h) Duration. (1) Interim waivers Address: 8701 Morrissette Drive, chloro-a-PVP in schedule I on a remain in effect until the earlier of the Springfield, Virginia 22152; Telephone: temporary basis to the Assistant following: (202) 598–6812. Secretary for Health of HHS by letter dated March 9, 2018. The Acting (i) DOE publishes a decision on a SUPPLEMENTARY INFORMATION: This petition for waiver pursuant to Assistant Secretary responded to this notice of intent contained in this notice of intent by letter dated March paragraph (f) of this section in the document is issued pursuant to the Federal Register; or 27, 2018, and advised that based on a temporary scheduling provisions of 21 review by the Food and Drug (ii) DOE publishes in the Federal U.S.C. 811(h). The Drug Enforcement Register a new or amended test Administration (FDA), there were Administration (DEA) intends to issue a currently no approved new drug procedure that addresses the issues temporary scheduling order (in the form presented in the waiver. applications or active investigational of a temporary amendment) placing N- new drug applications for N- * * * * * ethylhexedrone, a-PHP, 4-MEAP, ethylhexedrone, a-PHP, 4-MEAP, [FR Doc. 2019–08699 Filed 4–30–19; 8:45 am] MPHP, PV8, and 4-chloro-a-PVP in MPHP, PV8, and 4-chloro-a-PVP. The BILLING CODE 6450–01–P schedule I of the Controlled Substances Acting Assistant Secretary also stated Act (CSA).1 The temporary scheduling that the HHS had no objection to the order will be published in the Federal temporary placement of N- DEPARTMENT OF JUSTICE Register on or after May 31, 2019. ethylhexedrone, a-PHP, 4-MEAP, Legal Authority MPHP, PV8, and 4-chloro-a-PVP in Drug Enforcement Administration schedule I of the CSA. N- Section 201 of the Controlled Ethylhexedrone, a-PHP, 4-MEAP, 21 CFR Part 1308 Substances Act (CSA), 21 U.S.C. 811, MPHP, PV8, and 4-chloro-a-PVP are not provides the Attorney General with the [Docket No. DEA–495] currently listed in any schedule under authority to temporarily place a the CSA, and no exemptions or Schedules of Controlled Substances: substance in schedule I of the CSA for approvals are in effect for N- Temporary Placement of N- two years without regard to the ethylhexedrone, a-PHP, 4-MEAP, Ethylhexedrone, α-PHP, 4-MEAP, requirements of 21 U.S.C. 811(b), if he MPHP, PV8, and 4-chloro-a-PVP under MPHP, PV8, and 4-Chloro-α-PVP in finds that such action is necessary to section 505 of the FDCA, 21 U.S.C. 355. Schedule I avoid an imminent hazard to the public In order to find that placing a safety. 21 U.S.C. 811(h)(1). In addition, substance temporarily in schedule I of AGENCY: Drug Enforcement if proceedings to control a substance the CSA is necessary to avoid an Administration, Department of Justice. permanently are initiated under 21 imminent hazard to the public safety, ACTION: Proposed amendment; notice of U.S.C. 811(a)(1) while the substance is the Administrator is required to intent. temporarily controlled under section consider three of the eight factors set 811(h), the Attorney General may forth in 21 U.S.C. 811(c): The SUMMARY: The Acting Administrator of extend the temporary scheduling for up substance’s history and current pattern the Drug Enforcement Administration is to one year. 21 U.S.C. 811(h)(2). of abuse; the scope, duration and issuing this notice of intent to publish Where the necessary findings are significance of abuse; and what, if any, a temporary order to schedule the made, a substance may be temporarily risk there is to the public health. 21 synthetic , N-ethylhexedrone; scheduled if it is not listed in any other U.S.C. 811(h)(3). Consideration of these alpha-pyrrolidinohexanophenone schedule under section 202 of the CSA, factors includes actual abuse, diversion (trivial name: a-PHP); 4-methyl-alpha- 21 U.S.C. 812, or if there is no from legitimate channels, and ethylaminopentiophenone (trivial name: exemption or approval in effect for the clandestine importation, manufacture, 4-MEAP); 4′-methyl-alpha- substance under section 505 of the or distribution. 21 U.S.C. 811(h)(3). pyrrolidinohexiophenone (trivial name: Federal Food, Drug, and Cosmetic Act A substance meeting the statutory MPHP); alpha-pyrrolidinoheptaphenone (FDCA), 21 U.S.C. 355. 21 U.S.C. requirements for temporary scheduling (trivial name: PV8); and 4-chloro-alpha- 811(h)(1); 21 CFR part 1308. The may only be placed in schedule I. 21 pyrrolidinovalerophenone (trivial name: Attorney General has delegated U.S.C. 811(h)(1). Substances in schedule 4-chloro-a-PVP), in schedule I. When it scheduling authority under 21 U.S.C. I are those that have a high potential for is issued, the temporary scheduling 811 to the Administrator of the DEA. 28 abuse, no currently accepted medical order will impose regulatory CFR 0.100. use in treatment in the United States, requirements under the Controlled Substances Act (CSA) on the Background 2 As discussed in a memorandum of manufacture, distribution, reverse Section 201(h)(4) of the CSA, 21 understanding entered into by the Food and Drug Administration (FDA) and the National Institute on distribution, possession, importation, U.S.C. 811(h)(4), requires the Drug Abuse (NIDA), the FDA acts as the lead agency exportation, research, conduct of within the HHS in carrying out the Secretary’s instructional activities, and chemical 1 Though DEA has used the term ‘‘final order’’ scheduling responsibilities under the CSA, with the analysis of these synthetic cathinones, with respect to temporary scheduling orders in the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. past, this notice of intent adheres to the statutory The Secretary of the HHS has delegated to the as well as administrative, civil, and language of 21 U.S.C. 811(h), which refers to a Assistant Secretary for Health of the HHS the criminal remedies with respect to ‘‘temporary scheduling order.’’ No substantive authority to make domestic drug scheduling persons who fail to comply with such change is intended. recommendations. 58 FR 35460, July 1, 1993.

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and a lack of accepted safety for use approximately 18.7 kilograms and were identified in the United States’ illicit under medical supervision. 21 U.S.C. encountered in powder, crystal, rock, drug market. Evidence indicates that 812(b)(1). resin, capsule, and tablet forms. these substances are being substituted As observed by the DEA and by the for schedule I synthetic cathinones. Synthetic Cathinones United States Customs and Border Products containing synthetic Recently, novel synthetic cathinones Protection (CBP), synthetic cathinones cathinones have been falsely marketed that mimic the biological effects of originate from foreign sources, such as as ‘‘research chemicals,’’ ‘‘jewelry substances with -like effects China. Bulk powder substances are cleaner,’’ ‘‘stain remover,’’ ‘‘plant food have emerged on the illicit drug market. smuggled via common carrier into the or fertilizer,’’ ‘‘insect repellants,’’ or These novel cathinones, also known as United States and find their way to ‘‘.’’ They have been sold at designer drugs, are structurally similar clandestine product smoke shops, head shops, convenience to several drugs of abuse such as manufacturing operations located in stores, adult bookstores, and gas schedule I synthetic cathinones (e.g., residential neighborhoods, garages, stations. They can also be purchased on , , warehouses, and other similar the internet. These substances are , , and 3,4- destinations throughout the country. commonly encountered in the form of methylenedioxypyrovalerone (MDPV)). Encounters of N-ethylhexedrone, a-PHP, powders, crystals, tablets, and capsules. The illicit use of synthetic cathinones 4-MEAP, MPHP, PV8, and 4-chloro-a- Other encountered forms include resin, has continued throughout the United PVP have occurred by the CBP (see DEA rock, liquid, and deposits on plant States, resulting in severe adverse 3-Factor Analysis). matter. Law enforcement has effects, overdoses, and deaths. Indeed, N-Ethylhexedrone, a-PHP, 4-MEAP, encountered N-ethylhexedrone, a-PHP, hospital reports, scientific publications MPHP, PV8, and 4-chloro-a-PVP have 4-MEAP, MPHP, PV8, and 4-chloro-a- and/or law enforcement reports no accepted medical use in the United PVP in powder, crystal, resin, rock, demonstrate that these types of States. N-Ethylhexedrone, a-PHP, 4- capsule, or tablet forms. The packages of substances are being abused for their MEAP, MPHP, PV8, and 4-chloro-a-PVP these commercial products usually psychoactive properties and they cause have been seized by law enforcement in contain the warning ‘‘not for human harm (see DEA 3-Factor Analysis). the United States. The misuse of a-PHP, consumption,’’ most likely in an effort Recreational effects reported by abusers 4-MEAP, MPHP, and PV8 has been to circumvent statutory restrictions for of synthetic cathinones include reported to result in adverse effects in these substances. euphoria, sense of well-being, increased humans in the United States. Although N-Ethylhexedrone, a-PHP, 4-MEAP, sociability, energy, empathy, increased no overdose information is currently MPHP, PV8, and 4-chloro-a-PVP are alertness, improved concentration, and available for N-ethylhexedrone and 4- likely to be abused in the same manner focus. Adverse effects such as chloro-a-PVP, law enforcement seizures as schedule I synthetic cathinones such tachycardia, hypertension, of these two substances and their as methcathinone, mephedrone, rhabdomyolysis, hyponatremia, pharmacological similarity to currently methylone, pentylone, and MDPV. seizures, and altered mental status controlled schedule I synthetic Information from published scientific (paranoia, hallucinations, and cathinones (e.g., methcathinone, studies indicate that the most common delusions) have also been reported from mephedrone, methylone, pentylone, the abuse of synthetic cathinones. MDPV) suggest that these two synthetic routes of administration for synthetic Consequently, there are documented cathinones are likely to produce adverse cathinones are nasal insufflation by reports of emergency room admissions effects similar to those produced by snorting the powder and ingestion by and deaths associated with the abuse of other synthetic cathinones. swallowing capsules or tablets. The synthetic substances. With N-Ethylhexedrone, a-PHP, 4-MEAP, powder can also be injected or many generations of synthetic MPHP, PV8, and 4-chloro-a-PVP are swallowed. Other methods of intake cathinones having been encountered synthetic cathinones that have include rectal administration, ingestion since 2009, the abuse of N- pharmacological effects similar to by ‘‘bombing’’ (wrapping a dose of ethylhexedrone, a-PHP, 4-MEAP, schedule I synthetic cathinone powder in a paper wrap and MPHP, PV8, and 4-chloro-a-PVP is substances such as methcathinone, swallowing) and intramuscular impacting or will negatively impact mephedrone, methylone, pentylone, and injection. communities. MDPV and schedule II such Based upon the information collected Law enforcement data indicate that N- as and . The from case reports, medical journals, and ethylhexedrone, a-PHP, 4-MEAP, misuse of a-PHP, 4-MEAP, MPHP, and scientific publications including survey MPHP, PV8, and 4-chloro-a-PVP have PV8 has been associated with one or data, the main users of synthetic appeared in the United States’ illicit more overdoses with some requiring cathinones are youths and young adults. drug market (see DEA 3-Factor emergency medical intervention in the Given that N-ethylhexedrone, a-PHP, 4- Analysis). Law enforcement encounters United States. With no approved MEAP, MPHP, PV8, and 4-chloro-a-PVP include those reported to the National medical use and limited safety or are newly emerging synthetic Forensic Laboratory Information System toxicological information, N- cathinones, it is likely that these (NFLIS), a DEA sponsored program that ethylhexedrone, a-PHP, 4-MEAP, substances will be used by the same systematically collects drug MPHP, PV8, and 4-chloro-a-PVP have population. This is consistent with data identification results and associated emerged on the designer drug market, collected from the use of schedule I information from drug cases analyzed and the abuse or trafficking of these synthetic cathinones (e.g., mephedrone, by Federal, State, and local forensic substances for their psychoactive methylone, pentylone, MDPV). laboratories. From January 2012 to properties is concerning. According to Monitoring the Future September 24, 2018, NFLIS registered (MTF) survey data,3 the 2017 annual 1,131 drug exhibits pertaining to the Factor 4. History and Current Pattern of trafficking, distribution and abuse of N- Abuse 3 Monitoring the Future (MTF) is a research a a program conducted at the University of Michigan’s ethylhexedrone, -PHP, 4-MEAP, N-Ethylhexedrone, -PHP, 4-MEAP, Institute for Social Research under grants from MPHP, PV8, and 4-chloro-a-PVP. These MPHP, PV8, and 4-chloro-a-PVP are NIDA. MTF tracks drug use trends among United exhibits had a net weight of synthetic cathinones that have been States adolescents in the 8th, 10th, and 12th grades

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prevalence rate of synthetic cathinone recreational drug market. N- New York, Ohio, Oklahoma, Oregon, use was 0.6% for high school seniors Ethylhexedrone, a-PHP, 4-MEAP, Pennsylvania, Tennessee, and Texas. and 0.3% for young adults (19–30 MPHP, PV8, and 4-chloro-a-PVP are MPHP: NFLIS—71 reports, first years). However, there was an 18 synthetic cathinones that have been encountered in June 2012, locations percentage point increase in the identified in the United States’ illicit include: California, Connecticut, perceived risk of trying ‘‘bath salts’’ in drug market (see DEA 3-Factor Analysis Florida, Georgia, Indiana, Kansas, young adults (aged 19–26 years). for a full discussion). Kentucky, Maine, Minnesota, Missouri, N-Ethylhexedrone, a-PHP, 4-MEAP, Law enforcement data indicate that N- Nebraska, Nevada, New Jersey, Ohio, MPHP, PV8, and 4-chloro-a-PVP are ethylhexedrone, a-PHP, 4-MEAP, Pennsylvania, and Texas. likely to have duration of effects similar MPHP, PV8, and 4-chloro-a-PVP are PV8: NFLIS—166 reports, first to those of schedule I synthetic being abused in the United States as encountered in December 2013, cathinones because of their structural recreational drugs. While law locations include: Arizona, Connecticut, and pharmacological similarities. Users enforcement data are not direct District of Columbia, Florida, Georgia, report (drug surveys, scientific and evidence of abuse, the data can infer Idaho, Indiana, Iowa, Kentucky, medical literature, etc.) that the effects that a drug has been diverted and Louisiana, Maine, Massachusetts, of synthetic cathinones occur a few abused.4 Forensic laboratories have Minnesota, Missouri, Nebraska, Nevada, minutes to 15 minutes after confirmed the presence of these New Hampshire, New Jersey, New York, administration, depending on the substances in drug exhibits received North Dakota, Ohio, Oklahoma, Oregon, synthetic cathinone and the route of from state, local, and federal law Pennsylvania, South Carolina, administration (oral, insufflation, enforcement agencies. From January Tennessee, Texas, Utah, Virginia, and intravenous, etc.), and can last up to 2012 to September 24, 2018, there were Wisconsin. three hours. 1,131 exhibits reported to NFLIS 4-Chloro-a-PVP: NFLIS—160 reports, Evidence indicated that N- databases (federal, state, and local first encountered in December 2015, ethylhexedrone, a-PHP, 4-MEAP, forensic laboratories) pertaining to the locations include: California, District of MPHP, PV8, and 4-chloro-a-PVP are trafficking, distribution and abuse of N- Columbia, Louisiana, Maryland, ingested with other substances. This is ethylhexedrone, a-PHP, 4-MEAP, Arizona, Connecticut, Florida, Georgia, likely to either heighten the effects or MPHP, PV8, and 4-chloro-a-PVP. These Idaho, Illinois, Indiana, Iowa, Kansas, ameliorate the come-down effects of the exhibits had a net weight of Kentucky, Maine, Massachusetts, synthetic cathinones. Co-ingestions can approximately 18.7 kilograms. These Minnesota, Missouri, New Jersey, New be from the ingestion of multiple data also indicated that the abuse of N- York, Ohio, Oklahoma, Oregon, products separately or a single product ethylhexedrone, a-PHP, 4-MEAP, Pennsylvania, Rhode Island, South that is composed of multiple substances MPHP, PV8, and 4-chloro-a-PVP is Carolina, Tennessee, Texas, Utah, (e.g., one tablet containing N- widespread and has been encountered Virginia, and Washington. ethylhexedrone, a-PHP, 4-MEAP, in many states since 2012 in the United Additionally, encounters/seizures of MPHP, PV8, 4-chloro-a-PVP and other States. these substances have occurred by the illicit substances). Indeed, law The following information details CBP at United States ports of entry. As enforcement routinely encounters data obtained from the NFLIS database observed by the DEA and CBP, synthetic synthetic cathinone mixtures. (queried on September 24, 2018), cathinones originate from foreign Substances found in combination with including dates of first encounter, sources, such as China. Bulk powder N-ethylhexedrone, a-PHP, 4-MEAP, exhibits/reports, and locations. substances are smuggled via common MPHP, PV8, or 4-chloro-a-PVP are: N-ethylhexedrone: NFLIS—233 carrier into the United States and find Other synthetic cathinones (e.g., MDPV, reports, first encountered in August their way to clandestine designer drug 4-chloromethcathinone, N- 2016, locations include: Arizona, product manufacturing operations ethylpentylone, a-PVP), common Florida, Georgia, Illinois, Indiana, located in residential neighborhoods, cutting agents (e.g., ), or other Kansas, Kentucky, Louisiana, Michigan, garages, warehouses, and other similar recreational substances (e.g., Minnesota, Mississippi, Missouri, North destinations throughout the country. methamphetamine, fentanyl, fentanyl Dakota, Ohio, Oklahoma, Oregon, From 2014 to 2017, CBP encountered 73 analogues, carfentanil, benzodiazepines Pennsylvania, South Carolina, shipments of products containing N- (e.g., alprazolam), heroin, cocaine, Tennessee, Texas, Virginia, and ethylhexedrone, a-PHP, 4-MEAP, synthetic cannabinoids, Wyoming. MPHP, PV8, or 4-chloro-a-PVP. fluoroamphetamine, MDMA). Multiple a-PHP: NFLIS—395 reports, first Additional evidence indicates that some drug use and potential co-ingestions are encountered in May 2014, locations of these synthetic cathinones have been confirmed by forensic analysis of seized include: Arkansas, California, Colorado, seized abroad. N-Ethylhexedrone and 4- and purchased synthetic cathinone Florida, Georgia, Idaho, Illinois, chloro-a-PVP have been identified in products. Indiana, Iowa, Kentucky, Maine, seized materials in China and Poland, Massachusetts, Michigan, Minnesota, respectively. These data demonstrate Factor 5. Scope, Duration and Missouri, New Hampshire, New Jersey, that these substances are being Significance of Abuse New York, Ohio, Oregon, Pennsylvania, trafficked and abused in the United Since 2009, the popularity of South Carolina, South Dakota, States and abroad. synthetic cathinones and their Tennessee, Texas, Utah, Virginia, Concerns over the abuse of synthetic associated products has continued, as Wisconsin, and Wyoming. cathinone substances have led to the evidenced by law enforcement seizures, 4–MEAP: NFLIS—105 reports, first control of many synthetic cathinones. public health information, and media encountered in August 2013, locations The DEA controlled 13 synthetic reports. As one synthetic cathinone is include: Alabama, Arkansas, California, cathinones: methylone, mephedrone, controlled, another unscheduled Colorado, Connecticut, Florida, Georgia, MDPV, 4-methyl-N-ethylcathinone (4- synthetic cathinone appears in the Illinois, Indiana, Kansas, Louisiana, MEC), 4-methyl-alpha- Maryland, Minnesota, New Hampshire, pyrrolidinopropiophenone (4-MePPP), and high school graduates into adulthood by alpha-pyrrolidinopentiophenone (a- conducting national surveys. 4 See 76 FR 77330, 77332, Dec. 12, 2011. PVP), (1-(1,3-benzodioxol-5-

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yl)-2-(methylamino)butan-1-one), be under-reported as these substances, these substances, pose an imminent pentedrone (2-(methylamino)-1- as well as N-ethylhexedrone and 4- hazard to the public safety. The DEA is phenylpentan-1-one), pentylone, 4- chloro-a-PVP, are not part of standard not aware of any currently accepted fluoro-N-methylcathinone (4-FMC), 3- panels for biological specimens. The medical uses for N-ethylhexedrone, a- fluoro-N-methylcathinone (3-FMC), pharmacological data for N- PHP, 4-MEAP, MPHP, PV8, and 4- (1-(naphthalen-2-yl)-2- ethylhexedrone, a-PHP, 4-MEAP, chloro-a-PVP in the United States. A (pyrrolidin-1-yl)pentan-1-one), and MPHP, PV8, and 4-chloro-a-PVP alone substance meeting the statutory alpha-pyrrolidinobutiophenone (a-PBP) or combined with documented case requirements for temporary scheduling, from 2011 to 2014 (October 21, 2011; 76 reports, if any, demonstrate that the 21 U.S.C. 811(h)(1), may only be placed FR 65371 and March 7, 2014; 79 FR potential for fatal and non-fatal in schedule I. Substances in schedule I 12938). Recently, the DEA controlled overdoses exists for N-ethylhexedrone, are those that have a high potential for another synthetic cathinone, N- a-PHP, 4-MEAP, MPHP, PV8, and 4- abuse, no currently accepted medical ethylpentylone (August, 31, 2018; 83 FR chloro-a-PVP; thus, these substances use in treatment in the United States, 44474), as a schedule I substance. pose an imminent hazard to the public and a lack of accepted safety for use health and safety. under medical supervision. Available Factor 6. What, if Any, Risk There Is to As found with other synthetic data and information for N- the Public Health cathinone substances, products ethylhexedrone, a-PHP, 4-MEAP, Available evidence on the overall containing synthetic cathinones often MPHP, PV8, and 4-chloro-a-PVP public health risks associated with the do not bear labeling information indicate that these synthetic cathinones use of synthetic cathinones suggests that regarding the ingredients or the health have a high potential for abuse, no N-ethylhexedrone, a-PHP, 4-MEAP, risks and potential hazards associated currently accepted medical use in MPHP, PV8, and 4-chloro-a-PVP can with these products. The limited treatment in the United States, and a cause acute health problems leading to knowledge about product content and lack of accepted safety for use under emergency department (ED) admissions, its purity, as well as lack of information medical supervision. As required by violent behaviors causing harm to self or about its effects, pose additional risks section 201(h)(4) of the CSA, 21 U.S.C. others, or death. Acute adverse effects of for significant adverse health effects to 811(h)(4), the Acting Administrator, synthetic cathinone substances are those the users. through a letter dated March 9, 2018, typical of sympathomimetic agents (e.g., Based on pharmacological data or notified the Acting Assistant Secretary cocaine, methamphetamine, documented case reports of overdose of the DEA’s intention to temporarily ) and include among other fatalities, the misuse and abuse of N- place N-ethylhexedrone, a-PHP, 4- effects tachycardia, headache, ethylhexedrone, a-PHP, 4-MEAP, MEAP, MPHP, PV8, and 4-chloro-a-PVP palpitations, agitation, anxiety, MPHP, PV8, and 4-chloro-a-PVP leads in schedule I. mydriasis, tremor, fever or sweating, to the same qualitative public health and hypertension. Other effects, with risks as schedule I and II substances Conclusion possible public health risk implications, such as cathinone, methcathinone, This notice of intent provides the 30- that have been reported from the use of mephedrone, methylone, pentylone, day notice pursuant to section 201(h) of synthetic cathinone substances include MDPV, methamphetamine, cocaine, and the CSA, 21 U.S.C. 811(h), of the DEA’s psychological effects such as psychosis, MDMA. a-PHP, MPHP, and PV8 have intent to issue a temporary scheduling paranoia, hallucinations, and agitation. been associated with fatalities. As the order. In accordance with the provisions a-PHP, 4-MEAP, MPHP, and PV8 data demonstrates, the potential for fatal of section 201(h) of the CSA, 21 U.S.C. have been associated with the overdoses and non-fatal overdoses exists for N- 811(h), the Acting Administrator or deaths of individuals. There have ethylhexedrone, a-PHP, 4-MEAP, considered available data and been documented reports of ED MPHP, PV8, and 4-chloro-a-PVP; thus, information, herein set forth the admissions or deaths associated with N-ethylhexedrone, a-PHP, 4-MEAP, grounds for his determination to the abuse of a-PHP, 4-MEAP, MPHP, MPHP, PV8, and 4-chloro-a-PVP pose temporarily schedule N-ethylhexedrone; and PV8. Individuals under the an imminent hazard to the public safety. alpha-pyrrolidinohexanophenone influence of 4-MEAP and MPHP have N-ethylhexedrone, a-PHP, 4-MEAP, (trivial name: a-PHP); 4-methyl-alpha- acted violently or unpredictably causing MPHP, PV8, and 4-chloro-a-PVP are ethylaminopentiophenone (trivial name: harm, or even death, to themselves or being encountered on the illicit drug 4-MEAP); 4′-methyl-alpha- others. Adverse effects associated with market in the United States and have no pyrrolidinohexiophenone (trivial name: a-PHP, 4-MEAP, MPHP, and PV8 abuse accepted medical use in the United MPHP); alpha-pyrrolidinoheptaphenone included vomiting, agitation, paranoia, States. Regardless, these products (trivial name: PV8); and 4-chloro-alpha- hypertension, unconsciousness, continue to be easily available and pyrrolidinovalerophenone (trivial name: tachycardia, seizures, cardiac arrest, abused by diverse populations. 4-chloro-a-PVP) in schedule I of the rhabdomyolysis, or death. No overdose CSA, and finds that placement of N- information is currently available for N- Finding of Necessity of Schedule I ethylhexedrone, a-PHP, 4-MEAP, ethylhexedrone and 4-chloro-a-PVP, but Placement To Avoid Imminent Hazard MPHP, PV8, and 4-chloro-a-PVP in the pharmacological similarity of these to Public Safety schedule I of the CSA on a temporary substances to other currently controlled In accordance with 21 U.S.C. basis is necessary to avoid an imminent schedule I synthetic cathinones (e.g., 811(h)(3), based on the available data hazard to the public safety. methcathinone, mephedrone, and information summarized above, the The temporary placement of N- methylone, pentylone, MDPV) suggests continued uncontrolled manufacture, ethylhexedrone, a-PHP, 4-MEAP, that these substances can also pose an distribution, reverse distribution, MPHP, PV8, and 4-chloro-a-PVP in imminent hazard to public safety. importation, exportation, conduct of schedule I of the CSA will take effect It remains highly likely that research and chemical analysis, pursuant to a temporary scheduling additional cases of adverse health possession, and/or abuse of N- order, which will not be issued before effects involving a-PHP, 4-MEAP, ethylhexedrone, a-PHP, 4-MEAP, May 31, 2019. Because the Acting MPHP, and PV8 in the United States MPHP, PV8, and 4-chloro-a-PVP, Administrator hereby finds that it is may have occurred and will continue to resulting from the lack of control of necessary to temporarily place N-

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ethylhexedrone, a-PHP, 4-MEAP, Inasmuch as section 201(h) of the by Executive Order 12866 (Regulatory MPHP, PV8, and 4-chloro-a-PVP in CSA directs that temporary scheduling Planning and Review), section 3(f), and, schedule I to avoid an imminent hazard actions be issued by order (as distinct accordingly, this action has not been to the public safety, the temporary order from a rule) and sets forth the reviewed by the Office of Management scheduling these substances will be procedures by which such orders are to and Budget. effective on the date that the order is be issued, the DEA believes that the This action will not have substantial published in the Federal Register and notice and comment requirements of direct effects on the States, on the will be in effect for a period of two section 553 of the Administrative relationship between the national years, with a possible extension of one Procedure Act (APA), 5 U.S.C. 553, government and the States, or on the additional year, pending completion of which are applicable to rulemaking, do distribution of power and the regular (permanent) scheduling not apply to this notice of intent. The responsibilities among the various process. 21 U.S.C. 811(h)(1) and (2). It APA expressly differentiates between an levels of government. Therefore, in is the intention of the Acting order and a rule, as it defines an ‘‘order’’ accordance with Executive Order 13132 Administrator to issue a temporary to mean a ‘‘final disposition, whether (Federalism), it is determined that this scheduling order as soon as possible affirmative, negative, injunctive, or action does not have sufficient after the expiration of 30 days from the declaratory in form, of an agency in a federalism implications to warrant the matter other than rule making.’’ 5 U.S.C. date of publication of this notice. Upon preparation of a Federalism Assessment. publication of the temporary order, N- 551(6) (emphasis added). The specific ethylhexedrone, a-PHP, 4-MEAP, language chosen by Congress indicates List of Subjects in 21 CFR Part 1308 MPHP, PV8, and 4-chloro-a-PVP will be an intention for the DEA to proceed Administrative practice and subject to the regulatory controls and through the issuance of an order instead procedure, Drug traffic control, administrative, civil, and criminal of proceeding by rulemaking. Given that Reporting and recordkeeping sanctions applicable to the manufacture, Congress specifically requires the requirements. distribution, reverse distribution, Attorney General to follow rulemaking importation, exportation, research, procedures for other kinds of scheduling For the reasons set out above, the DEA conduct of instructional activities and actions, see section 201(a) of the CSA, proposes to amend 21 CFR part 1308 as chemical analysis, and possession of a 21 U.S.C. 811(a), it is noteworthy that, follows: schedule I controlled substance. in section 201(h), Congress authorized The CSA sets forth specific criteria for the issuance of temporary scheduling PART 1308—SCHEDULES OF scheduling a drug or other substance. actions by order rather than by rule. CONTROLLED SUBSTANCES In the alternative, even assuming that Regular scheduling actions in this notice of intent might be subject to accordance with 21 U.S.C. 811(a) are ■ 1. The authority citation for part 1308 section 553 of the APA, the Acting continues to read as follows: subject to formal rulemaking procedures Administrator finds that there is good done ‘‘on the record after opportunity cause to forgo the notice and comment Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. for a hearing’’ conducted pursuant to requirements of section 553, as any the provisions of 5 U.S.C. 556 and 557. further delays in the process for ■ 21 U.S.C. 811. The regular scheduling 2. In § 1308.11, add paragraphs (h)(42) issuance of temporary scheduling orders through (47) to read as follows: process of formal rulemaking affords would be impracticable and contrary to interested parties with appropriate the public interest in view of the § 1308.11 Schedule I. process and the government with any manifest urgency to avoid an imminent * * * * * additional relevant information needed hazard to the public safety. (h) * * * to make a determination. Final Although the DEA believes this notice decisions that conclude the regular of intent to issue a temporary (42) N-Ethylhexedrone, its optical, scheduling process of formal positional, and geometric iso- scheduling order is not subject to the mers, salts and salts of isomers .. (7246) rulemaking are subject to judicial notice and comment requirements of review. 21 U.S.C. 877. Temporary (43) alpha- section 553 of the APA, the DEA notes Pyrrolidinohexanophenone, its scheduling orders are not subject to that in accordance with 21 U.S.C. optical, positional, and geometric judicial review. 21 U.S.C. 811(h)(6). 811(h)(4), the Acting Administrator took isomers, salts and salts of iso- Regulatory Matters into consideration comments submitted mers (Other names: a-PHP) ...... (7544) by the Assistant Secretary in response to (44) 4-Methyl-alpha- Section 201(h) of the CSA, 21 U.S.C. the notice that DEA transmitted to the ethylaminopentiophenone, its 811(h), provides for a temporary Assistant Secretary pursuant to section optical, positional, and geometric scheduling action where such action is 811(h)(4). isomers, salts and salts of iso- necessary to avoid an imminent hazard Further, the DEA believes that this mers (Other names: 4-MEAP) ...... (7245) (45) 4′-Methyl-alpha- to the public safety. As provided in this temporary scheduling action is not a pyrrolidinohexiophenone, its op- subsection, the Attorney General may, ‘‘rule’’ as defined by 5 U.S.C. 601(2), tical, positional, and geometric by order, schedule a substance in and, accordingly, is not subject to the isomers, salts and salts of iso- schedule I on a temporary basis. Such requirements of the Regulatory mers (Other names: MPHP) ...... (7446) an order may not be issued before the Flexibility Act (RFA). The requirements (46) alpha- expiration of 30 days from (1) the for the preparation of an initial Pyrrolidinoheptaphenone, its op- publication of a notice in the Federal regulatory flexibility analysis in 5 U.S.C. tical, positional, and geometric Register of the intention to issue such 603(a) are not applicable where, as here, isomers, salts and salts of iso- order and the grounds upon which such the DEA is not required by section 553 mers (Other names: PV8) ...... (7548) (47) 4-Chloro-alpha- order is to be issued, and (2) the date of the APA or any other law to publish pyrrolidinovalerophenone, its that notice of the proposed temporary a general notice of proposed optical, positional, and geometric scheduling order is transmitted to the rulemaking. isomers, salts and salts of iso- Assistant Secretary of HHS. 21 U.S.C. Additionally, this action is not a mers (Other names: 4-chloro-a- 811(h)(1). significant regulatory action as defined PVP) ...... (7443)

VerDate Sep<11>2014 18:57 Apr 30, 2019 Jkt 247001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\01MYP1.SGM 01MYP1 jbell on DSK30RV082PROD with PROPOSALS 18428 Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Proposed Rules

Dated: April 22, 2019. • Fax: (618) 463–6470 You can find background information Uttam Dhillon, • Federal eRulemaking Portal: The on the Illinois program, including the Acting Administrator. amendment has been assigned Docket Secretary’s findings, the disposition of [FR Doc. 2019–08704 Filed 4–30–19; 8:45 am] ID OSM–2019–0003. If you would like comments, and the conditions of to submit comments go to http:// BILLING CODE 4410–09–P approval of the Illinois program in the www.regulations.gov. Follow the June 1, 1982, Federal Register (47 FR instructions for submitting comments. 23858). You can also find later actions Instructions: All submissions received concerning the Illinois program and DEPARTMENT OF THE INTERIOR must include the agency name and program amendments at 30 CFR 913.10, docket number for this rulemaking. For Office of Surface Mining Reclamation 913.15, and 913.17. and Enforcement detailed instructions on submitting comments and additional information II. Description of the Proposed 30 CFR Part 913 on the rulemaking process, see the Amendment ‘‘Public Comment Procedures’’ heading [SATS No. IL–109–FOR; Docket ID: OSM– of the SUPPLEMENTARY INFORMATION By letter dated December 5, 2018 2019–0003 S1D1S SS08011000 SX064A000 section of this document. (Administrative Record No. IL–5100), 190S180110; S2D2S SS08011000 Docket: For access to the docket to Illinois sent us an amendment to its SX064A000 19XS501520] review copies of the Illinois program, program under SMCRA (30 U.S.C. 1201 this amendment, a listing of any Illinois Regulatory Program et seq.) at its own initiative. By email scheduled public hearings, and all dated December 11, 2018, Illinois AGENCY: Office of Surface Mining written comments received in response requested that OSMRE’s review be put Reclamation and Enforcement, Interior. to this document, you must go to the on hold until they could resubmit the ACTION: Proposed rule; public comment address listed below during normal proposed amendment due to editorial period and opportunity for public business hours, Monday through Friday, changes requested by the Illinois Joint hearing on proposed amendment. excluding holidays. You may receive Committee on Administrative Rules. one free copy of the amendment by Illinois resubmitted the proposed SUMMARY: We, the Office of Surface contacting OSMRE’s Alton Field amendment to OSMRE on February 20, Mining Reclamation and Enforcement Division, or the full text of the program 2019. OSMRE will use this date for its (OSMRE), are announcing receipt of a amendment is available for you to review. Below is a summary of the proposed amendment to the Illinois review at www.regulations.gov. Paul J. changes proposed by Illinois. The full regulatory program (Illinois program) Ehret, Acting Chief, Alton Field text of the program amendment is Division, Office of Surface Mining under the Surface Mining Control and available for you to read at the locations Reclamation Act of 1977 (SMCRA or the Reclamation and Enforcement, 501 Belle listed above under ADDRESSES. Act). Illinois proposes revisions to its Street, Suite 216, Alton, Illinois 62002– regulations, including allowing the 6169, Telephone: (618) 463–6463, Illinois proposes to revise the Illinois extraction of coal as an incidental part Email: [email protected]. Surface Coal Mining Land Conservation of a government-financed construction In addition, you may review a copy of and Reclamation Act (225 ILCS 720), project, revising its Ownership and the amendment during regular business Section 1.06, ‘‘Scope of the Act,’’ by Control rules, and clarifying land use hours at the following location: Office of adding language allowing coal changes requiring a significant permit Mines and Minerals, Illinois Department extraction as an incidental part of a revision. Illinois intends to revise its of Natural Resources, One Natural government-financed project. The program to be as effective as the Federal Resources Way, Springfield, IL 62702– language added is nearly identical to regulations. This document gives the 1271, Telephone: (618) 439–9111. that found in Section 528 of SMCRA (30 times and locations where the Illinois FOR FURTHER INFORMATION CONTACT: Paul U.S.C. 1278). program documents and this proposed Ehret, Acting Chief, Alton Field Illinois also proposes to revise the amendment to that program are Division, Telephone: (618) 463–6463, following Parts of Title 62 of the Illinois available for your inspection, Email: [email protected]. Administrative Code: establishes the comment period during SUPPLEMENTARY INFORMATION: which you may submit written I. Background on the Illinois Program Section 1701 Appendix A. Definitions comments on the amendment, and II. Description of the Proposed Amendment describes the procedures that we will III. Public Comment Procedures Illinois proposes to revise its follow for the public hearing, if one is IV. Procedural Determinations regulation at section 1701 Appendix A, requested. I. Background on the Illinois Program amending a number of its definitions, including those for ‘‘ownership,’’ DATES: We will accept written Section 503(a) of the Act permits a comments on this amendment until 4:00 ‘‘control,’’ and ‘‘violations,’’ to conform State to assume primacy for the with the Federal definitions at 30 CFR p.m., CST, May 31, 2019. If requested, regulation of surface coal mining and 701.5 and 707.5. we will hold a public hearing on the reclamation operations on non-Federal amendment on May 28, 2019. We will and non-Indian lands within its borders Section 1703 Exemption for Coal accept requests to speak at a hearing by demonstrating that its program Extraction Incident to Government- until 4:00 p.m., CST on May 16, 2019. includes, among other things, State laws Financed Highway or Other ADDRESSES: You may submit comments, and regulations that govern surface coal Construction identified by SATS No. IL–109–FOR, by mining and reclamation operations in any of the following methods: accordance with the Act and consistent Illinois proposes adding a new section • Mail/Hand Delivery: Paul Ehret, with the Federal regulations. See 30 1703 to allow the extraction of coal as Acting Chief, Alton Field Division, U.S.C. 1253(a)(1) and (7). On the basis an incidental part of a government- Office of Surface Mining Reclamation of these criteria, the Secretary of the financed construction project, which and Enforcement, 501 Belle Street, Suite Interior conditionally approved the incorporates language identical to the 216, Alton, Illinois 62002–6169. Illinois program effective June 1, 1982. Federal regulations at 30 CFR part 707.

VerDate Sep<11>2014 18:57 Apr 30, 2019 Jkt 247001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\01MYP1.SGM 01MYP1 jbell on DSK30RV082PROD with PROPOSALS