Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Proposed Rules 29359

DATES: The due date of comments ‘‘Begin Web-based ADAMS Search.’’ For For the Nuclear Regulatory Commission. requested in the document published on problems with ADAMS, please contact Jennifer L. Dixon-Herrity, March 23, 2020 (85 FR 16278) is the NRC’s Public Document Room (PDR) Chief, Plant Licensing Branch IV, Division extended. Comments should be filed no reference staff at 1–800–397–4209, 301– of Operating Reactor Licensing, Office of later than July 22, 2020. Comments 415–4737, or by email to pdr.resource@ Nuclear Reactor Regulation. received after this date will be nrc.gov. The ADAMS accession number [FR Doc. 2020–09654 Filed 5–14–20; 8:45 am] considered if it is practical to do so, but for each document referenced (if it is BILLING CODE 7590–01–P the Commission is able to ensure available in ADAMS) is provided the consideration only for comments first time that it is mentioned in this received before this date. The NRC staff document. FEDERAL TRADE COMMISSION will continue to monitor the COVID–19 PHE to determine if an additional B. Submitting Comments 16 CFR Chapter I extension may be warranted. Please include Docket ID NRC–2018– Semiannual Regulatory Agenda; ADDRESSES: You may submit comments 0142 in your comment submission. Withdrawal by any of the following methods: The NRC cautions you not to include • Federal Rulemaking Website: Go to AGENCY: Federal Trade Commission. identifying or contact information that https://www.regulations.gov and search ACTION: Proposed rule; Withdrawal. for Docket ID NRC–2018–0142. Address you do not want to be publicly questions about NRC docket IDs in disclosed in your comment submission. SUMMARY: The Federal Trade Regulations.gov to Jennifer Borges; The NRC will post all comment Commission (FTC or Commission) is telephone: 301–287–9127; email: submissions at https:// withdrawing the proposed rule titled, [email protected]. For technical www.regulations.gov as well as enter the ‘‘Semiannual Regulatory Agenda,’’ questions, contact the individuals listed comment submissions into ADAMS. published on May 7, 2020. This agenda in the FOR FURTHER INFORMATION The NRC does not routinely edit will be incorporated in the upcoming CONTACT section of this document. comment submissions to remove government-wide Unified Agenda of • Mail comments to: Office of identifying or contact information. Federal Regulatory and Deregulatory Administration, Mail Stop: TWFN–7– If you are requesting or aggregating Actions. A60M, U.S. Nuclear Regulatory comments from other persons for DATES: The FTC is withdrawing the Commission, Washington, DC 20555– submission to the NRC, then you should proposed rule published May 7, 2020 0001, ATTN: Program Management, inform those persons not to include (85 FR 27191) as of May 15, 2020. Announcements and Editing Staff. identifying or contact information that ADDRESSES: Federal Trade Commission, For additional direction on obtaining they do not want to be publicly 600 Pennsylvania Avenue NW, information and submitting comments, disclosed in their comment submission. Washington, DC 20580. see ‘‘Obtaining Information and Your request should state that the NRC Submitting Comments’’ in the FOR FURTHER INFORMATION CONTACT: G. does not routinely edit comment SUPPLEMENTARY INFORMATION section of Richard Gold, Attorney, Federal Trade this document. submissions to remove such information Commission, 600 Pennsylvania Avenue before making the comment NW, Washington, DC 20580; telephone FOR FURTHER INFORMATION CONTACT: Tim submissions available to the public or number: (202) 326–3355; email address: Reed, telephone: 301–415–1462, email: entering the comment into ADAMS. [email protected]. [email protected]; or Audrey Klett, SUPPLEMENTARY INFORMATION: None. telephone: 301–415–0489, email: II. Discussion [email protected]. Both are staff of Dated: May 8, 2020. the Office of Nuclear Reactor On March 23, 2020, the NRC issued April J. Tabor, Regulation, U.S. Nuclear Regulatory for public comment draft NUREG–1409, Acting Secretary. Commission, Washington, DC 20555– ‘‘Backfitting Guidelines,’’ Revision 1 [FR Doc. 2020–10301 Filed 5–14–20; 8:45 am] 0001. (ADAMS Accession No. ML18109A498). BILLING CODE 6750–01–P This draft NUREG provides guidance on SUPPLEMENTARY INFORMATION: the implementation of the backfitting I. Obtaining Information and and issue finality provisions of the DEPARTMENT OF JUSTICE Submitting Comments NRC’s regulations and the NRC’s A. Obtaining Information forward fitting policy in accordance Drug Enforcement Administration with Management Directive and Please refer to Docket ID NRC–2018– Handbook 8.4, ‘‘Management of 21 CFR Part 1308 0142 when contacting the NRC about Backfitting, Forward Fitting, Issue [Docket No. DEA–509] the availability of information for this Finality, and Information Requests’’ action. You may obtain publicly- dated September 20, 2019 (ADAMS available information related to this Schedules of Controlled Substances: Accession No. ML18093B087). The Placement of para- action by any of the following methods: public comment period was originally • Federal Rulemaking Website: Go to Methoxymethamphetamine (PMMA) in scheduled to close on May 22, 2020. In https://www.regulations.gov and search Schedule I recognition of the impacts of the current for Docket ID NRC–2018–0142. COVID–19 PHE across the nation, the AGENCY: Drug Enforcement • NRC’s Agencywide Documents NRC has decided to extend the public Administration, Department of Justice. Access and Management System comment period on this document until ACTION: Notice of proposed rulemaking. (ADAMS): You may obtain publicly- July 22, 2020, to allow more time for available documents online in the SUMMARY: The Drug Enforcement ADAMS Public Documents collection at members of the public to develop and Administration proposes placing 1-(4- https://www.nrc.gov/reading-rm/ submit comments. methoxyphenyl)-N-methylpropan-2- adams.html. To begin the search, select Dated: April 30, 2020. amine (para-

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methoxymethamphetamine, PMMA), electronic comment, it should be sent business information identified as including its salts, isomers, and salts of via regular or express mail to: Drug directed above will be made publicly isomers whenever the existence of such Enforcement Administration, Attn: DEA available in redacted form. If a comment salts, isomers, and salts of isomers is Federal Register Representative/DRW, has so much confidential business possible, in schedule I of the Controlled 8701 Morrissette Drive, Springfield, information or personal identifying Substances Act. This action is being Virginia 22152. information that it cannot be effectively taken to enable the United States to • Hearing requests: All requests for redacted, all or part of that comment meet its obligations under the 1971 hearing and waivers of participation may not be made publicly available. Convention on Psychotropic must be sent to: Drug Enforcement Comments posted to http:// Substances. If finalized, this action Administration, Attn: Administrator, www.regulations.gov may include any would impose the regulatory controls 8701 Morrissette Drive, Springfield, personal identifying information (such and administrative, civil, and criminal Virginia 22152. All requests for hearing as name, address, and phone number) sanctions applicable to schedule I and waivers of participation should be included in the text of your electronic controlled substances on persons who sent to: Drug Enforcement submission that is not identified as handle (manufacture, distribute, import, Administration, Attn: Hearing Clerk/LJ, directed above as confidential. export, engage in research, conduct 8701 Morrissette Drive, Springfield, An electronic copy of this document instructional activities or chemical Virginia 22152; and (2) Drug and supplemental information to this analysis, or possess), or propose to Enforcement Administration, Attn: DEA proposed rule are available at http:// handle PMMA. Federal Register Representative/DPW, www.regulations.gov for easy reference. 8701 Morrissette Drive, Springfield, DATES: Comments must be submitted Request for Hearing or Waiver of Virginia 22152. electronically or postmarked on or Participation in a Hearing FOR FURTHER INFORMATION CONTACT: before June 15, 2020. Pursuant to 21 U.S.C. 811(a), this Interested persons may file a request Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion action is a formal rulemaking ‘‘on the for hearing or waiver of hearing record after opportunity for a hearing.’’ pursuant to 21 CFR 1308.44 and in Control Division, Drug Enforcement Administration; Mailing Address: 8701 Such proceedings are conducted accordance with 21 CFR 1316.45 and/or pursuant to the provisions of the 1316.47, as applicable. Requests for Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362–8209. Administrative Procedure Act (APA), 5 hearing and waivers of an opportunity U.S.C. 551–559. 21 CFR 1308.41– SUPPLEMENTARY INFORMATION: for a hearing or to participate in a 1308.45; 21 CFR part 1316, subpart D. hearing must be received on or before Posting of Public Comments Such requests or notices must conform June 15, 2020. Please note that all comments to the requirements of 21 CFR ADDRESSES: Interested persons may file received in response to this docket are 1308.44(a) or (b), and 1316.47 or written comments on this proposal in considered part of the public record. 1316.48, as applicable, and include a accordance with 21 CFR 1308.43(g). They will, unless reasonable cause is statement of the person’s interests in the Commenters should be aware that the given, be made available by the Drug proceeding and the objections or issues, electronic Federal Docket Management Enforcement Administration (DEA) for if any, concerning which the person System will not accept comments after public inspection online at http:// desires to be heard. Any waiver must 11:59 p.m. Eastern Time on the last day www.regulations.gov. Such information conform to the requirements of 21 CFR of the comment period. To ensure includes personal identifying 1308.44(c) and may include a written proper handling of comments, please information (such as your name, statement regarding the interested reference ‘‘Docket No. DEA–509’’ on all address, etc.) voluntarily submitted by person’s position on the matters of fact electronic and written correspondence, the commenter. The Freedom of and law involved in any hearing. including any attachments. All requests for hearing and waivers • Information Act applies to all comments Electronic comments: DEA received. If you want to submit personal of participation must be sent to DEA encourages that all comments be identifying information (such as your using the address information provided submitted electronically through the name, address, etc.) as part of your above. Federal eRulemaking Portal, which comment, but do not want it to be made Legal Authority provides the ability to type short publicly available, you must include the comments directly into the comment phrase ‘‘PERSONAL IDENTIFYING The United States is a party to the field on the web page or to attach a file INFORMATION’’ in the first paragraph 1971 United Nations Convention on for lengthier comments. Please go to of your comment. You must also place Psychotropic Substances (1971 http://www.regulations.gov and follow all of the personal identifying Convention), February 21, 1971, 32 the online instructions at that site for information you do not want made U.S.T. 543 as amended. Procedures submitting comments. Upon completion publicly available in the first paragraph respecting changes in drug schedules of your submission, you will receive a of your comment and identify what under the 1971 Convention are Comment Tracking Number for your information you want redacted. governed domestically by 21 U.S.C. comment. Please be aware that If you want to submit confidential 811(d)(2–4). When the United States submitted comments are not business information as part of your receives notification of a scheduling instantaneously available for public comment, but do not want it to be made decision pursuant to Article 2 of the view on Regulations.gov. If you have publicly available, you must include the 1971 Convention adding a drug or other received a Comment Tracking Number, phrase ‘‘CONFIDENTIAL BUSINESS substance to a specific schedule, the your comment has been successfully INFORMATION’’ in the first paragraph Secretary of the Department of Health submitted and there is no need to of your comment. You must also and Human Services (HHS),1 after resubmit the same comment. prominently identify confidential • Paper comments: Paper comments business information to be redacted 1 As discussed in a memorandum of understanding entered into by the Food and Drug that duplicate the electronic submission within the comment. Administration (FDA) and the National Institute on are not necessary. Should you wish to Comments containing personal Drug Abuse (NIDA), FDA acts as the lead agency mail a paper comment in lieu of an identifying information and confidential within HHS in carrying out the Secretary’s

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consultation with the Attorney General, encountered PMMA on the recreational substance in amounts sufficient to create a shall first determine whether existing drug market. In this market, PMMA is hazard to their health or to the safety of other legal controls under subchapter I of the available and sold as ‘‘ecstasy’’ either individuals or to the community; or Controlled Substances Act (CSA) and alone or in combination with MDMA or (b) There is significant diversion of the the Federal Food, Drug, and Cosmetic PMA for oral consumption. For many drug or drugs containing such a substance from legitimate drug channels; or Act meet the requirements of the years, there has been worldwide (mostly (c) Individuals are taking the drug or drugs schedule specified in the notification in Europe) reporting of non-fatal and containing such a substance on their own with respect to the specific drug or fatal cases of overdoses involving initiative rather than on the basis of medical substance. 21 U.S.C. 811(d)(3). If such PMMA. PMMA has no accepted medical advice from a practitioner licensed by law to requirements are not met by existing use in treatment in the United States. administer such drugs in the course of his controls and the Secretary of HHS professional practice; or Proposed Determination To Schedule concurs in the scheduling decision, the (d) The drug or drugs containing such a PMMA Secretary shall recommend to the substance are new drugs so related in their Attorney General that he initiate On March 18, 2016, the Commission action to a drug or drugs already listed as proceedings for scheduling the drug or on Narcotic Drugs (CND) voted to place having a potential for abuse to make it likely that the drug will have the same potentiality substance under the appropriate PMMA in Schedule I of the 1971 Convention (CND Dec/59/3) during its for abuse as such drugs, thus making it schedule pursuant to 21 U.S.C. 811(a) reasonable to assume that there may be and (b). 21 U.S.C. 811(d)(3)(B). 59th Session due to its dependence and significant diversions from legitimate In the event that the Secretary of HHS abuse potential. The United States is a channels, significant use contrary to or did not consult with the Attorney member of the 1971 Convention, and in without medical advice, or that it has a General, as provided under 21 U.S.C. accordance with 21 U.S.C. 811(b), on substantial capability of creating hazards to 811(d)(3), and the Attorney General did April 7, 2017, DEA, after gathering the the health of the user or to the safety of the not issue a temporary order, as provided necessary data, requested from HHS 2 a community. under 21 U.S.C. 811(d)(4), the scientific and medical evaluation and a According to HHS, there is currently procedures for permanent scheduling scheduling recommendation for PMMA. no approved medical use in treatment set forth in 21 U.S.C. 811(a) and (b) On December 18, 2018, pursuant to 21 for PMMA anywhere in the world, and control. Pursuant to 21 U.S.C. 811(a)(1), U.S.C. 811(b), HHS provided DEA with there is no Food and Drug the Attorney General may, by rule, add a scheduling recommendation entitled Administration (FDA)-approved drug to such a schedule or transfer between ‘‘Basis for the Recommendation to Place product containing PMMA used in such schedules any drug or other 1-(4-methoxyphenyl)-N-methylpropan- treatment in the United States. Evidence substance, if he finds that such drug or 2-amine (para- demonstrates that PMMA, similar to other substance has a potential for methoxymethamphetamine, PMMA) in MDMA, is abused for its stimulant, abuse, and makes with respect to such Schedule I of the Controlled Substances psychedelic, and empathogenic effects. drug or other substance the findings Act.’’ Over a period of approximately 30 years prescribed by 21 U.S.C. 812(b) for the Upon receipt of the scientific and starting in the 1990s, PMMA has been schedule in which such drug or other medical evaluation and scheduling associated with numerous cases of non- substance is to be placed. The Attorney recommendation from HHS, DEA fatal intoxications (n = 31) and fatal General has delegated this scheduling reviewed the documents and all other intoxications (n = 131) in three authority to the Administrator of DEA relevant data, and conducted its own 8- continents. PMMA and its metabolites (Administrator). 28 CFR 0.100. Factor analysis in accordance with 21 have been positively identified in blood, U.S.C. 811(c). Included below is a brief urine, and hair samples of individuals Background summary of each factor as analyzed by with a substance use disorder. Evidence para-Methoxymethamphetamine HHS and DEA, and as considered by posits that PMMA is abused knowingly (PMMA) is a substituted DEA in the scheduling decision. Please and/or unknowingly as an MDMA phenethylamine and shares structural note that both DEA and HHS 8-Factor (ecstasy) substitute. similarity to methamphetamine analyses are available in their entirety Law enforcement seizure 4 data (schedule II) and para- under the tab ‘‘Supporting Documents’’ indicate that individuals have abused methoxyamphetamine (PMA), schedule of the public docket for this action at and are continuing to abuse PMMA. I. PMMA shares a similar http://www.regulations.gov under According to the National Forensic pharmacological profile with 3,4- Docket Number ‘‘DEA–509.’’ Laboratory Information System methylenedioxymethamphetamine 1. The Drug’s Actual or Relative (NFLIS) 5 database, which collects drug (MDMA or ecstasy), a schedule I Potential for Abuse: The term ‘‘abuse’’ is identification results from drug cases substance with high potential for abuse. not defined in the CSA. However, the Similar to MDMA, data obtained from legislative history of the CSA suggests 4 While law enforcement data is not direct preclinical studies show that PMMA’s that DEA consider the following criteria evidence of abuse, it can lead to an inference that effects are mediated by monoaminergic when determining whether a particular a drug has been diverted and abused. See 76 FR (dopamine, norepinephrine, and drug or substance has a potential for 77330, 77332, December 12, 2011. serotonin) transmission, mostly via abuse: 3 5 NFLIS represents an important resource in monitoring illicit drug trafficking, including the activation of the serotonergic system. In diversion of legally manufactured pharmaceuticals animals, PMMA mimics MDMA in (a) There is evidence that individuals are taking the drug or drugs containing such a into illegal markets. NFLIS-Drug is a comprehensive producing discriminative stimulus information system that includes data from forensic effect, indicative of similar subjective laboratories that handle the Nation’s drug analysis 2 Administrative responsibilities for evaluating a cases. NFLIS-Drug participation rate, defined as the effects. Law enforcement has substance for control under the CSA are performed percentage of the national drug caseload for HHS by FDA, with the concurrence of NIDA, represented by laboratories that have joined NFLIS, scheduling responsibilities under the CSA, with the according to a Memorandum of Understanding. 50 is currently 98.5%. NFLIS includes drug chemistry concurrence of NIDA. 50 FR 9518, March 8, 1985. FR 9518, March 8, 1985. results from completed analyses only. While NFLIS The Secretary of HHS has delegated to the Assistant 3 Comprehensive Drug Abuse Prevention and data is not direct evidence of abuse, it can lead to Secretary for Health of HHS the authority to make Control Act of 1970, H.R. Rep. No. 91–1444, 91st an inference that a drug has been diverted and domestic drug scheduling recommendations. 58 FR Cong., Sess. 1 (1970); reprinted in 1970 abused. See 76 FR 77330, 77332, December 12, 35460, July 1, 1993. U.S.C.C.A.N. 4566, 4603. 2011. NFLIS data were queried October 23, 2019.

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submitted to and analyzed by some in rats trained to discriminate between As stated by HHS, there are several Federal, State, and local forensic MDMA or PMMA, MDMA and PMMA sources describing the synthesis of laboratories, there have been 39 reports cross-substitute for one another. Based PMMA either directly or through for PMMA between January 2002 and on these and additional data, HHS alternate route by conversion of PMA to October 2019, and no reports for PMMA stated that PMMA likely has similar PMMA. The precursor substances that from January 2003 to December 2010, psychoactive effects as MDMA. can be used for the synthesis of PMMA January 2013 to December 2013, and There are no clinical studies include methylamine, 4- January 2017 to December 2017 (query conducted with PMMA. However, methoxyphenyacetone, and date: October 23, 2019).6 The according to HHS, an article described cyanoborohydride. Additional identification of this substance on the that a self-administered 110 milligram chemicals and solvents required for illicit drug market is an indication that (mg) dose of PMMA resulted in PMMA synthesis include methanol, individuals are taking PMMA in compulsive yawning and increased dichloromethane, isopropanol, amounts sufficient to create a hazard to pulse one hour post-administration. The hydrochloric acid, ethyl chloroformate, public health. In the United States, described effects returned ‘‘back to trimethylamine, carbamate, formamide, PMMA is not an approved drug product, baseline’’ four hours post- and lithium aluminum hydride. and there appears to be no legitimate administration. A study examined the Pharmacokinetic studies of PMMA in source for this substance as a marketed psychoactive effects of individuals who rats showed that after subcutaneous drug product. had taken ‘‘ecstasy.’’ The study followed administration, peak PMMA Based on available data, PMMA is 5,786 individuals who provided the concentration was detected in the related in its effects to the actions of tablets for a chemical analysis and plasma within 30 minutes. Brain levels other substances such as PMA (schedule reported on their subjective effects. Out of PMMA were delayed behind the I) and MDMA (schedule I) that are of this sample set, 70 (1.2 percent) plasma levels for several hours. HHS already listed as having potential for ‘‘ecstasy’’ tablets were identified as states that this delay supports user abuse. According to HHS, PMMA has containing PMMA and MDMA together, comments that PMMA has a longer similar pharmacological effects to with PMMA concentrations in a range of onset of effect than MDMA. Most of MDMA, and thus is expected to have a 5.0 to 128.0 mg/tablet. It was noted that PMMA and its metabolites were high potential for abuse and high risk to abusers of the PMMA and MDMA excreted within the first 24-hours post- public health. combination experienced hyperthermic administration. Metabolites detected 2. Scientific Evidence of the Drug’s seizures, palpitations, agitation, were products of O-demethylation or N- Pharmacological Effects, if Known: hallucinations, abdominal cramps, demethylation of PMMA to 4- According to HHS, PMMA is an nausea, dizziness, and headache. methoxyamphetamine (PMA), 4- empathogenic drug that produces mild In summary, PMMA is a psychoactive hydroxymethamphetamine (OH-MAM), stimulant and psychedelic effects. Data substance with a mechanism of action 4-hydroxyamphetamine (OH-AM), 4- obtained from in vitro studies show that similar to that of MDMA. Data from in hydroxy-3′-methoxymethamphetamine similar to MDMA, PMMA significantly vitro studies show that PMMA increases (HM-MAM), and 4′-hydroxy-3′- increased dopamine (DA) and serotonin serotonin levels more than dopamine methoxyamphetamine (HM-AM). The (5-HT) levels in brain regions associated levels in the brain reward circuitry. In cytochrome P450 enzyme CYP2D6 was with abuse liability. Data obtained from addition, PMMA has an inhibitory effect identified as being the only enzyme an enzymatic assay demonstrate that on monoamine oxidase-A enzyme that capable of demethylating PMMA. PMMA inhibited monoamine oxidase A further increases monoamine levels and PMMA toxicity data in animals and B. According to HHS, results from can lead to serotonin syndrome, a demonstrate that toxicity occurs at early the enzymatic study may partially dangerous medical condition. Data from stages of administration. In PMMA- explain the higher levels of monoamines animal studies demonstrate that PMMA dosed animals, prior to lethality, seen with PMMA administration in produced locomotor stimulant effects at hyperactivity, increased respiration, brain microdialysis studies. High levels high doses with potency of about six salivation, and tremor were observed. of monoamines, especially 5-HT, can times less than that of (+)-amphetamine. 4. Its History and Current Pattern of lead to a serious medical condition In drug discrimination studies, PMMA Abuse: Abuse of PMMA was first referred to as serotonin syndrome. High produces stimulus effect similar to documented in the late 1980s and doses of PMMA have been associated MDMA in rats. Both PMMA and MDMA associated with ‘‘ecstasy’’ tablets as this with symptoms of serotonin syndrome, cross-substitute for one another. There drug was often substituted for MDMA. including increased body temperature are currently no controlled clinical Abuse of PMMA has been documented (hyperthermia), tremor, and agitation, studies that have evaluated the effects of worldwide with usage particularly which can lead to death. PMMA in humans. However, anecdotal extensive in Europe, Asia, and Canada. In preclinical studies, high doses of reports show that similar to MDMA, PMMA was originally used as a powder PMMA transiently increased locomotor PMMA produces adverse health effects, with doses ranging around 100 mg or activity. HHS stated that PMMA’s such as hyperthermia, seizures, less. PMMA is now most commonly locomotor stimulatory effects are not as hallucinations, and nausea. Taken encountered in a tablet form, and robust as that of amphetamine or together, these data demonstrate that PMMA tablets have been seized in methamphetamine. In drug PMMA shares a mechanism of action Europe, Asia, and the United States. discrimination studies, using a test to and discriminative stimulus effects PMMA tablets are primarily sold as determine physical or behavioral effects similar to the schedule I substance, ‘‘ecstasy’’ and are sometimes (an interoceptive response) of an MDMA. encountered along with amphetamine, unknown drug, the effects of PMMA are 3. The State of Current Scientific methamphetamine, or ephedrine. different from structural analogs, Knowledge Regarding the Drug or Other PMMA tablets may be marked with amphetamine or 2,5-dimethoxy-4- Substance: PMMA is a substituted different logos, including ‘‘E,’’ methylamphetamine (DOM). However, phenethylamine and is a methoxy- ‘‘Mitsubishi,’’ ‘‘Jumbo,’’ or ‘‘Superman.’’ derivative of methamphetamine. PMMA Street names for PMMA tablets include 6 NFLIS is still reporting data for October– is also related to PMA and MDMA, ‘‘Dr. Death,’’ ‘‘Death,’’ or ‘‘Killer.’’ December 2018, due to normal lag time in reporting. which are schedule I substances. According to a review of PMMA by the

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European Monitoring Centre for Drugs been associated with ‘‘ecstasy’’ tablets majority of them under the age of 30. and Drug Addition (EMCDDA) in 2003, and is used as a substitute for MDMA. Common symptoms that were observed tablets were reported to contain between As a result, most users think they are prior to death were hyperthermia, 20 and 97 mg of PMMA. PMMA is taking ‘‘ecstasy’’ with MDMA and are decreased respiratory rate, seizures, and primarily administered orally in a tablet not intentionally purchasing PMMA on cardiac arrest. In most of the PMMA- form. Data indicate that MDMA is often the illicit market. One study reported related fatalities, other drugs were mixed with other substances, one of that tablets containing a combination of detected in the blood or urine. which is PMMA. It was observed that MDMA and PMMA resulted in adverse 7. Its Psychic or Physiological MDMA mixed with PMMA led to a effects, such as hyperthermic seizures, Dependence Liability: According to higher number of adverse events than palpitations, agitation, nausea, and HHS, abuse liability of PMMA has only other MDMA combinations. According hallucinations. Most abusers of PMMA been characterized through drug to HHS, there is little anecdotal take the drug in combination with other discrimination studies. The drug information on the use of PMMA most drugs as noted in the PMMA-associated discrimination studies do not provide likely because individuals ingesting this deaths (see Factor 6). Furthermore, there information that can be used to assess substance in the context of abuse is evidence of PMMA drug seizures or the psychic or physiological believe they are taking MDMA rather confiscation in the United States, as dependence liability of PMMA, than a mixture of drugs that may reported by DEA’s STRIDE/STARLiMS although they provide information on include PMMA thus attributing its or NFLIS databases. the subjective effects of the drug. Data effects to MDMA. Numerous deaths and overdoses from drug discrimination studies DEA conducted a search of NFLIS and associated with PMMA usage showed that both PMMA and MDMA the System to Retrieve Information from demonstrate that there is a considerable share discriminative stimulus effects. Drug Evidence (STRIDE)/STARLiMS for population abusing PMMA, and its Diagnostic and Statistical Manual of law enforcement encounters of PMMA. abuse is a significant public health Mental Disorders, 5th Edition, indicated Prior to October 1, 2014, STRIDE concern. Prior to death, individuals that there is evidence of a withdrawal collected the analytical results of drug exhibit high temperatures, seizures, syndrome from MDMA with evidence submitted by DEA, other coma, and respiratory distress. The observations of both psychological and Federal law enforcement agencies, and PMMA-related public health risks, such physical dependence. Similarities in the some local law enforcement agencies to as deaths and overdoses, led the drug discriminative stimulus properties DEA forensic laboratories. Since European Union Member States to of PMMA and MDMA indicate that the October 1, 2014, STARLiMS (a web- control PMMA in 2002. subjective effects of PMMA are similar based, commercial laboratory 6. What, if Any, Risk There is to the to that of the schedule I substance, information management system) has Public Health: According to HHS, there MDMA. As stated by HHS, both PMMA replaced STRIDE as DEA laboratory are several risk factors associated with and MDMA also largely share a common drug evidence data system of record. the use of PMMA. The first risk is that mechanism of action. Thus, it is DEA laboratory data submitted after individuals inadvertently use PMMA plausible to extrapolate that PMMA has September 30, 2014, are reposited in because it is sold as MDMA and such a dependence liability similar to that of STARLiMS. According to data from products may contain other drugs. This MDMA. HHS states some individuals STRIDE 7 and STARLiMS 8 between risk can lead to poly-drug use, which is have become tolerant to MDMA January 2000 and December 2018, DEA inherently more dangerous to the resulting in taking high doses of the laboratories analyzed 41 drug exhibits individuals who consume such drug, and these individuals have containing PMMA. NFLIS is a DEA products. The second risk described by reported undergoing a withdrawal program that collects drug identification HHS is the slow onset of action of syndrome, although it is unclear results from drug cases analyzed by PMMA compared to MDMA. The delay whether they were undergoing other Federal, State, and local forensic in onset of effect for PMMA can make withdrawal or adverse effects from high laboratories. Within the NFLIS database, individuals consume more PMMA, and doses of MDMA. Thus, evidence there have been 39 reports 9 for PMMA such action can lead to overdose or suggests that MDMA causes between January 2002 and October death. Thirdly, HHS described that the psychological dependence and may be 2019, and no reports from January 2003 pharmacological actions of PMMA, such associated with physical dependence, to December 2010, January 2013 to as increase in monoamine levels (DA although not to the same extent as that December 2013, and January 2017 to and 5-HT) combined with inhibition of of cocaine. December 2017 from state and local monoamine oxidase-A, an enzyme HHS concludes that PMMA most laboratories. The NFLIS database shows responsible for degradation of these likely has a psychic dependence there were two reports in 2002 from one monoamines, can lead to a serious liability similar to that of MDMA, state; three reports from two states in medical condition known as serotonin though not as strong as that of cocaine. 2011; three reports from three states in syndrome. The symptoms of serotonin The use of PMMA may be associated 2012; 21 reports from one state in 2014; syndrome are similar to those seen with physical dependence. three reports from two states in 2015; when high doses of PMMA are used. 8. Whether the Substance is an two reports from one state in 2016; four These include hyperthermia, tremor, Immediate Precursor of a Substance reports from two states in 2018; and one agitation, and can result in death. Already Controlled Under the CSA: report from one state in 2019. Over a period of approximately 30 PMMA is not an immediate precursor to 5. The Scope, Duration, and years starting in the 1990s, a total of 131 any substance already controlled in the Significance of Abuse: PMMA abuse has analytically confirmed PMMA (detected CSA as defined by 21 U.S.C. 802(23). in either blood and/or urine)-associated Conclusion: After considering the 7 STRIDE data were queried through September deaths in Europe (69 deaths), Israel (27 scientific and medical evaluation 30, 2014, by the date of collection for DEA forensic deaths), Canada (27 deaths), and Taiwan conducted by HHS, HHS’s scheduling laboratories. (8 deaths) has been reported. Published recommendation, and DEA’s own 8- 8 STRIDE/STARLIMS was queried October 23, 2019, by the date of collection. case reports on PMMA-related deaths Factor analysis, DEA finds that the facts 9 NFLIS is still reporting data for October– occurred mostly in males and ages and all relevant data constitute December 2018, due to normal lag time in reporting. ranged from 14–59 years with the substantial evidence of the potential for

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abuse of PMMA. As such, DEA hereby (3) There Is a Lack of Accepted Safety scheduling action unless DEA has proposes to schedule PMMA as a for Use of the Drug or Substance Under approved that application for schedule I controlled substance under Medical Supervision registration pursuant to 21 U.S.C. 822, the CSA. Because PMMA has no approved 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Proposed Determination of Appropriate medical use in treatment in the United Schedule States and has not been investigated as 2. Disposal of stocks. Any person who a new drug, its safety for use under does not desire or is not able to obtain The CSA establishes five schedules of medical supervision has not been a schedule I registration would be controlled substances known as determined. Therefore, there is a lack of required to surrender all quantities of schedules I, II, III, IV, and V. The CSA accepted safety for use of PMMA under currently held PMMA or transfer all also outlines the findings required to medical supervision. quantities of currently held PMMA to a place a drug or other substance in any Based on these findings, the Acting person registered with DEA before the particular schedule. 21 U.S.C. 812(b). Administrator of DEA concludes that effective date of a final scheduling After consideration of the analysis and PMMA warrants control in schedule I of action, in accordance with all applicable recommendation of the Assistant the CSA. 21 U.S.C. 812(b)(1). More Federal, State, local, and tribal laws. As Secretary for Health of HHS and review precisely, because PMMA shares a of the effective date of a final scheduling of all available data, the Acting pharmacological mechanism of action action, PMMA would be required to be Administrator of DEA, pursuant to 21 and psychoactive effects similar to the disposed of in accordance with 21 CFR U.S.C. 811(c) and 812(b)(1), finds the schedule 1 substance MDMA, DEA is part 1317, in addition to all other following: proposing to place PMMA in 21 CFR applicable Federal, State, local, and (1) The Drug or Substance Has a High 1308.11(d) (the hallucinogenic category tribal laws. Potential for Abuse of schedule I). As such, the proposed 3. Security. PMMA would be subject PMMA has a mechanism of action control of PMMA includes the to schedule I security requirements and similar to that of the schedule I substance, as well as its salts, isomers, would need to be handled and stored in substance MDMA. Similar to MDMA, and salts of isomers whenever the accordance with 21 CFR 1301.71– PMMA increases levels of monoamines, existence of such isomers and salts is 1301.93 as of the effective date of a final specifically DA and 5-HT, in the brain possible, within the specific chemical scheduling action. reward circuitry. Data from animal designation. 4. Labeling and Packaging. All labels, studies demonstrate that PMMA fully Requirements for Handling PMMA labeling, and packaging for commercial substitutes for the discriminative containers of PMMA would need to be If this rule is finalized as proposed, in compliance with 21 U.S.C. 825 and stimulus effect of MDMA, indicative of PMMA would be subject to the CSA’s similar subjective effects. Although 958(e), and be in accordance with 21 schedule I regulatory controls and CFR part 1302, as of the effective date there is currently no data that has administrative, civil, and criminal directly assessed the psychological or of a final scheduling action. sanctions applicable to the manufacture, 5. Quota. Only registered physiological dependence liability of distribution, reverse distribution, PMMA, its pharmacological similarities manufacturers would be permitted to import, export, engagement in research, manufacture PMMA in accordance with to MDMA suggest it likely has low conduct of instructional activities or physical dependence liability similar to a quota assigned, pursuant to 21 U.S.C. chemical analysis with, and possession 826 and in accordance with 21 CFR part that of MDMA. Evidence demonstrates of schedule I controlled substances, that users of PMMA seem to be seeking 1303, as of the effective date of a final including the following: scheduling action. MDMA, which may be mixed with 1. Registration. Any person who 6. Inventory. Every DEA registrant PMMA. Because PMMA shares a handles (manufactures, distributes, pharmacological mechanism of action reverse distributes, imports, exports, who possesses any quantity of PMMA and psychoactive effects similar to the engages in research, or conducts on the effective date of a final schedule 1 substance MDMA, PMMA instructional activities or chemical scheduling action would be required to has a high potential for abuse. analysis with, or possesses) PMMA, or take an inventory of PMMA on hand at that time, pursuant to 21 U.S.C. 827 and (2) The Drug or Substance Has No who desires to handle PMMA, would 958, and in accordance with 21 CFR Currently Accepted Medical Use in need to be registered with DEA to 1304.03, 1304.04, and 1304.11(a) and Treatment in the United States conduct such activities pursuant to 21 U.S.C. 822, 823, 957, 958, and in (d). According to HHS, FDA has not Any person who becomes registered approved any marketing application for accordance with 21 CFR parts 1301 and 1312, as of the effective date of a final with DEA on or after the effective date a drug product containing PMMA for of the final scheduling action would be any indication. In addition, there are no scheduling action. Any person who currently handles PMMA, and is not required to take an initial inventory of clinical studies or petitioners that have all stocks of controlled substances claimed an accepted medical use of registered with DEA, would need to submit an application for registration (including PMMA) on hand on the date PMMA in the United States. Thus, the registrant first engages in the PMMA has no currently accepted and may not continue to handle PMMA after the effective date of a final handling of controlled substances, medical use in treatment in the United pursuant to 21 U.S.C. 827 and 958, and States.10 i. The drug’s chemistry must be known and in accordance with 21 CFR 1304.03, reproducible; 1304.04, and 1304.11(a) and (b). 10 Although there is no evidence suggesting that ii. there must be adequate safety studies; After the initial inventory, every DEA PMMA has a currently accepted medical use in treatment in the United States, it bears noting that iii. there must be adequate and well-controlled registrant would be required to take an a drug cannot be found to have such medical use studies proving efficacy; inventory of all controlled substances unless DEA concludes that it satisfies a five-part iv. the drug must be accepted by qualified (including PMMA) on hand every two experts; and test. Specifically, with respect to a drug that has not years, pursuant to 21 U.S.C. 827 and been approved by FDA, to have a currently v. the scientific evidence must be widely accepted medical use in treatment in the United available. 958, and in accordance with 21 CFR States, all of the following must be demonstrated: 57 FR 10499 (1992). 1304.03, 1304.04, and 1304.11.

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7. Records and Reports. Every DEA sections 3(a) and 3(b)(2) of Executive legitimate commercial market for registrant would be required to maintain Order 12988, Civil Justice Reform, to PMMA in the United States. Therefore, records and submit reports for PMMA, eliminate drafting errors and ambiguity, DEA estimates that no United States or products containing PMMA, pursuant minimize litigation, provide a clear legal entity currently handles PMMA and to 21 U.S.C. 827 and 958, and in standard for affected conduct, and does not expect any United States entity accordance with 21 CFR parts 1304, promote simplification and burden to handle PMMA in the foreseeable 1312, and 1317, as of the effective date reduction. future. DEA concludes that no of a final scheduling action. Executive Order 13132, Federalism legitimate United States entity would be Manufacturers and distributors would This proposed rulemaking does not affected by this rule if finalized. As be required to submit reports regarding such, the proposed rule will not have a PMMA to the Automation of Reports have federalism implications warranting the application of Executive Order significant effect on a substantial and Consolidated Order System number of small entities. pursuant to 21 U.S.C. 827 and in 13132. The proposed rule does not have accordance with 21 CFR parts 1304 and substantial direct effects on the States, Unfunded Mandates Reform Act of 1995 1312, as of the effective date of a final on the relationship between the national scheduling action. government and the States, or the In accordance with Unfunded 8. Order Forms. Every DEA registrant distribution of power and Mandates Reform Act (UMRA) of 1995, who distributes PMMA would be responsibilities among the various 2 U.S.C. 1501 et seq., DEA has required to comply with order form levels of government. determined and certifies that this action requirements, pursuant to 21 U.S.C. 828, Executive Order 13175, Consultation would not result in any Federal and in accordance with 21 CFR part and Coordination With Indian Tribal mandate that may result ‘‘in the 1305, as of the effective date of a final Governments expenditure by State, local, and tribal scheduling action. governments, in the aggregate, or by the This proposed rule does not have 9. Importation and Exportation. All private sector, of $100 million or more tribal implications warranting the importation and exportation of PMMA (adjusted annually for inflation) in any application of Executive Order 13175. It would need to be in compliance with 21 1 year * * *.’’ Therefore, neither a does not have substantial direct effects U.S.C. 952, 953, 957, and 958, and in Small Government Agency Plan nor any accordance with 21 CFR part 1312, as of on one or more Indian tribes, on the relationship between the Federal other action is required under UMRA of the effective date of a final scheduling 1995. action. Government and Indian tribes, or on the 10. Liability. Any activity involving distribution of power and Paperwork Reduction Act of 1995 PMMA not authorized by, or in responsibilities between the Federal This action does not impose a new violation of, the CSA or its Government and Indian tribes. collection of information under the implementing regulations, would be Regulatory Flexibility Act unlawful, and may subject the person to Paperwork Reduction Act of 1995. 44 The Acting Administrator, in U.S.C. 3501–3521. This action would administrative, civil, and/or criminal accordance with the Regulatory sanctions. not impose recordkeeping or reporting Flexibility Act, 5 U.S.C. 601–602, has requirements on State or local Regulatory Analyses reviewed this proposed rule, and by governments, individuals, businesses, or approving it, certifies that it will not organizations. An agency may not Executive Orders 12866, 13563, and have a significant economic impact on 13771, Regulatory Planning and Review, conduct or sponsor, and a person is not a substantial number of small entities. required to respond to, a collection of Improving Regulation and Regulatory DEA proposes placing the substance information unless it displays a Review, and Reducing Regulation and PMMA (chemical name: 1-(4- currently valid OMB control number. Controlling Regulatory Costs methoxyphenyl)-N-methylpropan-2- In accordance with 21 U.S.C. 811(a), amine), including its salts, isomers, and List of Subjects in 21 CFR Part 1308 this proposed scheduling action is salts of isomers whenever the existence subject to formal rulemaking procedures of such salts, isomers, and salts of Administrative practice and performed ‘‘on the record after isomers is possible, in schedule I of the procedure, Drug traffic control, opportunity for a hearing,’’ which are CSA. This action is being taken to Reporting and recordkeeping conducted pursuant to the provisions of enable the United States to meet its requirements. 5 U.S.C. 556 and 557. The CSA sets obligations under the 1971 Convention For the reasons set out above, 21 CFR on Psychotropic Substances. If finalized, forth the procedures and criteria for part 1308 is proposed to read as follows: scheduling a drug or other substance. this action would impose the regulatory Such actions are exempt from review by controls and administrative, civil, and PART 1308—SCHEDULES OF the Office of Management and Budget criminal sanctions applicable to CONTROLLED SUBSTANCES (OMB) pursuant to section 3(d)(1) of schedule I controlled substances on Executive Order 12866 and the persons who handle (manufacture, ■ 1. The authority citation for 21 CFR principles reaffirmed in Executive Order distribute, reverse distribute, import, part 1308 continues to read as follows: 13563. export, engage in research, conduct This rulemaking is not an Executive instructional activities or chemical Authority: 21 U.S.C. 811, 812, 871(b), Order 13771 regulatory action because analysis with, or possess), or propose to 956(b), unless otherwise noted. this rule is not significant under handle PMMA. ■ Executive Order 12866. According to HHS, PMMA has a high 2. In § 1308.11, add paragraph (d)(80) potential for abuse, has no currently to read as follows: Executive Order 12988, Civil Justice accepted medical use in treatment in the § 1308.11 Schedule I. Reform United States, and lacks accepted safety This proposed regulation meets the for use under medical supervision. * * * * * applicable standards set forth in DEA’s research confirms that there is no (d) * * *

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• Mail: Executive Office of the comment, but do not want it to be (79) 1-(4-methoxyphenyl)-N- President, Office of National Drug posted online, you must include the methylpropan-2-amine (other Control Policy, 1800 G Street NW, 9th phrase ‘‘CONFIDENTIAL BUSINESS names: para- Floor, Washington, DC 20006, Attn: INFORMATION’’ in the first paragraph methoxymethamphetamine, Office of General Counsel. of your comment and precisely and PMMA), ...... (1245) Instructions: All submissions received prominently identify the confidential * * * * * must include the agency name and business information for which you seek docket number or Regulatory redaction. If a comment has so much Uttam Dhillon, Information Number (RIN) for this confidential business information that it Acting Administrator. rulemaking. All comments received will cannot be effectively redacted, all or [FR Doc. 2020–09599 Filed 5–14–20; 8:45 am] be posted without change to http:// part of that comment may not be posted BILLING CODE 4410–09–P www.regulations.gov including any on www.regulations.gov. Personally personal information provided. For identifiable information and detailed instructions on sending confidential business information EXECUTIVE OFFICE OF THE comments and additional information provided as set forth above will be PRESIDENT on the rulemaking process, see the placed in the agency’s public docket ‘‘Public Participation’’ heading of the file, but not posted online. To inspect Office of National Drug Control Policy SUPPLEMENTARY INFORMATION section of the agency’s public docket file in this document. person, you must make an appointment 21 CFR Part 1401 FOR FURTHER INFORMATION CONTACT: with agency counsel. Please see the FOR RIN 3201–AA02 Questions concerning this ANPRM FURTHER INFORMATION CONTACT should be directed to Michael J. paragraph above for the agency Criteria for Designation of Emerging Passante, Acting General Counsel, counsel’s contact information specific to Drug Threats in the United States Office of General Counsel, Office of this rulemaking. AGENCY: Office of National Drug Control National Drug Control Policy, Executive II. Introduction Policy. Office of the President, at OGC@ Through enacting Section 8218 of the ondcp.eop.gov (email) or (202) 395– ACTION: Advance notice of proposed SUPPORT Act, 21 U.S.C. 1708, Congress 6622 (voice). rulemaking. codified its intention for the Federal SUPPLEMENTARY INFORMATION: government to closely monitor emerging SUMMARY: The Office of National Drug I. Public Participation drug threats and to take action at the Control Policy is announcing this outset of a trend to prevent such threats Advance Notice of Proposed ONDCP strongly recommends using from reaching levels seen during the Rulemaking (ANPRM) and requests electronic means for submitting opioid crisis. The SUPPORT Act information relevant to criteria for comments. Due to COVID–19, requires ONDCP to promulgate designating and terminating the comments submitted through standards for designating an emerging designation of emerging drug threats in conventional mail delivery services may drug threat and terminating such a the United States pursuant to the not be received in a timely manner. To designation. 21 U.S.C. 1708(c). The Substance Use-Disorder Prevention that ensure proper handling, please SUPPORT Act created the Emerging Promotes Opioid Recovery and reference RIN 3201–AA02 on your Threats Committee consisting of Treatment for Patients and Communities correspondence. The mailing address representatives from National Drug Act (SUPPORT Act). This ANPRM may be used for paper, disk, or CD– Control Program Agencies and other briefly summarizes the White House ROM submissions. agencies, representatives from State, Office of National Drug Control Policy’s Interested persons are invited to local and Tribal governments, and (ONDCP) ongoing work in this area and submit written data, views, or representatives from other entities describes the criteria that ONDCP is arguments on all aspects of this designated by the ONDCP Director. 21 considering to monitor and identify ANPRM. All comments must be U.S.C. 1708(b). The Emerging Threats emerging drug threats. The ANPRM submitted in English, or accompanied Committee is responsible for, among invites interested parties to submit by an English translation. Please note other matters, monitoring evolving and comments, data, and other pertinent that all comments received are emerging drug threats in the United information concerning ONDCP’s considered part of the public record and States. One of the Committee’s principal development of proposed criteria for made available for public inspection at responsibilities is to develop and designating emerging drug threats and www.regulations.gov. Such information recommend criteria that ONDCP may terminating such designations. includes personally identifiable use to designate and terminate the DATES: Send comments on or before information (such as a person’s name, designation of emerging drug threats. 21 June 30, 2020. address, or any other data that might U.S.C. 1708(b)(6). ADDRESSES: You may send comments, personally identify that individual) that How best to monitor and identify identified by RIN number 3201–AA02 the commenter voluntarily submits. emerging drug threats in the United and/or docket number ONDCP–2020– If you want to submit personally States is a question with broad public 0001, by any of the following methods: identifiable information as part of your health implications. Before proceeding, • Federal eRulemaking Portal: http:// comment, but do not want it to be ONDCP intends to benefit from a full www.regulations.gov. Follow the posted online, you must include the airing of the issues through the public instructions for submitting comments. phrase ‘‘PERSONALLY IDENTIFIABLE comment process. ONDCP’s objective is See SUPPLEMENTARY INFORMATION for file INFORMATION’’ in the first paragraph to develop criteria that will enable the formats and other information about of your comment and precisely and United States to be proactive in electronic filing. prominently identify the information for identifying emerging drug threats and • Email: [email protected], which you seek redaction. taking action to prevent such drug Include docket number ONDCP–2020– If you want to submit confidential threats from becoming public health 0001 and/or RIN number 3201–AA02 in business information as part of your emergencies. the subject line of the message.

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