43978 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules

■ 2. Section 430.32 is amended by: § 430.32 Energy and water conservation (4) Clothes washers manufactured on ■ a. Removing paragraph (f)(1)(iii); and standards and their compliance dates. or after January 1, 2018, shall have an ■ b. Revising paragraphs (g)(4) and * * * * * Integrated Modified Energy Factor no (h)(3). (g) * * * less than, and an Integrated Water The revisions read as follows: Factor no greater than:

Integrated modified Integrated Product class energy factor water factor (cu.ft./kWh/ (gal/cycle/ cycle) cu.ft.)

(i) Top-loading, Compact ...... (less than 1.6 ft3 capacity) ...... 1.15 12.0 (ii) Top-loading, Standard ...... (1.6 ft3 or greater capacity) ...... 1.57 6.5 (iii) Front-loading, Compact ...... (less than 1.6 ft3 capacity) ...... 1.13 8.3 (iv) Front-loading, Standard ...... (1.6 ft3 or greater capacity) ...... 1.84 4.7

(h) * * * (3) Clothes dryers manufactured on or after January 1, 2015, shall have a combined energy factor no less than:

Combined energy Product class factor (lbs/kWh)

(i) Vented Electric, Standard (4.4 ft3 or greater capacity) ...... 3.73 (ii) Vented Electric, Compact (120V) (less than 4.4 ft3 capacity) ...... 3.61 (iii) Vented Electric, Compact (240V) (less than 4.4 ft3 capacity) ...... 3.27 (iv) Vented Gas ...... 3.30 (v) Ventless Electric, Compact (240V) (less than 4.4 ft3 capacity) ...... 2.55 (vi) Ventless Electric, Combination Washer-Dryer ...... 2.08

* * * * * controls and administrative, civil, and proper handling of comments, please [FR Doc. 2021–16830 Filed 8–10–21; 8:45 am] criminal sanctions applicable to reference ‘‘Docket No. DEA–397’’ on all BILLING CODE 6450–01–P schedule I controlled substances on electronic and written correspondence, persons who handle (manufacture, including any attachments. distribute, reverse distribute, import, • Electronic comments: Drug DEPARTMENT OF JUSTICE export, engage in research, conduct Enforcement Administration (DEA) instructional activities or chemical encourages that all comments be Drug Enforcement Administration analysis with, or possess), or propose to submitted electronically through the handle, . Federal eRulemaking Portal, which 21 CFR Part 1308 DATES: Comments must be submitted provides the ability to type short electronically or postmarked, on or comments directly into the comment [Docket No. DEA–397] before October 12, 2021. field on the web page or attach a file for Schedules of Controlled Substances: Interested persons may file a request lengthier comments. Please go to http:// for hearing or waiver of hearing Placement of Mesocarb in Schedule I www.regulations.gov and follow the on- pursuant to 21 CFR 1308.44 and in line instructions at that site for AGENCY: Drug Enforcement accordance with 21 CFR 1316.45 and/or submitting comments. Upon completion Administration, Department of Justice. 1316.47, as applicable. Requests for of your submission, you will receive a ACTION: Notice of proposed rulemaking. hearing and waivers of an opportunity Comment Tracking Number. Please be for a hearing or to participate in a aware that submitted comments are not SUMMARY: The Drug Enforcement hearing, together with a written instantaneously available for public Administration proposes placing the statement of position on the matters of view on http://www.regulations.gov. If substance mesocarb (chemical name: N- fact and law asserted in the hearing, you have received a Comment Tracking phenyl-N′-(3-(1-phenylpropan-2-yl)- must be received on or before Number, your comment has been 1,2,3-oxadiazol-3-ium-5- September 10, 2021. submitted successfully, and there is no yl)carbamimidate), including its salts, ADDRESSES: Interested persons may file need to resubmit the same comment. isomers, and salts of isomers, in written comments on this proposal in • Paper comments: Paper comments schedule I of the Controlled Substances accordance with 21 CFR 1308.43(g). that duplicate electronic submissions Act. This action is being taken to enable Commenters should be aware that the are not necessary and are discouraged. the United States to meet its obligations electronic Federal Docket Management Should you wish to mail a paper under the 1971 Convention on System will not accept comments after comment in lieu of an electronic Psychotropic Substances. If finalized, 11:59 p.m. Eastern Time on the last day comment, send via regular or express this action would impose the regulatory of the comment period. To ensure mail to: Drug Enforcement

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 43979

Administration, Attn: DEA Federal containing personal identifying Health and Human Services (HHS),1 Register Representative/DPW, 8701 information and confidential business after consultation with the Attorney Morrissette Drive, Springfield, Virginia information identified as directed General, shall first determine whether 22152. above. If a comment has so much existing legal controls under subchapter • Hearing requests: All requests for a confidential business information that it I of the Controlled Substances Act (CSA) hearing and waivers of participation, cannot be effectively redacted, DEA may and the Federal Food, Drug, and together with a written statement of not make available publicly all or part Cosmetic Act meet the requirements of position on the matters of fact and law of that comment. Comments posted to the schedule specified in the asserted in the hearing, must be sent to: http://www.regulations.gov may include notification with respect to the specific Drug Enforcement Administration, Attn: any personal identifying information drug or substance. 21 U.S.C. 811(d)(3). Administrator, 8701 Morrissette Drive, (such as name, address, and phone In the event that the Secretary of HHS Springfield, Virginia 22152. All requests number) included in the text of your (Secretary) did not so consult with the for hearing and waivers of participation electronic submission that is not Attorney General, and the Attorney should also be sent to: (1) Drug identified as directed above as General did not issue a temporary order, Enforcement Administration, Attn: confidential. as provided under 21 U.S.C. 811(d)(4), Hearing Clerk/OALJ, 8701 Morrissette An electronic copy of this document the procedures for permanent Drive, Springfield, Virginia 22152; and and supplemental information to this scheduling set forth in 21 U.S.C. 811(a) (2) Drug Enforcement Administration, proposed rule are available at http:// and (b) control. Pursuant to 21 U.S.C. Attn: DEA Federal Register www.regulations.gov for easy reference. 811(a)(1), the Attorney General may, by Representative/DPW 8701 Morrissette Request for Hearing, or Waiver of rule, add to such a schedule any drug Drive, Springfield, Virginia 22152. Participation in Hearing or other substance, if he finds that such FOR FURTHER INFORMATION CONTACT: drug or other substance has a potential Pursuant to 21 U.S.C. 811(a), this Terrence L. Boos, Drug & Chemical for abuse, and makes with respect to action is a formal rulemaking ‘‘on the such drug or other substance the Evaluation Section, Diversion Control record after opportunity for a hearing.’’ Division, Drug Enforcement findings prescribed by 21 U.S.C. 812(b) Such proceedings are conducted for the schedule in which such drug is Administration; Telephone: (571) 362– pursuant to the provisions of the 3249. to be placed. The Attorney General has Administrative Procedure Act, 5 U.S.C. delegated this scheduling authority to SUPPLEMENTARY INFORMATION: 551–559. 21 CFR 1308.41–1308.45; 21 the Administrator of DEA. 28 CFR CFR part 1316, subpart D. Interested Posting of Public Comments 0.100. persons may file requests for a hearing Please note that all comments or notices of intent to participate in a Background received in response to this docket are hearing in conformity with the Mesocarb, known chemically as N- considered part of the public record. requirements of 21 CFR 1308.44(a) or phenyl-N′-(3-(1-phenylpropan-2-yl)- They will, unless reasonable cause is (b), and they shall include a statement 1,2,3-oxadiazol-3-ium-5- given, be made available by the Drug of interest in the proceeding and the yl)carbamimidate, has central nervous Enforcement Administration (DEA) for objections or issues, if any, concerning system (CNS) stimulating properties, public inspection online at http:// which the person desires to be heard. 21 and it has no approved medical use in www.regulations.gov. Such information CFR 1316.47(a). Any interested person the United States. Mesocarb (Sydnocarb) includes personal identifying may file a waiver of an opportunity for is marketed in Russia as a treatment for information (such as your name, a hearing or to participate in a hearing attention deficit hyperactivity disorder. address, etc.) voluntarily submitted by together with a written statement Mesocarb’s primary mode of action is to the commenter. The Freedom of regarding the interested person’s stimulate the CNS via (DA) Information Act applies to all comments position on the matters of fact and law activation resulting in increased mental received. If you want to submit personal involved in any hearing as set forth in capacity and activity. identifying information (such as your 21 CFR 1308.44(c). Pursuant to 21 U.S.C. 811(d)(2), HHS name, address, etc.) as part of your All requests for hearing and waivers published two notices in the Federal comment, but do not want to make it of participation, together with a written Register regarding mesocarb. The first publicly available, you must include the statement of position on the matters of notice requested the World Health phrase ‘‘PERSONAL IDENTIFYING fact and law involved in such hearing, Organization (WHO) consider INFORMATION’’ in the first paragraph must be sent to DEA using the address information in preparing its scientific of your comment. You must also place information provided above. and medical evaluation for mesocarb.2 all of the personal identifying The second notice solicited public information you do not want made Legal Authority comment regarding a recommendation publicly available in the first paragraph The United States is a party to the by WHO to impose international of your comment and identify what 1971 Convention on Psychotropic information you want redacted. Substances (1971 Convention), February 1 As discussed in a memorandum of If you want to submit confidential 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. understanding entered into by the Food and Drug Administration (FDA) and the National Institute on business information as part of your 175, as amended. Procedures respecting Drug Abuse (NIDA), FDA acts as the lead agency comment, but do not want to make it changes in drug schedules under the within HHS in carrying out the Secretary’s publicly available, you must include the 1971 Convention are governed scheduling responsibilities under the Controlled phrase ‘‘CONFIDENTIAL BUSINESS domestically by 21 U.S.C. 811(d)(2)–(4). Substances Act, with the concurrence of NIDA. 50 FR 9518 (March 8, 1985). The Secretary of HHS has INFORMATION’’ in the first paragraph When the United States receives delegated to the Assistant Secretary for Health of of your comment. You must also notification of a scheduling decision HHS the authority to make domestic drug prominently identify the confidential pursuant to Article 2 of the 1971 scheduling recommendations. 58 FR 35460 (July 1, business information to be redacted Convention indicating that a drug or 1993). 2 International Drug Scheduling; Convention on within the comment. other substance has been added to a Psychotropic Substances; Certain / DEA will generally make available in schedule specified in the notification, Hallucinogenic Drugs and Certain Nonbarbiturate publicly redacted form comments the Secretary of the Department of Sedative Drugs, 59 FR 31639, June 20, 1994.

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS 43980 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules

controls on mesocarb.3 At its 38th (INCB). Using INCB Form P, the United 1. The Drug’s Actual or Relative session (1995), the United Nations States shall provide the following Potential for Abuse: As reported by Commission on Narcotic Drugs (UN/ information: (1) In regard to each HHS, DA is known to increase CND) listed mesocarb in Schedule IV of Schedule I and II substance of the 1971 locomotion and is also directly involved the 1971 Convention. Specifically, Convention, quantities manufactured in, in the rewarding, stimulatory, and based on advice from WHO, UN/CND exported to, and imported from each effects induced by placed mesocarb in Schedule IV due to country or region as well as stocks held psychostimulants. Mesocarb, known to its low to moderate dependence by manufacturers; (2) in regard to each be a selective inhibitor of the DA potential and its appreciable abuse Schedule II and III substance of the 1971 transporter, is readily self-administered liability. Furthermore, mesocarb was Convention, quantities used in the at levels equal to that of found to have both little to moderate manufacture of exempt preparations; in animals, therapeutic usefulness and a similar and (3) in regard to each Schedule II— demonstrating the reinforcing effects of spectrum of pharmacological effects as IV substance of the 1971 Convention, mesocarb. Clinical studies have also other substances in Schedule IV of the quantities used for the manufacture of confirmed the reinforcing effect of 1971 Convention. The CSA, in 21 U.S.C. non-psychotropic substances or mesocarb as compared to both 812(b), sets forth findings required to products. Lastly, under Article 2 of the and methamphetamine, place a substance in a certain schedule 1971 Convention, the United States both of which are schedule II drugs. under the CSA. As discussed below in must adopt measures in accordance While reports of mesocarb abuse are the Proposed Determination to Schedule with Article 22 to address violations of rare, anti-doping tests have led to the Mesocarb and Proposed Determination any statutes or regulations that are detection of unauthorized use of the of Appropriate Schedule sections, DEA adopted pursuant to its obligations drug by athletes during training and found that mesocarb must be placed in under the 1971 Convention. Persons competition. Effects following schedule I of the CSA. acting outside the legal framework administration of mesocarb include Article 2, paragraph 7(d), of the 1971 established by the CSA are subject to increased locomotion, increased work Convention sets forth the minimum administrative, civil, and/or criminal capacity, improved cardiovascular requirements that the United States action; therefore, the United States function, a marked psychostimulant must meet when a substance has been complies with this provision. effect, excessive vitality or nervous added to Schedule IV of the 1971 energy, tachycardia, hypertension, Proposed Determination To Schedule Convention. Pursuant to the 1971 weight loss, and decreased appetite. Mesocarb Convention, the United States must These data indicate that mesocarb has require licenses for the manufacture, Pursuant to 21 U.S.C. 811(b), DEA the potential for abuse similar to other export and import, and distribution of gathered the necessary data on mesocarb CNS . mesocarb. The CSA’s registration and, in 2008, submitted it to the 2. Scientific Evidence of the Drug’s Pharmacological Effects, If Known: requirement accomplishes this license Assistant Secretary for Health of HHS Mesocarb modulates the uptake of DA, requirement, as set forth in 21 U.S.C. with a request for a scientific and and 5- 822, 823, 957, and 958 and in medical evaluation of available hydroxytryptomine, all of which are accordance with 21 CFR parts 1301 and information and a scheduling directly involved in the rewarding, 1312. In addition, the United States recommendation for mesocarb. On April stimulatory, and antidepressant effects must adhere to specific export and 3, 2012, HHS provided to DEA a written induced by these psychostimulants. In import provisions set forth in the 1971 scientific and medical evaluation and comparison to amphetamine, mesocarb Convention. The CSA’s export and scheduling recommendation entitled has a slower onset of action and is less import provisions accomplish this ‘‘Basis for the Recommendation for potent; however, the stimulant effects of requirement, as established in 21 U.S.C. Control of Mesocarb in Schedule I of the mesocarb on the CNS are longer lasting. 952, 953, 957, and 958 and in Controlled Substances Act (CSA).’’ Mesocarb is readily self-administered in accordance with 21 CFR part 1312. Pursuant to 21 U.S.C. 811(b), this both mice and monkeys and is shown to Likewise, under Article 13, paragraphs document contained HHS’ eight-factor substitute fully for both amphetamine 1 and 2, of the 1971 Convention, a party analysis of the abuse potential of and methamphetamine when tested in a to the 1971 Convention may notify mesocarb, along with its discriminative paradigm. Self- another party, through the Secretary- recommendation that mesocarb be administration findings have also General of the United Nations, that it added to schedule I of the CSA. predicted that mesocarb has abuse prohibits the importation of a substance In response, DEA reviewed the potential, even though it is in Schedule II, III, or IV of the 1971 scientific and medical evaluation and approximately ten times less potent Convention. If such notice is presented scheduling recommendation provided than methamphetamine. to the United States, the United States by HHS and all other relevant data and Mesocarb use in the United States is shall take measures to ensure that the conducted its own eight-factor analysis rare, and clinical information pertaining named substance is not exported to the of mesocarb’s abuse potential pursuant to its abuse potential is limited. country of the notifying party. The to 21 U.S.C. 811(c). Included below is a Mesocarb is not studied scientifically CSA’s export provisions mentioned brief summary of each factor as outside of Russia or other countries that above accomplish this requirement. analyzed by HHS and DEA in their made up the former Union of Soviet Article 16, paragraph 4, of the 1971 respective eight-factor analyses, and as Socialist Republics (USSR). In a clinical Convention requires the United States to considered by DEA in its proposed review by the Institute of Psychiatry of provide annual statistical reports to the scheduling determination. Please note the Academy of Medical Sciences USSR International Narcotics Control Board that both DEA and HHS analyses are and the Institute of Psychiatry of the available in their entirety under Ministry of Health (Moscow), mesocarb 3 International Drug Scheduling; Convention on ‘‘Supporting Documents’’ of the public was reported to produce a marked Psychotropic Substances; World Health docket for this rule at http:// psychostimulant effect characterized by Organization Scheduling Recommendations for Seven Drug Substances, 60 FR 4169, January 20, www.regulations.gov under docket increased mental and physical activity 1995. number ‘‘DEA–397.’’ along with increased locomotor and

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 43981

speech activity. Clinical observations mesocarb is prohibited by WADA and finds that these facts and all relevant demonstrate that mesocarb, while less banned by the International Olympic data constitute substantial evidence of potent than both methamphetamine and Committee. It has been used by athletes potential for abuse of mesocarb. As amphetamine, has similar CNS effects as worldwide both in training and in such, DEA hereby proposes to schedule other stimulants, providing evidence competition due to reported effects on mesocarb as a controlled substance that mesocarb has a similar abuse learning, memory, work capacity, and under the CSA. antihypoxia. Case reports involving liability. Proposed Determination of Appropriate mesocarb abuse have included: (1) A 3. The State of Current Scientific Schedule Knowledge Regarding the Drug or Other Lithuanian athlete in the Barcelona Substance: Mesocarb is a white 1992 Olympic games; (2) a U.S. citizen The CSA establishes five schedules of crystalline powder, nearly insoluble in in the Tokyo 1991 International controlled substances known as water and barely soluble in alcohol. Of Amateur Federation World schedules I, II, III, IV, and V. The CSA the 19 reported metabolites of mesocarb, Championships; (3) a Bulgarian athlete outlines the findings required to place a the main metabolite is p- in the Helsinki 1994 European drug or other substance in any hydroxymesocarb (conjugated with Championships; (4) a report by particular schedule. 21 U.S.C. 812(b). sulfate), which is detected in human observers for WADA covering the After consideration of the analysis and urine and plasma. Amphetamine in Mediterranean Games of Tunis (Tunisia) recommendation of the Assistant trace amounts has also been detected as in 2001; and (5) another WADA report Secretary for Health of HHS and review a metabolite of mesocarb (in human in 2005 following a positive laboratory of all available data, the Administrator urine and blood plasma, and in rat result that tested positive for mesocarb. of DEA, pursuant to 21 U.S.C. 812(b)(1), urine). In healthy human volunteers, the 6. What, if any, Risk There is to the finds that: (1) Mesocarb has a high potential for estimated detection time for mesocarb Public Health: The presence of abuse. Mesocarb, similar to after administration was approximately mesocarb in the United States is limited amphetamine and many other CNS 10–11 days, due to the long half-lives of because of its lack of accepted medical stimulants, is a DA uptake inhibitor. In the metabolites. use. According to HHS, mesocarb is not clinical observations, mesocarb 4. Its History and Current Pattern of an approved drug, and there have been produced marked pyschostimulation Abuse: Abused by athletes worldwide no reports of adverse effects related to accompanied with increased mental, both in training and in competition, mesocarb in the United States. Due to physical, locomotor, and speech activity mesocarb is on the list of prohibited the pharmacological similarity of similar to amphetamine, albeit with less substances of the World Anti-Doping mesocarb to amphetamine and potency. Pre-clinical research has also Agency (WADA) and banned by the methamphetamine, even though the availability of mesocarb is limited, directly compared mesocarb to other International Olympics Committee. In CNS stimulants, including addition, mesocarb is internationally mesocarb likely presents similar risks to the public health as amphetamine and amphetamine and methamphetamine controlled as a Schedule IV substance that are scheduled and controlled under under the 1971 Convention. Diversion methamphetamine. 7. Its Psychic or Physiological the CSA due to their well-known high of legitimately produced mesocarb in Dependence Liability: For amphetamine abuse liability. The effects of mesocarb Bulgaria was mentioned as a possible or amphetamine-like substances, related on DA are qualitatively similar to these problem in the International Narcotics withdrawal symptoms can be moderate schedule II stimulants. Intravenous drug Control Strategy Report (INCSR) of or limited and are characterized by self-administration studies in animals 1993. In 2000, INCSR reported the craving, irritability, nervousness, have shown that mesocarb has primary stimulant of abuse, psychomotor agitation, paranoia, and reinforcing effects. Mesocarb shares amphetamine, was being replaced by sleep disturbances. Although there are similar discriminative stimulus effects (schedule I of the CSA), no direct assessments of the physiologic with amphetamine and pemoline (schedule IV of the CSA), and psychic dependence of mesocarb, it methamphetamine, though at larger mesocarb, and (in that order) does induce locomotor and self- doses. Amphetamine and in western Africa. Queries of DEA’s administration behaviors that are methamphetamine have medical use System to Retrieve Information from similar to those behaviors induced by and have high potential for abuse. 4 Drug Evidence (STRIDE)/STARLiMS amphetamine and methamphetamine. (2) There are no approved New Drug and the National Forensic Laboratory Mesocarb has been shown to substitute Applications for mesocarb nor is there 5 Information System (NFLIS) on May fully at high doses to amphetamine and a known therapeutic application for 26, 2021, did not report any occurrence methamphetamine in a drug mesocarb in the United States. of mesocarb, suggesting that mesocarb is discriminative paradigm. Therefore, Therefore, mesocarb has no currently not trafficked in the United States. mesocarb likely elicits a similar accepted medical use in treatment in the 5. The Scope, Duration, and physiologic and psychic dependence United States.6 Significance of Abuse: As noted above, profile as amphetamine and methamphetamine. 6 Although there is no evidence suggesting that 4 STRIDE is a database of drug exhibits sent to 8. Whether the Substance is an mesocarb has currently accepted medical uses in DEA laboratories for analysis. Exhibits from the treatment in the United States, it bears noting that database are from DEA, other federal agencies, and Immediate Precursor of a Substance a drug cannot be found to have such medical use law enforcement agencies. On October 1, 2014, Already Controlled under the CSA: Both unless DEA concludes that it satisfies a five-part STARLiMS replaced STRIDE as DEA laboratory HHS and DEA find that mesocarb is not test. Specifically, with respect to a drug that has not drug evidence data system of record. an immediate precursor of any been approved by FDA, to have a currently 5 NFLIS is a national drug forensic laboratory accepted medical use in treatment in the United reporting system that systematically collects results substance already controlled under the States, all of the following must be demonstrated: from drug chemistry analyses conducted by state CSA. i. The drug’s chemistry must be known and and local forensic laboratories across the country. Conclusion: Based on consideration of reproducible; ii. there must be adequate safety The NFLIS participation rate, defined as the the scientific and medical evaluation studies; iii. there must be adequate and well- percentage of the national drug caseload controlled studies proving efficacy; iv. the drug represented by laboratories that have joined NFLIS, and accompanying recommendation of must be accepted by qualified experts; and v. the is over 97%. NFLIS includes drug chemistry results HHS, and based on DEA’s consideration scientific evidence must be widely available. 57 FR from completed analyses only. of its own eight-factor analysis, DEA Continued

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS 43982 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules

(3) There is a lack of accepted safety a person registered with DEA before the 958 and in accordance with 21 CFR for use of mesocarb under medical effective date of a final scheduling 1301.74(b) and (c) and parts 1304, 1312, supervision since mesocarb lacks any action in accordance with all applicable and 1317, as of the effective date of a accepted medical use in the United federal, State, local, and tribal laws. As final scheduling action. Manufacturers States. Clinical findings demonstrate of the effective date of a final scheduling and distributors would be required to that mesocarb induces similar effects action, mesocarb would be required to submit reports regarding mesocarb to characteristic of other CNS stimulants be disposed of in accordance with 21 the Automation of Reports and including amphetamine and CFR part 1317, in addition to all other Consolidated Order System pursuant to methamphetamine. Adverse effects applicable Federal, State, local, and 21 U.S.C. 827 and in accordance with 21 reported for mesocarb include tribal laws. CFR parts 1304 and 1312 as of the tachycardia, hypertension, weight loss, 3. Security. Mesocarb would be effective date of a final scheduling and decreased appetite. subject to schedule I security action. Based on these findings, the requirements and would need to be 8. Order Forms. Every DEA registrant Administrator of DEA concludes that handled and stored pursuant to 21 who distributes mesocarb would be mesocarb warrants control under U.S.C. 821 and 823, and in accordance required to comply with order form schedule I of the CSA. 21 U.S.C. with 21 CFR 1301.71–1301.76, as of the requirements, pursuant to 21 U.S.C. 828 812(b)(1). More precisely, because of its effective date of a final scheduling and in accordance with 21 CFR part stimulant effects, DEA proposes placing action. Non-practitioners handling 1305, as of the effective date of a final mesocarb in 21 CFR 1308.11(f) (the mesocarb would also need to comply scheduling action. stimulants category of schedule I). As with the employee screening 9. Importation and Exportation. All such, the proposed control of mesocarb requirements of 21 CFR 1301.90 importation and exportation of includes the substance as well as its –1301.93. mesocarb would need to be in salts, isomers, and salts of isomers. 4. Labeling and Packaging. All labels, compliance with 21 U.S.C. 952, 953, labeling, and packaging for commercial Requirements for Handling Mesocarb 957, and 958 and in accordance with 21 containers of mesocarb would need to CFR part 1312 as of the effective date of If this rule is finalized as proposed, be in compliance with 21 U.S.C. 825 a final scheduling action. mesocarb would be subject to the CSA’s and 958(e) and in accordance with 21 10. Liability. Any activity involving schedule I regulatory controls and CFR part 1302, as of the effective date mesocarb not authorized by, or in administrative, civil, and criminal of a final scheduling action. violation of, the CSA or its 5. Quota. Only registered sanctions applicable to the manufacture, implementing regulations, would be manufacturers would be permitted to distribution, reverse distribution, unlawful, and may subject the person to manufacture mesocarb in accordance import, export, engagement in research, administrative, civil, and/or criminal with a quota assigned pursuant to 21 conduct of instructional activities or sanctions. chemical analysis with, and possession U.S.C. 826 and in accordance with 21 of schedule I controlled substances, CFR part 1303, as of the effective date Regulatory Analyses including the following: of a final scheduling action. 6. Inventory. Every DEA registrant Executive Orders 12866 (Regulatory 1. Registration. Any person who Planning and Review) and 13563 handles (manufactures, distributes, who possesses any quantity of mesocarb on the effective date of a final (Improving Regulation and Regulatory reverse distributes, imports, exports, Review) engages in research, or conducts scheduling action would be required to instructional activities or chemical take an inventory of mesocarb on hand In accordance with 21 U.S.C. 811(a), analysis with, or possesses) mesocarb, at that time, pursuant to 21 U.S.C. 827 this proposed scheduling action is or who desires to handle mesocarb, and 958 and in accordance with 21 CFR subject to formal rulemaking procedures would need to be registered with DEA 1304.03, 1304.04, and 1304.11(a) and performed ‘‘on the record after to conduct such activities pursuant to (d). opportunity for a hearing,’’ which are 21 U.S.C. 822, 823, 957, and 958, and Any person who becomes registered conducted pursuant to the provisions of in accordance with 21 CFR parts 1301 with DEA on or after the effective date 5 U.S.C. 556 and 557. The CSA sets and 1312 as of the effective date of a of the final scheduling action would be forth procedures and criteria for final scheduling action. Any person required to take an initial inventory of scheduling a drug or other substance. who currently handles mesocarb and is all stocks of controlled substances Such actions are exempt from review by not registered with DEA would need to (including mesocarb) on hand on the the Office of Management and Budget submit an application for registration date the registrant first engages in the pursuant to Section 3(d)(1) of Executive and may not continue to handle handling of controlled substances, Order (E.O.) 12866 and the principles mesocarb as of the effective date of a pursuant to 21 U.S.C. 827 and 958 and reaffirmed in E.O. 13563. in accordance with 21 CFR 1304.03, final scheduling action, unless DEA has Executive Order 12988, Civil Justice 1304.04, and 1304.11(a) and (b). approved that application for Reform registration pursuant to 21 U.S.C. 822, After the initial inventory, every DEA 823, 957, and 958, and in accordance registrant would be required to take a This proposed regulation meets the with 21 CFR parts 1301 and 1312. new inventory of all controlled applicable standards set forth in 2. Disposal of stocks. Any person who substances (including mesocarb) on sections 3(a) and 3(b)(2) of E.O. 12988 does not desire or is not able to obtain hand every two years, pursuant to 21 to eliminate drafting errors and a schedule I registration would be U.S.C. 827 and 958 and in accordance ambiguity, minimize litigation, provide required to surrender all quantities of with 21 CFR 1304.03, 1304.04, and a clear legal standard for affected currently held mesocarb or transfer all 1304.11. conduct, and promote simplification 7. Records and Reports. Every DEA quantities of currently held mesocarb to and burden reduction. registrant would be required to maintain records and submit reports for Executive Order 13132, Federalism 10499 (1992), pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 mesocarb, or products containing This proposed rulemaking does not (DC Cir. 1994). mesocarb, pursuant to 21 U.S.C. 827 and have federalism implications warranting

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 43983

the application of E.O. 13132. The sanctions applicable to schedule I 1 year * * *.’’ Therefore, neither a proposed rule does not have substantial controlled substances on persons who Small Government Agency Plan nor any direct effects on the States, on the handle (manufacture, distribute, reverse other action is required under relationship between the national distribute, import, export, engage in provisions of the UMRA of 1995. government and the States, or the research, conduct instructional List of Subjects in 21 CFR Part 1308 distribution of power and activities or chemical analysis with, or responsibilities among the various possess), or propose to handle, Administrative practice and levels of government. mesocarb. procedure, Drug traffic control, According to HHS, mesocarb has a Executive Order 13175, Consultation Reporting and recordkeeping high potential for abuse, has no requirements. and Coordination With Indian Tribal currently accepted medical use in Governments treatment in the United States, and lacks For the reasons set out above, 21 CFR This proposed rule does not have accepted safety for use under medical part 1308 is proposed to be amended to tribal implications warranting the supervision. DEA’s research confirms read as follows: application of E.O. 13175. It does not that there is no commercial market for PART 1308—SCHEDULES OF have substantial direct effects on one or mesocarb in the United States. CONTROLLED SUBSTANCES more Indian tribes, on the relationship Additionally, queries of DEA’s STRIDE/ between the Federal government and STARLiMS and the NFLIS databases on ■ 1. The authority citation for 21 CFR Indian tribes, or on the distribution of May 26, 2021, did not generate any part 1308 continues to read as follows: power and responsibilities between the reports of mesocarb, suggesting that it is Federal government and Indian tribes. not trafficked in the United States. Authority: 21 U.S.C. 811, 812, 871(b), Therefore, DEA estimates that no United 956(b), unless otherwise noted. Paperwork Reduction Act of 1995 States entity currently handles mesocarb ■ 2. Section 1308.11 is amended by This action does not impose a new and does not expect any United States redesignating paragraphs (f)(7) through collection of information requirement entity to handle mesocarb in the (10) as paragraphs (f)(8) through (11), under the Paperwork Reduction Act of foreseeable future. DEA concludes that and adding a new paragraph (f)(7) to 1995 (44 U.S.C. 3501–3521). no United States entity would be read as follows: Regulatory Flexibility Act affected by this rule if finalized. As such, the proposed rule will not have a § 1308.11 Schedule I. The Administrator, in accordance significant effect on a substantial * * * * * with the Regulatory Flexibility Act, 5 number of small entities. (f) * * * U.S.C. 601–612, has reviewed this ′ proposed rule, and by approving it, Unfunded Mandates Reform Act of 1995 (7) Mesocarb (N-phenyl-N -(3-(1- certifies that it will not have a On the basis of information contained phenylpropan-2-yl)-1,2,3-oxadiazol-3- significant economic impact on a in the ‘‘Regulatory Flexibility Act’’ ium-5-yl)carbamimidate). 15. substantial number of small entities. section above, DEA has determined and 1227XXXXXXXXXXXXXXXXXX DEA proposes placing the substance certifies pursuant to the Unfunded * * * * * mesocarb, including its isomers, salts, Mandates Reform Act (UMRA) of 1995 (f) Stimulants. Unless specifically and salts of isomers, in schedule I of the (2 U.S.C. 1501 et seq.) that this action excepted or unless listed in another CSA. This action is being taken to would not result in any Federal schedule, any material, compound, enable the United States to meet its mandate that may result ‘‘in the mixture, or preparation which contains obligations under the 1971 Convention. expenditure by State, local, and tribal any quantity of the following substances If finalized, this action would impose governments, in the aggregate, or by the having a stimulant effect on the central the regulatory controls and private sector of $100,000,000 or more nervous system, including its salts, administrative, civil, and criminal (adjusted annually for inflation) in any isomers, and salts of isomers:

(1) (Some other names: aminoxaphen; 2-amino-5-phenyl-2-; or 4,5-dihydro-5-phenly-2-oxazolamine) ...... 1585 (2) N- (some other names: BZP, 1-benzylpiperazine) ...... 7493 (3) ...... 1235 Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone ...... (4) Fenethylline ...... 1503 (5) (Some other names: 2-(methylamino)-propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-1- phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone; methylcathinone; AL–464; AL–422; AL–463 and UR1432), its salts, optical isomers and salts of optical isomers ...... 1237 (6) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) ...... 1590 (7) N-ethylamphetamine ...... 1475 (8) N,N- (also known as N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine) ...... Anne Milgram, Administrator. [FR Doc. 2021–16489 Filed 8–10–21; 8:45 am] BILLING CODE 4410–09–P

VerDate Sep<11>2014 17:48 Aug 10, 2021 Jkt 253001 PO 00000 Frm 00014 Fmt 4702 Sfmt 9990 E:\FR\FM\11AUP1.SGM 11AUP1 jbell on DSKJLSW7X2PROD with PROPOSALS