The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would amend Class E airspace for Hampton, GA to support IFR operations in the area.

Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (Docket No. FAA-2021-1049 and Airspace Docket No. 21-ASO-36) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number). You may also submit comments through the internet at https://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-1049; Airspace Docket No. 21-ASO-36.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at https://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays, at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA proposes an amendment to 14 CFR part 71 to amend Class E airspace extending upward from 700 feet above the surface at Atlanta Speedway Airport (formerly Clayton County-Tara Field), Hampton, GA by updating the airports name and updating the geographical coordinates of the airport to coincide with the FAA's database. This action would also increase the radius to 9.2 miles (formerly 6.8 miles) and eliminate excessive verbiage in the legal description.

Class E airspace designations are published in Paragraphs 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures”, prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The notice of intent contained in this document is issued pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to issue a temporary scheduling order  1 (in the form of a temporary amendment) to add the following seven substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, to schedule I under the Controlled Substances Act (CSA):

• 2-(2-(4-butoxybenzyl)-5-nitro-1 H -benzimidazol-1-yl)- N,N -diethylethan-1-amine (butonitazene),

• 2-(2-(4-ethoxybenzyl)-1 H -benzimidazol-1-yl)- N,N -diethylethan-1-amine (etodesnitazene; etazene),

• N,N -diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1 H -benzimidazol-1-yl)ethan-1-amine) (flunitazene),

• N,N -diethyl-2-(2-(4-methoxybenzyl)-1 H -benzimidazol-1-yl)ethan-1-amine (metodesnitazene),

• N,N -diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1 H - benzimidazol-1-yl)ethan-1-amine (metonitazene),

• 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1 H -benzimidazole ( N -pyrrolidino etonitazene; etonitazepyne), and

• N,N -diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1 H -benzimidazol-1-yl)ethan-1-amine (protonitazene).

The temporary scheduling order will be published in the Federal Register on or after January 6, 2022.

The CSA provides the Attorney General (as delegated to the Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b), if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily controlled under section 811(h), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308.

The CSA requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of an intent to place a substance in schedule I of the CSA temporarily ( i.e., to issue a temporary scheduling order). 21 U.S.C. 811(h)(4). The then-Acting Administrator transmitted the required notice to the Assistant Secretary for Health of HHS (Assistant Secretary), 2 by letter dated June 16, 2021, regarding butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene. In a subsequent letter dated August 25, 2021, the Administrator transmitted the required notice to the Assistant Secretary for N -pyrrolidino etonitazene. The Assistant Secretary responded to these notices by letters dated July 7 and September 10, 2021, and advised that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications (IND) or approved new drug applications (NDA) for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene. The Assistant Secretary also stated that HHS had no objection to the temporary placement of these substances in schedule I. Butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene currently are not listed in any schedule under the CSA, and no exemptions or approvals under 21 U.S.C. 355 are in effect for these seven benzimidazole-opioids.

To find that temporarily placing a substance in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). This consideration includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of these substances. 21 U.S.C. 811(h)(3).

Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, and no accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).

The United States currently is experiencing an opioid overdose epidemic, and the presence of synthetic opioids in the illicit drug market threatens to exacerbate this. The trafficking, continued evolution, and abuse of new synthetic opioids are deadly trends posing imminent hazards to public safety. Adverse health effects associated with abuse of synthetic opioids and increased popularity of these substances have been serious concerns in recent years. Butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene are synthetic opioids recently identified on the illicit drug market in the United States.

Data obtained from preclinical pharmacology studies show that butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene have pharmacological profiles similar to those of the potent benzimidazole-opioids etonitazene and isotonitazene, both schedule I controlled substances. Because of their pharmacological similarities, use of these seven benzimidazole-opioid substances presents a high risk of abuse and may negatively affect users and communities. They have been identified in at least 44 toxicology and post-mortem cases in the United States between November 2020 and July 2021. Specifically, butonitazene has been identified in one case, etodesnitazene in five cases, flunitazene in four cases, metodesnitazene in one case, metonitazene in twenty cases, N -pyrrolidino etonitazene in eight cases, and protonitazene in five cases, which together create serious public safety concerns.

Available data and information for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene, summarized below, indicate that these substances have high potential for abuse, no currently accepted medical use in treatment in the United States, and lack of accepted safety for use under medical supervision. DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at www.regulations.gov under Docket Number DEA-900.

In the late 1950s, pharmaceutical research laboratories of the Swiss chemical company CIBA Aktiengesellschaft synthesized a group of benzimidazole derivatives with analgesic properties; however, the research did not lead to any medically approved analgesic products. These benzimidazole derivatives include schedule I substances such as synthetic opioids clonitazene, etonitazene, and isotonitazene. In 2019, isotonitazene emerged on the illicit drug market and was involved in numerous fatal overdose events. In August 2020, DEA temporarily controlled it as a schedule I substance under the CSA (85 FR 51342).

Subsequently, the benzimidazole-opioids at issue here have emerged on the illicit drug market. Law enforcement agencies have encountered etodesnitazene, flunitazene, metonitazene, and protonitazene in several solid ( e.g., powder and rock) and liquid forms. These substances are not approved for medical use anywhere in the world. The Assistant Secretary, by letters dated July 7 and September 10, 2021, informed DEA that there are no FDA-approved NDAs or INDs for them in the United States. Hence, there are no legitimate channels for these substances as marketed drug products. Their appearance on the illicit drug market is similar to other synthetic opioids trafficked for their psychoactive effects. These seven opioid substances are likely to be abused in the same manner as schedule I opioids such as etonitazene, isotonitazene, and heroin. They have been identified as white to beige powders or in liquid forms, typically of unknown purity or concentration.

In 2020 and 2021, butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene emerged on the illicit synthetic drug market as evidenced by their identification in forensic drug seizures or biological samples. In July 2020, metonitazene was first reported seized as a white powdery substance in a North Carolina case. Based on data from the National Forensic Laboratory Information System (NFLIS), 3 law enforcement often encounters etodesnitazene, flunitazene, metonitazene, and protonitazene in mixtures. Substances found in combination with some of these benzimidazole-opioids include cutting agents (caffeine, xylazine, etc.) or other substances of abuse such as heroin, fentanyl (schedule II), fentanyl analogs, and tramadol (schedule IV).

In the United States, butonitazene, etodesnitazene, flunitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene have been identified alone or in combination with other substances such as designer benzodiazepines and fentanyl (see Factors 5 and 6). Evidence suggests that individuals are using these substances as a replacement for other opioids, either knowingly or unknowingly. Information gathered from case histories and autopsy findings show that deaths involving metonitazene were similar to those of opioid-related deaths. Identified material or paraphernalia from death-scene investigations also were consistent with opioid use. The seven substances are likely to be abused in the same manner as schedule I opioids such as isotonitazene and heroin.

The subject substances have been described as synthetic opioids, and evidence suggests they are abused for their opioidergic effects (see Factor 6). Their abuse has resulted in their identification in toxicology and post-mortem cases. Between January and February of 2021, metonitazene has been positively identified in 20 forensic post-mortem cases from seven different states: Tennessee (10), Illinois (5), Florida (1), Iowa (1), Ohio (1), South Carolina (1), and Wisconsin (1). Most (18) of the decedents were male, with ages ranging from 19 to 63 years and an average age of 41 years. Metonitazene was identified as the sole drug detected in only three cases, and the only opioid in six cases.

Detection of N -pyrrolidino etonitazene in a toxicology case first was reported  4 in May 2021. It has been identified in a total of eight post-mortem cases from five different states (Colorado (1), Florida (1), New York (1), Pennsylvania (1), and West Virginia (4)) between January and April 2021. The decedents' ages spanned their 20s to 50s. N -Pyrrolidino etonitazene was the only drug of interest in one of these cases. In the other cases, it was co-identified with designer benzodiazepines (7), fentanyl (4), and methamphetamine (4). Data from law enforcement encounters suggests that etodesnitazene, flunitazene, metonitazene, and protonitazene are abused  5 in the United States as recreational drugs. Law enforcement encounters of etodesnitazene, flunitazene, metonitazene, and protonitazene as reported to NFLIS (Federal, State, and local laboratories) includes 270 exhibits since 2020 (queried 08/04/2021). NFLIS registered one encounter of etodesnitazene from one state, five encounters of flunitazene from four states, 262 encounters of metonitazene from eight states, and two encounters of protonitazene from two states. Data from NFLIS show that 561.55 grams of metonitazene has been encountered by law enforcement since 2020, and it was often suspected as heroin or fentanyl. This suggests that metonitazene might be presented as a substitute for heroin or fentanyl and likely abused in the same manner as either of these substances. The lack of identification of butonitazene, metodesnitazene, and N -pyrrolidino etonitazene in law enforcement reports might be due to the rapid appearance of these benzimidazole-opioids and under-reporting as forensic laboratories try to secure reference standards for these substances. However, butonitazene, metodesnitazene, and N -pyrrolidino etonitazene have been identified in toxicology cases.

The population likely to abuse these seven benzimidazole-opioids appears to be the same as those abusing other opioid substances such as heroin, tramadol, fentanyl, and other synthetic opioids. This is evidenced by the types of other drugs co-identified in biological samples and law enforcement encounters. Because abusers are likely to obtain these substances through unregulated sources, their identity, purity, and quantity are uncertain and likely to be inconsistent, thus posing significant adverse health risks to the end user. The misuse and abuse of opioids have been demonstrated and are well-characterized. According to the most recent data from the National Survey on Drug Use and Health (NSDUH), 6 as of 2019, an estimated 10.1 million people aged 12 years or older misused opioids in the past year, including 9.7 million prescription pain reliever misusers and 745,000 heroin users. In 2019, an estimated 1.6 million people had an opioid use disorder, including 1.4 million people with a prescription pain reliever use disorder and 438,000 people with heroin use disorder. This population likely is at risk of abusing butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene. Individuals who initiate ( i.e., use a drug for the first time) use of these benzimidazole-opioids are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics ( e.g., fentanyl, morphine, etc.). Law enforcement or toxicology reports demonstrate that the seven substances at issue are being distributed illicitly and abused.

The increase in opioid overdose deaths in the United States has been exacerbated recently by the availability of potent synthetic opioids in the illicit drug market. Data obtained from pre-clinical studies demonstrate that butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene exhibit pharmacological profiles similar to that of schedule I substances such as etonitazene, isotonitazene, and other mu-opioid receptor agonists. These seven benzimidazole-opioids bind to and act as agonists at the mu-opioid receptors. It is well established that substances that act as mu-opioid receptor agonists have a high potential for abuse and addiction and can induce dose-dependent respiratory depression.

As with any mu-opioid receptor agonist, the potential health and safety risks for users of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene are high. Consistently, these substances have been identified in toxicology cases. The public health risks attendant to the abuse of mu-opioid receptor agonists are well established. These risks include large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. According to the Centers for Disease Control and Prevention (CDC), opioids, mainly synthetic opioids other than methadone, are predominantly responsible for drug overdose deaths in recent years. According to CDC data, synthetic opioid-related overdose deaths in the United States increased from 36,359 in 2019, to 56,688 in 2020 (CDC, 2021). 7 Of the drug overdose death data (70,630) for 2019, synthetic opioids were involved in about 51.4 percent (36,359) of all drug-involved overdose deaths.

According to a recent publication, since November 2020, there has been an increase in metonitazene-related adverse events, including deaths. 8 Metonitazene has been co-identified with other substances in biological samples from 20 post-mortem cases from seven different states: Florida (1), Illinois (5), Iowa (1), Ohio (1), South Carolina (1), Tennessee (10), and Wisconsin (1). Information gathered from case histories and autopsy findings show that deaths involving metonitazene were similar to those of opioid-related deaths. Identified material or paraphernalia from death-scene investigations were consistent with opioid use. Reports obtained from autopsy findings showed that deaths involving metonitazene presented pulmonary and cerebral edema, as well as distended bladder and signs of intravenous drug use. Of the cases for which death certificate data were available, metonitazene was reported as a cause of death in four cases, of which three cases listed metonitazene as the only cause.

According to recent reports, butonitazene (1 instance), etodesnitazene (5), flunitazene (4), metodesnitazene (1), metonitazene (20), protonitazene (5), and N -pyrrolidino etonitazene (10) have been identified in toxicology cases in the United States. 9 For cases involving N -pyrrolidino etonitazene, it was co-identified with fentanyl in four cases and with novel benzodiazepines ( e.g., flualprazolam, etizolam, and clonazolam) in six others.

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene pose imminent hazards to public safety. DEA is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I must have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene indicate that these substances meet the three statutory criteria. As required by 21 U.S.C. 811(h)(4), the then-Acting Administrator transmitted to the Assistant Secretary for Health, via letter dated June 16, 2021, notice of his intent to place butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene in schedule I on a temporary basis. In a letter to the Assistant Secretary for Health dated August 25, 2021, the Administrator transmitted notice of her intent to place N -pyrrolidino etonitazene in schedule I on a temporary basis.

This Notice of Intent provides the 30-day notice pursuant to 21 U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order. In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for her determination that it is necessary to temporarily schedule butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene in schedule I of the CSA, and finds that placement of these substances in schedule I is necessary to avoid an imminent hazard to the public safety.

The temporary placement of butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before January 6, 2022. Because the Administrator hereby finds this temporary scheduling order necessary to avoid an imminent hazard to the public safety, it will take effect on the date the order is published in the Federal Register , and remain in effect for two years, with a possible extension of one year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The Administrator intends to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this document. Upon the temporary order's publication, butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, N -pyrrolidino etonitazene, and protonitazene will then be subject to the CSA's schedule I regulatory controls and to administrative, civil, and criminal sanctions applicable to their manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession.

The CSA sets forth specific criteria for scheduling drugs or other substances. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make determinations. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to the public safety. Under 21 U.S.C. 811(h), the Administrator, as delegated by the Attorney General, may, by order, temporarily place substances in schedule I. Such orders may not be issued before the expiration of 30 days from: (1) The publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary for Health of HHS, as delegated by the Secretary of HHS. 21 U.S.C. 811(h)(1).

Inasmuch as section 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, including the requirement to publish in the Federal Register a Notice of Intent, the notice-and-comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this Notice of Intent. The APA expressly differentiates between orders and rules, as it defines an “order” to mean a “final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making. ” 5 U.S.C. 551(6) (emphasis added). The specific language chosen by Congress indicates its intent that DEA issue orders instead of proceeding by rulemaking when temporarily scheduling substances. Given that Congress specifically requires the Administrator (as delegated by the Attorney General) to follow rulemaking procedures for other kinds of scheduling actions, see 21 U.S.C. 811(a), it is noteworthy that, in section 811(h), Congress authorized the issuance of temporary scheduling actions by order rather than by rule.

Even assuming that this Notice of Intent is subject to section 553 of the APA, the Administrator finds that there is good cause to forgo its notice-and-comment requirements, as any further delays in the process for issuing temporary scheduling orders would be impracticable and contrary to the public interest given the manifest urgency to avoid an imminent hazard to the public safety.

Although DEA believes this Notice of Intent to issue a temporary scheduling order is not subject to the notice-and-comment requirements of section 553 of the APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator took into consideration comments submitted by the Assistant Secretary in response to the notices that DEA transmitted to the Assistant Secretary pursuant to such subsection.

Further, DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.

In accordance with the principles of Executive Orders (E.O.) 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. Because this is not a rulemaking action, this is not a significant regulatory action as defined in Section 3(f) of E.O. 12866.

This action will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132 (Federalism), it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows:

All comments received in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available, unless reasonable cause is given, for public inspection online at https://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want DEA to make it publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want DEA to make it publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

DEA will generally make available in publicly redacted form comments containing personal identifying information and confidential business information identified, as directed above. If a comment has so much confidential business information that DEA cannot effectively redact it, DEA may not make available publicly all or part of that comment. Comments posted to https://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as confidential as directed above.

An electronic copy of this document and supplemental information to this proposed rule are available at https://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for a hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(a) or (b), and such requests must include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. 21 CFR 1316.47(a). Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested person's position on the matters of fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).

All requests for a hearing and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above.

The United States is a party to the 1971 United Nations Convention on Psychotropic Substances (“1971 Convention”), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of the Department Health and Human Services (HHS), 1 after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. 21 U.S.C. 811(d)(3). In the event that the Secretary of HHS (Secretary) did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may add to such a schedule any drug or other substance, if he finds that such drug or other substance has a potential for abuse, and makes the findings prescribed by 21 U.S.C. 812(b) for the schedule in which such drug or other substance is to be placed. The Attorney General has delegated this scheduling authority to the Administrator of DEA. 28 CFR 0.100.

Methoxetamine (MXE), also known as 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one or 2-(3-methoxyphenyl)-2-( N -ethylamino)cyclohexanone belongs to the arylcyclohexylamine class of drugs with dissociative anesthetic and hallucinogenic properties, similar to phencyclidine (PCP) and ketamine. Methoxetamine has no approved medical use in the United States.

On December 30, 2014, DEA, in accordance with the provisions of 21 U.S.C. 811(b), requested HHS provide a scientific and medical evaluation as well as a scheduling recommendation for methoxetamine. On April 14, 2017, DEA provided HHS additional scientific and updated information on methoxetamine. The April 14, 2017, communication included that on May 17, 2016, the Secretary-General of the United Nations (UN Secretary General) advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND), during its 59th Session in March 2016, voted to place methoxetamine in Schedule II of the 1971 Convention (CND Dec/59/6). As a signatory to this international treaty, the United States is required, by scheduling under the CSA, to place appropriate controls on methoxetamine to meet the minimum requirements of the treaty.

Article 2, paragraph 7(b), of the 1971 Convention sets forth the minimum requirements that the United States must meet when a substance has been added to Schedule II of the 1971 Convention. Pursuant to the 1971 Convention, the United States must require licenses for the manufacture, export and import, and distribution of methoxetamine. This license requirement is accomplished by the CSA with the registration requirement as set forth in 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. In addition, the United States must adhere to specific export and import provisions that are provided in the 1971 Convention. This requirement is accomplished by the CSA with the export and import provisions established in 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. Likewise, under Article 13, paragraphs 1 and 2, of the 1971 Convention, a party to the 1971 Convention may notify another party, through the UN Secretary-General, that it prohibits the importation of a substance in Schedule II, III, or IV of the 1971 Convention. If such notice is presented to the United States, the United States shall take measures to ensure that the named substance is not exported to the country of the notifying party. This requirement is also accomplished by the export provisions of the CSA mentioned above. Under Article 16, paragraph 4, of the 1971 Convention, the United States is required to provide annual statistical reports to the International Narcotics Control Board (INCB). Using INCB Form P, the United States shall provide the following information: (1) In regard to each substance in Schedule I and II of the 1971 Convention, quantities manufactured, exported to and imported from each country or region as well as stocks held by manufacturers; (2) in regard to each substance in Schedule III and IV of the 1971 Convention, quantities manufactured, as well as quantities exported and imported; (3) in regard to each substance in Schedule II and III of the 1971 Convention, quantities used in the manufacture of exempt preparations; and (4) in regard to each substance in Schedule II-IV of the 1971 Convention, quantities used for the manufacture of non-psychotropic substances or products. Lastly, under Article 2 of the 1971 Convention, the United States must adopt measures in accordance with Article 22 to address violations of any statutes or regulations that are adopted pursuant to its obligations under the 1971 Convention. The United States complies with this provision as persons acting outside the legal framework established by the CSA are subject to administrative, civil, and/or criminal action.

DEA notes that there are differences between the schedules of substances in the 1971 Convention and the CSA. The CSA has five schedules (schedules I-V) with specific criteria set forth for each schedule. Schedule I is the only possible schedule in which a drug or other substance may be placed if it has high potential for abuse and no currently accepted medical use in treatment in the United States. See 21 U.S.C. 812(b). In contrast, the 1971 Convention has four schedules (Schedules I-IV) but does not have specific criteria for each schedule. The 1971 Convention simply defines its four schedules, in Article 1, to mean the correspondingly numbered lists of psychotropic substances annexed to the Convention, and altered in accordance with Article 2.

Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on methoxetamine and on December 30, 2014, submitted it to the Acting Assistant Secretary for Health of HHS (Acting Assistant Secretary) with a request for a scientific and medical evaluation of available information and a scheduling recommendation for methoxetamine. Subsequently, on April 14, 2017, DEA submitted additional data on methoxetamine to the Acting Assistant Secretary. On April 14, 2018, HHS provided to DEA a scientific and medical evaluation entitled “Basis for the Recommendation to Place (2-(3-methoxyphenyl)-2-( N -ethylamino)-cyclohexanone) Methoxetamine and its Optical Isomers and Salts in Schedule I of the Controlled Substances Act” and a scheduling recommendation. Following consideration of the eight factors and findings related to the substance's abuse potential, legitimate medical use, and dependence liability, HHS recommended that methoxetamine and its optical isomers and salts be controlled in schedule I of the CSA under 21 U.S.C. 812(b). In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS and all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each factor as analyzed by HHS and DEA in their respective eight-factor analyses, and as considered by DEA in this proposed scheduling determination. Please note that both DEA and HHS analyses are available in their entirety under “Supporting Documents” of the public docket for this proposed rule at https://www.regulations.gov under docket number “DEA-568.”

In addition to considering the information HHS provided in its scientific and medical evaluation document for methoxetamine, DEA also considered all other relevant data regarding actual or relative potential for abuse of methoxetamine. The term “abuse” is not defined in the CSA, however the legislative history of the CSA suggests the following four prongs in determining whether a particular drug or substance has a potential for abuse:  2

a. Individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or

b. There is a significant diversion of the drug or other substance from legitimate drug channels; or

c. Individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or

d. The drug is so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

DEA reviewed the scientific and medical evaluation provided by HHS and all other data relevant to the abuse potential of methoxetamine. These data as presented below demonstrate that methoxetamine has a high potential for abuse.

According to HHS, individuals are taking methoxetamine in amounts sufficient to create a hazard to their health or to the safety of other individuals and to the community. Published case reports described non-fatal and fatal intoxications from the United States and Europe, including Poland, the United Kingdom, and Switzerland. The 2014 European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) report on methoxetamine mentioned 20 confirmed (by analysis of postmortem biological samples) death reports received between 2011 and 2013 from European Union Member States to the Early Warning System. Between 2011 and 2014, scientific publications have reported one death related to methoxetamine from Switzerland, eight deaths from the United Kingdom, and at least two deaths from Poland. In the United States, methoxetamine has been reported as the cause of death in two cases; one case was mentioned in the 2014 Annual Report of the American Association of Poison Control Centers' National Poison Data System, and the second case was from a 2013 news report mentioning the Medical Examiner's findings from that death. Additionally, two case reports suggest that some individuals use methoxetamine to self-medicate for some clinical conditions, specifically chronic foot pain and post-traumatic stress disorder. Further, a case report published in 2019 suggests a single injection of methoxetamine can induce prolonged psychosis with confirmed cognitive deficits. As stated by HHS, when abused, methoxetamine can be administered through intranasal (insufflation or snorting), oral, sublingual, rectal, intramuscular, and intravenous routes of administration. Abuse of methoxetamine, similar to PCP and ketamine abuse, produces dissociative anesthetic and hallucinogenic effects, including somatic and psychological effects such as: Euphoria, increased empathy, sense of dissociation from the body, vivid visual hallucinations, and pleasant intensification of sensory experiences. Users report in online forums that methoxetamine generally produces longer lasting effects, with a delayed onset compared to PCP or ketamine. At higher doses (>40 mg), users describe the experience as reaching the “m-hole,” which is similar to the ketamine “k-hole” experience and characterized by extreme dissociation from the body, comparable to an out-of-body experience.

HHS reports that commonly reported side effects of methoxetamine include dizziness, confusion, time distortion, aphasia, psychomotor agitation, vertigo, incoordination, nausea, and vomiting. Similar to PCP and ketamine toxicity, signs and symptoms (toxidrome) of methoxetamine toxicity can be grouped into three types: Dissociative/delirious, sympathomimetic, and cerebellar symptoms. Dissociative or delirious symptoms include depersonalization, derealization, catatonia, audiovisual hallucinations, delusions, confusion, altered or loss of consciousness, agitation, aggression, amnesia, and mood lability. Sympathomimetic symptoms include rapid heart rate (tachycardia), high blood pressure (hypertension), elevated body temperature (pyrexia), rapid breathing (tachypnea), and pupillary dilation (mydriasis). Cerebellar symptoms include inability to sit (truncal ataxia), incoordination, speech impairment (dysarthria), impaired ability to perform rapid alternating movements (dysdiadochokinesis), and rapid and repetitive uncontrolled eye movements (nystagmus). Summarized withdrawal symptoms reported on online forums include low mood, depressive thoughts, and cognitive impairment for many hours in one user followed by two days of insomnia after a single 100 mg intranasal administration. One user reported a suicide attempt after discontinued use of methoxetamine.

HHS states that treatment of acute toxicity caused by methoxetamine and other drugs of the same class ( e.g., PCP and ketamine) consists of supportive treatment to control or relieve psychological complications and side effects. This treatment may include administration of benzodiazepines, antiemetics, intravenous fluids, and respiratory support, if needed.

DEA notes that ketamine has been known to cause toxicities to the bladder and renal system. When mice were given daily dose of 30 mg/kg methoxetamine intraperitoneally (i.p.) for 90 days, significant bladder and renal toxicity occurred. Thus, like ketamine, chronic administration of methoxetamine is associated with bladder and renal toxicity, including inflammatory changes with subsequent fibrosis that could lead to bladder and kidney damage.

HHS states that methoxetamine is not a Food and Drug Administration (FDA)-approved drug product for treatment in the United States and is unaware of any country in which its use is legal. There appear to be no legitimate sources for methoxetamine as a marketed drug. Thus, there is no evidence of significant diversion of methoxetamine from legitimate drug channels.

Methoxetamine is not approved for medical use and is not formulated or available for clinical use. Therefore, it is assumed that individuals are taking methoxetamine on their own initiative, rather than based on medical advice from a properly-licensed practitioner. This is consistent with the data from law enforcement seizures and case reports indicating that individuals are taking methoxetamine on their own initiative rather than on the medical advice of a licensed practitioner.

Methoxetamine is a synthetic arylcyclohexylamine and has pharmacological properties similar to other arylcyclohexylamines such as the ethylamine analog of phencyclidine (PCE; schedule I), the thiophene analog of phencyclidine (TCP; schedule I), phencyclidine (PCP, schedule II), and ketamine (schedule III). Methoxetamine, similar to PCE, TCP, PCP, and ketamine, has been shown to produce dissociative anesthetic and hallucinogenic effects.

As mentioned in HHS' review, the primary mechanism of action of methoxetamine is thought to be on glutamatergic neurotransmission. Glutamate is the major excitatory neurotransmitter system in the brain. In vitro binding studies show that methoxetamine binds to the glutamatergic N -methyl-D-aspartate (NMDA) receptor and acts as an antagonist with similar potency as PCP and ketamine. HHS notes that, similar to PCP, methoxetamine also has affinity for the serotonin reuptake transporter and acts as a serotonin reuptake inhibitor. Further, like many drugs of abuse, methoxetamine acutely increases the firing rate and bursting activity of ventral tegmental area (VTA) dopaminergic neurons projecting to the nucleus accumbens (NAc), and inhibits the reuptake of dopamine. The VTA is an area of the brain, rich in dopamine and serotonin neurons, which along with the NAc is part of the brain reward pathway. The increase in the firing rate and bursting activity of dopamine neurons produced by PCP, ketamine, and methoxetamine that results in increased dopamine levels in the VTA may underlie the psychotomimetic and reinforcing properties of these drugs.

Drug discrimination (an in vivo test to assess drug abuse liability and compare drugs to known drugs of abuse) data demonstrate that methoxetamine, similar to PCP, fully substitutes for the discriminative stimulus effect of ketamine in rats. Additionally, conditioned place preference (CPP) studies and self-administration studies used to assess rewarding and reinforcing effects show that methoxetamine produces both rewarding and reinforcing effects. Taken together, methoxetamine produces psychopharmacological effects similar to those produced by ketamine and PCP in animal models that are predictive of abuse potential in humans.

As stated by HHS, users of methoxetamine experience effects similar to those of ketamine and PCP including depersonalization, a mild to strong sense of dissociation from the physical body, distortion of the sense of reality, and vivid visual hallucinations. More negative or challenging effects of methoxetamine, similar to PCP and ketamine, may also occur and include delusions, tachycardia, hypertension, agitation, aggression, and cerebellar toxicity. Case reports of overdose and deaths resulting from methoxetamine abuse have been reported between 2011 and 2019 in scientific literature and by international authorities.

As mentioned by HHS, methoxetamine is being abused for its psychoactive effects. DEA further notes that based on concerns related to trafficking and availability, as well as the risks to the public health associated with its abuse, at least ten states in the United States have controlled methoxetamine. At the international level, as of June 2020, methoxetamine has been controlled in Russia, Switzerland, Israel, Sweden, United Kingdom, Japan, Germany, France, Brazil, China, Poland, and the European Union member states.

Methoxetamine is an antagonist at the glutamatergic NMDA receptors (with moderately high affinity) and a reuptake inhibitor at the serotonin transporter. Acute methoxetamine exposure increases the firing rate and bursting activity of the ventral tegmental area (VTA) dopaminergic neurons projecting to the nucleus accumbens (NAc) and inhibits reuptake of dopamine, similarly to PCP and ketamine. The VTA is an area of the brain that is rich in dopamine and serotonin neurons and is a contributing part of the brain reward pathway, as is the NAc. The net result is an increase in dopamine levels in the VTA, which may underlie the psychomimetic and reinforcing effects of these drugs.

Animal testing data in rats show that methoxetamine, like PCP, fully substitutes for ketamine discriminative stimulus. Additionally, rats self-administer methoxetamine. Data from self-administration and CPP studies show that methoxetamine has rewarding and reinforcing effects. Thus, methoxetamine produces psychopharmacologic effects similar to those produced by other NMDA antagonists (PCP and ketamine) in animal models, which are predictive of its abuse in humans.

In humans, users of methoxetamine report dissociative anesthetic and hallucinogenic effects similar to PCP and ketamine including euphoria, increased empathy, dissociation from the body, vivid visual hallucinations, and pleasant intensification of sensory experiences. Delusion, tachycardia, hypertension, agitation, aggression, and cerebellar toxicity have also been reported. Methoxetamine-associated overdose and deaths have been reported in scientific literature and by international authorities between 2011 and 2019.

Methoxetamine, also known as also known as MXE, 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one, or 2-(3-methoxyphenyl)-2-( N -ethylamino)cyclohexanone, has a molecular weight of 247.338 g/mol. Methoxetamine is primarily present as a white crystalline powder and has also been reported as being off-white, beige, or yellow in color. The Chemical Abstract Service Registry Numbers for methoxetamine are 1239943-76-0 for methoxetamine base and 1239908-48-5 for methoxetamine as the hydrochloride salt. Its molecular formula (as base) is C 15 H 21 NO 2 . Methoxetamine hydrochloride (salt) is soluble in organic solvents like ethanol (10 mg/mL) at 25 °C, dimethyl sulfoxide (DMSO) (14 mg/mL), and dimethyl formamide (5 mg/mL). It is also soluble in aqueous solvents like a pH 7.2 phosphate buffer (5 mg/mL). Synthesis and characterization of methoxetamine and analytical data (nuclear magnetic resonance spectroscopy, mass spectroscopy, and infrared spectroscopy) are reported in the scientific literature.

Controlled pharmacokinetic clinical research studies have not been conducted to characterize the onset of action, the plasma concentrations after ingestion of a fixed dose of methoxetamine, or to determine the half-life of methoxetamine. However, since methoxetamine has been used recreationally, a summary and description of the onset and duration of the effects of methoxetamine that come from user reports, generally via online forums, can be found in the scientific literature.

A summary of online user reports suggests that methoxetamine is generally administered through intranasal (insufflation or snorting), oral, sublingual, rectal, and intramuscular routes with additional reports of intravenous use. Dose range administered, onset of drug effects, and duration of drug effects vary by the route of administration. Dose associated with intranasal use is 20 to 60 mg, oral administration is 20 to 100 mg, and intramuscular administration is 10 to 50 mg, with reported onset of drug effects of 30 to 90 minutes following intranasal use, up to 90 minutes following oral administration, and five minutes following intramuscular administration. Drug effects can last 2.5 to 7 hours following nasal use, 3 to 5 hours following oral ingestion, and 1 to 4 hours after intramuscular injection. Typical doses and drug-related time effects were not reported for other routes of administration.

As HHS reports, the metabolism of methoxetamine was investigated using human liver microsomes in vitro and compared to toxicological analysis of urine from individuals presenting with analytically confirmed acute methoxetamine toxicity. Liquid chromatography high-resolution mass spectrometry was used to identify and characterize the metabolites of methoxetamine in vitro and in vivo. These studies reported complex metabolism of methoxetamine including N -deethylation, O -demethylation, hydroxylation, reduction, and dehydrogenation followed by glucuronization (conjugation of the metabolites with glucuronic acid). The normethoxytamine (desethylmethoxetamine) is the main metabolite identified in both in vivo and in vitro studies.

HHS further states that kinetic studies with human hepatic CYP isozymes have showed that N -deethylation is catalyzed by CYP2B6 and CYP3A4, O -demethylation by CYP2B6 and CYP2C19, and hydroxylation by CYP2B6. These studies also showed that normethoxamine is the major metabolite in humans and rats.

The role of CYP2B6 in methoxetamine metabolism is of particular importance. Because CYP2B6 is involved in metabolism of numerous drugs ( e.g., bupropion, methadone, propofol, sertraline), pharmacokinetic interactions between methoxetamine and other compounds are likely to occur. In addition, the rate of methoxetamine metabolism and toxicity may depend on genetic polymorphism of CYP2B6. Currently, it is unknown if any specific methoxetamine metabolites are biologically active.

As HHS notes, methoxetamine, similar to ketamine and PCP, is a synthetic arylcyclohexylamine with dissociative anesthetic properties. Typical routes of administration by drug users include oral, nasal insufflation, intramuscular, rectal, and intravenous. Based on available abuse data, public health risk, and drug trafficking data, the World Health Organization (WHO) recommended to the United Nations that methoxetamine be controlled internationally. In March 2016, the CND voted to place methoxetamine in Schedule II of the 1971 Convention.

In 2014, WHO reported that methoxetamine has been available in Europe since 2010. Distribution and trafficking of methoxetamine occurred largely via the internet. According to the law enforcement data, the first encounter in the United States occurred in mid-2011.

In 2015, WHO reported non-fatal intoxications and more than 20 deaths associated with methoxetamine. Since 2014 through 2019, there have been reports of several other overdoses and deaths in which methoxetamine was implicated in Europe. In the United States, there have been at least two documented deaths associated with the use of methoxetamine, one occurring in 2012 and the other in 2014.

In the United States, evidence of abuse of methoxetamine initially appeared in mid-2011 when a case study was published regarding an individual who was brought to the emergency department following methoxetamine intoxication in Massachusetts. The first reported death in the United States from methoxetamine abuse occurred in Milwaukee County, Wisconsin, in May 2012.

Data from the System to Retrieve Information on Drug Evidence (STRIDE) and STARLiMS  3 and the National Forensic Laboratory Information System (NFLIS)  4 indicate that methoxetamine was found in samples starting in August 2004, in California. Specifically, there were 114 STRIDE/STARLIMS reports from August 2004 through July 2021, and 677 NFLIS reports from January 2011 to July 2021. Combining drug reports and exhibits from both NFLIS and STRIDE between August 2004 and July 2021, methoxetamine has been encountered in 45 states and the District of Columbia. Methoxetamine drug quantities seized by United States Customs and Border Protection (CBP) have ranged from 2 to 200 grams. Reportedly, a small percentage of the methoxetamine reports from CBP were in combination with other drugs, such as synthetic cannabinoids, synthetic cathinones, ketamine, caffeine, and sildenafil.

In response to abuse and safety concerns, methoxetamine has been controlled in Virginia, Minnesota, North Dakota, Florida, Ohio, Indiana, Louisiana, Alabama, Arizona, and Utah.

Abuse of methoxetamine has been characterized as causing acute public health and safety issues worldwide. Methoxetamine is now controlled in Russia, Switzerland, Israel, Sweden, United Kingdom, Japan, Germany, France, Brazil, China, Poland and the European Union member states. On September 25, 2014, the European Union council decided to control methoxetamine in all European member states, and on March 18, 2016, the CND, at its 59th Session, added methoxetamine to Schedule II of the 1971 Convention.

Methoxetamine shares similar mechanisms of action with and produces similar physiological and subjective effects (see Factor 2 for more information) as other controlled arylcyclohexylamines, such as the ethylamine analog of phencyclidine (PCE; schedule I), the thiophene analog of phencyclidine (TCP; schedule I), phencyclidine (PCP; schedule II), and ketamine (schedule III). Thus, methoxetamine poses the same risks to public health as PCE, TCP, PCP, and ketamine. Predominantly, the risks to public health are centralized to risks of the user, but in some cases do affect the general public, as is the case of driving under the influence.

Users of methoxetamine describe the drug effects as being similar to those of PCP and ketamine. Effects often include hallucinations and dissociation of the physical body, and can produce antidepressant-like effects. Online reports of use of methoxetamine suggest it is used via all routes of administration ( i.e., intranasal, oral, intramuscular, rectal, and intravenous). Due to the various routes of administration, the onset of effects can vary widely (one minute for intravenous to 90 minutes intranasal).

As HHS notes, several case reports pertaining to methoxetamine use, toxicities, and fatal intoxications have been published in the scientific and medical literature in several countries. In particular, in 2014 EMCDDA reported that methoxetamine was mentioned in 20 biologically confirmed death reports from the European Union member states Early Warning System. At least one published death related to methoxetamine has occurred in Switzerland, eight deaths in the United Kingdom, two deaths in Poland, and two deaths in the United States. In 2015, WHO indicated that a total of 120 nonfatal intoxications and 22 deaths related to methoxetamine had been reported, in which many but not all had been biologically confirmed. Two case reports suggest some individuals use methoxetamine to self-medicate to treat various clinical conditions, specifically chronic foot pain and post-traumatic stress disorder. In addition, DEA further notes one case report published in 2019 suggests methoxetamine can induce prolonged psychosis after a single injection.

Psychological and physiological dependence are associated with methoxetamine. The euphoric and hallucinogenic effects associated with methoxetamine and other arylcyclohexylamine drugs serve as reinforcers and can result in psychological dependence and are supported by case studies with methoxetamine abusers. Several preclinical studies and case reports examined and described physical dependence and withdrawal effects associated with methoxetamine abuse. Signs of methoxetamine withdrawal have included low mood and/or depressive thoughts, cognitive impairment lasting several hours followed by two days of insomnia after last use, and a reported suicide attempt.

DEA and HHS find that methoxetamine is not an immediate precursor of any controlled substance of the CSA.

Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and on DEA's consideration of its own eight-factor analysis, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of methoxetamine. As such, DEA hereby proposes to schedule methoxetamine as a controlled substance under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule, 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Acting Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(1), finds that:

(1) Methoxetamine has a high potential for abuse that is comparable to other scheduled substances such as the ethylamine analog of phencyclidine (PCE; schedule I), the thiophene analog of phencyclidine (TCP; schedule I), phencyclidine (PCP; schedule II), and ketamine (schedule III);

(2) Methoxetamine has no currently accepted medical use in treatment in the United States. There are no approved New Drug Applications for methoxetamine and no known therapeutic applications for methoxetamine in the United States. Therefore, methoxetamine has no currently accepted medical use in treatment in the United States. 5

(3) There is a lack of accepted safety for use of methoxetamine under medical supervision. Because methoxetamine has no approved medical use and has not been investigated as a new drug, its safety for use under medical supervision has not been determined. Therefore, there is a lack of accepted safety for use of methoxetamine under medical supervision.

Based on these findings, the Acting Administrator of DEA concludes that methoxetamine warrants control in schedule I of the CSA. More precisely, because of its hallucinogenic effects, and because it may produce hallucinogenic-like tolerance and dependence in humans, DEA proposes to placing methoxetamine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical description, in 21 CFR 1308.11(d) (the hallucinogenic substances category of schedule I).

If this rule is finalized as proposed, methoxetamine would be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, conduct instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, methoxetamine would be required to be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312, as of the effective date of a final scheduling action. Any person who currently handles methoxetamine and is not registered with DEA would need to submit an application for registration and may not continue to handle methoxetamine as of the effective date of a final scheduling action, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration would be required to surrender or transfer all quantities of currently held methoxetamine to a person registered with DEA before the effective date of a final scheduling action in accordance with all applicable Federal, State, local, and tribal laws. As of the effective date of a final scheduling action, methoxetamine would be required to be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.

3. Security. Methoxetamine would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.71-1301.93, as of the effective date of a final scheduling action. Non-practitioners handling methoxetamine would also need to comply with the employee screening requirements of 21 CFR 1301.90-1301.93.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of methoxetamine would need to be in compliance with 21 U.S.C. 825, and be in accordance with 21 CFR part 1302, as of the effective date of a final scheduling action.

5. Quota. Only registered manufacturers would be permitted to manufacture methoxetamine in accordance with a quota assigned pursuant to 21 U.S.C. 826, and in accordance with 21 CFR part 1303, as of the effective date of a final scheduling action.

6. Inventory. Every DEA registrant who possesses any quantity of methoxetamine on the effective date of the final scheduling action would be required to take an inventory of methoxetamine on hand at that time, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).

Any person who becomes registered with DEA on or after the effective date of the final scheduling action would be required to take an initial inventory of all stocks of controlled substances (including methoxetamine) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).

After the initial inventory, every DEA registrant would be required to take a new inventory of all controlled substances (including methoxetamine) on hand every two years, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

7. Records and Reports. Every DEA registrant would be required to maintain records and submit reports for methoxetamine, or products containing methoxetamine, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317, as of the effective date of a final scheduling action. Manufacturers and distributors would need to submit reports regarding methoxetamine to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312, as of the effective date of a final scheduling action.

8. Order Forms. Every DEA registrant who distributes methoxetamine would be required to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305, as of the effective date of a final scheduling action.

9. Importation and Exportation. All importation and exportation of methoxetamine would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312, as of the effective date of a final scheduling action.

10. Liability. Any activity involving methoxetamine not authorized by, or in violation of, the CSA or its implementing regulations, would be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Acting Administrator of DEA, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this proposed rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.

DEA proposes placing the substance methoxetamine (chemical name: 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the CSA. This action is being taken to enable the United States to meet its obligations under the 1971 Convention. If finalized, this action would impose the regulatory controls and administrative, civil, and/or criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle methoxetamine.

According to HHS, and also per DEA's findings in this proposed rule, methoxetamine has high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. DEA's research confirms that there is no commercial market for methoxetamine in the United States. As such, the proposed rule will not have a significant effect on a substantial number of small entities.

On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq. ) that this proposed action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

For the reasons set out above, 21 CFR part 1308 is proposed to be amended as follows:

Under current 37 CFR 1.6(a)(4), the receipt date of correspondence submitted to the USPTO by way of the Office electronic filing system is “the date the correspondence is received at the correspondence address for the USPTO set forth in 37 CFR 1.1 when it was officially submitted.” Current 37 CFR 1.1 sets forth an Alexandria, Virginia, correspondence address for the Office. The USPTO's physical servers that receive electronic submissions are currently located in Alexandria, Virginia. However, in order to enhance resiliency, the USPTO is in the process of providing servers in Manassas, Virginia, and in the future may provide servers outside of the Eastern time zone. Once the USPTO begins receiving electronically submitted patent correspondence at locations other than Alexandria, Virginia, the language in current 37 CFR 1.6(a)(4) that defines the date the correspondence is received at Alexandria, Virginia, as the receipt date would be inapplicable. Thus, the USPTO is proposing to revise 37 CFR 1.6(a)(4) to specify that the receipt date of correspondence that is officially submitted electronically by way of the Office electronic filing system is the date in Eastern Time when the USPTO received the correspondence, regardless of the physical location of the USPTO server that receives the correspondence. Other clarifying changes regarding the receipt date of electronic submissions, including providing a definition for Eastern Time, are also proposed.

In addition, the changes will align the patent rules with the Legal Framework for the Patent Electronic System, available at www.uspto.gov/patents/apply/filing-online/legal-framework-efs-web and in the Manual of Patent Examining Procedure (MPEP) section 502.05, subsection I. The Legal Framework already indicates that the time and date of receipt of an application filed via the Office electronic filing system is the local time and date (Eastern Time) at the USPTO headquarters in Alexandria, Virginia, when the USPTO received the submission. The date of receipt is recorded after the user clicks the “SUBMIT” button on the “Confirm and Submit” screen. This is the date shown on the Electronic Acknowledgement Receipt. Similarly, follow-on documents filed in a patent application after the initial filing of the application are also accorded the date when the document is received at the USPTO as the date of receipt under existing practice. See MPEP section 502.05, subsection I.C.

With respect to patent correspondence, any references to the Office electronic filing system in this Notice (including in 37 CFR part 1) include EFS-Web and Patent Center. Patent Center is a new tool for the electronic filing and management of patent applications. Patent Center is currently in the Beta phase but is available for all users. Once fully developed, Patent Center will replace EFS-Web and the Patent Application Information Retrieval (PAIR) system. Users of Patent Center Beta are required to abide by the Legal Framework for the Patent Electronic System to the extent applicable and are expected to abide by the Patent Electronic System Subscriber Agreement. See the Patent Center Beta Release Guidelines available at www.uspto.gov/patents/apply/patent-center. In the future, as Patent Center gets closer to full development, the Legal Framework for the Patent Electronic System will be revised to expressly refer to and more specifically cover electronic submissions via Patent Center.

The rules of practice in trademark cases already provide that filing dates of electronic submissions are based on Eastern Time. See 37 CFR 2.195(a). Therefore, it is unnecessary to amend the trademark rules of practice.

The following is a discussion of the proposed amendments to 37 CFR part 1.

Section 1.1: Section 1.1(a) is amended to clarify the appropriate address information for patent-related correspondence. In particular, the clause “[e]xcept as provided in paragraphs (a)(3)(i) and (a)(3)(ii) of this section” is being changed to “[e]xcept for correspondence submitted via the Office electronic filing system in accordance with § 1.6(a)(4).” Further, the phrase “to specific areas within the Office as set out in paragraphs (a)(1) and (a)(3)(iii) of this section” is being replaced with “to specific areas within the Office as provided in this section.” Since the USPTO does not strictly require the provision of an address when patent-related correspondence is submitted via the Office electronic filing system, it is appropriate to exclude such correspondence from the address marking requirements of § 1.1(a). Applicants may continue to provide an address on correspondence submitted via the Office electronic filing system consistent with § 1.1(a), but it is not mandatory. The removal of references to specific sub-paragraphs (a)(3)(i) and (a)(3)(ii) from the introductory text of paragraph (a) is a technical correction in view of the remaining language in this section.

Section 1.6: Section 1.6(a)(4) is proposed to be amended to remove the reference to the physical location where correspondence must be received, and to provide that the receipt date of patent correspondence submitted using the Office electronic filing system is the date in Eastern Time when the correspondence is received in the USPTO. Specifically, the USPTO proposes to change the phrase “Correspondence submitted to the Office by way of the Office electronic filing system will be accorded a receipt date, which is the date the correspondence is received at the correspondence address for the Office set forth in § 1.1 when it was officially submitted” to “Correspondence officially submitted to the Office by way of the Office electronic filing system will be accorded a receipt date, which is the date in Eastern Time when the correspondence is received in the Office.” In view of the relocation of the servers, it is appropriate to eliminate the reference to the correspondence address set forth in § 1.1 in connection with the receipt date of correspondence being filed electronically. Correspondence submitted via the Office electronic filing system will be accorded a receipt date based on the local time and date at the USPTO headquarters in Alexandria, Virginia, when the correspondence is received in the USPTO. Specifically, the Office electronic filing system will record the receipt date in Eastern Time after the user officially submits the correspondence by clicking the “SUBMIT” button on the “Confirm and Submit” screen and the correspondence is successfully received in the USPTO. Furthermore, the phrase “regardless of whether that date is a Saturday, Sunday, or Federal holiday within the District of Columbia” is being added to provide clarity in the rule. This is not a change in practice. See MPEP 502.05, subsection I.C.

It should be noted that the Legal Framework for the Patent Electronic System does not permit certain patent correspondence to be officially submitted via the Office electronic filing system. See MPEP 502.05, subsection I.B.2. Such correspondence will not be accorded a date of receipt or considered officially filed in the USPTO when submitted via the Office electronic filing system. For example, notices of appeal to a court, district court complaints, or other complaints or lawsuits involving the USPTO may not be filed via the Office electronic filing system. See MPEP 1216 for instructions on how to properly serve and/or file documents seeking judicial review of a decision by the Patent Trial and Appeal Board.

Section 1.9: Section 1.9 is proposed to be amended to add a new paragraph (o) to set forth a definition for Eastern Time. In particular, Eastern Time is defined as meaning Eastern Standard Time or Eastern Daylight Time in the United States, as appropriate.

A. Administrative Procedure Act: The changes proposed in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive).

Accordingly, prior notice and opportunity for public comment for the changes proposed in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). However, the USPTO has chosen to seek public comment before implementing the rule to benefit from the public's input.

B. Regulatory Flexibility Act: Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), whenever an agency is required by 5 U.S.C. 553 (or any other law) to publish a notice of proposed rulemaking, the agency must prepare and make available for public comment an Initial Regulatory Flexibility Analysis, unless the agency certifies under 5 U.S.C. 605(b) that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603, 605. For the reasons set forth herein, the Senior Counsel for Regulatory and Legislative Affairs, Office of General Law, of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that the changes proposed in this rule will not have a significant economic impact on a substantial number of small entities (see 5 U.S.C. 605(b)).

This rulemaking amends the rules of practice to provide that the receipt date of correspondence officially submitted electronically by way of the Office electronic filing system is the date in Eastern Time when the Office received the correspondence. The USPTO is also proposing to amend the patent rules of practice to make other clarifying changes regarding the receipt of electronic submissions. These changes are procedural in nature and would not result in a change in the burden imposed on any patent applicant, including a small entity.

For the reasons described above, the proposed changes will not have a significant economic impact on a substantial number of small entities.

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

D. Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

E. Executive Order 13132 (Federalism): This rulemaking does not contain policies with federalism implications sufficient to warrant the preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

F. Executive Order 13175 (Tribal Consultation): This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

G. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform): This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

I. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

J. Executive Order 12630 (Taking of Private Property): This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

K. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), prior to issuing any final rule, the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this rulemaking is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

L. Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

M. National Environmental Policy Act of 1969: This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

N. National Technology Transfer and Advancement Act of 1995: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 1995 requires that the USPTO consider the impact of paperwork and other information collection burdens imposed on the public. This rulemaking does not involve any new information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information has a currently valid OMB control number.

For the reasons set forth in the preamble, 37 CFR part 1 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On December 10, 2009, the Indiana Department of Environmental Management (IDEM) submitted a site-specific SO 2 SIP revision request to EPA for the Burns Harbor plant. The revised State rule removed the SO 2 emission limit applicable to the blast furnace flare from SIP rule 326 Indiana Administrative Code (IAC) 7-4-14. EPA proposed to disapprove this requested revision on March 20, 2013 (78 FR 17157) and finalized its disapproval on December 27, 2013 (78 FR 78720). The basis for this action was that IDEM had not provided an adequate demonstration that removing the flare limit would enable continued protection of the SO 2 National Ambient Air Quality Standard (NAAQS or standard), as required by section 110(l) of the Clean Air Act (CAA).

On February 25, 2014, ArcelorMittal Burns Harbor LLC filed a petition for review challenging EPA's action in the United States Court of Appeals for the Seventh Circuit. ArcelorMittal Burns Harbor LLC v. EPA, No. 1412. The Court of Appeals subsequently granted the State of Indiana's request to intervene as a Petitioner.

On May 28, 2019, the parties entered a Settlement Agreement under which the State is required to adopt revised emission limits and other associated requirements into 326 IAC 7-4-14, as further discussed below. The parties entered into an Amended Settlement Agreement on March 23, 2021. On March 31, 2021, IDEM submitted revisions to 326 IAC 7-4-14 to EPA as proposed SIP revisions.

The revised rule 326 IAC 7-4-14(1) increases the blast furnace gas flare limit from 0.07 pounds SO 2 per million British thermal units (lb/mmBtu) to 0.50 lb/mmBtu. The revision adds a blast furnace gas testing protocol in 326 IAC 7-4-14(1)(G), which includes a requirement to perform quarterly gas testing of blast furnace gas from blast furnaces C and D, and a requirement to use the test results to calculate the emission rate in lb/mmBtu associated with combusting the blast furnace gas.

Additional revisions in 326 IAC 7-4-14(1) remove the limits and listing for the slab mill soaking pits and the 160-inch plate mill I & O furnace No. 8. The rule clarifies that those units have been permanently shut down (326 IAC 7-4-14 (1)(F)). The limits in pounds of SO 2 per hour (lb/hr) for the 110-inch plate mill furnaces No. 1 and 2 and the 160-inch plate mill I & O furnaces No. 4, 5, 6, and 7 have been reduced by 90 percent. The total lb/hr limit for the power station boilers No. 8, 9, 10, 11, and 12 has been reduced from 2,798 lb/hr to 2,378 lb/hr. The rule revision also removes a separate set of alternative emission limits for the Burns Harbor plant's SO 2 emission units. The remaining emission limits in the rule are unchanged. Table 1 shows the emission limit changes.

Section 110(l) of the CAA provides that State submissions cannot be approved as SIP revisions if they interfere with applicable requirements concerning attainment and reasonable further progress. The Burns Harbor plant is located in Porter County, which is designated attainment/unclassifiable for the 2010 1-hour SO 2 standard (86 FR 16055, March 26, 2021). EPA is proposing to find that the overall reductions in allowable SO 2 emissions in IDEM's March 31, 2021 revised rule offset the effect of increasing the limit on the blast furnace gas flare. The rule revisions, which reflect the units that have new, lower emission limits and the closed units that no longer emit SO 2 , result in a reduction in total allowable SO 2 emissions of 2,265.6 lb/hr. The increased allowable flare emissions are estimated at 8.89 lb/hr. The net result is an overall allowable SO 2 emissions decrease of 2,256.7 lb/hr. The flare limit has been increased to allow the Burns Harbor plant operational flexibility, as the flare is a necessary safety device. In addition, the improved compliance and testing protocol will greatly improve the accuracy of the actual SO 2 emissions calculations for blast furnace gas combustion. This is because having more accurate SO 2 emissions information should help the Burns Harbor plant personnel properly evaluate and demonstrate its blast furnace flare compliance status. EPA believes that the March 31, 2021 revised rule 326 IAC 7-4-14(1) will not adversely affect Porter County's maintenance of the 2010 1-hour SO 2 standard. EPA proposes to find that IDEM's March 31, 2021 submittal is consistent with CAA section 110(l).

EPA is proposing to approve the March 31, 2021 SIP revision request for Indiana's SO 2 rule 326 IAC 7-4-14(1) for the Burns Harbor plant. If approved, this revision would satisfy a provision in a Federal Settlement Agreement. It would also strengthen the Indiana SO 2 SIP by lowering SO 2 emission limits and adding improved SO 2 compliance test procedures for the Burns Harbor plant.

In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Indiana rule 326 IAC 7-4-14(1), effective March 20, 2021. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

On March 27, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm) (73 FR 16436). Promulgation of a revised NAAQS triggers a requirement for EPA to designate areas of the country as nonattainment, attainment, or unclassifiable for the standard. For the ozone NAAQS, this also involves classifying any nonattainment areas at the time of designation. Ozone nonattainment areas are classified based on the severity of their ozone levels (as determined based on the area's “design value,” which represents air quality in the area for the most recent 3 years). The classifications for ozone nonattainment areas are marginal, moderate, serious, severe, and extreme.

Areas that EPA designates nonattainment for the ozone NAAQS are subject to certain requirements, including the general nonattainment area planning requirements of CAA section 172 and the ozone-specific nonattainment planning requirements of CAA section 182. Ozone nonattainment areas in the lower classification levels have fewer and/or less stringent mandatory air quality planning and control requirements than those in higher classifications. For marginal areas, CAA section 182(a) details that a state is required to submit a baseline emissions inventory, adopt provisions into the SIP requiring emissions statements from stationary sources in the area, and implement a nonattainment new source review (NSR) program for the relevant ozone NAAQS. For moderate areas, the SIP requirements are found in CAA section 182(b), a state needs to comply with the marginal area requirements, plus additional moderate area requirements, including the requirement to submit a modeled demonstration that the area will attain the NAAQS as expeditiously as practicable but no later than 6 years after designation, the requirement to submit an Reasonable Further Progress (RFP) plan, the requirement to adopt and implement certain emissions controls, such as RACT and Inspection and Maintenance (I/M), and the requirement for greater emissions offsets for new or modified major stationary sources under the state's nonattainment NSR program. For serious nonattainment areas, the SIP requirements are found in CAA section 182(c) and include: an attainment demonstration, RACT for VOC and NO X , Reasonably Available Control Measures, RFP reductions in VOC and/or NO X emissions in the area, contingency measures to be implemented in the event of failure to attain the standard, enhanced I/M program, an EMP, a CFVP, a transportation control demonstration, and changes to permitting programs for serious areas.

On June 11, 2012 (77 FR 34221), EPA designated the Chicago area as a marginal nonattainment area for the 2008 ozone NAAQS. The Chicago area includes Cook, DuPage, Kane, Lake, McHenry, and Will Counties and part of Grundy and Kendall Counties in Illinois; Lake and Porter Counties in Indiana; and the eastern portion of Kenosha County in Wisconsin. On May 4, 2016 (81 FR 26697), pursuant to section 181(b)(2) of the CAA, EPA determined that the Chicago area failed to attain the 2008 ozone NAAQS by the July 20, 2015 marginal area attainment deadline and thus reclassified the area from marginal to moderate nonattainment. On August 23, 2019, EPA again reclassified the Chicago nonattainment area from moderate to serious nonattainment status, effective September 23, 2019 (84 FR 44238). This reclassification was based on 2015-2017 monitoring data.

Wisconsin submitted a SIP revision on December 1, 2020, to address the serious nonattainment area requirements for the Wisconsin portion of the Chicago area for the 2008 ozone NAAQS. The submission contained several nonattainment plan elements, including a VOC and NO X RACT plan, the CFVP, and the EMP. The submission also included an attainment demonstration, RFP, RFP contingency measures, enhanced I/M, transportation conformity motor vehicle emissions budgets, and a transportation control demonstration which will be addressed in a separate action(s).

Sections 172(c)(1) and 182(b)(2) of the CAA require states to implement RACT in ozone nonattainment areas classified as moderate (and higher). Specifically, these areas are required to implement RACT for all major VOC emissions sources and for all sources covered by a Control Techniques Guideline (CTG). The major source threshold for serious nonattainment ozone areas is a potential to emit (PTE) 50 tons per year (TPY). A CTG is a document issued by EPA which establishes a “presumptive norm” for RACT for a specific VOC source category. States must submit rules, or negative declarations when no such sources exist for CTG source categories.

EPA's SIP Requirements Rule for the 2008 ozone NAAQS indicates that states may meet RACT through the establishment of new or more stringent requirements that meet RACT control levels, through a certification that previously adopted RACT controls in their SIPs approved by EPA for a prior ozone NAAQS also represent adequate RACT control levels for attainment of the 2008 ozone NAAQS, or with a combination of these two approaches. In addition, a state may submit a negative declaration in instances where there are no CTG sources.

Wisconsin previously addressed RACT requirements in the Kenosha portion of the nonattainment area when it developed attainment plans for the 1979 and 1997 ozone standards. Wisconsin has previously adopted RACT rules for VOC emission sources in the nonattainment areas under Wisconsin Administrative Code NR 420. Wisconsin has evaluated the previously adopted regulations and determined that these rules still satisfy RACT for its current submittal. Wisconsin's December 1, 2020 submittal describes the VOC RACT program for the Wisconsin portion of the Chicago area for the 2008 ozone NAAQS. Wisconsin has implemented a VOC RACT program for the Wisconsin portion 2008 ozone nonattainment area through: (1) Implementation of CTG-recommended control measures through state administrative rules and an administrative order, (2) Negative declarations certifying that no sources exist in the nonattainment area that are subject to the CTGs whose control measures have not been codified in state administrative rules or enforced through an administrative order, and (3) A negative declaration certifying that no non-CTG major source of VOCs exists in the nonattainment area.

The submittal provided a list of the CTGs for which RACT requirements have been codified in the Wisconsin Administrative Code. Wisconsin has not adopted VOC RACT regulations for four CTGs: Shipbuilding and ship repair, aerospace manufacturing, fiberglass boat manufacturing, and the oil and natural gas industry. In addition, while Wisconsin has adopted rules to cover industrial adhesive use, metal and plastic parts coatings, and automobile and light-duty truck manufacturing, the Wisconsin Administrative Code does not reflect the most recently published CTGs for these categories. Wisconsin performed an applicability analysis for these categories in the Wisconsin portion of the Chicago area. Wisconsin's analysis determined that there are no facilities for these CTGs in the Kenosha nonattainment area: Shipbuilding and ship repair, aerospace manufacturing, fiberglass boat manufacturing, oil and natural gas industry, miscellaneous industrial adhesives, and automobile and light-duty truck assembly coatings. Wisconsin provided negative declarations for these CTG categories.

For the remaining CTG category, miscellaneous metal and plastic parts coatings, Wisconsin's analysis identified three facilities in the Kenosha County 2008 ozone nonattainment area. For two of the facilities, KKSP Precision Machining LLC (Facility Identification 230198760) and IEA, Inc. (Facility Identification 230167520), Wisconsin determined that the emissions were well below the CTG applicability threshold of 15 lb VOC per day, or equivalently, 3 TPY. The State found the remaining facility, Insinkerator (Facility Identification 230167630), to have CTG-applicable emissions of 3.1 TPY in 2017, which is above the CTG threshold. Insinkerator entered into an Administrative Order (AM-20-01) with Wisconsin that established permanent and enforceable emission limits, among other requirements, on this facility, which are consistent with the control requirements and limits set forth in the 2008 Miscellaneous Metal and Plastic Parts Coatings CTG. AM-20-01 was submitted to EPA for incorporation into the SIP on February 12, 2020. EPA approved these components of the VOC RACT program as satisfying moderate area VOC RACT requirements on September 16, 2020 (85 FR 57729).

Wisconsin certified that the Wisconsin portion of the Chicago area's VOC RACT program also satisfies serious area VOC RACT requirements. The approved non-CTG major source negative declaration certifies that there are no sources within the Wisconsin portion of the Chicago area for the 2008 ozone NAAQS that produce non-CTG VOC emissions with a PTE of greater than 50 TPY, the serious nonattainment area major source threshold. Wisconsin has verified with recent emissions data that there continues to be no source within the Wisconsin portion of the Chicago area that meets the non-CTG major source threshold or the applicability criteria for CTGs not incorporated into the State's administrative code.

Therefore, EPA is proposing to find that Wisconsin submittal has met VOC RACT requirements for its portion of the Chicago area for the serious 2008 ozone NAAQS.

Section 182(f) of the CAA requires RACT level controls for major stationary sources of NO X located in moderate ozone (and higher) nonattainment areas. EPA approved Wisconsin's NO X RACT program into the SIP on October 19, 2010 (44 FR 53762), for purposes of the 1997 ozone NAAQS. Wisconsin's NO X RACT requirements are codified at NR 428.20 to 428.26 of the Wisconsin Administrative Code and were established to fulfill the moderate nonattainment requirements for the 1997 ozone NAAQS and to apply to the facilities with a PTE of NO X greater than 100 TPY. Wisconsin's RACT rules are applicable to major stationary sources of NO X located in Wisconsin's moderate ozone nonattainment areas, including Kenosha County. With the reclassification from moderate to serious nonattainment for the 2008 ozone NAAQS, the major source threshold has decreased from 100 TPY to 50 TPY. Currently there are no facilities located in the Wisconsin portion of the Chicago area 2008 ozone nonattainment area with PTE of NO X exceeding 50 TPY. Therefore, no additional facility in this area has become subject to NO X RACT due to the reclassification of the area from moderate to serious nonattainment.

The 2008 ozone implementation rule provides that states can show that existing NO X RACT programs fulfill requirements for the 2008 ozone NAAQS. In 2017, the Wisconsin Department of Natural Resources (WDNR) submitted the analysis of the current NO X RACT program to demonstrate compliance with the implementation rule for the 2008 ozone NAAQS. The analysis showed that there is no incremental difference in control technologies between the existing NO X RACT program and the updated assessment for the facilities operating in 2008. On February 13, 2019, EPA approved WDNR's NO X RACT program for compliance with the 2008 ozone NAAQS for moderate nonattainment areas (84 FR 3701). Since the assessment was required for conditions in 2008 and is not dependent on the nonattainment classification level, an updated NO X RACT control technology assessment is not required for this SIP revision. Thus, based on equivalency in major source applicability and RACT control technology, the WDNR concludes that Wisconsin's current NO X RACT program under state statute NR 428.20 to 428.26 fulfills RACT requirements for serious nonattainment for the 2008 ozone NAAQS. Therefore, EPA is proposing to find that Wisconsin has met the NO X RACT for its portion of the Chicago area for the 2008 ozone NAAQS.

CAA section 182(c)(4) requires states with ozone nonattainment areas classified as serious or higher to submit a SIP revision describing implementation of a CFVP, as described in CAA title II part C (40 CFR 88). EPA approved Wisconsin's CFVP on March 11, 1996 (61 FR 9641). EPA issued a memorandum on July 21, 2005, that found that then-current emission standards for vehicles (regulated under 40 CFR 86) were as or more stringent than the emission standards specified in 40 CFR 88 for the CFVP. Additionally, EPA issued a memorandum on April 17, 2006, noting that after the CFVP requirement became law, EPA promulgated new vehicle emission standards ( e.g., Tier 2 Rule and heavy-duty engine standards) that are generally more stringent, or equivalent to, the CFV emission standards for light-duty vehicles, light-duty trucks, and heavy-duty vehicles and engines. The memorandum also stated that “[t]o meet the requirements of the Clean Fuel Fleet Program fleet managers can be assured that vehicles and engines certified to current Part 86 emission standards, which EPA has determined to be as or more stringent than corresponding CFV emission standards per the attached EPA Dear Manufacturer Letter meet the CFV emission standards and the CFFP requirements as defined in CFR part 88.” We expected emission benefits of Tier 2 and heavy-duty engine standards over LEV standards. For example, Tier 2 NO X standards have a benefit over LEV ranging from 0.09 grams/mile to 0.99 grams/mile on a per vehicle basis. With regard to the heavy-duty engine standards, there is a benefit of 1.4 grams/brake-horsepower per hour for the combination of non-methane hydrocarbons and NO X on a per vehicle basis. Further reductions from these same vehicles will be achieved by EPA's newly promulgated Tier 3 emission standards.

Since vehicle emission standards have only become more stringent since the memo was issued in 2005, the CAA section 182(c)(4) CFVP requirement remains satisfied without the need for further action by the State.

Section 182(c)(1) of the CAA requires states with nonattainment areas classified serious or higher to adopt and implement a program to improve air monitoring for ambient concentrations of ozone, NO X and VOC. EPA initiated the Photochemical Assessment Monitoring Stations (PAMS) program in February 1993. The PAMS program required the establishment of an enhanced monitoring network in all ozone nonattainment areas classified as serious, severe, or extreme. On March 18, 1994 (59 FR 6021), EPA approved Wisconsin's SIP revision establishing an enhanced monitoring program.

Since that time, EPA concluded that requiring enhanced monitoring for ozone nonattainment areas classified as moderate or above is appropriate for the purposes of monitoring ambient air quality and better understanding ozone pollution. In EPA's revision to the ozone standard on October 1, 2015, EPA relied on the authority provided in sections 103(c), 110(a)(2)(B), 114(a) and 301(a)(1) of the CAA to expand the PAMS applicability to areas other than those that are serious or above ozone nonattainment and substantially to revise the PAMS requirements in 40 CFR part 58 appendix D (80 FR 65292). Specifically, this rule required states with moderate and above ozone nonattainment areas to develop and implement an EMP. These plans should detail enhanced ozone and ozone precursor monitoring activities to be performed to better understand area-specific ozone issues.

To meet this requirement, Wisconsin submitted its updated EMP as part of the 2018 Wisconsin Air Monitoring Network Plan, which EPA approved via a letter dated September 1, 2017. Wisconsin has submitted subsequent updates to its EMP with each year's network plan. Measures included in Wisconsin's current EMP include: Monitoring of ozone and ozone precursors beyond federal requirements, ozone event triggered VOC samples for the PAMS suite of compounds, engaging and supporting external partners collecting ozone-related data, and analyzing monitoring data that had been previously collected. Wisconsin's EMP specifically includes several enhanced monitoring efforts within the Wisconsin portion of the Chicago area.

Wisconsin will continue to meet its CAA section 182(c)(1) EMP requirements by including its EMP in Wisconsin's Air Monitoring Network Plan, which is subject to EPA review and approval on an annual basis. Therefore, EPA is proposing to find that Wisconsin has met the EMP requirements for its portion of the Chicago area for the 2008 ozone NAAQS.

EPA is proposing to approve revisions to Wisconsin's SIP pursuant to section 110 and part D of the CAA and EPA's regulations, because Wisconsin's December 1, 2020 nonattainment plan satisfies the requirements for the VOC and NO X RACT, the CFVP, and the EMP, in the Wisconsin portion of the Chicago serious nonattainment area for the 2008 ozone NAAQS.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Native American Programs Act of 1974 (NAPA), Public Law 93-644, was first enacted on January 4, 1975. The last time substantial amendments to the NAPA regulations were made was 1996. Section 802 of the NAPA establishes as its broad statutory purpose the promotion of “the goal of economic and social self-sufficiency for American Indians, Native Hawaiians, other Native American Pacific Islanders (including American Samoan Natives), and Alaska Natives.” ANA executes this purpose through the provision of project-based financial assistance to Native Americans authorized under sections 803 and 803C of the NAPA, as well as through advocacy on behalf of Native Americans within HHS and with other departments and agencies of the Federal Government “regarding all Federal policies affecting Native Americans,” under section 803B (c) of the NAPA.

Current regulations (45 CFR 1336.50) state that grant recipients can only apply for a waiver for NFS at the time of application or while applying for a non-competitive continuation award. The on-going public health emergency has greatly impacted our recipients. The pandemic has greatly increased the risk of language and cultural decline among Native communities with many Elders dying from the COVID-19 virus. As tribes began closing their revenue generating businesses and other governmental operations due to the COVID-19 pandemic, they lost income they needed to fund Federal projects requiring a NFS. In addition, planned sources of income, such as use of tribal-owned facilities from which to operate the project, as part of the NFS also diminished. NAPA requires a 20 percent cost-share and match requirement. ANA's current cost-share waiver does not allow for a process to address a recipient's inability to meet the cost-share due to an emergency in the middle of a budget period. The proposed revisions to the regulations (45 CFR 1336.50(b)(2)(ii)) add a provision allowing grant recipients to apply for an emergency waiver within the current budget period in order to remedy this burden.

Pursuant to 42 U.S.C. 2991b of the NAPA, ANA is authorized to allow applicants the ability to submit a request for a waiver of the required 20 percent non-Federal cost match, subject to ANA regulations. 1

This NPRM proposes changes to 45 CFR part 1336, subpart E, Financial Assistance Provisions, in § 1336.50. These changes will have no regulatory burden impact but will provide a waiver provision and ensure programmatic success of American Indian, Native Hawaiian, other Native American Pacific Islander (including American Samoan Natives), and Alaska Native-based recipients.

This section includes the conditions that must be met in order to submit a 20 percent, non-Federal, cost-sharing or match requirement. The proposed rule would amend the existing language and application requirements under § 1336.50(b)(2). Specifically, we propose in § 1336.50(b)(2)(i) that if an applicant anticipates that they will be unable to meet the cost-sharing or matching requirement and wishes to request a waiver of the requirement, they must include with the application for funding, the submission of a revised SF 424A, a written justification that clearly explains why the applicant cannot provide the matching share including the amount of non-Federal share to be waived, and how it meets the criteria indicated in the revised § 1336.50(b)(3)(ii). The request for a waiver must be submitted at the time of the initial application or Non-Competing Continuation (NCC) application.

Further, the proposed rule adds a provision for an emergency waiver in § 1336.50(b)(2)(ii) to include the ability to request a waiver during the budget period. If a recipient is unable to contribute part or all of the required non-Federal matching share during a budget period due to an emergency situation such as a natural disaster, man-made disaster, act of terrorism, public health emergency, or other qualifying event, the recipient may request a waiver of all or part of the requirement for a 20 percent non-Federal matching share specified under § 1336.50(b)(1).

Finally, this proposed rule amends the language in § 1336.50(b)(3)(ii). We propose that an applicant should provide evidence of the emergency situation and document that reasonable efforts to obtain cash or in-kind contributions for the purposes of the project from third parties have been unsuccessful, including evidence and the results of such attempts. Evidence of such efforts can include letters from possible sources of funding or any relevant correspondence, indicating that the requested resources are not available for that project. The requests must be appropriate to the source in terms of project purpose, applicant eligibility, and reasonableness of the request.

Section 1336.50(b) does not contain new information collection requirements. This action does not include any information collection requirements, only an additional circumstance that would allow for the submission of the information already outlined in the regulation.

The Secretary certifies, under 5 U.S.C. 605(b), and enacted by the Regulatory Flexibility Act (Pub. L. 96, 354), that this proposed rule will not result in a significant impact on a substantial number of small entities.

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a proposed policy or regulation may affect family well-being. If the agency's determination is affirmative, then the agency must prepare an impact assessment addressing criteria specified in the law. This regulation will not have an impact on family well-being as defined in this legislation, which asks agencies to assess policies with respect to whether the policy strengthens or erodes family stability and the authority and rights of parents in the education, nurturing, and supervision of their children; helps the family perform its functions; and increases or decreases disposable income.

Section 202 of the Unfunded Mandates Reform Act of 1995 requires that a covered agency prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $141 million or more in any one year. The Department has determined that this proposed rule would not impose a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year.

Executive Order 13132 on federalism applies to policies that have federalism implications, defined as “regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the states, or on the distributions of power and responsibilities among the various levels of government.” This rulemaking does not have federalism implications for state or local governments as defined in the Executive order.

This regulation is not a major rule as defined in 5 U.S.C. 8.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select the regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. While there are some costs associated with these regulations, they are not economically significant as defined under Executive Order 12866. However, the regulation is significant and has been reviewed by Office of Management and Budget.

The proposed regulation change would benefit recipients that have been financially impacted by an emergency event and are unable to meet their matching cost requirement, as required by the grant award. It would reduce the financial burden to recipients that need a waiver to provide the 20 percent cost share. Also, there is no cost to the agency other than the administrative time that it would take to review and approve the waiver request.

For reasons stated in the preamble, we propose to amend 45 CFR part 1336 as follows:

On October 15, 2021, the Federal Acquisition Regulatory Council published an advance notice of proposed rulemaking (ANPR) in the Federal Register at 86 FR 57404 seeking public input on a potential FAR amendment to implement section 5(b)(ii) of Executive Order 14030, Climate-Related Financial Risk. The comment period is extended to January 13, 2022, to allow additional time for interested parties to submit comments in response to the questions posed in the ANPR.