Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Proposed Rules 78047

DEPARTMENT OF JUSTICE Administrator of DEA (Administrator) from legitimate channels; and pursuant to 28 CFR 0.100) with the clandestine importation, manufacture, Drug Enforcement Administration authority to temporarily place a or distribution. 21 U.S.C. 811(h)(3). substance in schedule I of the CSA for A substance meeting the statutory 21 CFR Part 1308 two years without regard to the requirements for temporary scheduling [Docket No. DEA–716] requirements of 21 U.S.C. 811(b), if he may only be placed in schedule I. 21 finds that such action is necessary to U.S.C. 811(h)(1). Substances in schedule Schedules of Controlled Substances: avoid an imminent hazard to the public I are those that have a high potential for safety. 21 U.S.C. 811(h)(1). In addition, Temporary Placement of Brorphine in abuse, no currently accepted medical Schedule I if proceedings to control a substance are use in treatment in the United States, initiated under 21 U.S.C. 811(a)(1) while AGENCY: and a lack of accepted safety for use Drug Enforcement the substance is temporarily controlled under medical supervision. 21 U.S.C. Administration, Department of Justice. under section 811(h), the Administrator 812(b)(1). ACTION: Proposed amendment; notice of may extend the temporary scheduling intent. for up to one year. 21 U.S.C. 811(h)(2). Brorphine SUMMARY: The Acting Administrator of Where the necessary findings are The availability of synthetic the Drug Enforcement Administration is made, a substance may be temporarily issuing this notice of intent to publish scheduled if it is not listed in any other on the illicit drug market continues to a temporary order to schedule 1-(1-(1-(4- schedule under 21 U.S.C. 812, or if there pose an imminent hazard to the public bromophenyl)ethyl)piperidin-4-yl)-1,3- is no exemption or approval in effect for safety. Adverse health effects associated dihydro-2H-benzo[d]imidazol-2-one the substance under section 505 of the with the abuse of synthetic opioids and (commonly known as brorphine), Federal Food, Drug, and Cosmetic Act, the increased popularity of these including its isomers, esters, ethers, 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 substances have been serious concerns salts, and salts of isomers, esters, and CFR part 1308. in recent years. The presence of new synthetic opioids with no approved ethers whenever the existence of such Background isomers, esters, ethers, and salts is medical use exacerbates the possible, in schedule I of the Controlled Section 811(h)(4) requires the unprecedented epidemic the Substances Act. When it is issued, the Administrator to notify the Secretary of United States continues to experience. temporary scheduling order will impose the Department of Health and Human The trafficking and abuse of new the regulatory controls and Services (HHS) of his intention to synthetic opioids are deadly new trends. temporarily place a substance in administrative, civil, and criminal The identification of brorphine on the schedule I of the CSA.2 The Acting sanctions applicable to schedule I illicit drug market has been reported in Administrator transmitted notice of his controlled substances on persons who the United States, Canada, Belgium, and handle (manufacture, distribute, reverse intent to place brorphine in schedule I on a temporary basis to the Assistant Sweden. Data obtained from preclinical distribute, import, export, engage in pharmacology studies show that research, conduct instructional Secretary for Health of HHS (Assistant Secretary) by letter dated September 22, brorphine has a pharmacological profile activities or chemical analysis, or similar to that of other potent opioids possess) or propose to handle brorphine. 2020. The Assistant Secretary such as and , DATES: December 3, 2020. responded to this notice by letter dated October 27, 2020, and advised that schedule II controlled substances. FOR FURTHER INFORMATION CONTACT: based on a review by the Food and Drug Because of the pharmacological Terrence L. Boos, Drug and Chemical similarities between brorphine and Evaluation Section, Diversion Control Administration (FDA), there are currently no investigational new drug other potent opioids, the use of Division, Drug Enforcement brorphine presents a high risk of abuse Administration; Mailing Address: 8701 applications or approved new drug applications for brorphine. The and may negatively affect users and Morrissette Drive, Springfield, Virginia their communities. The positive 22152; Telephone: (571) 362–8207. Assistant Secretary also stated that HHS had no objection to the temporary identification of this substance in law SUPPLEMENTARY INFORMATION: This placement of brorphine in schedule I of enforcement seizures and post-mortem document is issued pursuant to the the CSA. Brorphine is not currently toxicology reports is a serious concern temporary scheduling provisions of 21 listed in any schedule under the CSA, to the public safety. The abuse of U.S.C. 811(h). The Drug Enforcement and no exemptions or approvals are in brorphine has been associated with at Administration (DEA) intends to issue a effect for brorphine under 21 U.S.C. 355. least seven fatalities between June 2020 temporary scheduling order (in the form To find that placing a substance and July 2020 in the United States. of a temporary amendment) to add temporarily in schedule I of the CSA is Thus, brorphine poses an imminent brorphine to schedule I under the hazard to public safety. 1 necessary to avoid an imminent hazard Controlled Substances Act (CSA). The to the public safety, the Administrator is temporary scheduling order will be Available data and information for required to consider three of the eight brorphine, as summarized below, published in the Federal Register on or factors set forth in 21 U.S.C. 811(c): The after January 4, 2021. indicates that this substance has a high substance’s history and current pattern potential for abuse, no currently Legal Authority of abuse; the scope, duration and accepted medical use in treatment in the The CSA provides the Attorney significance of abuse; and what, if any, United States, and a lack of accepted General (as delegated to the risk there is to the public health. 21 safety for use under medical U.S.C. 811(h)(3). Consideration of these supervision. DEA’s three-factor analysis 1 Though DEA has used the term ‘‘final order’’ factors includes actual abuse; diversion is available in its entirety under with respect to temporary scheduling orders in the ‘‘Supporting and Related Material’’ of past, this notice of intent adheres to the statutory 2 The Secretary of HHS has delegated to the the public docket for this action at language of 21 U.S.C. 811(h), which refers to a Assistant Secretary for Health of HHS the authority ‘‘temporary scheduling order.’’ No substantive to make domestic drug scheduling www.regulations.gov under Docket change is intended. recommendations. 58 FR 35460, July 1, 1993. Number DEA–716.

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Factor 4. History and Current Pattern of substance) and fentanyl (a schedule II NFLIS registered 20 reports of Abuse substance). In reports from the brorphine from Ohio (4), Pennsylvania Brorphine is part of a structural class Northeastern Illinois Regional Crime (1), and Wisconsin (15) in 2019 and of compounds known as substituted Laboratory, suspected /fentanyl 2020. NFLIS was queried on August 18, piperidine benzimidazolones. The powders were analyzed and found to be 2020, for brorphine. Due to the rapid general synthesis of brorphine was first brorphine in combination with appearance of the drug, brorphine is reported in the literature in 2018. , a non-scheduled most likely under reported as forensic benzodiazepine, and diphenhydramine, laboratories secure reference standards Brorphine is not an approved 5 pharmaceutical product and is not an over-the-counter antihistamine. for the confirmative identification and approved for medical use anywhere in Post-mortem toxicology samples reporting of this substance. the world. The Assistant Secretary, by a collected and submitted to National The population likely to abuse letter to DEA dated October 27, 2020, Medical Services (NMS) Laboratory 6 in brorphine appears to be the same as stated that there are no FDA-approved June and July 2020 verified the those abusing prescription opioid new drug applications or investigational appearance of brorphine. Brorphine was , heroin, , fentanyl, new drug applications for brorphine in first reported by the Center for Forensic and other synthetic opioid substances. the United States; hence, there is no Science Research and Education This is evidenced by the types of other legitimate channel for brorphine as a (CFSRE)—Novel Psychoactive drugs co-identified in samples obtained marketed drug product. The appearance Substance (NPS) Discovery Program from brorphine seizures and post- of brorphine on the illicit drug market (under the novel psychoactive mortem toxicology reports. Because is similar to other designer drugs substances discovery program, in abusers of brorphine are likely to obtain trafficked for their psychoactive effects. collaboration with NMS Labs) in July it through unregulated sources, the Since 2014, numerous synthetic 2020. In seven post-mortem toxicology identity, purity, and quantity of opioids structurally related to fentanyl reports in June 2020 and July 2020, brorphine are uncertain and and several synthetic opioids from other brorphine was found in combination inconsistent, thus posing significant structural classes have begun to emerge with fentanyl, flualprazolam, and adverse health risks to the end user. The on the illicit drug market as evidenced heroin. Evidence suggests that misuse and abuse of opioids have been by the identification of these drugs in individuals are using brorphine as a demonstrated and are well- forensic drug exhibits and toxicology replacement to heroin or other opioids, characterized. According to the most either knowingly or unknowingly. recent data from the National Survey on samples. Beginning in June 2019, 7 brorphine emerged in the U.S. illicit, Drug Use and Health (NSDUH), as of Factor 5. Scope, Duration, and 2018, an estimated 10.3 million people synthetic drug market as evidenced by Significance of Abuse brorphine’s identification in drug aged 12 years or older misused opioids seizures. Between July and September of Brorphine has been described as a in the past year, including 9.9 million 2019, brorphine was first reported in potent synthetic opioid and evidence prescription pain reliever misusers and drug casework in Canada and was first suggests it is being abused for its 808,000 heroin users. In 2018, an reported in police seizures in Sweden in opioidergic effects (see Factor 6). estimated 2 million people had an March 2020.3 According to a recent publication by opioid use disorder which included 1.7 Brorphine has been encountered by CFSRE—NPS Discovery, brorphine has million people with a prescription pain U.S. law enforcement in powder form. been positively identified in seven reliever use disorder and 500,000 In the United States, brorphine has been death investigation cases spanning people with heroin use disorder. This identified as a single substance and in between June 2020 and July 2020. These population abusing opioids is likely to combination with other substances. cases correspond to three states— be at risk of abusing brorphine. Twenty reports of brorphine have been Illinois (3), Minnesota (3), and Arizona Individuals who initiate use (i.e., use a reported in the National Forensic (1). Most (n = 6) of the decedents were drug for the first time) of brorphine are Laboratory Information System (NFLIS) male. The decedents’ ages ranged likely to be at risk of developing in 2019 and 2020 from three different between 40’s and 60’s with an average substance use disorder, overdose, and states (see Factor 5).4 In several NFLIS age of 52 years. Other substances death similar to that of other opioid encounters, brorphine was found in identified in postmortem blood analgesics (e.g., fentanyl, morphine, combination with heroin (a schedule I specimens obtained from these etc.). Law enforcement reports decedents include flualprazolam, a demonstrate that brorphine is being 3 Health Canada Drug Analysis Service (2019); nonscheduled benzodiazepine (n = 5), illicitly distributed and abused. Analyzed Drug Report Canada 2019—Q3 (July to fentanyl, a schedule II substance (n = 7), September); European Monitoring Centre for Drugs 7 The National Survey on Drug Use and Health and Drug Addiction (EMCDDA) (2020); EU Early and heroin, a schedule I substance (n = (NSDUH), formerly known as the National Warning System Situation Report, Situation report 4). The appearance of benzodiazepines Household Survey on Drug Abuse (NHSDA), is 1—June 2020. and other opioids is common with conducted annually by the Department of Health 4 NFLIS represents an important resource in polysubstance abuse. and Human Services Substance Abuse and Mental monitoring illicit drug trafficking, including the Health Services Administration (SAMHSA). It is the diversion of legally manufactured pharmaceuticals primary source of estimates of the prevalence and into illegal markets. NFLIS-Drug is a comprehensive 5 Email communications with Northeastern incidence of nonmedical use of pharmaceutical information system that includes data from forensic Illinois Regional Crime Laboratory, dated 7/1/2020 drugs, illicit drugs, alcohol, and tobacco use in the laboratories that handle the nation’s drug analysis and 6/11/2020. United States. The survey is based on a nationally cases. NFLIS-Drug participation rate, defined as the 6 NMS Labs, in collaboration with the Center for representative sample of the civilian, non- percentage of the national drug caseload Forensic Science Research and Education at the institutionalized population 12 years of age and represented by laboratories that have joined NFLIS, Fredric Rieders Family Foundation and the older. The survey excludes homeless people who is currently 98.5 percent. NFLIS includes drug Organized Crime Drug Enforcement Task Force at do not use shelters, active military personnel, and chemistry results from completed analyses only. the United States Department of Justice, has residents of institutional group quarters such as While NFLIS data is not direct evidence of abuse, received funding from the Centers for Disease jails and hospitals. The NSDUH provides yearly it can lead to an inference that a drug has been Control and Prevention to develop systems for the national and state level estimates of drug abuse, and diverted and abused. See 76 FR 77330, 77332, early identification and notification of novel includes prevalence estimates by lifetime (i.e., ever December 12, 2011. NFLIS data was queried on psychoactive substances in the drug supply within used), past year, and past month abuse or August 18, 2020. the United States. dependence.

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Factor 6. What, if Any, Risk There Is to Minnesota. Information gathered from imminent hazard to the public safety, the Public Health case history findings shows that the temporary order scheduling this The increase in opioid overdose brorphine use is similar to that of classic substance will be effective on the date deaths in the United States has been opioid agonists. As documented by the order is published in the Federal exacerbated recently by the availability toxicology reports, poly-substance abuse Register, and will be in effect for a of potent synthetic opioids on the illicit remains common in fatalities associated period of two years, with a possible drug market. Data obtained from pre- with the abuse of brorphine. extension of one additional year, pending completion of the regular clinical studies demonstrate that Finding of Necessity of Schedule I (permanent) scheduling process. 21 brorphine exhibits a pharmacological Placement To Avoid Imminent Hazard U.S.C. 811(h)(1) and (2). It is the profile similar to that of other mu (m)- to Public Safety intention of the Acting Administrator to agonists. Data from in In accordance with 21 U.S.C. issue a temporary scheduling order as vitro studies completed in 2020 showed 811(h)(3), based on the available data soon as possible after the expiration of that brorphine binds to and activates the and information summarized above, the 30 days from the date of publication of m-opioid receptors. In the [35S]GTPgS uncontrolled manufacture, distribution, this document. Upon publication of the cell-based receptor assay, brorphine, reverse distribution, importation, temporary order, brorphine will then be similar to fentanyl, acted as a m-opioid exportation, conduct of research and subject to the CSA’s schedule I receptor agonist. Brorphine’s activation chemical analysis, possession, and regulatory controls and administrative, of m-opioid receptor was also shown to abuse of brorphine pose an imminent civil, and criminal sanctions applicable involve recruitment of beta-arrestin-2, a hazard to the public safety. DEA is not to the manufacture, distribution, reverse regulatory protein whose interaction aware of any currently accepted medical distribution, importation, exportation, m with the -opioid receptor has been uses for brorphine in the United States. research, conduct of instructional implicated in the adverse effects of m- A substance meeting the statutory activities and chemical analysis, and opioid receptor activation. Brorphine requirements for temporary scheduling, possession. binds to and activates the m-opioid found in 21 U.S.C. 811(h)(1), may only The CSA sets forth specific criteria for receptor and has efficacy on scale with be placed in schedule I. Substances in scheduling a drug or other substance. fentanyl. It is well established that schedule I are those that have a high Regular scheduling actions in substances that act as m-opioid receptor potential for abuse, no currently accordance with 21 U.S.C. 811(a) are agonists have a high potential for accepted medical use in treatment in the subject to formal rulemaking procedures addiction and can induce dose- United States, and a lack of accepted done ‘‘on the record after opportunity dependent respiratory depression. safety for use under medical for a hearing’’ conducted pursuant to As with any m-opioid receptor agonist, supervision. Available data and the provisions of 5 U.S.C. 556 and 557. the potential health and safety risks for information for brorphine indicate that 21 U.S.C. 811. The regular scheduling users of brorphine are high. The public this substance has a high potential for process of formal rulemaking affords health risks associated to the abuse of abuse, no currently accepted medical interested parties with appropriate heroin and other m-opioid receptor use in treatment in the United States, process and the government with any agonists are well established and have and a lack of accepted safety for use additional relevant information needed resulted in large numbers of drug under medical supervision. As required to make a determination. Final treatment admissions, emergency by 21 U.S.C. 811(h)(4), the Acting decisions that conclude the regular department visits, and fatal overdoses. Administrator, through a letter dated scheduling process of formal According to the Centers for Disease September 22, 2020, notified the rulemaking are subject to judicial Control and Prevention (CDC), opioids, Assistant Secretary of DEA’s intention review. 21 U.S.C. 877. Temporary mainly synthetic opioids other than to temporarily place brorphine in scheduling orders are not subject to , are predominantly schedule I. judicial review. 21 U.S.C. 811(h)(6). responsible for drug overdose deaths in recent years. A CDC report shows that, Conclusion Regulatory Analyses from 2013 to 2018, opioid-related This notice of intent provides the 30- The CSA provides for a temporary overdose deaths in the United States day notice pursuant to 21 U.S.C. scheduling action where such action is increased from 25,052 to 46,802. Of the 811(h)(1) of DEA’s intent to issue a necessary to avoid an imminent hazard drug overdose deaths for 2018, opioids temporary scheduling order. In to the public safety. 21 U.S.C. 811(h)(1). were involved in about 69.5 percent of accordance with 21 U.S.C. 811(h)(1) and As provided in this subsection, the all drug-involved overdose deaths. (3), the Acting Administrator considered Administrator (as delegated by the In the United States, the abuse of available data and information, herein Attorney General) may, by order, opioid analgesics has resulted in large set forth the grounds for his schedule a substance in schedule I on a numbers of treatment admissions, determination that it is necessary to temporary basis. Such an order may not emergency department visits, and fatal temporarily schedule brorphine in be issued before the expiration of 30 overdoses. The introduction of potent schedule I of the CSA, and finds that days from: (1) The publication of a synthetic opioids such as brorphine into placement of this substance in schedule notice in the Federal Register of the the illicit market may serve as a portal I of the CSA is necessary in order to intention to issue such order and the to problematic opioid use for those avoid an imminent hazard to the grounds upon which such order is to be seeking these powerful opioids. public’s safety. issued, and (2) the date that notice of Brorphine has been co-identified with The temporary placement of the proposed temporary scheduling other substances in seven post-mortem brorphine in schedule I of the CSA will order is transmitted to the Secretary of toxicology cases in June and July of take effect pursuant to a temporary HHS. 2020. These substances include other scheduling order, which will not be Inasmuch as 21 U.S.C. 811(h)(1) opioids such as fentanyl and heroin, issued before January 4, 2021. Because directs that temporary scheduling and other substance classes such as the Acting Administrator hereby finds actions be issued by order and sets forth benzodiazepines. These deaths occurred that it is necessary to temporarily place the procedures by which such orders are in three states: Illinois, Arizona, and brorphine in schedule I to avoid an to be issued, including the requirement

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of a publication in the Federal Register (including potential economic, § 1308.11 Schedule I of a notice of intent, the notice-and- environmental, public health, and safety * * * * * comment requirements of section 553 of effects; distributive impacts; and (h) * * * the Administrative Procedure Act equity). E.O. 13563 is supplemental to (49) 1-(1-(1-(4-bromophenyl) (APA), 5 U.S.C. 553, do not apply to this and reaffirms the principles, structures, ethyl)piperidin-4-yl)-1,3-dihydro- notice of intent. The APA expressly and definitions governing regulatory 2H-benzo[d]imidazol-2-one, its differentiates between an order and a review as established in E.O. 12866. isomers, esters, ethers, salts and rule, as it defines an ‘‘order’’ to mean a E.O. 12866 classifies a ‘‘significant salts of isomers, esters and ethers ‘‘final disposition, whether affirmative, regulatory action,’’ requiring review by (Other names: brorphine; 1-[1-[1- negative, injunctive, or declaratory in the Office of Management and Budget (4-bromophenyl)ethyl]-4- form, of an agency in a matter other (OMB), as any regulatory action that is piperidinyl]-1,3-dihydro-2H- benzimidazol-2-one) ...... 9098 than rule making.’’ 5 U.S.C. 551(6) likely to result in a rule that may: (1) (emphasis added). The specific language Have an annual effect on the economy * * * * * chosen by Congress indicates an of $100 million or more or adversely Timothy J. Shea, intention for DEA to proceed through affect in a material way the economy; a Acting Administrator. the issuance of an order instead of sector of the economy; productivity; proceeding by rulemaking. Given that competition; jobs; the environment; [FR Doc. 2020–26301 Filed 12–2–20; 8:45 am] Congress specifically requires the public health or safety; or State, local, BILLING CODE 4410–09–P Administrator to follow rulemaking or tribal governments or communities; procedures for other kinds of scheduling (2) create a serious inconsistency or actions, see 21 U.S.C. 811(a), it is otherwise interfere with an action taken ENVIRONMENTAL PROTECTION noteworthy that, in 21 U.S.C. 811(h)(1), or planned by another agency; (3) AGENCY Congress authorized the issuance of materially alter the budgetary impact of 40 CFR Part 52 temporary scheduling actions by order entitlements, grants, user fees, or loan rather than by rule. programs, or the rights and obligations [EPA–R09–OAR–2020–0534; FRL–10016– In the alternative, even assuming that of recipients thereof; or (4) raise novel 98–Region 9] this notice of intent might be subject to legal or policy issues arising out of legal section 553 of the APA, the Acting mandates, the President’s priorities, or Approval and Promulgation of Air Administrator finds that there is good the principles set forth in the Executive Quality State Implementation Plans; cause to forgo the notice-and-comment Order. Because this is not a rulemaking California; Plumas County; Moderate requirements of section 553, as any action, this is not a significant Area Plan for the 2012 PM2.5 NAAQS further delays in the process for regulatory action as defined in Section issuance of temporary scheduling orders AGENCY: Environmental Protection 3(f) of E.O. 12866. In addition, this Agency (EPA). would be impracticable and contrary to action does not meet the definition of an ACTION: Proposed rule. the public interest in view of the E.O. 13771 regulatory action, and the manifest urgency to avoid an imminent repeal and cost offset requirements of SUMMARY: The Environmental Protection hazard to the public safety. E.O. 13771 have not been triggered. Although DEA believes this notice of Agency (EPA) is proposing to approve This action will not have substantial intent to issue a temporary scheduling through parallel processing a state direct effects on the states, on the order is not subject to the notice-and- implementation plan (SIP) revision relationship between the national comment requirements of section 553 of submitted by the State of California to government and the states, or on the the APA, DEA notes that in accordance address Clean Air Act (CAA or ‘‘Act’’) distribution of power and with 21 U.S.C. 811(h)(4), the Acting requirements for the 2012 annual fine responsibilities among the various Administrator took into consideration particulate matter (PM2.5) national comments submitted by the Assistant levels of government. Therefore, in ambient air quality standard (NAAQS or Secretary in response to the notice that accordance with E.O. 13132 ‘‘standard’’) in the Plumas County (Federalism), it is determined that this DEA transmitted to the Assistant Moderate PM2.5 nonattainment area Secretary pursuant to such subsection. action does not have sufficient (‘‘Portola nonattainment area’’). The Further, DEA believes that this federalism implications to warrant the submitted SIP revision is the State’s temporary scheduling action is not a preparation of a Federalism Assessment. ‘‘Proposed Portola PM2.5 Plan ‘‘rule’’ as defined by 5 U.S.C. 601(2), List of Subjects in 21 CFR Part 1308 Contingency Measure SIP Submittal’’ and, accordingly, is not subject to the (‘‘Proposed PM2.5 Plan Revision’’), requirements of the Regulatory Administrative practice and which includes a revised City of Portola procedure, Drug traffic control, Flexibility Act. The requirements for the ordinance regulating PM2.5 emission preparation of an initial regulatory Reporting and recordkeeping sources and the State’s demonstration flexibility analysis in 5 U.S.C. 603(a) are requirements. that this submission meets the Moderate not applicable where, as here, DEA is For the reasons set out above, DEA area contingency measure requirement not required by section 553 of the APA proposes to amend 21 CFR part 1308 as for the 2012 annual PM2.5 NAAQS in the or any other law to publish a general follows: Portola nonattainment area. The EPA is notice of proposed rulemaking. also proposing to approve the In accordance with the principles of PART 1308—SCHEDULES OF contingency measure element of the Executive Orders (E.O.) 12866, 13563, CONTROLLED SUBSTANCES Moderate area attainment plan for the and 13771, this notice of intent is not ■ 1. The authority citation for part 1308 Portola nonattainment area, as revised a significant regulatory action. E.O. continues to read as follows: and supplemented by the Proposed 12866 directs agencies to assess all costs PM2.5 Plan Revision. Because the EPA is and benefits of available regulatory Authority: 21 U.S.C. 811, 812, 871(b), proceeding by parallel processing, the alternatives and, if regulation is 956(b), unless otherwise noted. agency is proposing, in the alternative, necessary, to select regulatory ■ 2. In § 1308.11, add paragraph (h)(49) to disapprove the contingency measure approaches that maximize net benefits to read as follows: element of the Moderate area attainment

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