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Article I: Effect of Designation underwater cultural sites in and around the Article VI. Alteration of This Designation The NMSA authorizes the issuance of such Wisconsin-Lake Michigan National Marine The terms of designation may be modified regulations as are necessary and reasonable Sanctuary possess exceptional historical, only by the same procedures by which the to implement the designation, including archaeological and recreational value. original designation is made, including managing and protecting the historical Article IV: Scope of Regulations public meetings, consultation according to resources and recreational, research, and the NMSA. Section 1. Activities Subject to Regulation. educational qualities of the Wisconsin-Lake The following activities are subject to [FR Doc. 2016–31741 Filed 1–6–17; 8:45 am] Michigan National Marine Sanctuary (the regulation, including prohibition, to the ‘‘Sanctuary’’). Section 1 of Article IV of this BILLING CODE 03510–NK–P extent necessary and reasonable to ensure the Designation Document lists those activities protection and management of the historical that may have to be regulated on the effective resources and recreational, research and date of designation, or at some later date, in educational qualities of the area: DEPARTMENT OF JUSTICE order to protect Sanctuary resources and a. Damaging sanctuary resources. qualities. Listing an activity does not b. Using grappling hooks and anchors at Drug Enforcement Administration necessarily mean that it will be regulated; shipwreck sites. however, if an activity is not listed it may not c. Interfering with, obstructing, delaying or 21 CFR Part 1308 be regulated, except on an emergency basis, preventing an investigation, search, seizure [Docket No. DEA–446] unless Section 1 of Article IV is amended by or disposition of seized property in the same procedures by which the original connection with enforcement of the Act or Schedules of Controlled Substances: Sanctuary designation was made. any regulation issued under the Act. Temporary Placement of Six Synthetic Article II: Description of the Area d. Reporting shipwreck discoveries and locations to the sanctuary. Cannabinoids (5F-ADB, 5F-AMB, 5F- The Wisconsin-Lake Michigan National Section 2. Emergencies. Where necessary APINACA, ADB-FUBINACA, MDMB- Marine Sanctuary consists of an area of to prevent or minimize the destruction of, CHMICA and MDMB-FUBINACA) Into approximately 812 square nautical miles loss of, or injury to a Sanctuary resource or (nmi2) (1,075 sq. mi) of Lake Michigan Schedule I quality; or minimize the imminent risk of waters within the state of Wisconsin and the such destruction, loss, or injury, any activity, AGENCY: Drug Enforcement submerged lands thereunder, over, around, including those not listed in Section 1, is Administration, Department of Justice. and under the submerged underwater subject to immediate temporary regulation. cultural resources in Lake Michigan. The ACTION: Notice of intent. An emergency regulation shall not take effect eastern boundary of the sanctuary begins without the approval of the Governor of SUMMARY: The Administrator of the Drug approximately 9.5 miles east of the Wisconsin or her/his designee or designated Wisconsin shoreline in Lake Michigan Enforcement Administration is issuing agency. roughly on the border between Manitowoc this notice of intent to temporarily and Kewaunee County. From this point the Article V: Relation to Other Regulatory schedule six synthetic cannabinoids: boundary continues in Lake Michigan Programs Methyl 2-(1-(5-fluoropentyl)-1H- roughly to the SSW until it intersects the Section 1. Fishing Regulations, Licenses, indazole-3-carboxamido)-3,3- border between Ozaukee and Milwaukee and Permits. Fishing in the Sanctuary shall dimethylbutanoate [5F-ADB; 5F-MDMB- County at a point approximately 13 miles not be regulated as part of the Sanctuary PINACA]; methyl 2-(1-(5-fluoropentyl)- east of the shoreline. The southern boundary management regime authorized by the Act. 1H-indazole-3-carboxamido)-3- continues west approximating the border However, fishing in the Sanctuary may be methylbutanoate [5F-AMB]; N- between these same two counties until it regulated by other Federal, State, Tribal and intersects the shoreline near Mequon, WI. (adamantan-1-yl)-1-(5-fluoropentyl)-1H- local authorities of competent jurisdiction, indazole-3-carboxamide [5F-APINACA, The western boundary continues north and designation of the Sanctuary shall have following the shoreline for approximately 90 no effect on any regulation, permit, or license 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- miles cutting across the mouths of rivers and issued thereunder. oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- streams; specifically those of Sauk Creek at Section 2. Other Regulations, Licenses, and indazole-3-carboxamide [ADB- Port Washington, the Sheboygan River at Permits. If any valid regulation issued by any FUBINACA]; methyl 2-(1- Sheboygan, Manitowoc Harbor as Federal, state, Tribal, or local authority of (cyclohexylmethyl)-1H-indole-3- Manitowoc, and East Twin River at Two competent jurisdiction, regardless of when carboxamido)-3,3-dimethylbutanoate Rivers as well as any other smaller streams issued, conflicts with a Sanctuary regulation, [MDMB-CHMICA, MMB-CHMINACA] and creeks. The western boundary ends at the regulation deemed by the Director of the and methyl 2-(1-(4-fluorobenzyl)-1H- roughly the border between Manitowoc and Office of National Marine Sanctuaries, Kewaunee County along the shoreline near National Oceanic and Atmospheric indazole-3-carboxamido)-3,3- Twin Creeks, WI. The northern boundary Administration, or designee, in consultation dimethylbutanoate [MDMB- continues from the shoreline east with the State of Wisconsin, to be more FUBINACA], into schedule I pursuant to approximating the border between these protective of Sanctuary resources and the temporary scheduling provisions of same two counties back to its point of origin qualities shall govern. Pursuant to section the Controlled Substances Act (CSA). 9.5 miles offshore. 304(c)(1) of the Act, 16 U.S.C. 1434(c)(1), no This action is based on a finding by the valid lease, permit, license, approval, or Article III: Special Characteristics of the Administrator that the placement of other authorization issued by any Federal, Area these synthetic cannabinoids into State, Tribal, or local authority of competent The historic shipwrecks in the Wisconsin- jurisdiction, or any right of subsistence use schedule I of the Controlled Substances Lake Michigan National Marine Sanctuary or access, may be terminated by the Secretary Act is necessary to avoid an imminent are representative of vessels that sailed and of Commerce, or designee, as a result of this hazard to the public safety. Any final steamed the Lake Michigan corridor, carrying designation, or as a result of any Sanctuary order will impose the administrative, grain and raw materials east as other vessels regulation, if such lease, permit, license, civil, and criminal sanctions and came west loaded with coal, manufactured approval, or other authorization, or right of regulatory controls applicable to good, and immigrants. Eighteen of the 37 subsistence use or access was issued or in schedule I substances under the shipwrecks are listed on the National existence as of the effective date of this Controlled Substances Act on the Register of Historic Places. Many of the designation. However, the Secretary of shipwrecks in the proposed sanctuary retain Commerce or designee, in consultation with manufacture, distribution, possession, an unusual degree of architectural integrity, the State of Wisconsin, may regulate the importation, exportation of, and with 14 vessels virtually intact. Well exercise of such authorization or right research and conduct with, instructional preserved by Lake Michigan’s cold, fresh consistent with the purposes for which the activities of these synthetic water, the shipwrecks and related Sanctuary is designated. cannabinoids.

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DATES: January 9, 2017. scheduled if it is not listed in any other actual abuse, diversion from legitimate FOR FURTHER INFORMATION CONTACT: schedule under section 202 of the CSA, channels, and clandestine importation, Michael J. Lewis, Office of Diversion 21 U.S.C. 812, or if there is no manufacture, or distribution. 21 U.S.C. Control, Drug Enforcement exemption or approval in effect for the 811(h)(3). Administration; Mailing Address: 8701 substance under section 505 of the A substance meeting the statutory Morrissette Drive, Springfield, Virginia Federal Food, Drug, and Cosmetic Act requirements for temporary scheduling 22152; Telephone: (202) 598–6812. (FDCA), 21 U.S.C. 355. 21 U.S.C. may only be placed in schedule I. 21 811(h)(1); 21 CFR part 1308. The U.S.C. 811(h)(1). Substances in schedule SUPPLEMENTARY INFORMATION: Any final I are those that have a high potential for order will be published in the Federal Attorney General has delegated scheduling authority under 21 U.S.C. abuse, no currently accepted medical Register and may not be effective prior 811 to the Administrator of the DEA. 28 use in treatment in the United States, to February 8, 2017. CFR 0.100. and a lack of accepted safety for use Legal Authority under medical supervision. 21 U.S.C. Background 812(b)(1). The Drug Enforcement Section 201(h)(4) of the CSA 21 U.S.C. Administration (DEA) implements and 811(h)(4), requires the Administrator to 5F-ADB, 5F-AMB, 5F-APINACA, ADB- enforces titles II and III of the notify the Secretary of the Department FUBINACA, MDMB-CHMICA and Comprehensive Drug Abuse Prevention of Health and Human Services (HHS) of MDMB-FUBINACA and Control Act of 1970, as amended. 21 any intention to temporarily place a Available data and information for 5F- U.S.C. 801–971. Titles II and III are substance into schedule I of the CSA.1 ADB, 5F-AMB, 5F-APINACA, ADB- referred to as the ‘‘Controlled The Acting Administrator transmitted FUBINACA, MDMB-CHMICA and Substances Act’’ and the ‘‘Controlled notice of his intent to place 5F-ADB, 5F- MDMB-FUBINACA indicate that these Substances Import and Export Act,’’ AMB, 5F-APINACA, ADB-FUBINACA, synthetic cannabinoids (SCs) have a respectively, and are collectively MDMB-CHMICA and MDMB- high potential for abuse, no currently referred to as the ‘‘Controlled FUBINACA in schedule I on a accepted medical use in treatment in the Substances Act’’ or the ‘‘CSA’’ for the temporary basis to the Assistant United States, and a lack of accepted purpose of this action. The DEA Secretary by letter dated April 22, 2016. safety for use under medical publishes the implementing regulations The Assistant Secretary responded to supervision. for these statutes in title 21 of the Code this notice by letter dated May 2, 2016, Synthetic Cannabinoids of Federal Regulations (CFR), chapter II. and advised that based on a review by The CSA and its implementing the Food and Drug Administration SCs are substances synthesized in regulations are designed to prevent, (FDA), there were no investigational laboratories that mimic the biological detect, and eliminate the diversion of new drug applications or approved new effects of delta-9-tetrahydrocannabinol controlled substances and listed drug applications for 5F-ADB, 5F-AMB, (THC), the main psychoactive ingredient chemicals into the illicit market while 5F-APINACA, ADB-FUBINACA, in marijuana. It is believed that SCs providing for the legitimate medical, MDMB-CHMICA or MDMB-FUBINACA. were first introduced on the designer scientific, research, and industrial needs The Assistant Secretary also stated that drug market in several European of the United States. Controlled the HHS had no objection to the countries as ‘‘herbal incense’’ before the substances have the potential for abuse temporary placement of 5F-ADB, 5F- initial encounter in the United States by and dependence and are controlled to AMB, 5F-APINACA, ADB-FUBINACA, U.S. Customs and Border Protection protect the public health and safety. MDMB-CHMICA or MDMB-FUBINACA (CBP) in November 2008. From 2009 to Under the CSA, every controlled into schedule I of the CSA. 5F-ADB, 5F- the present, misuse and abuse of SCs substance is classified into one of five AMB, 5F-APINACA, ADB-FUBINACA, has increased in the United States with schedules based upon its potential for MDMB-CHMICA or MDMB-FUBINACA law enforcement encounters describing abuse, its currently accepted medical are not currently listed in any schedule SCs applied onto plant material and in use in treatment in the United States, under the CSA. designer drug products intended for and the degree of dependence the drug To find that placing a substance human consumption. It has been or other substance may cause. 21 U.S.C. temporarily into schedule I of the CSA demonstrated that the substances and 812. The initial schedules of controlled is necessary to avoid an imminent the associated designer drug products substances established by Congress are hazard to the public safety, the are abused for their psychoactive found at 21 U.S.C. 812(c), and the Administrator is required to consider properties. With many generations of current list of all scheduled substances three of the eight factors set forth in 21 SCs having been encountered since is published at 21 CFR part 1308. U.S.C. 811(c): The substance’s history 2009, 5F-ADB, 5F-AMB, 5F-APINACA, Section 201 of the CSA, 21 U.S.C. 811, and current pattern of abuse; the scope, ADB-FUBINACA, MDMB-CHMICA and provides the Attorney General with the duration and significance of abuse; and MDMB-FUBINACA are some of the authority to temporarily place a what, if any, risk there is to the public latest, and the abuse of these substances substance into schedule I of the CSA for health. 21 U.S.C. 811(h)(3). is negatively impacting communities. two years without regard to the Consideration of these factors includes As observed by the DEA and CBP, SCs requirements of 21 U.S.C. 811(b) if she originate from foreign sources, such as finds that such action is necessary to 1 As discussed in a memorandum of China. Bulk powder substances are avoid an imminent hazard to the public understanding entered into by the Food and Drug smuggled via common carrier into the safety. 21 U.S.C. 811(h)(1). In addition, Administration (FDA) and the National Institute on United States and find their way to Drug Abuse (NIDA), the FDA acts as the lead agency if proceedings to control a substance are within the Department of Health and Human clandestine designer drug product initiated under 21 U.S.C. 811(a)(1), the Service (HHS) in carrying out the Secretary’s manufacturing operations located in Attorney General may extend the scheduling responsibilities under the CSA, with the residential neighborhoods, garages, temporary scheduling for up to one concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. warehouses, and other similar The Secretary of the HHS has delegated to the year. 21 U.S.C. 811(h)(2). Assistant Secretary for Health of the HHS the destinations throughout the country. Where the necessary findings are authority to make domestic drug scheduling According to online discussion boards made, a substance may be temporarily recommendations. 58 FR 35460, July 1, 1993. and law enforcement encounters,

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applying by spraying or mixing the SCs emergency medical intervention or human consumption’’ is a legal defense with plant material provides a vehicle deaths have been associated with 5F- to criminal prosecution. for the most common route of ADB, 5F-AMB, 5F-APINACA, ADB- A major concern, as reiterated by administration—smoking (using a pipe, FUBINACA, MDMB-CHMICA and public health officials and medical a water pipe, or rolling the drug-laced MDMB-FUBINACA. professionals, is the targeting and direct plant material in cigarette papers). Research and clinical reports have marketing of SCs and SC-containing 5F-ADB, 5F-AMB, 5F-APINACA, demonstrated that SCs are applied onto products to adolescents and youth. This ADB-FUBINACA, MDMB-CHMICA, and plant material so that the material may is supported by law enforcement MDMB-FUBINACA have no accepted be smoked as users attempt to obtain a encounters and reports from emergency medical use in the United States. Use of euphoric and/or psychoactive ‘‘high,’’ departments; however, all age groups these specific SCs has been reported to believed to be similar to marijuana. Data have been reported by media as abusing result in adverse effects in humans gathered from published studies, these substances and related products. including deaths (see 3-Factor supplemented by discussions on Individuals, including minors, are document in ‘‘Supporting and Related Internet discussion Web sites, purchasing SCs from Internet Web sites, Material’’ section). Use of other SCs has demonstrate that these products are gas stations, convenience stores, and resulted in signs of addiction and being abused mainly by smoking for head shops. withdrawal, and based on the similar their psychoactive properties. The Factor 5. Scope, Duration and pharmacological profile of these six adulterated products are marketed as Significance of Abuse substances, it is believed that there will ‘‘legal’’ alternatives to marijuana. In be similar observed adverse effects. recent overdoses, 5F-ADB, 5F-AMB, 5F- SCs, including 5F-ADB, 5F-AMB, 5F- 5F-ADB, 5F-AMB, 5F-APINACA, APINACA, ADB-FUBINACA, MDMB- APINACA, ADB-FUBINACA, MDMB- ADB-FUBINACA, MDMB-CHMICA and CHMICA and MDMB-FUBINACA have CHMICA and MDMB-FUBINACA, MDMB-FUBINACA are SCs that have been shown to be applied onto plant continue to be encountered on the illicit pharmacological effects similar to the material, similar to the SCs that have market regardless of scheduling actions schedule I hallucinogen delta-D- been previously available. that attempt to safeguard the public tetrahydrocannabinol (THC) and Law enforcement personnel have from the adverse effects and safety temporarily and permanently controlled encountered various application issues associated with these substances. schedule I synthetic cannabinoid methods including buckets or cement Numerous substances are encountered substances. In addition, the misuse of mixers in which plant material and one each month, differing only by small 5F-ADB, 5F-AMB, 5F-APINACA, ADB- or more SCs (including 5F-ADB, 5F- modifications intended to avoid FUBINACA, MDMB-CHMICA and/or AMB, 5F-APINACA, ADB-FUBINACA, prosecution while maintaining the MDMB-FUBINACA have been MDMB-CHMICA and/or MDMB- pharmacological effects. Law associated with either overdoses FUBINACA) are mixed together, as well enforcement and health care requiring emergency medical as large areas where the plant material professionals continue to report abuse of intervention or death (see factor 6). With is spread out so that a dissolved SC these substances and their associated no approved medical use and limited mixture can be applied directly. Once products. safety or toxicological information, 5F- mixed, the SC plant material is then As described by the National Institute ADB, 5F-AMB, 5F-APINACA, ADB- allowed to dry before manufacturers on Drug Abuse (NIDA), many FUBINACA, MDMB-CHMICA and package the product for distribution, substances being encountered in the MDMB-FUBINACA have emerged on ignoring any control mechanisms to illicit market, specifically SCs, have the designer drug market, and the abuse prevent contamination or to ensure a been available for years but have of these substances for their consistent, uniform concentration of the reentered the marketplace due to a psychoactive properties is concerning. substance in each package. Adverse renewed popularity. The DEA’s analysis is available in its health consequences may also occur The threat of serious injury to the entirety under ‘‘Supporting and Related from directly ingesting the substance(s) individual following the ingestion of 5F- Material’’ of the public docket for this during the manufacturing process. 5F- ADB, 5F-AMB, 5F-APINACA, ADB- action at www.regulations.gov under ADB, 5F-AMB, 5F-APINACA, ADB- FUBINACA, MDMB-CHMICA and docket number DEA–443. FUBINACA, MDMB-CHMICA and MDMB-FUBINACA and other SCs MDMB-FUBINACA, similar to other persists. Numerous calls have been Factor 4. History and Current Pattern of SCs, have been encountered in form of received by poison centers regarding the Abuse dried leaves or herbal blends. abuse of products potentially laced with Synthetic cannabinoids have been The designer drug products laced SCs that have resulted in visits to developed over the last 30 years as tools with SCs, including 5F-ADB, 5F-AMB, emergency departments. Law for investigating the endocannabinoid 5F-APINACA, ADB-FUBINACA, enforcement continues to encounter system (e.g., determining CB1 and CB2 MDMB-CHMICA and MDMB- novel SCs on the illicit market, receptor activity). The first encounter of FUBINACA, are often sold under the including 5F-ADB, 5F-AMB, 5F- SCs within the United States occurred guise of ‘‘herbal incense’’ or APINACA, ADB-FUBINACA, MDMB- in November 2008 by CBP. Since then ‘‘potpourri,’’ use various product names, CHMICA and MDMB-FUBINACA (see the popularity of SCs and their and are routinely labeled ‘‘not for factor 5 in ‘‘Supporting and Related associated products has increased human consumption.’’ Additionally, Material’’). steadily as evidenced by law these products are marketed as a ‘‘legal The following information details enforcement seizures, public health high’’ or ‘‘legal alternative to marijuana’’ information obtained through NFLIS 2 information, and media reports. 5F- and are readily available over the (queried on November 7, 2016), ADB, 5F-AMB, 5F-APINACA, ADB- Internet, in head shops, or sold in FUBINACA, MDMB-CHMICA and convenience stores. There is an 2 The National Forensic Laboratory Information MDMB-FUBINACA are SCs that have incorrect assumption that these System (NFLIS) is a national drug forensic laboratory reporting system that systematically been recently encountered (see products are safe, that they are a collects results from drug chemistry analyses ‘‘Supporting and Related Material,’’ synthetic form of marijuana, and that conducted by state and local forensic laboratories Factor 5). Multiple overdoses involving labeling these products as ‘‘not for in the United States.

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including dates of first encounter, identified in overdose and/or cases Conclusion exhibits/reports, and locations. involving death attributed to their This notice of intent initiates a 5F-ADB: NFLIS—2,311 reports, first abuse. Adverse health effects reported temporary scheduling action and encountered in September 2014, from these incidents involving 5F-ADB, provides the 30-day notice pursuant to locations include: Arizona, Arkansas, 5F-AMB, 5F-APINACA, ADB- section 201(h) of the CSA, 21 U.S.C. California, Florida, Georgia, Idaho, FUBINACA, MDMB-CHMICA and/or 811(h). In accordance with the Indiana, Iowa, Kansas, Kentucky, MDMB-FUBINACA have included: provisions of section 201(h) of the CSA, Louisiana, Missouri, New Jersey, North nausea, persistent vomiting, agitation, 21 U.S.C. 811(h), the Administrator Dakota, Ohio, Oklahoma, Pennsylvania, altered mental status, seizures, considered available data and South Carolina, Texas, Virginia, and convulsions, loss of consciousness and/ information, herein sets forth the Wisconsin. 5F-AMB: NFLIS—3,349 reports, first or cardio toxicity. Large clusters of grounds for his determination that it is encountered in January 2014, locations overdoses requiring medical care have necessary to temporarily schedule include: Arizona, Arkansas, California, been reported involving 5F-AMB, methyl 2-(1-(5-fluoropentyl)-1H- Colorado, Florida, Georgia, Hawaii, MDMB-FUBINACA, MDMB-CHMICA indazole-3-carboxamido)-3,3- Idaho, Illinois, Indiana, Iowa, Kansas, and 5F-ADB. Reported deaths involving dimethylbutanoate [5F-ADB; 5F-MDMB- Kentucky, Louisiana, Maryland, these SCs have included 5F-ADB (8); PINACA]; methyl 2-(1-(5-fluoropentyl)- Massachusetts, Minnesota, Mississippi, 5F-AMB (6); 5F-APINACA (1); ADB- 1H-indazole-3-carboxamido)-3- Missouri, Nebraska, New Hampshire, FUBINACA (2); MDMB-CHMICA (4), methylbutanoate [5F-AMB]; N- New Jersey, New Mexico, New York, European Monitoring Centre for Drugs (adamantan-1-yl)-1-(5-fluoropentyl)-1H- North Dakota, Ohio, Oklahoma, Oregon, and Drug Addiction has reported an indazole-3-carboxamide [5F-APINACA, Pennsylvania, South Carolina, additional 12 deaths involving MDMB- 5F-AKB48]; N-(1-amino-3,3-dimethyl-1- Tennessee, Texas, Utah, Virginia, CHMICA; and MDMB-FUBINACA (1) oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- Wisconsin, and Wyoming. (see factor 6 in ‘‘Supporting and Related indazole-3-carboxamide [ADB- 5F-APINACA: NFLIS—1,936 reports, Material’’). FUBINACA]; methyl 2-(1- first encountered in August 2012, (cyclohexylmethyl)-1H-indole-3- locations include: Alabama, Arizona, Finding of Necessity of Schedule I carboxamido)-3,3-dimethylbutanoate Arkansas, California, Colorado, Placement To Avoid Imminent Hazard [MDMB-CHMICA, MMB-CHMINACA] Connecticut, Florida, Georgia, Idaho, to Public Safety and methyl 2-(1-(4-fluorobenzyl)-1H- indazole-3-carboxamido)-3,3- Illinois, Indiana, Iowa, Kansas, In accordance with 21 U.S.C. Kentucky, Louisiana, Maryland, dimethylbutanoate [MDMB-FUBINACA] 811(h)(3), based on the available data Minnesota, Mississippi, Missouri, in schedule I of the CSA, and finds that and information summarized above, the Nebraska, New Hampshire, New Jersey, the placement of these substances into continued uncontrolled manufacture, North Dakota, Ohio, Oklahoma, schedule I of the CSA on a temporary Pennsylvania, Puerto Rico, South distribution, importation, exportation, basis is necessary to avoid an imminent Carolina, Tennessee, Texas, Utah, conduct of research and chemical hazard to the public safety. Virginia, West Virginia, Wisconsin, and analysis, possession, and abuse of 5F- Because the Administrator hereby Wyoming. ADB, 5F-AMB, 5F-APINACA, ADB- finds that it is necessary to temporarily ADB-FUBINACA: NFLIS—942 FUBINACA, MDMB-CHMICA and place these SCs into schedule I to avoid reports, first encountered in March MDMB-FUBINACA pose an imminent an imminent hazard to the public safety, 2014, locations include: Arkansas, hazard to the public safety. The DEA is any subsequent final order temporarily California, Colorado, Florida, Georgia, not aware of any currently accepted scheduling these substances will be Illinois, Indiana, Iowa, Kansas, medical uses for these substances in the effective on the date of publication in Kentucky, Louisiana, Maryland, United States. A substance meeting the the Federal Register, and will be in Mississippi, Missouri, New Jersey, New statutory requirements for temporary effect for a period of two years, with a Mexico, New York, North Dakota, Ohio, scheduling, 21 U.S.C. 811(h)(1), may possible extension of one additional Pennsylvania, Texas, Utah, Virginia, only be placed in schedule I. Substances year, pending completion of the regular and Wyoming. in schedule I are those that have a high (permanent) scheduling process. 21 MDMB-CHMICA: NFLIS—227 reports, potential for abuse, no currently U.S.C. 811(h)(1) and (2). It is the first encountered in March 2015, accepted medical use in treatment in the intention of the Administrator to issue locations include: Arkansas, Georgia, United States, and a lack of accepted such a final order as soon as possible after the expiration of 30 days from the Indiana, Kentucky, Louisiana, Nevada, safety for use under medical date of publication of this notice. 5F- Ohio, Oklahoma, South Carolina, and supervision. Available data and ADB, 5F-AMB, 5F-APINACA, ADB- Texas. information for 5F-ADB, 5F-AMB, 5F- MDMB-FUBINACA: NFLIS—507 FUBINACA, MDMB-CHMICA and APINACA, ADB-FUBINACA, MDMB- MDMB-FUBINACA will then be subject reports, first encountered in July 2015, CHMICA and MDMB-FUBINACA locations include: Arkansas, California, to the regulatory controls and indicate that these SCs have a high Colorado, Connecticut, Georgia, Idaho, administrative, civil, and criminal potential for abuse, no currently Indiana, Kansas, Kentucky, Louisiana, sanctions applicable to the manufacture, accepted medical use in treatment in the Missouri, Nevada, New Jersey, New distribution, importation, exportation, United States, and a lack of accepted Mexico, North Dakota, Ohio, Oklahoma, research, conduct of instructional Pennsylvania, Texas, Virginia, safety for use under medical activities, and chemical analysis and Wisconsin, and West Virginia. supervision. As required by section possession of a schedule I controlled 201(h)(4) of the CSA, 21 U.S.C. substance. Factor 6. What, if Any, Risk There Is to 811(h)(4), the Administrator, through a The CSA sets forth specific criteria for the Public Health letter dated April 22, 2016, notified the scheduling a drug or other substance. 5F-ADB, 5F-AMB, 5F-APINACA, Assistant Secretary of the DEA’s Regular scheduling actions in ADB-FUBINACA, MDMB-CHMICA and intention to temporarily place these six accordance with 21 U.S.C. 811(a) are MDMB-FUBINACA have all been substances in schedule I. subject to formal rulemaking procedures

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done ‘‘on the record after opportunity section 553 of the Administrative by Executive Order 12866 (Regulatory for a hearing’’ conducted pursuant to Procedure Act (APA), 5 U.S.C. 553, do Planning and Review), section 3(f), and, the provisions of 5 U.S.C. 556 and 557. not apply to this notice of intent. In the accordingly, this action has not been 21 U.S.C. 811. The regular scheduling alternative, even assuming that this reviewed by the Office of Management process of formal rulemaking affords notice of intent might be subject to and Budget. interested parties with appropriate section 553 of the APA, the This action will not have substantial process and the government with any Administrator finds that there is good direct effects on the States, on the additional relevant information needed cause to forgo the notice and comment relationship between the national to make a determination. Final requirements of section 553, as any government and the States, or on the decisions that conclude the regular further delays in the process for distribution of power and scheduling process of formal issuance of temporary scheduling orders responsibilities among the various rulemaking are subject to judicial would be impracticable and contrary to levels of government. Therefore, in review. 21 U.S.C. 877. Temporary the public interest in view of the accordance with Executive Order 13132 scheduling orders are not subject to manifest urgency to avoid an imminent (Federalism) it is determined that this judicial review. 21 U.S.C. 811(h)(6). hazard to the public safety. action does not have sufficient Although the DEA believes this notice Regulatory Matters federalism implications to warrant the of intent to issue a temporary preparation of a Federalism Assessment. Section 201(h) of the CSA, 21 U.S.C. scheduling order is not subject to the 811(h), provides for an expedited notice and comment requirements of List of Subjects in 21 CFR Part 1308 temporary scheduling action where section 553 of the APA, the DEA notes Administrative practice and such action is necessary to avoid an that in accordance with 21 U.S.C. procedure, Drug traffic control, imminent hazard to the public safety. 811(h)(4), the Administrator will take Reporting and recordkeeping As provided in this subsection, the into consideration any comments requirements. Attorney General may, by order, submitted by the Assistant Secretary For the reasons set out above, the DEA schedule a substance in schedule I on a with regard to the proposed temporary proposes to amend 21 CFR part 1308 as temporary basis. Such an order may not scheduling order. be issued before the expiration of 30 Further, the DEA believes that this follows: days from (1) the publication of a notice temporary scheduling action is not a PART 1308—SCHEDULES OF in the Federal Register of the intention ‘‘rule’’ as defined by 5 U.S.C. 601(2), CONTROLLED SUBSTANCES to issue such order and the grounds and, accordingly, is not subject to the upon which such order is to be issued, requirements of the Regulatory ■ 1. The authority citation for part 1308 and (2) the date that notice of the Flexibility Act (RFA). The requirements continues to read as follows: proposed temporary scheduling order is for the preparation of an initial transmitted to the Assistant Secretary. regulatory flexibility analysis in 5 U.S.C. Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 21 U.S.C. 811(h)(1). 603(a) are not applicable where, as here, Inasmuch as section 201(h) of the the DEA is not required by section 553 ■ 2. In § 1308.11, add paragraph (h)(23) CSA directs that temporary scheduling of the APA or any other law to publish through (28) to read as follows: actions be issued by order and sets forth a general notice of proposed the procedures by which such orders are rulemaking. § 1308.11 Schedule I to be issued, the DEA believes that the Additionally, this action is not a * * * * * notice and comment requirements of significant regulatory action as defined (h) * * *

(23) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-ADB; 5F-MDMB-PINACA) ...... (7034) (24) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-AMB) ...... (7033) (25) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-APINACA, 5F-AKB48) ...... (7049) (26) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: ADB-FUBINACA) ...... (7010) (27) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric iso- mers, salts and salts of isomers (Other names: MDMB-CHMICA, MMB-CHMINACA) ...... (7042) (28) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB-FUBINACA) ...... (7020)

* * * * * DEPARTMENT OF LABOR ACTION: Request for information; Dated: December 13, 2016. reopening of the comment period. Mine Safety and Health Administration Chuck Rosenberg, SUMMARY: In response to requests from Acting Administrator. 30 CFR Parts 57, 70, 72, and 75 the public, the Mine Safety and Health [FR Doc. 2017–00275 Filed 1–6–17; 8:45 am] Administration (MSHA) is reopening [Docket No. MSHA–2014–0031] BILLING CODE 4410–09–P the proposed rulemaking record for RIN 1219–AB86 public comment on the Agency’s request for information on Exposure of Exposure of Underground Miners to Underground Miners to Diesel Exhaust. Diesel Exhaust DATES: The comment period for the AGENCY: Mine Safety and Health request for information, published on Administration, Labor. June 8, 2016 (81 FR 36826), and closed

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