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telephone +33 5 61 93 36 96; fax +33 5 61 Management System will not accept Administration; Mailing Address: 8701 93 44 51; email account.airworth-eas@ comments after 11:59 p.m. Eastern Time Morrissette Drive, Springfield, Virginia airbus.com; Internet http://www.airbus.com. on the last day of the comment period. 22152; Telephone: (202) 598–6812. You may view this service information at the Interested persons, defined at 21 CFR FAA, Transport Airplane Directorate, 1601 SUPPLEMENTARY INFORMATION: Lind Avenue SW., Renton, WA. For 1300.01 as those ‘‘adversely affected or information on the availability of this aggrieved by any rule or proposed rule Posting of Public Comments material at the FAA, call 425–227–1221. issuable pursuant to section 201 of the Act (21 U.S.C. 811),’’ may file a request Please note that all comments Issued in Renton, Washington, on April 30, 2015. for hearing, notice of appearance, or received are considered part of the waiver of hearing pursuant to 21 CFR public record. They will, unless Michael Kaszycki, 1308.44 and in accordance with 21 CFR reasonable cause is given, be made Acting Manager, Transport Airplane 1316.45, 1316.47, 1316.48, or 1316.49, Directorate, Aircraft Certification Service. available by the Drug Enforcement as applicable. Requests for hearing, Administration (DEA) for public [FR Doc. 2015–11554 Filed 5–13–15; 8:45 am] notices of appearance, and waivers of an inspection online at http:// BILLING CODE 4910–13–P opportunity for a hearing or to www.regulations.gov. Such information participate in a hearing must be includes personal identifying received on or before June 15, 2015. information (such as your name, DEPARTMENT OF JUSTICE ADDRESSES: To ensure proper handling address, etc.) voluntarily submitted by Drug Enforcement Administration of comments, please reference ‘‘Docket the commenter. The Freedom of No. DEA–417N’’ on all correspondence, Information Act (FOIA) applies to all including any attachments. 21 CFR Part 1308 • comments received. If you want to Electronic comments: The Drug submit personal identifying information [Docket No. DEA–417N] Enforcement Administration encourages (such as your name, address, etc.) as that all comments be submitted part of your comment, but do not want Schedules of Controlled Substances: electronically through the Federal it to be made publicly available, you Placement of UR–144, XLR11, and eRulemaking Portal, which provides the must include the phrase ‘‘PERSONAL AKB48 Into Schedule I ability to type short comments directly IDENTIFYING INFORMATION’’ in the AGENCY: Drug Enforcement into the comment field on the Web page or to attach a file for lengthier first paragraph of your comment. You Administration, Department of Justice. must also place all of the personal ACTION: Notice of proposed rulemaking. comments. Please go to http:// www.regulations.gov and follow the identifying information you do not want SUMMARY: The Drug Enforcement online instructions at that site for made publicly available in the first Administration (DEA) proposes placing submitting comments. Upon completion paragraph of your comment and identify (1-pentyl-1H-indol-3-yl)(2,2,3,3- of your submission you will receive a what information you want redacted. tetramethylcyclopropyl)methanone Comment Tracking Number for your If you want to submit confidential (UR–144), [1-(5-fluoro-pentyl)-1H-indol- comment. Please be aware that business information as part of your 3-yl](2,2,3,3- submitted comments are not comment, but do not want it to be made tetramethylcyclopropyl)methanone (5- instantaneously available for public publicly available, you must include the fluoro-UR–144, XLR11), and N-(1- view on Regulations.gov. If you have phrase ‘‘CONFIDENTIAL BUSINESS adamantyl)-1-pentyl-1H-indazole-3- received a Comment Tracking Number, INFORMATION’’ in the first paragraph carboxamide (APINACA, AKB48) your comment has been successfully of your comment. You must also including their salts, isomers, and salts submitted and there is no need to prominently identify confidential of isomers whenever the existence of resubmit the same comment. business information to be redacted such salts, isomers, and salts of isomers • Paper comments: Paper comments within the comment. is possible, into schedule I of the that duplicate the electronic submission Controlled Substances Act. This are not necessary and are discouraged. Comments containing personal proposed scheduling action is pursuant Should you wish to mail a paper identifying information and confidential to the Controlled Substance Act which comment in lieu of an electronic business information identified as requires that such actions be made on comment, it should be sent via regular directed above will generally be made the record after opportunity for a or express mail to: Drug Enforcement publicly available in redacted form. If a hearing through formal rulemaking. If Administration, Attn: DEA Federal comment has so much confidential finalized, this action would impose the Register Representative/ODXL, 8701 business information or personal regulatory controls and administrative, Morrissette Drive, Springfield, Virginia identifying information that it cannot be civil, and criminal sanctions applicable 22152. effectively redacted, all or part of that • to schedule I controlled substances on Hearing requests: All requests for comment may not be made publicly persons who handle (manufacture, hearing and waivers of participation available. Comments posted to http:// distribute, import, export, engage in must be sent to: Drug Enforcement www.regulations.gov may include any research, conduct instructional Administration, Attn: Federal Register personal identifying information (such activities, or possess), or propose to Representative/ODL, 8701 Morrissette as name, address, and phone number) handle UR–144, XLR11, or AKB48. Drive, Springfield, Virginia 22152. All included in the text of your electronic requests for hearing and waivers of DATES: Interested persons may file submission that is not identified as participation should also be sent to: written comments on this proposal in directed above as confidential. accordance with 21 CFR 1308.43(g). Drug Enforcement Administration, Attn: Electronic comments must be Hearing Clerk/LJ, 8701 Morrissette An electronic copy of this document submitted, and written comments must Drive, Springfield, Virginia 22152. and supplemental information to this be postmarked, on or before June 15, FOR FURTHER INFORMATION CONTACT: John proposed rule are available at http:// 2015. Commenters should be aware that R. Scherbenske, Office of Diversion www.regulations.gov for easy reference. the electronic Federal Docket Control, Drug Enforcement

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Request for Hearing, Notice of substances and listed chemicals into the Background Appearance at Hearing, Waiver of an illicit market while providing for the On April 12, 2013, the Deputy Opportunity for a Hearing or To legitimate medical, scientific, research, Administrator of the DEA published a Participate in a Hearing and industrial needs of the United Notice of Intent to temporarily place (1- Pursuant to 21 U.S.C. 811(a), this States. Controlled substances have the pentyl-1H-indol-3-yl)(2,2,3,3- action is a formal rulemaking ‘‘on the potential for abuse and dependence and tetramethylcyclopropyl)methanone record after opportunity for a hearing.’’ are controlled to protect the public (UR–144), [1-(5-fluoro-pentyl)-1H-indol- Such proceedings are conducted health and safety. 3-yl](2,2,3,3- pursuant to the provisions of the Under the CSA, each controlled tetramethylcyclopropyl)methanone (5- Administrative Procedure Act (APA), 5 substance is classified into one of five fluoro-UR–144, XLR11), and N-(1- U.S.C. 551–559. 21 CFR 1308.41– schedules based upon its potential for adamantyl)-1-pentyl-1H-indazole-3- 1308.45; 21 CFR part 1316, subpart D. abuse, its currently accepted medical carboxamide (APINACA, AKB48) into In accordance with 21 CFR 1308.44 (a)– use in treatment in the United States, schedule I pursuant to the temporary (c), requests for hearing, notices of and the degree of dependence the scheduling provisions of the CSA (78 FR appearance, and waivers of an substance may cause. 21 U.S.C. 812. The 21858). On May 16, 2013, the Deputy opportunity for a hearing or to initial schedules of controlled Administrator of the DEA published a participate in a hearing may be substances established by Congress are Final Order in the Federal Register (78 FR 28735) amending 21 CFR 1308.11(h) submitted only by interested persons, found at 21 U.S.C. 812(c) and the to temporarily place these three defined as those ‘‘adversely affected or current list of scheduled substances is synthetic into schedule I aggrieved by any rule or proposed rule published at 21 CFR part 1308. 21 of the CSA pursuant to the temporary issuable pursuant to section 201 of the U.S.C. 812(a). Act (21 U.S.C. 811).’’ 21 CFR 1300.01. scheduling provisions of 21 U.S.C. Such requests or notices must conform Pursuant to 21 U.S.C. 811(a)(1), the 811(h). That Final Order, which became to the requirements of 21 CFR 1308.44 Attorney General may, by rule, ‘‘add to effective on the date of publication, was (a) or (b), and 1316.47 or 1316.48, as such a schedule or transfer between based on findings by the Deputy applicable, and include a statement of such schedules any drug or other Administrator of the DEA that the interest of the person in the proceeding substance if he . . . finds that such drug temporary scheduling of these three and the objections or issues, if any, or other substance has a potential for was necessary to concerning which the person desires to abuse, and . . . makes with respect to avoid an imminent hazard to the public be heard. Any waiver must conform to such drug or other substance the safety pursuant to 21 U.S.C. 811(h)(1). the requirements of 21 CFR 1308.44(c) findings prescribed by subsection (b) of At the time the Final Order took effect, and 1316.49, including a written section 812 of this title for the schedule Section 201(h)(2) of the CSA (21 U.S.C. statement regarding the interested in which such drug is to be placed . . . 811(h)(2)) required that the temporary person’s position on the matters of fact .’’ The Attorney General has delegated scheduling of a substance expire at the and law involved in any hearing. scheduling authority under 21 U.S.C. end of two years from the date of Please note that pursuant to 21 U.S.C. 811 to the Administrator of the DEA. 28 issuance of the scheduling order, and it 811(a), the purpose and subject matter CFR 0.100. provided that, during the pendency of of a hearing is restricted to: ‘‘find[ing] The CSA provides that proceedings proceedings under 21 U.S.C. 811(a)(1) that such drug or other substance has a for the issuance, amendment, or repeal with respect to the substance, temporary scheduling of that substance could be potential for abuse, and . . . mak[ing] of the scheduling of any drug or other extended for up to 1 year. Pursuant to with respect to such drug or other substance may be initiated by the substance the findings prescribed by 21 U.S.C. 811(h)(2), the temporary Attorney General (1) on her own subsection (b) of section 812 of this title scheduling of UR–144, XLR11, and motion; (2) at the request of the for the schedule in which such drug is AKB48 expires on May 15, 2015, unless Secretary of the Department of Health to be placed . . .’’ All requests for extended. An extension of the and Human Services (HHS),1 or (3) on hearing and waivers of participation temporary order is being ordered by the must be sent to the DEA using the the petition of any interested party. 21 DEA Administrator in a separate action. address information provided above. U.S.C. 811(a). This proposed action is As described in the Final Order supported by a recommendation from published on May 16, 2013, UR–144, Legal Authority the Assistant Secretary of the HHS and XLR11, and AKB48 are synthetic The DEA implements and enforces an evaluation of all other relevant data cannabinoids that are pharmacologically Titles II and III of the Comprehensive by the DEA. If finalized, this action similar to delta 9- Drug Abuse Prevention and Control Act would impose the regulatory controls (D 9–THC) and JWH–018. While UR– of 1970, as amended. 21 U.S.C. 801–971. and administrative, civil, and criminal 144, XLR11, and AKB48 have been used Titles II and III are referred to as the sanctions of schedule I controlled as research chemicals and/or studied ‘‘Controlled Substances Act’’ and the substances on any person who handles, due to their misuse and abuse, based on ‘‘Controlled Substances Import and or proposes to handle, UR–144, XLR11, the review of the scientific literature, Export Act,’’ respectively, and are or AKB48. there are no known medical uses for collectively referred to as the UR–144, XLR11, and AKB48. The ‘‘Controlled Substances Act’’ or the 1 As discussed in a memorandum of Assistant Secretary of Health for the ‘‘CSA’’ for the purposes of this action. understanding entered into by the Food and Drug HHS has advised that there are no Administration (FDA) and the National Institute on 21 U.S.C. 801–971. The DEA publishes Drug Abuse (NIDA), the FDA acts as the lead agency exemptions or approvals in effect for the implementing regulations for these within the HHS in carrying out the Secretary’s UR–144, XLR11, and AKB48 under statutes in title 21 of the Code of Federal scheduling responsibilities under the CSA, with the section 505 (21 U.S.C. 355) of the Regulations (CFR), chapter II. The CSA concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. Federal Food, Drug and Cosmetic Act The Secretary of the HHS has delegated to the and its implementing regulations are Assistant Secretary for Health of the HHS the (FD&C Act). As stated by the HHS, UR– designed to prevent, detect, and authority to make domestic drug scheduling 144, XLR11, and AKB48 have no known eliminate the diversion of controlled recommendations. 58 FR 35460, July 1, 1993. accepted medical use. They are not the

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subject of any approved new drug (4) The drug or drugs containing such a Interest in the various structural classes applications (NDA) or investigational substance are new drugs so related in their was generated by the mouse vas new drug applications (IND), and are action to a drug or drugs already listed as deferens (MVD) and prostaglandin having a potential for abuse to make it likely synthetase activity of and not currently marketed as approved that the drug will have the same potentiality drug products. for abuse as such drugs, thus making it subsequent findings of affinity to the reasonable to assume that there may be receptor. Proposed Determination to Schedule The emergence of synthetic UR–144, XLR11, and AKB48 significant diversions from legitimate channels, significant use contrary to or cannabinoids in the designer drug Pursuant to 21 U.S.C. 811(a)(1), without medical advice, or that it has a market can be traced back to the initial proceedings to add a drug or substance substantial capability of creating hazards to forensic laboratory confirmation in to those controlled under the CSA may the health of the user or to the safety of the December 2008 at a forensic laboratory be initiated by the Attorney General, or community. in Frankfurt, Germany that announced her delegate, the DEA Administrator. On The substances UR–144, XLR11, and the identification of JWH–018 in August 31, 2013, the DEA requested a AKB48 share pharmacological samples of herbal incense, and others scientific and medical evaluation and properties with schedule I substances, shortly thereafter. UR–144 and XLR11 scheduling recommendation from the including D 9–THC and JWH–018. are classified as cyclopropoylindoles Assistant Secretary of Health for the Evaluations in animal models, whereas AKB48 is classified as an HHS for UR–144, XLR11, and AKB48 specifically in drug discrimination indazole-3-carboximide. While UR–144 pursuant to 21 U.S.C. 811(b). Upon studies, have demonstrated that was first developed as a research tool by receipt of the scientific and medical cyclopropoylindoles (such as UR–144 Abbott Laboratories, XLR11 and AKB48 evaluation and scheduling and XLR11) and indazole-3- were not designed for use in the recommendations from the HHS, the carboximides (such as AKB48) produce laboratory and began showing up in DEA reviewed the documents and all D 9–THC-like discriminative stimulus drug seizures in 2011. other relevant data, and conducted its effects. There have also been numerous The DEA is not aware of any currently own eight-factor analysis of the abuse anecdotal self-reports substantiating that accepted medical use or NDAs for UR– potential of UR–144, XLR11, and these substances and their products are 144, XLR11, or AKB48. A letter dated AKB48 pursuant to 21 U.S.C. 811(c). abused by humans for their February 14, 2013, was sent from the Included below is a brief summary of hallucinogenic effects, as well as DEA Deputy Administrator to the each of the eight factors as analyzed by published reports indicating an increase Assistant Secretary for the HHS as the HHS and the DEA, and as in the abuse of these substances. State notification of intent to temporarily considered by the DEA in this proposed public health departments and poison place these three substances into action. Please note that both the DEA control centers have issued warnings in schedule I and solicit comments, and the HHS analyses are available response to adverse health effects including whether there was an under ‘‘Supporting and Related associated with herbal incense products exemption or if an approval was in Material’’ of the public docket for this containing synthetic cannabinoids effect for the substances in question proposed rule at http:// which include: tachycardia, elevated under the FD&C Act. The Assistant www.regulations.gov under docket blood pressure, unconsciousness, Secretary of HHS responded that there number DEA–417N. tremors, seizures, vomiting, were no current INDs or NDAs for these 1. The Drug’s Actual or Relative hallucinations, agitation, anxiety, pallor, synthetic cannabinoids in a letter Potential for Abuse: As described by the numbness, and tingling. Numerous addressed to the DEA Deputy HHS, the abuse potential of UR–144, public health and poison control centers Administrator dated March 14, 2013. In XLR11, and AKB48 is associated with have issued warnings regarding the their recent scheduling their ability to evoke pharmacological abuse of synthetic cannabinoids and recommendation, the HHS reiterated effects similar to those evoked by other their associated products. Law that UR–144, XLR11, and AKB48 have schedule I substances that have a high enforcement has also encountered no known accepted medical use, are not potential for abuse such as D 9–THC and incidents of exposure, primarily in the subject of any approved NDAs or JWH–018. response to the smoking of products INDs, and are not currently marketed as The legislative history of the CSA purported to be laced with these any approved drug products. suggests the DEA consider the following substances. 4. Its History and Current Pattern of factors when determining whether a 2. Scientific Evidence of the Drug’s Abuse: Synthetic cannabinoids were particular drug or substance has a Pharmacological Effects, If Known: As first reported in the United States in a potential for abuse: 2 described by the HHS, UR–144, XLR11, December 2008 encounter, where a and AKB48 have all been shown to bind shipment of ‘‘Spice’’ was seized and (1) There is evidence that individuals are to the cannabinoid 1 (CB1) receptor, act analyzed by U.S. Customs and Border taking the drug or drugs containing such a as agonists at the CB1 receptor, and Protection in Dayton, Ohio. substance in amounts sufficient to create a hazard to their health or to the safety of other substitute fully for the discriminative Additionally, around the same time, in 9 individuals or to the community; stimulus effects of D –THC in the drug December 2008, JWH–018 and (2) There is significant diversion of the discrimination assay. To date, no were being drug or drugs containing such a substance human pharmacological studies identified by German forensic from legitimate drug channels; involving UR–144, XLR11, or AKB48 laboratories. Though these substances (3) Individuals are taking the drug or drugs have been reported. were identified in 2008, these containing such a substance on their own 3. The State of Current Scientific substances likely existed and were initiative rather than on the basis of medical Knowledge Regarding the Drug or Other abused some time prior to their advice from a practitioner licensed by law to Substance: Synthetic cannabinoids identification. administer such drugs in the course of his emerged in the early 1980s. They were Since the initial identification of professional practice; or originally designed to investigate JWH–018 in December 2008, many 2 Comprehensive Drug Abuse Prevention and structure activity relationships (SAR) additional synthetic cannabinoids have Control Act of 1970, H.R. Rep. No. 91–1444, 91st based on the potent substance, 9-nor-9b- been found laced on designer drug Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 4566, 4601. hydroxyhexahydrocannabinol (HHC). products abused for their psychoactive

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effects. The popularity of synthetic December 2014) related to UR–144, describe large variations in the amount cannabinoids has increased XLR11, and AKB48 from 44 states of synthetic cannabinoid laced on the tremendously since January 2010 in the (query date: April 30, 2015). From plant material even within samplings of United States based on seizure exhibits January 1, 2010, through December 31, the same product. These unknowns and media reports. This trend is similar 2014, according to the System to present a significant risk of danger to and consistent with the increased Retrieve Information on Drug Evidence the abusing individuals. Some of the popularity of synthetic cannabinoids in (STRIDE) and STARLiMS data,4 there common clinical effects reported in Europe since 2008. Synthetic were 2,049 reports involving 245 cases emergency rooms in response to the cannabinoids are being encountered in for UR–144, 4,041 reports involving 487 abuse of synthetic cannabinoids most regions of the United States with cases for XLR11, and 201 reports include: vomiting, anxiety, agitation, the substances found as adulterants on involving 63 cases for AKB48 (query irritability, seizures, hallucinations, plant material or being abused alone as date: April 30, 2015). Recently, tachycardia, elevated blood pressure, self-reported on internet discussion numerous exposure incidents have been and loss of consciousness. boards. documented by poison control centers At least one death has been reported Data gathered from published studies, in the United States as the abuse of in Minnesota following ingestion of UR– supplemented by internet discussion synthetic cannabinoids has become 144 and XLR11. In 2013, in California, Web sites, and personal associated with both acute and long- a 27-year-old female developed communications demonstrate that these term public health and safety concerns. hypertension, tachycardia, and products are being abused mainly by The American Association of Poison rhabdomyolisis prior to being intubated smoking for their psychoactive Control Centers (AAPCC) has reported and admitted to the ICU for protection properties and are marketed as ‘‘legal’’ exposure calls corresponding to of the airway following ingestion of a alternatives to marijuana. This products purportedly laced with synthetic cannabinoid product characterization and their reputation as synthetic cannabinoids since 2011, containing XLR11. A 33-year-old-man potent herbal intoxicants increased their although the data provided do not developed acute cerebral ischemia and popularity. These substances alone or generally include biological sample infarction shortly following the use of laced on plant material have the testing that would confirm the specific XLR11. In addition, reports have potential to be extremely harmful due to cannabinoid. AAPCC reported 6,968 detailed various driving under the their method of manufacture and the exposure calls in 2011 and 5,230 calls influence cases where users operated a potency of the substances. Smoking in 2012. While exposure calls decreased motor vehicle while intoxicated with mixtures of these substances for the in 2013 to 2,668, calls involving synthetic cannabinoids, including UR– purpose of achieving intoxication has exposure to a synthetic cannabinoid 144, XLR11, and/or AKB48. resulted in numerous emergency room rebounded in 2014 reaching 3,680. In In February 2013, the Centers for visits and calls to poison control addition, 623 calls have been reported Disease Control (CDC) reported on an centers. Numerous states, local from January 1 through February 28, association between XLR11 exposure jurisdictions, and the international 2015. A majority of exposure incidents and acute kidney injury. The CDC community have also controlled these resulted in seeking medical attention at examined 16 patients with acute kidney health care facilities. In 2010, the substances. injury who reported recent smoking of Substance Abuse and Mental Health Youth appear to be the primary synthetic cannabinoids. Seven of the 16 Services Administration (SAMHSA) abusers of synthetic cannabinoids and patients smoked substances that were reported 11,406 emergency department synthetic cannabinoid-containing positive for XLR11 or its metabolite. In visits involving a synthetic cannabinoid products, as supported by law addition, one of these seven cases also product. In 2011, SAMHSA reported the enforcement encounters and reports tested positive for UR–144. from emergency rooms; however, all age number of emergency department visits involving a synthetic cannabinoid Additional cases reported adverse groups have been discussed in media health effects including nausea, reports as abusing these substances and product had increased 2.5 times to 28,531. vomiting, agitation, panic attacks, related products. More recently, involuntary muscle twitching and clandestinely produced synthetic 6. What, if Any, Risk There is to the Public Health: Law enforcement, confusion following ingestion of UR– cannabinoid products have been 144 and/or XLR11. encountered in liquid forms, and law military, and public health officials 7. Its Psychic or Physiological enforcement has communicated that have reported exposure incidents that Dependence Liability: Chronic abuse of these designer drug products are demonstrate the dangers associated with synthetic cannabinoids has been linked intended for use in electronic cigarettes abuse of synthetic cannabinoids to both to signs of addiction and withdrawal. and vaporizers. the individual abusers and those According to the HHS, the 5. The Scope, Duration, and connected to the misuse and abuse of pharmacologic profiles of UR–144, Significance of Abuse: As stated by the these substances not intended for XLR11, and AKB48 strongly suggest that HHS, based on their pharmacological human use. Warnings regarding the they possess physiological and properties, it is reasonable to assume dangers associated with abuse of psychological dependence liability that that, if uncontrolled, the scope, synthetic cannabinoids and their is similar to that of delta-9- duration, and significance of UR–144, products have been issued by numerous tetrahydrocannabinol (D 9 XLR11, and AKB48 abuse could be state public health departments, poison –THC) similar to marijuana. National Forensic control centers, and private (schedule I) and JWH–018 (schedule I). Laboratory Information Systems organizations. Detailed product analyses Additionally, tolerance to these drugs may develop fairly rapidly with larger (NFLIS),3 a national database capturing 4 doses being required to achieve the data from forensic laboratories, has STRIDE collected the results of drug evidence analyzed at DEA laboratories and reflects evidence desired effect. However, there are no reported 46,324 reports (January 2010 to submitted by the DEA, other Federal law studies or case reports that document enforcement agencies, and some local law 3 NFLIS is a program of the DEA that collects drug enforcement agencies. On October 1, 2014, the psychic or physiological identification results from drug cases analyzed by STARLiMS replaced STRIDE as the DEA laboratory dependence potential of UR–144, other Federal, State, and local forensic laboratories. drug evidence data system of record. XLR11, or AKB48.

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8. Whether the Substance is an Based on these findings, the AKB48 on hand, pursuant to 21 U.S.C. Immediate Precursor of a Substance Administrator of the DEA concludes 827, and in accordance with 21 CFR Already Controlled Under the CSA: UR– that (1-pentyl-1H-indol-3-yl)(2,2,3,3- 1304.03, 1304.04, and 1304.11. 144, XLR11, and AKB48 are not tetramethylcyclopropyl)methanone 6. Records and Reports. Every DEA considered immediate precursors of any (UR–144), [1-(5-fluoro-pentyl)-1H-indol- registrant would be required to maintain controlled substance of the CSA as 3-yl](2,2,3,3- records and submit reports with respect defined by 21 U.S.C 802(23). tetramethylcyclopropyl)methanone (5- to UR–144, XLR11, and/or AKB48 Conclusion: Based on consideration of fluoro-UR–144, XLR11), and N-(1- pursuant to 21 U.S.C. 827 and 958, and the scientific and medical evaluations adamantyl)-1-pentyl-1H-indazole-3- in accordance with 21 CFR parts 1304 and accompanying recommendation of carboxamide (APINACA, AKB48) and 1312. the HHS, and based on the DEA’s including their salts, isomers and salts 7. Order Forms. Every DEA registrant considerations of its own eight-factor of isomers, whenever the existence of who distributes UR–144, XLR11, and/or analysis, the DEA finds that these facts such salts, isomers, and salts of isomers AKB48 would be required to comply and all other relevant data constitute is possible, warrant control in schedule with the order form requirements, substantial evidence of the potential for I of the CSA. 21 U.S.C. 812(b)(1). pursuant to 21 U.S.C. 828, and 21 CFR part 1305. abuse of UR–144, XLR11, and AKB48. Requirements for Handling UR–144, 8. Importation and Exportation. All As such, the DEA hereby proposes to XLR11 and AKB48 schedule UR–144, XLR11, and AKB48 importation and exportation of UR–144, as controlled substances under the CSA. If this rule is finalized as proposed, XLR11, and AKB48 would need to be in persons who handle UR–144, XLR11, or compliance with 21 U.S.C. 952, 953, Proposed Determination of Appropriate AKB48 would continue 5 to be subject to 957, and 958, and in accordance with 21 Schedule the regulatory controls and CFR part 1312. The CSA establishes five schedules of administrative, civil, and criminal 9. Liability. Any activity involving controlled substances known as sanctions applicable to the manufacture, UR–144, XLR11, or AKB48 not schedules I, II, III, IV, and V. The CSA distribution, possession, importing, and authorized by, or in violation of the CSA also outlines the findings required to exporting of schedule I controlled or its implementing regulations would place a drug or other substance in any substances, including those listed be unlawful, and could subject the particular schedule. 21 U.S.C. 812(b). below: person to administrative, civil, and/or After consideration of the analysis and 1. Registration. Any person who criminal sanctions. recommendation of the Assistant handles (manufactures, distributes, Regulatory Analyses Secretary for HHS and review of all imports, exports, engages in research, or other available data, the Administrator conducts instructional activities or Executive Orders 12866 and 13563 chemical analysis with, or possesses) of the DEA, pursuant to 21 U.S.C. 811(a) In accordance with 21 U.S.C. 811(a), and 21 U.S.C. 812(b)(1), finds that: UR–144, XLR11, or AKB48, or who desires to handle UR–144, XLR11, or this proposed scheduling action is (1) (1-pentyl-1H-indol-3-yl)(2,2,3,3- subject to formal rulemaking procedures tetramethylcyclopropyl)methanone AKB48 would be required to be registered with the DEA to conduct such done ‘‘on the record after opportunity (UR–144), [1-(5-fluoro-pentyl)-1H-indol- for a hearing,’’ which are conducted 3-yl](2,2,3,3- activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance pursuant to the provisions of 5 U.S.C. tetramethylcyclopropyl)methanone (5- 556 and 557. The CSA sets forth the fluoro-UR–144, XLR11), and N-(1- with 21 CFR parts 1301 and 1312. 2. Security. UR–144, XLR11, and criteria for scheduling a drug or other adamantyl)-1-pentyl-1H-indazole-3- substance. Such actions are exempt carboxamide (APINACA, AKB48) have a AKB48 would be subject to schedule I security requirements and would need from review by the Office of high potential for abuse that is Management and Budget (OMB) comparable to other schedule I to be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in pursuant to Section 3(d)(1) of Executive substances such as delta-9- Order 12866 and the principles 9 accordance with 21 CFR 1301.71– tetrahydrocannabinol (D –THC) and reaffirmed in Executive Order 13563. JWH–018; 1301.93. (2) (1-pentyl-1H-indol-3-yl)(2,2,3,3- 3. Labeling and Packaging. All labels, Executive Order 12988 tetramethylcyclopropyl)methanone labeling, and packaging for commercial containers of UR–144, XLR11, and This proposed regulation meets the (UR–144), [1-(5-fluoro-pentyl)-1H-indol- applicable standards set forth in 3-yl](2,2,3,3- AKB48 would need to be in compliance with 21 U.S.C. 825 and 958(e), and be sections 3(a) and 3(b)(2) of Executive tetramethylcyclopropyl)methanone (5- Order 12988 to eliminate drafting errors fluoro-UR–144, XLR11), and N-(1- in accordance with 21 CFR part 1302. 4. Quota. Only registered and ambiguity, minimize litigation, adamantyl)-1-pentyl-1H-indazole-3- manufacturers would be permitted to provide a clear legal standard for carboxamide (APINACA, AKB48) have manufacture UR–144, XLR11, or AKB48 affected conduct, and promote no currently accepted medical use in in accordance with a quota assigned simplification and burden reduction. treatment in the United States; and pursuant to 21 U.S.C. 826 and in (3) There is a lack of accepted safety Executive Order 13132 accordance with 21 CFR part 1303. This proposed rulemaking does not for use of (1-pentyl-1H-indol-3- 5. Inventory. Every DEA registrant have federalism implications warranting yl)(2,2,3,3- who possesses any quantity of UR–144, the application of Executive Order tetramethylcyclopropyl)methanone XLR11, and/or AKB48 on the effective 13132. The proposed rule does not have (UR–144), [1-(5-fluoro-pentyl)-1H-indol- date of the final rule would be required substantial direct effects on the States, 3-yl](2,2,3,3- to continue to maintain an inventory of on the relationship between the national tetramethylcyclopropyl)methanone (5- all stocks of UR–144, XLR11, and/or fluoro-UR–144, XLR11) and N-(1- government and the States, or the adamantyl)-1-pentyl-1H-indazole-3- 5 UR–144, XLR11, and AKB48 are currently distribution of power and carboxamide (APINACA, AKB48) under subject to schedule I controls on a temporary basis, responsibilities among the various medical supervision. pursuant to 21 U.S.C. 811(h). levels of government.

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Executive Order 13175 no economic impact on businesses that organizations. An agency may not This proposed rule does not have currently handle UR–144, XLR11, or conduct or sponsor, and a person is not tribal implications warranting the AKB48 for lawful purposes. This required to respond to, a collection of application of Executive Order 13175. It estimate applies to entities large and information unless it displays a does not have substantial direct effects small. Therefore, DEA has concluded currently valid OMB control number. that this proposed rule will not have a on one or more Indian tribes, on the List of Subjects in 21 CFR Part 1308 relationship between the Federal significant effect on a substantial Government and Indian tribes, or on the number of small entities. Administrative practice and procedure, Drug traffic control, distribution of power and Unfunded Mandates Reform Act of 1995 responsibilities between the Federal Reporting and recordkeeping Government and Indian tribes. On the basis of information contained requirements. in the ‘‘Regulatory Flexibility Act’’ Regulatory Flexibility Act For the reasons set out above, 21 CFR section above, the DEA has determined part 1308 is proposed to be amended to The Administrator, in accordance and certifies pursuant to the Unfunded read as follows: with the Regulatory Flexibility Act Mandates Reform Act (UMRA) of 1995 (RFA), 5 U.S.C. 601–602, has reviewed (2 U.S.C. 1501 et seq.), that this action PART 1308—SCHEDULES OF this proposed rule and by approving it would not result in any Federal CONTROLLED SUBSTANCES certifies that it will not have a mandate that may result in the significant economic impact on a expenditure by State, local, and tribal ■ 1. The authority citation for 21 CFR substantial number of small entities. On governments, in the aggregate, or by the part 1308 continues to read as follows: May 16, 2013, the Deputy Administrator private sector, of $100,000,000 or more Authority: 21 U.S.C. 811, 812, 871(b), published a Final Order in the Federal (adjusted for inflation) in any one year. unless otherwise noted. Register (78 FR 28735) amending 21 Therefore, neither a Small Government ■ CFR 1308.11(h) to temporarily place Agency Plan nor any other action is 2. Amend § 1308.11 by: these three synthetic cannabinoids into required under provisions of the UMRA ■ a. Adding paragraphs (g)(16) through schedule I of the CSA pursuant to the of 1995. (18); and temporary scheduling provisions of 21 ■ b. Removing paragraphs (h)(1) through Paperwork Reduction Act of 1995 U.S.C. 811(h). All entities that currently (3) and redesignating paragraphs (h)(4) handle or plan to handle these synthetic This action does not impose a new through (23) as paragraphs (h)(1) cannabinoids are estimated to have collection of information under the through (20), respectively. already established and implemented Paperwork Reduction Act of 1995 (44 The additions read as follows: the systems and processes required to U.S.C. 3501–3521). This action would handle UR–144, XLR11, and AKB48. not impose recordkeeping or reporting § 1308.11 Schedule I. Therefore, the DEA anticipates that this requirements on State or local * * * * * proposed rule will impose minimal or governments, individuals, businesses, or (g) * * *

(16) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR–144) ...... (7144) (17) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR–144, XLR11) ...... (7011) (18) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) ...... (7048)

* * * * * Bucksport, South Carolina during the ADDRESSES: You may submit comments Dated: May 12, 2015. Southeast Drag Boat Championships, a identified by docket number using any Michele M. Leonhart, series of high-speed boat races. The one of the following methods: event is scheduled to take place from 10 (1) Federal eRulemaking Portal: Administrator. a.m. on July 24, 2015, through 6 p.m. on http://www.regulations.gov. [FR Doc. 2015–11762 Filed 5–13–15; 8:45 am] July 26, 2015. Approximately 50 high- (2) Fax: 202–493–2251. BILLING CODE 4410–09–P speed race boats are anticipated to (3) Mail or Delivery: Docket participate in the races. This special Management Facility (M–30), U.S. local regulation is necessary to provide Department of Transportation, West DEPARTMENT OF HOMELAND for the safety of life and property on Building Ground Floor, Room W12–140, SECURITY navigable waters of the United States 1200 New Jersey Avenue SE., during the event. This special local Washington, DC 20590–0001. Deliveries Coast Guard regulation would temporarily restrict accepted between 9 a.m. and 5 p.m., Monday through Friday, except federal 33 CFR Part 100 vessel traffic in a portion of the Atlantic Intracoastal Waterway. Persons and holidays. The telephone number is 202– [Docket Number USCG–2015–0045] vessels that are not participating in the 366–9329. See the ‘‘Public Participation and RIN 1625–AA08 races would be prohibited from entering, transiting through, anchoring Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section Special Local Regulation; Southeast in, or remaining within the restricted area unless authorized by the Captain of below for further instructions on Drag Boat Championships, Atlantic submitting comments. To avoid Intracoastal Waterway; Bucksport, SC the Port Charleston or a designated representative. duplication, please use only one of AGENCY: Coast Guard, DHS. these three methods. ACTION: Notice of proposed rulemaking. DATES: Comments and related material FOR FURTHER INFORMATION CONTACT: If must be received by the Coast Guard on you have questions on this rule, call or SUMMARY: The Coast Guard proposes to or before June 15, 2015. Requests for email Chief Warrant Officer Christopher establish a special local regulation on public meetings must be received by the Ruleman, Sector Charleston Office of the Atlantic Intracoastal Waterway in Coast Guard on or before May 29, 2015. Waterways Management, Coast Guard;

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