80 FR 27611 - Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 93 (May 14, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 93 (May 14, 2015)
| Page Range | 27611-27616 | |
| FR Document | 2015-11762 |
[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)] [Proposed Rules] [Pages 27611-27616] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11762] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-417N] Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) proposes placing (1- pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR- 144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1- adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substance Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities, or possess), or propose to handle UR- 144, XLR11, or AKB48. DATES: Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before June 15, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),'' may file a request for hearing, notice of appearance, or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as applicable. Requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before June 15, 2015. ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-417N'' on all correspondence, including any attachments.Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Hearing requests: All requests for hearing and waivers of participation must be sent to: Drug Enforcement Administration, Attn: Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing and waivers of participation should also be sent to: Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document and supplemental information to this proposed rule are available at http://www.regulations.gov for easy reference. [[Page 27612]] Request for Hearing, Notice of Appearance at Hearing, Waiver of an Opportunity for a Hearing or To Participate in a Hearing Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking ``on the record after opportunity for a hearing.'' Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44 (a)-(c), requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).'' 21 CFR 1300.01. Such requests or notices must conform to the requirements of 21 CFR 1308.44 (a) or (b), and 1316.47 or 1316.48, as applicable, and include a statement of interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) and 1316.49, including a written statement regarding the interested person's position on the matters of fact and law involved in any hearing. Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of a hearing is restricted to: ``find[ing] that such drug or other substance has a potential for abuse, and . . . mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . .'' All requests for hearing and waivers of participation must be sent to the DEA using the address information provided above. Legal Authority The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, and are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purposes of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a). Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, ``add to such a schedule or transfer between such schedules any drug or other substance if he . . . finds that such drug or other substance has a potential for abuse, and . . . makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . . .'' The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS),\1\ or (3) on the petition of any interested party. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the Assistant Secretary of the HHS and an evaluation of all other relevant data by the DEA. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles, or proposes to handle, UR-144, XLR11, or AKB48. --------------------------------------------------------------------------- \1\ As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. --------------------------------------------------------------------------- Background On April 12, 2013, the Deputy Administrator of the DEA published a Notice of Intent to temporarily place (1-pentyl-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H- indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) into schedule I pursuant to the temporary scheduling provisions of the CSA (78 FR 21858). On May 16, 2013, the Deputy Administrator of the DEA published a Final Order in the Federal Register (78 FR 28735) amending 21 CFR 1308.11(h) to temporarily place these three synthetic cannabinoids into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). That Final Order, which became effective on the date of publication, was based on findings by the Deputy Administrator of the DEA that the temporary scheduling of these three synthetic cannabinoids was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). At the time the Final Order took effect, Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) required that the temporary scheduling of a substance expire at the end of two years from the date of issuance of the scheduling order, and it provided that, during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, temporary scheduling of that substance could be extended for up to 1 year. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of UR- 144, XLR11, and AKB48 expires on May 15, 2015, unless extended. An extension of the temporary order is being ordered by the DEA Administrator in a separate action. As described in the Final Order published on May 16, 2013, UR-144, XLR11, and AKB48 are synthetic cannabinoids that are pharmacologically similar to delta 9-tetrahydrocannabinol ([Delta] \9\-THC) and JWH-018. While UR-144, XLR11, and AKB48 have been used as research chemicals and/or studied due to their misuse and abuse, based on the review of the scientific literature, there are no known medical uses for UR-144, XLR11, and AKB48. The Assistant Secretary of Health for the HHS has advised that there are no exemptions or approvals in effect for UR-144, XLR11, and AKB48 under section 505 (21 U.S.C. 355) of the Federal Food, Drug and Cosmetic Act (FD&C Act). As stated by the HHS, UR-144, XLR11, and AKB48 have no known accepted medical use. They are not the [[Page 27613]] subject of any approved new drug applications (NDA) or investigational new drug applications (IND), and are not currently marketed as approved drug products. Proposed Determination to Schedule UR-144, XLR11, and AKB48 Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or substance to those controlled under the CSA may be initiated by the Attorney General, or her delegate, the DEA Administrator. On August 31, 2013, the DEA requested a scientific and medical evaluation and scheduling recommendation from the Assistant Secretary of Health for the HHS for UR-144, XLR11, and AKB48 pursuant to 21 U.S.C. 811(b). Upon receipt of the scientific and medical evaluation and scheduling recommendations from the HHS, the DEA reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of UR-144, XLR11, and AKB48 pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each of the eight factors as analyzed by the HHS and the DEA, and as considered by the DEA in this proposed action. Please note that both the DEA and the HHS analyses are available under ``Supporting and Related Material'' of the public docket for this proposed rule at http://www.regulations.gov under docket number DEA-417N. 1. The Drug's Actual or Relative Potential for Abuse: As described by the HHS, the abuse potential of UR-144, XLR11, and AKB48 is associated with their ability to evoke pharmacological effects similar to those evoked by other schedule I substances that have a high potential for abuse such as [Delta] \9\-THC and JWH-018. The legislative history of the CSA suggests the DEA consider the following factors when determining whether a particular drug or substance has a potential for abuse: \2\ --------------------------------------------------------------------------- \2\ Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 4566, 4601. (1) There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; (2) There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; (3) Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or (4) The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community. The substances UR-144, XLR11, and AKB48 share pharmacological properties with schedule I substances, including [Delta] \9\-THC and JWH-018. Evaluations in animal models, specifically in drug discrimination studies, have demonstrated that cyclopropoylindoles (such as UR-144 and XLR11) and indazole-3-carboximides (such as AKB48) produce [Delta] \9\-THC-like discriminative stimulus effects. There have also been numerous anecdotal self-reports substantiating that these substances and their products are abused by humans for their hallucinogenic effects, as well as published reports indicating an increase in the abuse of these substances. State public health departments and poison control centers have issued warnings in response to adverse health effects associated with herbal incense products containing synthetic cannabinoids which include: tachycardia, elevated blood pressure, unconsciousness, tremors, seizures, vomiting, hallucinations, agitation, anxiety, pallor, numbness, and tingling. Numerous public health and poison control centers have issued warnings regarding the abuse of synthetic cannabinoids and their associated products. Law enforcement has also encountered incidents of exposure, primarily in response to the smoking of products purported to be laced with these substances. 2. Scientific Evidence of the Drug's Pharmacological Effects, If Known: As described by the HHS, UR-144, XLR11, and AKB48 have all been shown to bind to the cannabinoid 1 (CB1) receptor, act as agonists at the CB1 receptor, and substitute fully for the discriminative stimulus effects of [Delta] \9\-THC in the drug discrimination assay. To date, no human pharmacological studies involving UR-144, XLR11, or AKB48 have been reported. 3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: Synthetic cannabinoids emerged in the early 1980s. They were originally designed to investigate structure activity relationships (SAR) based on the potent substance, 9-nor-9[beta]- hydroxyhexahydrocannabinol (HHC). Interest in the various structural classes was generated by the mouse vas deferens (MVD) and prostaglandin synthetase activity of pravadoline and subsequent findings of affinity to the cannabinoid receptor. The emergence of synthetic cannabinoids in the designer drug market can be traced back to the initial forensic laboratory confirmation in December 2008 at a forensic laboratory in Frankfurt, Germany that announced the identification of JWH-018 in samples of herbal incense, and others shortly thereafter. UR-144 and XLR11 are classified as cyclopropoylindoles whereas AKB48 is classified as an indazole-3- carboximide. While UR-144 was first developed as a research tool by Abbott Laboratories, XLR11 and AKB48 were not designed for use in the laboratory and began showing up in drug seizures in 2011. The DEA is not aware of any currently accepted medical use or NDAs for UR-144, XLR11, or AKB48. A letter dated February 14, 2013, was sent from the DEA Deputy Administrator to the Assistant Secretary for the HHS as notification of intent to temporarily place these three substances into schedule I and solicit comments, including whether there was an exemption or if an approval was in effect for the substances in question under the FD&C Act. The Assistant Secretary of HHS responded that there were no current INDs or NDAs for these synthetic cannabinoids in a letter addressed to the DEA Deputy Administrator dated March 14, 2013. In their recent scheduling recommendation, the HHS reiterated that UR-144, XLR11, and AKB48 have no known accepted medical use, are not the subject of any approved NDAs or INDs, and are not currently marketed as any approved drug products. 4. Its History and Current Pattern of Abuse: Synthetic cannabinoids were first reported in the United States in a December 2008 encounter, where a shipment of ``Spice'' was seized and analyzed by U.S. Customs and Border Protection in Dayton, Ohio. Additionally, around the same time, in December 2008, JWH-018 and cannabicyclohexanol were being identified by German forensic laboratories. Though these substances were identified in 2008, these substances likely existed and were abused some time prior to their identification. Since the initial identification of JWH-018 in December 2008, many additional synthetic cannabinoids have been found laced on designer drug products abused for their psychoactive [[Page 27614]] effects. The popularity of synthetic cannabinoids has increased tremendously since January 2010 in the United States based on seizure exhibits and media reports. This trend is similar and consistent with the increased popularity of synthetic cannabinoids in Europe since 2008. Synthetic cannabinoids are being encountered in most regions of the United States with the substances found as adulterants on plant material or being abused alone as self-reported on internet discussion boards. Data gathered from published studies, supplemented by internet discussion Web sites, and personal communications demonstrate that these products are being abused mainly by smoking for their psychoactive properties and are marketed as ``legal'' alternatives to marijuana. This characterization and their reputation as potent herbal intoxicants increased their popularity. These substances alone or laced on plant material have the potential to be extremely harmful due to their method of manufacture and the potency of the substances. Smoking mixtures of these substances for the purpose of achieving intoxication has resulted in numerous emergency room visits and calls to poison control centers. Numerous states, local jurisdictions, and the international community have also controlled these substances. Youth appear to be the primary abusers of synthetic cannabinoids and synthetic cannabinoid-containing products, as supported by law enforcement encounters and reports from emergency rooms; however, all age groups have been discussed in media reports as abusing these substances and related products. More recently, clandestinely produced synthetic cannabinoid products have been encountered in liquid forms, and law enforcement has communicated that these designer drug products are intended for use in electronic cigarettes and vaporizers. 5. The Scope, Duration, and Significance of Abuse: As stated by the HHS, based on their pharmacological properties, it is reasonable to assume that, if uncontrolled, the scope, duration, and significance of UR-144, XLR11, and AKB48 abuse could be similar to marijuana. National Forensic Laboratory Information Systems (NFLIS),\3\ a national database capturing data from forensic laboratories, has reported 46,324 reports (January 2010 to December 2014) related to UR-144, XLR11, and AKB48 from 44 states (query date: April 30, 2015). From January 1, 2010, through December 31, 2014, according to the System to Retrieve Information on Drug Evidence (STRIDE) and STARLiMS data,\4\ there were 2,049 reports involving 245 cases for UR-144, 4,041 reports involving 487 cases for XLR11, and 201 reports involving 63 cases for AKB48 (query date: April 30, 2015). Recently, numerous exposure incidents have been documented by poison control centers in the United States as the abuse of synthetic cannabinoids has become associated with both acute and long-term public health and safety concerns. The American Association of Poison Control Centers (AAPCC) has reported exposure calls corresponding to products purportedly laced with synthetic cannabinoids since 2011, although the data provided do not generally include biological sample testing that would confirm the specific cannabinoid. AAPCC reported 6,968 exposure calls in 2011 and 5,230 calls in 2012. While exposure calls decreased in 2013 to 2,668, calls involving exposure to a synthetic cannabinoid rebounded in 2014 reaching 3,680. In addition, 623 calls have been reported from January 1 through February 28, 2015. A majority of exposure incidents resulted in seeking medical attention at health care facilities. In 2010, the Substance Abuse and Mental Health Services Administration (SAMHSA) reported 11,406 emergency department visits involving a synthetic cannabinoid product. In 2011, SAMHSA reported the number of emergency department visits involving a synthetic cannabinoid product had increased 2.5 times to 28,531. --------------------------------------------------------------------------- \3\ NFLIS is a program of the DEA that collects drug identification results from drug cases analyzed by other Federal, State, and local forensic laboratories. \4\ STRIDE collected the results of drug evidence analyzed at DEA laboratories and reflects evidence submitted by the DEA, other Federal law enforcement agencies, and some local law enforcement agencies. On October 1, 2014, STARLiMS replaced STRIDE as the DEA laboratory drug evidence data system of record. --------------------------------------------------------------------------- 6. What, if Any, Risk There is to the Public Health: Law enforcement, military, and public health officials have reported exposure incidents that demonstrate the dangers associated with abuse of synthetic cannabinoids to both the individual abusers and those connected to the misuse and abuse of these substances not intended for human use. Warnings regarding the dangers associated with abuse of synthetic cannabinoids and their products have been issued by numerous state public health departments, poison control centers, and private organizations. Detailed product analyses describe large variations in the amount of synthetic cannabinoid laced on the plant material even within samplings of the same product. These unknowns present a significant risk of danger to the abusing individuals. Some of the common clinical effects reported in emergency rooms in response to the abuse of synthetic cannabinoids include: vomiting, anxiety, agitation, irritability, seizures, hallucinations, tachycardia, elevated blood pressure, and loss of consciousness. At least one death has been reported in Minnesota following ingestion of UR-144 and XLR11. In 2013, in California, a 27-year-old female developed hypertension, tachycardia, and rhabdomyolisis prior to being intubated and admitted to the ICU for protection of the airway following ingestion of a synthetic cannabinoid product containing XLR11. A 33-year-old-man developed acute cerebral ischemia and infarction shortly following the use of XLR11. In addition, reports have detailed various driving under the influence cases where users operated a motor vehicle while intoxicated with synthetic cannabinoids, including UR-144, XLR11, and/or AKB48. In February 2013, the Centers for Disease Control (CDC) reported on an association between XLR11 exposure and acute kidney injury. The CDC examined 16 patients with acute kidney injury who reported recent smoking of synthetic cannabinoids. Seven of the 16 patients smoked substances that were positive for XLR11 or its metabolite. In addition, one of these seven cases also tested positive for UR-144. Additional cases reported adverse health effects including nausea, vomiting, agitation, panic attacks, involuntary muscle twitching and confusion following ingestion of UR-144 and/or XLR11. 7. Its Psychic or Physiological Dependence Liability: Chronic abuse of synthetic cannabinoids has been linked to signs of addiction and withdrawal. According to the HHS, the pharmacologic profiles of UR-144, XLR11, and AKB48 strongly suggest that they possess physiological and psychological dependence liability that is similar to that of delta-9- tetrahydrocannabinol ([Delta] \9\-THC) (schedule I) and JWH-018 (schedule I). Additionally, tolerance to these drugs may develop fairly rapidly with larger doses being required to achieve the desired effect. However, there are no studies or case reports that document the psychic or physiological dependence potential of UR-144, XLR11, or AKB48. [[Page 27615]] 8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA: UR-144, XLR11, and AKB48 are not considered immediate precursors of any controlled substance of the CSA as defined by 21 U.S.C 802(23). Conclusion: Based on consideration of the scientific and medical evaluations and accompanying recommendation of the HHS, and based on the DEA's considerations of its own eight-factor analysis, the DEA finds that these facts and all other relevant data constitute substantial evidence of the potential for abuse of UR-144, XLR11, and AKB48. As such, the DEA hereby proposes to schedule UR-144, XLR11, and AKB48 as controlled substances under the CSA. Proposed Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that: (1) (1-pentyl-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H- indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol ([Delta] \9\-THC) and JWH-018; (2) (1-pentyl-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H- indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) have no currently accepted medical use in treatment in the United States; and (3) There is a lack of accepted safety for use of (1-pentyl-1H- indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5- fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3- carboxamide (APINACA, AKB48) under medical supervision. Based on these findings, the Administrator of the DEA concludes that (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1- adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) including their salts, isomers and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1). Requirements for Handling UR-144, XLR11 and AKB48 If this rule is finalized as proposed, persons who handle UR-144, XLR11, or AKB48 would continue \5\ to be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, possession, importing, and exporting of schedule I controlled substances, including those listed below: --------------------------------------------------------------------------- \5\ UR-144, XLR11, and AKB48 are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). --------------------------------------------------------------------------- 1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) UR-144, XLR11, or AKB48, or who desires to handle UR-144, XLR11, or AKB48 would be required to be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. 2. Security. UR-144, XLR11, and AKB48 would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance with 21 CFR 1301.71-1301.93. 3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of UR-144, XLR11, and AKB48 would need to be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. 4. Quota. Only registered manufacturers would be permitted to manufacture UR-144, XLR11, or AKB48 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303. 5. Inventory. Every DEA registrant who possesses any quantity of UR-144, XLR11, and/or AKB48 on the effective date of the final rule would be required to continue to maintain an inventory of all stocks of UR-144, XLR11, and/or AKB48 on hand, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records and Reports. Every DEA registrant would be required to maintain records and submit reports with respect to UR-144, XLR11, and/ or AKB48 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 1312. 7. Order Forms. Every DEA registrant who distributes UR-144, XLR11, and/or AKB48 would be required to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305. 8. Importation and Exportation. All importation and exportation of UR-144, XLR11, and AKB48 would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. 9. Liability. Any activity involving UR-144, XLR11, or AKB48 not authorized by, or in violation of the CSA or its implementing regulations would be unlawful, and could subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Executive Orders 12866 and 13563 In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures done ``on the record after opportunity for a hearing,'' which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to Section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Executive Order 12988 This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132 This proposed rulemaking does not have federalism implications warranting the application of Executive Order 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. [[Page 27616]] Executive Order 13175 This proposed rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On May 16, 2013, the Deputy Administrator published a Final Order in the Federal Register (78 FR 28735) amending 21 CFR 1308.11(h) to temporarily place these three synthetic cannabinoids into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). All entities that currently handle or plan to handle these synthetic cannabinoids are estimated to have already established and implemented the systems and processes required to handle UR-144, XLR11, and AKB48. Therefore, the DEA anticipates that this proposed rule will impose minimal or no economic impact on businesses that currently handle UR-144, XLR11, or AKB48 for lawful purposes. This estimate applies to entities large and small. Therefore, DEA has concluded that this proposed rule will not have a significant effect on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 On the basis of information contained in the ``Regulatory Flexibility Act'' section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.), that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of the UMRA of 1995. Paperwork Reduction Act of 1995 This action does not impose a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is proposed to be amended to read as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 0 2. Amend Sec. 1308.11 by: 0 a. Adding paragraphs (g)(16) through (18); and 0 b. Removing paragraphs (h)(1) through (3) and redesignating paragraphs (h)(4) through (23) as paragraphs (h)(1) through (20), respectively. The additions read as follows: Sec. 1308.11 Schedule I. * * * * * (g) * * * (16) (1-pentyl-1H-indol-3-yl)(2,2,3,3- (7144) tetramethylcyclopropyl)methanone (UR-144)................. (17) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- (7011) tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11). (18) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (7048) (APINACA, AKB48).......................................... * * * * * Dated: May 12, 2015. Michele M. Leonhart, Administrator. [FR Doc. 2015-11762 Filed 5-13-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 27611
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
21 CFR Part 1308 including any attachments. 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
Schedules of Controlled Substances: part of your comment, but do not want
electronically through the Federal
Placement of UR–144, XLR11, and it to be made publicly available, you
eRulemaking Portal, which provides the
AKB48 Into Schedule I must include the phrase ‘‘PERSONAL
ability to type short comments directly
into the comment field on the Web page IDENTIFYING INFORMATION’’ in the
AGENCY: Drug Enforcement first paragraph of your comment. You
Administration, Department of Justice. or to attach a file for lengthier
comments. Please go to http:// must also place all of the personal
ACTION: Notice of proposed rulemaking. identifying information you do not want
www.regulations.gov and follow the
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
tkelley on DSK3SPTVN1PROD with PROPOSALS
DATES: Interested persons may file submission that is not identified as
written comments on this proposal in participation should also be sent to:
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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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
submitted only by interested persons, FR 28735) amending 21 CFR 1308.11(h)
found at 21 U.S.C. 812(c) and the
defined as those ‘‘adversely affected or to temporarily place these three
current list of scheduled substances is
aggrieved by any rule or proposed rule synthetic cannabinoids into schedule I
published at 21 CFR part 1308. 21
issuable pursuant to section 201 of the of the CSA pursuant to the temporary
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 synthetic cannabinoids 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
potential for abuse, and . . . mak[ing] scheduling of that substance could be
of the scheduling of any drug or other
with respect to such drug or other extended for up to 1 year. Pursuant to
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 temporary order is being ordered by the
hearing and waivers of participation
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-tetrahydrocannabinol
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
understanding entered into by the Food and Drug
tkelley on DSK3SPTVN1PROD with PROPOSALS
‘‘CSA’’ for the purposes of this action. 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
VerDate Sep<11>2014 17:00 May 13, 2015 Jkt 235001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\14MYP1.SGM 14MYP1](https://thefederalregister.org/doc/80_FR_27704/page/2.svg)
. 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
abuse of UR–144, XLR11, and AKB48. part 1305.
Requirements for Handling UR–144,
As such, the DEA hereby proposes to 8. Importation and Exportation. All
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,
imports, exports, engages in research, or Regulatory Analyses
Secretary for HHS and review of all
other available data, the Administrator conducts instructional activities or Executive Orders 12866 and 13563
of the DEA, pursuant to 21 U.S.C. 811(a) chemical analysis with, or possesses)
UR–144, XLR11, or AKB48, or who In accordance with 21 U.S.C. 811(a),
and 21 U.S.C. 812(b)(1), finds that: this proposed scheduling action is
(1) (1-pentyl-1H-indol-3-yl)(2,2,3,3- desires to handle UR–144, XLR11, or
AKB48 would be required to be subject to formal rulemaking procedures
tetramethylcyclopropyl)methanone done ‘‘on the record after opportunity
(UR–144), [1-(5-fluoro-pentyl)-1H-indol- registered with the DEA to conduct such
activities pursuant to 21 U.S.C. 822, for a hearing,’’ which are conducted
3-yl](2,2,3,3- pursuant to the provisions of 5 U.S.C.
tetramethylcyclopropyl)methanone (5- 823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312. 556 and 557. The CSA sets forth the
fluoro-UR–144, XLR11), and N-(1- criteria for scheduling a drug or other
adamantyl)-1-pentyl-1H-indazole-3- 2. Security. UR–144, XLR11, and
AKB48 would be subject to schedule I substance. Such actions are exempt
carboxamide (APINACA, AKB48) have a from review by the Office of
high potential for abuse that is security requirements and would need
to be handled and stored pursuant to 21 Management and Budget (OMB)
comparable to other schedule I pursuant to Section 3(d)(1) of Executive
substances such as delta-9- U.S.C. 821, 823, and 871(b), and in
accordance with 21 CFR 1301.71– Order 12866 and the principles
tetrahydrocannabinol (D 9–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- provide a clear legal standard for
manufacturers would be permitted to
carboxamide (APINACA, AKB48) have affected conduct, and promote
manufacture UR–144, XLR11, or AKB48
no currently accepted medical use in simplification and burden reduction.
in accordance with a quota assigned
treatment in the United States; and
pursuant to 21 U.S.C. 826 and in Executive Order 13132
(3) There is a lack of accepted safety
accordance with 21 CFR part 1303.
for use of (1-pentyl-1H-indol-3- This proposed rulemaking does not
5. Inventory. Every DEA registrant
yl)(2,2,3,3- have federalism implications warranting
who possesses any quantity of UR–144,
tkelley on DSK3SPTVN1PROD with PROPOSALS
tetramethylcyclopropyl)methanone the application of Executive Order
XLR11, and/or AKB48 on the effective
(UR–144), [1-(5-fluoro-pentyl)-1H-indol- 13132. The proposed rule does not have
date of the final rule would be required
3-yl](2,2,3,3- substantial direct effects on the States,
to continue to maintain an inventory of
tetramethylcyclopropyl)methanone (5- on the relationship between the national
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.
VerDate Sep<11>2014 17:00 May 13, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\14MYP1.SGM 14MYP1](https://thefederalregister.org/doc/80_FR_27704/page/5.svg)
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] (2) Fax: 202–493–2251.
July 26, 2015. Approximately 50 high-
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 accepted between 9 a.m. and 5 p.m.,
regulation would temporarily restrict
vessel traffic in a portion of the Atlantic Monday through Friday, except federal
33 CFR Part 100 holidays. The telephone number is 202–
Intracoastal Waterway. Persons and
[Docket Number USCG–2015–0045] vessels that are not participating in the 366–9329.
races would be prohibited from See the ‘‘Public Participation and
RIN 1625–AA08 Request for Comments’’ portion of the
entering, transiting through, anchoring
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
tkelley on DSK3SPTVN1PROD with PROPOSALS
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;
VerDate Sep<11>2014 17:00 May 13, 2015 Jkt 235001 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 E:\FR\FM\14MYP1.SGM 14MYP1](https://thefederalregister.org/doc/80_FR_27704/page/6.svg)
Document Created: 2015-12-15 15:33:11
Document Modified: 2015-12-15 15:33:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of proposed rulemaking. | |
| Dates | Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before June 15, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. | |
| Contact | John R. Scherbenske, Office of | |
| FR Citation | 80 FR 27611 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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