Federal Register/Vol. 77, No. 41/Thursday, March 1, 2012

12508 Federal Register / Vol. 77, No. 41 / Thursday, March 1, 2012 / Proposed Rules

Authority for This Rulemaking § 39.13 [Amended] (i) Alternative Methods of Compliance (AMOCs) Title 49 of the United States Code 2. The FAA amends § 39.13 by adding specifies the FAA’s authority to issue the following new airworthiness (1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, rules on aviation safety. Subtitle I, directive (AD): if requested using the procedures found in 14 section 106, describes the authority of The Boeing Company: Docket No. FAA– CFR 39.19. In accordance with 14 CFR 39.19, the FAA Administrator. Subtitle VII: 2012–0187; Directorate Identifier 2011– send your request to your principal inspector Aviation Programs, describes in more NM–094–AD. or local Flight Standards District Office, as detail the scope of the Agency’s appropriate. If sending information directly authority. (a) Comments Due Date to the manager of the ACO, send it to the We are issuing this rulemaking under We must receive comments by April 30, attention of the person identified in the the authority described in subtitle VII, 2012. Related Information section of this AD. part A, subpart III, section 44701: Information may be emailed to: 9-ANM- (b) Affected ADs [email protected]. ‘‘General requirements.’’ Under that None. (2) Before using any approved AMOC, section, Congress charges the FAA with notify your appropriate principal inspector, promoting safe flight of civil aircraft in (c) Applicability or lacking a principal inspector, the manager air commerce by prescribing regulations This AD applies to The Boeing Company of the local flight standards district office/ for practices, methods, and procedures Model 757–200, –200PF, –200CB, and –300 certificate holding district office. series airplanes; certificated in any category; the Administrator finds necessary for (j) Related Information safety in air commerce. This regulation for which compliance with 14 CFR is within the scope of that authority 121.1117(d), 125.509(d), or 129.117(d) is not For more information about this AD, contact Tak Kobayashi, Aerospace Engineer, because it addresses an unsafe condition required; regardless of the date of issuance of the original certificate of airworthiness or Propulsion Branch, ANM–140S, FAA, Seattle that is likely to exist or develop on export airworthiness approval. Aircraft Certification Office (ACO), 1601 Lind products identified in this rulemaking Avenue SW., Renton, Washington 98057– action. (d) Subject 3356; phone: 425–917–6499; fax: 425–917– Joint Aircraft System Component (JASC)/ 6590; email: [email protected]. Regulatory Findings Air Transport Association (ATA) of America Issued in Renton, Washington, on February We determined that this proposed AD Code 7397: Engine fuel system wiring. 21, 2012. would not have federalism implications (e) Unsafe Condition Ali Bahrami, under Executive Order 13132. This proposed AD would not have a This AD was prompted by fuel system Manager, Transport Airplane Directorate, Aircraft Certification Service. substantial direct effect on the States, on reviews conducted by the manufacturer. We are issuing this AD to prevent development the relationship between the national [FR Doc. 2012–4931 Filed 2–29–12; 8:45 am] of an ignition source inside the center fuel BILLING CODE 4910–13–P Government and the States, or on the tank caused by a latent in-tank failure distribution of power and combined with electrical energy transmitted responsibilities among the various into the center fuel tank via the fuel quantity levels of government. indicating system (FQIS) wiring due to a DEPARTMENT OF JUSTICE For the reasons discussed above, I single out-tank failure. Drug Enforcement Administration certify this proposed regulation: (f) Compliance (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, Comply with this AD within the 21 CFR Part 1308 (2) Is not a ‘‘significant rule’’ under compliance times specified, unless already done. [Docket No. DEA–345] the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, (g) Modification Schedules of Controlled Substances: 1979), Within 60 months after the effective date Placement of Five Synthetic (3) Will not affect intrastate aviation of this AD, modify the FQIS wiring or fuel Cannabinoids Into Schedule I in Alaska, and tank systems to prevent development of an AGENCY: (4) Will not have a significant ignition source inside the center fuel tank, in Drug Enforcement economic impact, positive or negative, accordance with a method approved by the Administration, Department of Justice. on a substantial number of small entities Manager, Seattle Aircraft Certification Office ACTION: Notice of proposed rulemaking. (ACO), FAA. under the criteria of the Regulatory SUMMARY: The Drug Enforcement Flexibility Act. Note 1 to paragraph (g) of this AD: After accomplishment of the actions required by Administration (DEA) proposes placing List of Subjects in 14 CFR Part 39 paragraph (g) of this AD, maintenance and/ five synthetic cannabinoids 1-pentyl-3- (1-naphthoyl)indole (JWH–018), 1-butyl- Air transportation, Aircraft, Aviation or preventive maintenance under 14 CFR part 43 is permitted provided the maintenance 3-(1-naphthoyl)indole (JWH–073), 1-[2- safety, Incorporation by reference, does not result in changing the AD-mandated (4-morpholinyl)ethyl]-3-(1- Safety. configuration (reference 14 CFR 39.7). naphthoyl)indole (JWH–200), 5-(1,1- The Proposed Amendment dimethylheptyl)-2-(3- (h) Optional Installation of Flammability hydroxycyclohexyl)-phenol (CP– Accordingly, under the authority Reduction Means delegated to me by the Administrator, 47,497), and 5-(1,1-dimethyloctyl)-2-(3- the FAA proposes to amend 14 CFR part As an alternative to the requirements of hydroxycyclohexyl)-phenol paragraph (g) of this AD, operators may elect 39 as follows: (cannabicyclohexanol, CP–47,497 C8 to comply with the requirements of 14 CFR homologue) including their salts, 121.1117 or 14 CFR 125.509 or 14 CFR isomers, and salts of isomers whenever PART 39—AIRWORTHINESS 129.117 (not including the exclusion of cargo DIRECTIVES airplanes in Sections 121.1117(j), 129.117(j), the existence of such salts, isomers, and salts of isomers is possible, into 1. The authority citation for part 39 and 125.509(j)). Following this election, failure to comply with Sections 121.1117, Schedule I of the Controlled Substances continues to read as follows: 129.117, and 125.509 is a violation of this Act (CSA). This proposed action is Authority: 49 U.S.C. 106(g), 40113, 44701. AD. pursuant to the CSA which requires that

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such actions be made on the record after made available for public inspection hearing must conform to the opportunity for a hearing through online at http://www.regulations.gov requirements of 21 CFR 1308.44(a) and formal rulemaking. and in the DEA’s public docket. Such 1316.47. A request should state, with DATES: DEA will permit interested information includes personal particularity, the interest of the person persons to file written comments on this identifying information (such as your in the proceeding and the objections or proposal pursuant to 21 CFR 1308.43(g). name, address, etc.) voluntarily issues, if any, concerning which the Electronic comments must be submitted submitted by the commenter. person desires to be heard. Any waiver and written comments must be If you want to submit personal must conform to the requirements of 21 postmarked on or before April 30, 2012. identifying information (such as your CFR 1308.44(c), including a written Commenters should be aware that the name, address, etc.) as part of your statement regarding the interested electronic Federal Docket Management comment, but do not want it to be person’s position on the matters of fact System will not accept comments after posted online or made available in the and law involved in any hearing. midnight Eastern Time on the last day public docket, you must include the Please note that pursuant to 21 U.S.C. of the comment period. phrase ‘‘PERSONAL IDENTIFYING 811(a), the purpose and subject matter Interested persons, defined as those INFORMATION’’ in the first paragraph of the hearing is restricted to ‘‘(A) ‘‘adversely affected or aggrieved by any of your comment. You must also place find[ing] that such drug or other rule or proposed rule issuable pursuant all of the personal identifying substance has a potential for abuse, and to section 201 of the Act (21 U.S.C. information you do not want posted (B) mak[ing] with respect to such drug 811),’’ 1 may file a request for hearing or online or made available in the public or other substance the findings waiver of participation pursuant to 21 docket in the first paragraph of your prescribed by subsection (b) of section CFR 1308.44 and in accordance with 21 comment and identify what information 812 of this title for the schedule in CFR 1316.45. Requests for hearing and you want redacted. which such drug is to be placed * * *’’ waivers of participation must be If you want to submit confidential Requests for hearing and waivers of received on or before April 2, 2012. business information as part of your participation in the hearing should be ADDRESSES: To ensure proper handling comment, but do not want it to be submitted to DEA using the address of comments, please reference ‘‘Docket posted online or made available in the information provided above. public docket, you must include the No. DEA–345’’ on all electronic and Legal Authority written correspondence. DEA phrase ‘‘CONFIDENTIAL BUSINESS encourages all comments be submitted INFORMATION’’ in the first paragraph The DEA implements and enforces electronically through http:// of your comment. You must also Titles II and III of the Comprehensive www.regulations.gov using the prominently identify confidential Drug Abuse Prevention and Control Act electronic comment form provided on business information to be redacted of 1970, often referred to as the Controlled Substances Act and the that site. An electronic copy of this within the comment. If a comment has Controlled Substances Import and document and supplemental so much confidential business Export Act (21 U.S.C. 801–971), as information to this proposed rule are information that it cannot be effectively amended (hereinafter, ‘‘CSA’’). The also available at the http:// redacted, all or part of that comment implementing regulations for these www.regulations.gov Web site for easy may not be posted online or made statutes are found in Title 21 of the reference. Paper comments that available in the public docket. Personal identifying information and Code of Federal Regulations (CFR), parts duplicate the electronic submission are confidential business information 1300 to 1321. Under the CSA, controlled not necessary as all comments identified and located as set forth above substances are classified in one of five submitted to www.regulations.gov will will be redacted, and the comment, in schedules based upon their potential for be posted for public review and are part redacted form, will be posted online and abuse, their currently accepted medical of the official docket record. Should placed in the DEA’s public docket file. use, and the degree of dependence the you, however, wish to submit written Please note that the Freedom of substance may cause. 21 U.S.C. 812. The comments via regular or express mail, Information Act applies to all comments initial schedules of controlled they should be sent to the Drug received. If you wish to inspect the substances by statute are found at 21 Enforcement Administration, Attention: agency’s public docket file in person by U.S.C. 812(c) and the current list of DEA Federal Register Representative/ appointment, please see the FOR scheduled substances are published at OD, 8701 Morrissette Drive, Springfield, FURTHER INFORMATION CONTACT 21 CFR Part 1308. VA 22152. All requests for hearing and paragraph. The CSA permits these initial waivers of participation must be sent to schedules to be modified by providing Drug Enforcement Administration, Request for Hearing or Waiver of that scheduling of any drug or other Attention: Hearing Clerk/LJ, 8701 Participation in Hearing substance may be initiated by the Morrissette Drive, Springfield, VA In accordance with the provisions of Attorney General (1) on his own motion; 22152. the CSA (21 U.S.C. 811(a)), this action (2) at the request of the Secretary of FOR FURTHER INFORMATION CONTACT: is a formal rulemaking ‘‘on the record HHS, or (3) on the petition of any Alan G. Santos, Associate Deputy after opportunity for a hearing.’’ Such interested party. 21 U.S.C. 811(a). The Assistant Administrator, Office of proceedings are conducted pursuant to Attorney General may, by rule, ‘‘add to Diversion Control, Drug Enforcement the provisions of the Administrative such a schedule or transfer between Administration; Mailing Address: 8701 Procedure Act (5 U.S.C. 556 and 557) such schedules any drug or other Morrissette Drive, Springfield, Virginia and 21 CFR 1308.41. Pursuant to 21 CFR substance if he (A) finds that such drug 22152; Telephone: (202) 307–7165. 1308.44(a) and (c), requests for hearing or other substance has a potential for SUPPLEMENTARY INFORMATION: and waivers of participation may be abuse, and (B) makes with respect to Posting of Public Comments: Please submitted only by interested persons, such drug or other substance the note that all comments received are defined as those ‘‘adversely affected or findings prescribed by subsection (b) of considered part of the public record and aggrieved by any rule or proposed rule section 812 of this title for the schedule issuable pursuant to section 201 of the in which such drug is to be placed 1 21 CFR 1300.01. Act (21 U.S.C. 811).’’ Requests for * * *’’

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Background under the guise being ‘‘herbal incense,’’ determining whether a particular drug 5 On November 24, 2010, DEA with trade names such as ‘‘Spice’’ and or substance has potential for abuse: published a Notice of Intent 2 to ‘‘K2’’ have conclusively been found to i. There is evidence that individuals temporarily place five synthetic contain these five substances. These are taking the drug or other substance in cannabinoids into Schedule I pursuant products are manufactured by spiking amounts sufficient to create a hazard to to the temporary scheduling provisions plant material with the synthetic their health or to the safety of other of the CSA: 1-pentyl-3-(1- cannabinoids and then distributed in a individuals or to the community; or naphthoyl)indole (JWH–018), 1-butyl-3- way that poses dangerous consequences ii. There is significant diversion of the (1-naphthoyl)indole (JWH–073), 1-[2-(4- to the consumer. Marketed as ‘‘legal’’ drug or substance from legitimate drug morpholinyl)ethyl]-3-(1- alternatives to marijuana, these products channels; or iii. Individuals are taking the drug or naphthoyl)indole (JWH–200), 5-(1,1- are being abused for their psychoactive drugs containing such a substance on dimethylheptyl)-2-(3- properties and are packaged without their own initiative rather than on the hydroxycyclohexyl)-phenol (CP– information as to their health and safety basis of medical advice from a 47,497), and 5-(1,1-dimethyloctyl)-2-(3- risks. practitioner licensed by law to hydroxycyclohexyl)-phenol Proposed Determination To Schedule administer such drugs in the course of (cannabicyclohexanol, CP–47,497 C8 Five Synthetic Cannabinoids his professional practice; or homologue). 75 FR 71635. Following This NPRM proposes the permanent iv. The drug is a new drug so related this, on March 1, 2011, the scheduling of JWH–018, JWH–200, in its action to a drug or other substance Administrator published a Final Order JWH–073, CP–47,497 and already listed as having a potential for in the Federal Register amending 21 cannabicyclohexanol pursuant to 21 abuse to make it likely that the drug or CFR 1308.11(g) to temporarily place the U.S.C. 811(a)(1). On June 21, 2011, DEA other substance will have the same five synthetic cannabinoids into requested a scientific and medical potential for abuse as such drugs, thus Schedule I of the CSA pursuant to the evaluation and scheduling making it reasonable to assume that temporary scheduling provisions of 21 recommendation from the Assistant there may be significant diversion from U.S.C. 811(h). 76 FR 11075. This Final Secretary of HHS for each of the five legitimate channels, significant use Order, which became effective on the synthetic cannabinoids pursuant to 21 contrary to or without medical advice, date of publication, was based on U.S.C. 811(b). Upon receipt and or that it has a substantial capability of findings by the Administrator that the evaluation of the scientific and medical creating hazards to the health of the user temporary scheduling of the five evaluation and scheduling or to the safety of the community. synthetic cannabinoids was necessary to recommendations from the Assistant With respect to the first factor, a avoid an imminent hazard to the public Secretary,4 DEA concluded its analysis number of case reports and case series safety. The CSA (21 U.S.C. 811(h)(2)) of all other relevant data for the (article grouping several case reports) requires that the temporary scheduling proposal to place JWH–018, JWH–200, have shown that individuals are taking of a substance expire at the end of one JWH–073, CP–47,497 and these substances and products year from the date of issuance of the cannabicyclohexanol into Schedule I of containing these substances in amount order. However, if proceedings to the CSA. sufficient to induce toxic effects similar schedule a substance pursuant to 21 Included below is a brief summary of to those induced by marijuana such as U.S.C. 811(a) are pending, the each factor as analyzed by HHS and anxiety, tachycardia and hallucinations. temporary scheduling of a substance DEA, and as considered by DEA in the Severe toxic effects including seizures, may be extended for up to six months. scheduling decision. Please note that tachyarrhythmias, extreme anxiety Under this provision, the temporary both the DEA and HHS analyses are leading to suicide and the precipitation scheduling of the cannabinoids, which available under ‘‘Supporting and of psychotic episodes have also been would expire on February 29, 2012, may Related Material’’ of the public docket reported following abuse of these be extended to August 29, 2012. This for this proposed rule at substances or products containing these extension is being ordered by the www.regulations.gov under docket substances. Administrator in a separate action. number DEA–345. In considering evidence of significant As described in the March 1, 2011 1. The Drug’s Actual or Relative diversion of the drug or substance from Final Order, a ‘‘cannabinoid’’ is a class Potential for Abuse: The abuse potential legitimate drug channels under the of chemical compounds in the of the five synthetic cannabinoids under second factor, it must be noted that as marijuana 3 plant that are structurally evaluation is associated with their of March 1, 2011, these synthetic related. The cannabinoid D9- ability to evoke cannabinoid-like cannabinoids have been temporarily tetrahydrocannabinol (THC) is the subjective effects similar to those controlled as Schedule I substances and primary psychoactive constituent of evoked by the Schedule I cannabinoid thus have not been legally available marijuana. ‘‘Synthetic cannabinoids’’ delta-9-tetrahydrocannabinol (THC). unless for research purposes. The are a large family of chemically The legislative history of the CSA National Forensic Laboratory unrelated structures functionally provides four factors to consider in Information System (NFLIS) details over (biologically) similar to THC, the active 5,450 reports from state and local principal of marijuana. 4 DEA received separate Evaluations and forensic laboratories identifying JWH– The emergence of these five synthetic Recommendation documents from HHS with 018, JWH–073, JWH–200, CP–47,497 or cannabinoids represents a recent respect to each of the five synthetic cannabinoids. cannabicyclohexanol in drug related phenomenon in the U.S. designer drug HHS recommended Schedule I placement for each exhibits for a period from January 2009 market. Numerous products, marketed of these five substances on the following dates: 1- pentyl-3-(1-naphthoyl)indole (JWH–018) (January 5, to December 2011 from 39 states. The 2012); 1-pentyl-3-(1-naphthoyl)indole (JWH–073) System to Retrieve Information from 2 This Notice of Intent was corrected on January and 1-[2-(4-morpholinyl)ethyl]-3-(1- 13, 2011. 76 FR 2287. naphthoyl)indole (JWH–200) (February 6, 2012), 5- Drug Evidence (STRIDE) also details 3 Note that ‘‘marihuana’’ is the spelling originally (1,1-dimethylheptyl)-2-[(1R,3S)-3- used in the Controlled Substances Act (CSA). This hydroxycyclohexyl]-phenol (CP–47,497) and 5-(1,1- 5 Comprehensive Drug Abuse Prevention and document uses the spelling that is more common dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- Control Act of 1970, H.R. Rep. No. 91–1444, 91st in current usage, ‘‘marijuana.’’ phenol (cannabicyclohexanol) (February 13, 2012). Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 4566, 4601.

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reports from federal forensic school seniors, second only to laboratory confirmation in mid- laboratories identifying JWH–018, JWH– marijuana. Additionally, while products December 2008. A commercial 073, and JWH–200 in drug related containing synthetic cannabinoids laboratory in Frankfurt, Germany exhibits for a period from January 2009 appear to produce subjective effects announced the identification of JWH– to December 2011. similar to marijuana, they are dissimilar 018 in samples of herbal incense and For the third factor, there is no to other licit and illicit drugs. others were identified shortly after this currently accepted medical use for any As evidence of abuse on the national initial determination. of the five synthetic cannabinoids, and, scale, State public health and poison These five cannabinoid substances outside of an extremely limited research centers have issued warnings in have been termed ‘synthetic’ or ‘non- setting, no medical practitioner is response to adverse health effects classical’ because they are agonists at currently licensed by law to administer associated with abuse of herbal incense the CB1 receptor but are structurally them. Thus, with no accepted medical products containing these synthetic distinct from naturally occurring use or administering practitioners, any cannabinoids. These adverse effects cannabinoids. individuals currently taking using included tachycardia, elevated blood HHS has confirmed to DEA in a letter products containing JWH–018, JWH– pressure, unconsciousness, tremors, dated November 22, 2010, that there are 073, JWH–200, CP–47,497 or seizures, vomiting, hallucinations, no Investigational New Drug cannabicyclohexanol are doing so on agitation, anxiety, pallor, numbness and Applications (INDs) or New Drug their own initiative without medical tingling. This is in addition to the Applications (NDAs) for these synthetic advice from a practitioner licensed to numerous public health and poison cannabinoids. DEA is also not aware of administer those substances. centers which have similarly issued any accepted medical use for these five Related to the fourth factor, HHS warnings regarding the abuse of these synthetic cannabinoids. states that JWH–018, JWH–073, JWH– synthetic cannabinoids and their 4. Its History and Current Pattern of 200, CP–47,497 and associated products, and the ban on the Abuse: Synthetic cannabinoids have cannabicyclohexanol are cannabinoids use of these synthetic cannabinoids by been developed over the last 30 years to with a potential for abuse similar to the military personnel issued in response to investigate their cannabimimetic Schedule I substances marijuana and reported instances of abuse by active properties and as research tools to THC. These synthetic cannabinoids personnel. investigate the cannabinoid systems appear to be marketed solely for abuse 2. Scientific Evidence of the Drug’s (Huffman et al., 1994; Wiley et al., of their marijuana-like activity and Pharmacological Effects, If Known: In 1998). Trafficking of synthetic because, prior to the March 1, 2011 their recommendations for the Final Order, they were not controlled placement of the five synthetic cannabinoids was first reported in the under the CSA. As such, commerce cannabinoids, HHS states that in vitro United States in a December 2008 involving these synthetic cannabinoids and preclinical studies suggest that the encounter, where a shipment of ‘Spice’ can only be for the purposes of abuse pharmacological effects of JWH–018, was seized and analyzed by U.S. and escaping the regulatory and JWH–200, JWH–073, CP–47,497 and Customs and Border Patrol in Dayton, criminal penalties of the CSA that cannabicyclohexanol are similar to Ohio. Around the same time, in pertain to marijuana. those of THC. December 2008, JWH–018 and JWH–018, JWH–200, JWH–073, CP– The CB1 receptors are thought to be cannabicyclohexanol were identified by 47,497 and cannabicyclohexanol have responsible for the euphoric and German forensic laboratories (EMCDDA, agonist properties at the CB1 receptor. psychoactive effects of THC and related 2009). The CB1 receptors are thought to be cannabinoids. JWH–018, JWH–200, JWH–018, JWH–073, JWH–200, CP– responsible for the euphoric and JWH–073, CP–47,497 and 47,497, and Cannabicyclohexanol have psychoactive effects of THC and related cannabicyclohexanol have agonist been found alone and found laced on cannabinoids. properties at the CB1 receptor. products that are marketed as herbal Drug discrimination is a method in Animal studies also provided incense. The abuse of these substances which laboratory animals indicate evidence of cannabinoid-like and their associated products for their whether a test drug produces physical pharmacological effects of these psychoactive effects has been widely or psychic perceptions similar to those synthetic cannabinoids. JWH–018, reported and their popularity has spread produced by a known drug of abuse. JWH–200, CP–47,497 and rapidly since December 2008. The Drug discrimination studies in rats cannabicyclohexanol were shown to be NFLIS has detailed over 5,450 reports suggest that JWH–018, JWH–200, JWH– active in all four parameters of the from state and local forensic laboratories 073, CP–47,497, and mouse tetrad, a well-established identifying JWH–018, JWH–073, JWH– cannabicyclohexanol have similar paradigm for evaluating substances for 200, CP–47,497 and/or subjective effects as THC, while cannabimimetic properties, while JWH– cannabicyclohexanol in drug related numerous anecdotal self-reports, as well 073 was only tested, and shown to be exhibits for a period from January 2009 as case reports and case series active, in three of the four parameters of to December 2011 from 39 states. Prior substantiate that these substances and the tetrad test. JWH–018, JWH–200, to being temporarily placed in Schedule their associated products are abused by JWH–073, CP–47,497 and I on March 1, 2011, these products were humans for their hallucinogenic effects. cannabicyclohexanol substitute fully for promoted as legal alternatives to An indication of the extent of such the discriminative stimulus effects of marijuana, were widely available over abuse may be found in the results of the THC in laboratory animals, suggesting the Internet, and were found to be sold 2011 Monitoring the Future survey of that they are likely to have similar in gas stations, convenience stores, high schools students, where 1 in 9 high subjective effects as THC, the main tobacco and head shops to all school seniors (11.4%) reported having active ingredient of marijuana. populations. used ‘‘synthetic marijuana’’ (products 3. The State of Current Scientific As of January 13, 2012, forty-eight often containing synthetic Knowledge Regarding the Drug or Other states in the U.S. as well as numerous cannabinoids) in the past year. These Substance: The appearance of these local jurisdictions and countries have statistics make it one of the most substances in the designer drug market controlled at least one of these five frequently mentioned among high can be traced to the initial forensic synthetic cannabinoids.

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5. The Scope, Duration, and Warnings regarding the dangers of the substances will have high psychic Significance of Abuse: HHS states that synthetic cannabinoid abuse and and physiologic dependence capacity. the current scope and duration of use of associated products have been issued by Case reports have shown that herbal the synthetic cannabinoids is likely numerous state public health products containing synthetic underestimated because of the lack of departments and poison centers and cannabinoids could produce physical widely available toxicological methods private organizations. Detailed product dependence and a withdrawal to identify its use using routine analyses analyses describe variations in the syndrome. The HHS analysis discusses (Peters and Martinez-Ramirez 2010). amount and type of synthetic one case report in which the authors Additionally, since these substances cannabinoid laced on the plant material; concluded that the patient satisfied were never intended for human this is true even within samplings of the criteria for a diagnosis of DSM–IV and consumption, minimal information same product. ICD–10 dependency syndrome on JWH– exists as to the health implications Because they share pharmacological 018. Some reported withdrawal resulting from exposure to these similarities with the Schedule I symptoms included elevated blood substances (Griffiths et al., 2010; substance THC, the synthetic pressure, restlessness, drug craving, Vardakou et al., 2010). As forensic cannabinoids JWH–018, JWH–073, nightmares, sweating, nausea, tremor procedures and toxicology screens are JWH–200, CP–47,497, and and headache. being developed, the amount of cannabicyclohexanol pose substantial Because these substances act through information concerning these risks to the abuser. Numerous the same molecular target as THC, the substances and the associated products emergency department admissions have main active ingredient of marijuana, it is increasing. been connected to these substances, can be reasonably expected that their The abuse of synthetic cannabinoids while law enforcement communications physical dependence liability will be has been associated with both acute and to DEA indicate multiple violent similar. Long-term, regular use of long-term public health and safety episodes linked to smoking these marijuana can lead to physical concerns. In the past year, increased synthetic cannabinoids. Health dependence and withdrawal following exposure incidents have been warnings issued by numerous state discontinuation as well as psychic documented by poison control centers public health departments and poison addiction or dependence. in the United States. As of December 31, centers have described adverse health 8. Whether the Substance is an 2011, the American Association of effects associated with smoking Immediate Precursor of a Substance Poison Centers (AAPCC) has reported (inhaling) these products, including Already Controlled Under the CSA: receiving 9,992 calls corresponding to agitation, vomiting, tachycardia, JWH–018, JWH–073, JWH–200, CP– products purportedly laced with elevated blood pressure, seizures, 47,497, and cannabicyclohexanol are synthetic cannabinoids. The calls paranoia, hallucinations and non- not considered immediate precursors of represented exposed individuals from responsiveness, and fatality. any controlled substance of the CSA as all 50 states and the District of Case reports describe presentations to defined by Title 21, U.S.C. 802(23). Columbia, as well as a few calls emergency departments of individuals Conclusion: Based on consideration of regarding exposed individuals in Puerto exposed to synthetic cannabinoids with the scientific and medical evaluations Rico, U.S. Territories, foreign countries, symptoms that include anxiety and and accompanying recommendations of and a category identified as ‘‘overseas/ panic attacks, tremors, generalized HHS, and based on DEA’s consideration US military/diplomatic.’’ Several of convulsions, psychosis, heart of its own eight-factor analyses, DEA these exposures were confirmed to palpitations and elevated pulse, severe finds that these facts and all relevant involve JWH–018 (141), and JWH–073 gastrointestinal distress, tremors, data constitute substantial evidence of (12). blurred peripheral vision, nausea, and potential for abuse of JWH–018, JWH– The increased abuse of these synthetic persistent vomiting with retching. Such 073, JWH–200, CP–47,497 and cannabinoids in the United States is abuse also includes instances of persons cannabicyclohexanol. As such, DEA supported by an increasing number of suspected of driving under the influence hereby proposes to schedule JWH–018, encounters by law enforcement. Over of these synthetic cannabinoids, JWH–073, JWH–200, CP–47,497 and the past year in the United States there including one incident where an cannabicyclohexanol as controlled has been a significant increase in automobile was driven through a substances under the CSA. availability, trafficking and abuse of residence. In that case the driver these substances as evident from the claimed to have no memory of the event Proposed Determination of Appropriate increasing number of encounters while a toxicology analysis confirmed Schedule reported by forensic laboratories (NFLIS that the driver had smoked a product The CSA establishes five schedules of and STRIDE data). Product containing JWH–018, but not any other controlled substances known as manufacturing and synthesis drugs. Schedules I, II, III, IV, and V. The statute laboratories have been discovered, and 7. Its Psychic or Physiological outlines the findings required to place a laboratories have been found Dependence Liability: HHS states that drug or other substance in any manufacturing products by lacing plant the pharmacological profile of JWH– particular schedule. 21 U.S.C. 812(b). material with synthetic cannabinoids. 018, JWH–200, JWH–073, CP–47,497 After consideration of the analysis and 6. What, if any, Risk There is to the and cannabicyclohexanol strongly recommendations of the Assistant Public Health: Law enforcement, suggests that they possess physiological Secretary for Health of HHS and review military, and public health officials and psychological dependence liability of all available data, the Administrator have reported exposure incidents that similar to that of the Schedule I of DEA, pursuant to 21 U.S.C. 812(b)(1), demonstrate the dangers associated with controlled substances marijuana and finds that: these substances to both the individual THC. While no laboratory controlled (1) 1-pentyl-3-(1-naphthoyl)indole abusers and other affected individuals. clinical studies of the psychic or (JWH–018), 1-butyl-3-(1- Two suicides, one also involving a physical dependence potential of these naphthoyl)indole (JWH–073), 1-[2-(4- murder, have been linked to the abuse five synthetic cannabinoids are morpholinyl)ethyl]-3-(1- of synthetic cannabinoids (law currently available, their naphthoyl)indole (JWH–200), 5-(1,1- enforcement communication to DEA). pharmacological profile indicates that dimethylheptyl)-2-(3-

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hydroxycyclohexyl)-phenol (CP– desires to manufacture, distribute, 018, JWH–200, JWH–073, CP–47,497 or 47,497), and 5-(1,1-dimethyloctyl)-2-(3- dispense, import, export, engage in cannabicyclohexanol would need to be hydroxycyclohexyl)-phenol research or conduct instructional done in accordance with 21 CFR Part (cannabicyclohexanol, CP–47,497 C8 activities with any of the five synthetic 1312, pursuant to 21 U.S.C. 952, 953, homologue) have a high potential for cannabinoids, would need to be 957, and 958. abuse; registered to conduct such activities Criminal Liability. Any activity with (2) 1-pentyl-3-(1-naphthoyl)indole pursuant to 21 U.S.C. 822 and 958 and JWH–018, JWH–200, JWH–073, CP– (JWH–018), 1-butyl-3-(1- in accordance with 21 CFR part 1301. 47,497 or cannabicyclohexanol not naphthoyl)indole (JWH–073), 1-[2-(4- Security. JWH–018, JWH–200, JWH– authorized by, or in violation of, morpholinyl)ethyl]-3-(1- 073, CP–47,497 or cannabicyclohexanol Subchapter I Part D and Subchapter II naphthoyl)indole (JWH–200), 5-(1,1- would be subject to Schedule I security of the CSA or the CSIEA occurring on dimethylheptyl)-2-(3- requirements and would need to be or after effective date of the finalization hydroxycyclohexyl)-phenol (CP– manufactured, distributed, and stored of this proposed rule would be 47,497), and 5-(1,1-dimethyloctyl)-2-(3- pursuant to 21 U.S.C. 823 and in unlawful. hydroxycyclohexyl)-phenol accordance with 21 CFR 1301.71, (cannabicyclohexanol, CP–47,497 C8 1301.72(a), (c) and (d), 1301.73, 1301.74, Regulatory Analyses homologue) have no currently accepted 1301.75(a) and (c), 1301.76. Executive Orders 12866 and 13563 medical use in treatment in the United Labeling and Packaging. All labels States; and and labeling for commercial containers In accordance with 21 U.S.C. 811(a), (3) there is a lack of accepted safety of JWH–018, JWH–200, JWH–073, CP– this proposed scheduling action is for use of 1-pentyl-3-(1- 47,497 or cannabicyclohexanol which subject to formal rulemaking procedures naphthoyl)indole (JWH–018), 1-butyl-3- are distributed on or after the effective done ‘‘on the record after opportunity (1-naphthoyl)indole (JWH–073), 1-[2-(4- date of the finalization of this rule for a hearing,’’ which are conducted morpholinyl)ethyl]-3-(1- would need to be in accordance with 21 pursuant to the provisions of 5 U.S.C. naphthoyl)indole (JWH–200), 5-(1,1- CFR 1302.03–1302.07, pursuant to 21 556 and 557. The CSA sets forth the dimethylheptyl)-2-(3- U.S.C. 825. criteria for scheduling a drug or other hydroxycyclohexyl)-phenol (CP– Quotas. Quotas for JWH–018, JWH– substance. Such actions are exempt 47,497), and 5-(1,1-dimethyloctyl)-2-(3- 200, JWH–073, CP–47,497 and from review by the Office of hydroxycyclohexyl)-phenol cannabicyclohexanol will be established Management and Budget pursuant to (cannabicyclohexanol, CP–47,497 C8 based on registrations granted and quota Section 3(d)(1) of Executive Order homologue) under medical supervision. applications received pursuant to part 12866 and the principles reaffirmed in Based on these findings, the 1303 of Title 21 of the Code of Federal Executive Order 13563. Administrator of DEA concludes that 1- Regulations. Executive Order 12988 pentyl-3-(1-naphthoyl)indole (JWH– Inventory. Every registrant required to 018), 1-butyl-3-(1-naphthoyl)indole keep records and who possesses any This proposed regulation meets the (JWH–073), 1-[2-(4-morpholinyl)ethyl]- quantity of JWH–018, JWH–200, JWH– applicable standards set forth in 3-(1-naphthoyl)indole (JWH–200), 5- 073, CP–47,497 or cannabicyclohexanol Sections 3(a) and 3(b)(2) of Executive (1,1-dimethylheptyl)-2-(3- would be required to keep an inventory Order 12988 Civil Justice Reform to hydroxycyclohexyl)-phenol (CP– of all stocks of any of the five synthetic eliminate ambiguity, minimize 47,497), and 5-(1,1-dimethyloctyl)-2-(3- cannabinoids on hand pursuant to 21 litigation, establish clear legal hydroxycyclohexyl)-phenol U.S.C. 827 and in accordance with 21 standards, and reduce burden. (cannabicyclohexanol, CP–47,497 C8 CFR 1304.03, 1304.04, and 1304.11. Executive Order 13132 homologue), including their salts, Every registrant who desires registration isomers and salts of isomers, whenever in Schedule I for any of the five This proposed rulemaking does not the existence of such salts, isomers, and synthetic cannabinoids would be preempt or modify any provision of salts of isomers is possible, warrant required to conduct an inventory of all State law; nor does it impose control in Schedule I of the CSA (21 stocks of the substance on hand at the enforcement responsibilities on any U.S.C. 812(b)(1)). time of registration. State; nor does it diminish the power of Records. All registrants would be any State to enforce its own laws. Requirements for Handling Five required to keep records pursuant to 21 Accordingly, this rulemaking does not Synthetic Cannabinoids U.S.C. 827 and in accordance with 21 have federalism implications warranting If this rule is finalized as proposed, CFR 1304.03, 1304.04, 1304.21, 1304.22, the application of Executive Order JWH–018, JWH–200, JWH–073, CP– and 1304.23. 13132. 47,497 and cannabicyclohexanol would Reports. All registrants required to Executive Order 13175 be permanently, as they are currently submit reports pursuant to 21 U.S.C. temporarily, subject to the CSA and the 827 and in accordance with 21 CFR This proposed rule will not have Controlled Substances Import and 1304.33 would be required to do so tribal implications and will not impose Export Act (CSIEA) regulatory controls regarding JWH–018, JWH–200, JWH– substantial direct compliance costs on and administrative, civil, and criminal 073, CP–47,497 and Indian tribal governments. sanctions applicable to the manufacture, cannabicyclohexanol. Paperwork Reduction Act of 1995 distribution, dispensing, importing, and Order Forms. All registrants involved exporting of a Schedule I controlled in the distribution of JWH–018, JWH– This action does not impose a new substance, including the following: 200, JWH–073, CP–47,497 or collection of information under the Registration. Any person who cannabicyclohexanol pursuant to 21 Paperwork Reduction Act of 1995, 44 manufactures, distributes, dispenses, U.S.C. 828 would be required to comply U.S.C. 3501–3521. imports, exports, engages in research or with the order form requirements of 21 List of Subjects in 21 CFR Part 1308 conducts instructional activities with CFR 1305. JWH–018, JWH–200, JWH–073, CP– Importation and Exportation. All Administrative practice and 47,497 or cannabicyclohexanols, or who importation and exportation of JWH– procedure, Drug traffic control,

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Reporting and recordkeeping PART 1308—SCHEDULES OF through (35) as paragraphs (d)(19) requirements. CONTROLLED SUBSTANCES through (36) and adding a new paragraph (d)(18) to read as follows: For the reasons set out above, 21 CFR 1. The authority citation for 21 CFR Part 1308 is proposed to be amended as part 1308 continues to read as follows: § 1308.11 Schedule I. follows: Authority: 21 U.S.C. 811, 812, 871(b), * * * * * unless otherwise noted. (d) * * * 2. Section 1308.11 is amended by redesignating paragraphs (d)(18) (18) Cannabimimetic agents

(i) 1-Butyl-3-(1-naphthoyl)indole (Other names: JWH–073) ...... 7173 (ii) 5-(1,1-Dimethylheptyl)-2-(3-hydroxycyclohexyl)-phenol (Other names: CP–47,497) ...... 7297 (iii) 5-(1,1-Dimethyloctyl)-2-(3-hydroxycyclohexyl)-phenol (Other names: Cannabicyclohexanol and CP–47,497 C8 homologue) ...... 7298 (iv) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (Other names: JWH–200) ...... 7200 (v) 1-Pentyl-3-(1-naphthoyl)indole (Other names: JWH–018 and AM678) ...... 7118 * * * * * misleading and are in need of modification would relieve heavy rush Dated: February 24, 2012. clarification. hour road traffic on State Routes 3 and 104, by allowing the draws of the bridge Michele M. Leonhart, Correction of Publication to not open for maritime traffic during Administrator. Accordingly, the publication of the afternoon rush hour in the summer [FR Doc. 2012–4982 Filed 2–28–12; 11:15 am] notice of public hearing on an advance months. BILLING CODE 4410–09–P proposed rulemaking (REG–157714–06) DATES: Comments and related material which was the subject of FR. Doc. 2012– must reach the Coast Guard on or before 2499, is corrected as follows: April 16, 2012. DEPARTMENT OF THE TREASURY ■ 1. On page 5442, column 2, in the ADDRESSES: You may submit comments preamble, under the caption DATES:, line Internal Revenue Service identified by docket number USCG– four, the language ‘‘Building. The IRS 2012–0074 using any one of the must receive outlines’’ is corrected to 26 CFR Part 1 following methods: read ‘‘Building. Written or electronic (1) Federal eRulemaking Portal: [REG–157714–06] comments must be received by June 18, http://www.regulations.gov. RIN 1545–BG43 2012. The IRS must receive outlines’’ (2) Fax: 202–493–2251. ■ 2. On page 5442, column 2, in the (3) Mail: Docket Management Facility Determination of Governmental Plan preamble, under the caption (M–30), U.S. Department of Status; Correction ADDRESSES:, second paragraph, first Transportation, West Building Ground line, the language ‘‘Mail outlines to Floor, Room W12–140, 1200 New Jersey AGENCY: Internal Revenue Service (IRS), CC:PA:LPD:PR (REG-’’ is corrected to Avenue SE., Washington, DC 20590– Treasury. read ’’ Mail submissions and outlines to 0001. ACTION: Notice of public hearing on an CC:PA:LPD:PR (REG-‘‘. (4) Hand delivery: Same as mail advance notice of proposed rulemaking; address above, between 9 a.m. and correction. LaNita Van Dyke, Chief, Publications and Regulations Branch, 5 p.m., Monday through Friday, except SUMMARY: This document corrects a Legal Processing Division, Associate Chief Federal holidays. The telephone number notice of public hearing on an advance Counsel, (Procedure and Administration). is 202–366–9329. proposed rulemaking (REG–157714–06) [FR Doc. 2012–4905 Filed 2–29–12; 8:45 am] To avoid duplication, please use only one of these four methods. See the that was published in the Federal BILLING CODE 4830–01–P Register on Friday, February 3, 2012 (77 ‘‘Public Participation and Request for FR 5442) relating to the determination Comments’’ portion of the SUPPLEMENTARY INFORMATION section of governmental plans. DEPARTMENT OF HOMELAND below for instructions on submitting FOR FURTHER INFORMATION CONTACT: SECURITY comments. Concerning the proposed regulations, Pamela Kinard at (202) 622–6060, and Coast Guard FOR FURTHER INFORMATION CONTACT: If regarding the submission of public you have questions on this rule, call or comments and the public hearing, Ms. 33 CFR Part 117 email the Bridge Administrator, Coast Oluwafunmilayo (Funmi) Taylor, at [Docket No. USCG–2012–0074, Formerly Guard Thirteenth District; telephone (202) 622–7180 (not toll-free numbers). USCG–2011–0314] 206–220–7282 email SUPPLEMENTARY INFORMATION: [email protected]. If you have RIN 1625–AA09 questions on viewing or submitting Background material to the docket, call Renee V. Drawbridge Operation Regulation; Wright, Program Manager, Docket The notice of public hearing on an Hood Canal, WA advance notice proposed rulemaking Operations, telephone 202–366–9826. (REG–133233–08) that is the subject of AGENCY: Coast Guard, DHS. SUPPLEMENTARY INFORMATION: this correction is under section 414(d) of ACTION: Notice of proposed rulemaking. Public Participation and Request for the Internal Revenue Code. SUMMARY: The Coast Guard proposes to Comments Need for Correction modify the drawbridge operating We encourage you to participate in As published, REG–157714–06, regulation for the Hood Canal floating this rulemaking by submitting contains errors that may prove to be drawbridge near Port Gamble. This comments and related materials. All

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