4
Rules and Regulations 11075 Federal Register Vol. 76. No. 40 Tuesday. March I, 2011 This section of the FEDERAL REGISTER contains regulatory documents having general applicabilityand legal effect. most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-345F] Schedules of Controlled Substances: Temporary Placement of Five Synthetic Cannabin aids Into Schedule I AGENCY: Drug Enforcement Administration (DEA), U.S. Department of Justice. ACTION: Final order. SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily place five synthetic cannabinoids into the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions. The substances are 1-pentyl- 3-(1-naphthoyl)indole (]WH-018), 1- butyl-3-(1-naphthoyl)indole (]WH-073), 1-[2-( 4-morpholinyl)ethyl]-3-( 1- naphthoyl)indole (]WH-200), 5-(1,1- dimethylheptyl)-2-[( lR,3S)-3- hydroxycyclohexyl]-phenol (CP- 47,497), and 5-(l,l-dimethyloctyl)-2- I( lR,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result ofthis order, the full effect of the CSA and its implementing regulations including criminal, civil and administrative penalties, sanctions and regulatory controls of Schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic cannabinoids. FOR FURTHER INFORMATION CONTACT: Christine A. Sannemd, PhD, Chief, Drug and Chemical Evaluation Section. Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, telephone (202) 307-7183, fax (202) 353-1263, or e-mail [email protected]. DATES: Effective Date: March I, 2011. SUPPLEMENTARY INFORMATION: Background The Comprehensive Crime Control Act of 1984 (Pub. L; 98-473), which was signed into law on October 12, 1984, amended section 201 of the CSA (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA for one year without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid imminent hazard to the public safety. The Attorney General may extend the temporary scheduling up to six months during pendency of proceedings under 21 U.S.C. 811(a)(1). A substance may be temporarily scheduled under the emergency provisions of the CSA if it is not listed in any other schedule under section 202 of the CSA (21 U.S.C. 812) or ifthere is no exemption or approval in effect under 21 U.S.C. 355 for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the DEA Administrator (28 CFR 0.100). As per section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)), the Deputy Administrator, now Administrator, transmitted notice of her intention to temporarily place ]WH-018, ]WH-073, ]WH-200, CP-47,497, and cannabicyclohexanol into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services (HHS) in a letter dated October 6, 2010. In response to this notification, the Assistant Secretary of Health, HHS communicated in a letter dated November 22, 2010, to the then- DEA Acting Administrator that there are no exemptions or approvals in effect for ~-o18,]VVH-073,~-200,CP- 47,497, and cannabicyclohexanol under Section 505 of the Federal Food. Drug and Cosmetic Act (21 U.S.C. 355). The substances are not listed in any other schedule in 21 V.S.C. 812. A notice of intent to temporarily place ]WH-018,]WH-o73,]WH-200,CP- 47,497, and cannabicyclohexanol into Schedule I of the CSA was published in the Federal Register on November 24, 2010 (75 FR 71635). Before making a finding that temporarily placing a substance into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator must consider three of the eight factors (factors 4, 5, and 6) set forth in section 201(c) of the CSA (21 U.S.C. 8U(c)). These factors are the history and current pattern of abuse, the scope, duration, and significance of abuse. and what, if any, risk there is to the public health, including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). The temporary placement of these five synthetic cannabinoids into Schedule I of the CSA is necessary in order to avoid an imminent hazard to the public safety. First, these substances are not intended for human consumption, but there has been a rapid and significant increase in abuse of these substances in the United States. As a result of this abuse, synthetic cannabinoids are banned in at least 18 states in the United States and several countries, and all five branches of the U.S. military prohibit military personnel from possessing or using synthetic cannabinoids. Second, law enforcement has seized synthetic cannabinoids in conjunction with controlled substances and based on self- reports to law enforcement and health care professionals, synthetic cannabinoids are abused for their psychoactive properties. Third, numerous state and local public health departments and poison control centers have issued health warnings describing the adverse health effects associated with synthetic cannabinoids. Based on scientific data currently available, these five substances have the potential to be extremely harmful and, therefore, pose an imminent hazard to the public safety. History and Current Pattern of Abuse A "cannabinoid" is a class of chemical compounds in the marijuana plant that are structurally related. The cannabinoid il9-tetrahydrocannabinol (THC) is the primary psychoactive constituent of marijuana. "Synthetic cannabinoids" are a large family of chemically unrelated structures functionally (biologically) similar to THC, the active principle of marijuana. Two oftha five synthetic cannabinoids (CP-47,497 and cannabicyclohexanol) were synthesized in the early 1980s for research purposes

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Rules and Regulations

11075

Federal Register

Vol. 76. No. 40

Tuesday. March I, 2011

This section of the FEDERALREGISTERcontains regulatory documents having generalapplicabilityand legal effect. most of whichare keyed to and codified in the Code ofFederal Regulations, which is published under50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold bythe Superintendent of Documents. Prices ofnew books are listed in the first FEDERALREGISTER issue of each week.

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-345F]

Schedules of Controlled Substances:Temporary Placement of FiveSynthetic Cannabin aids IntoSchedule I

AGENCY: Drug EnforcementAdministration (DEA), U.S. Departmentof Justice.ACTION: Final order.

SUMMARY: The Administrator of the DrugEnforcement Administration (DEA) isissuing this final order to temporarilyplace five synthetic cannabinoids intothe Controlled Substances Act (CSA)pursuant to the temporary schedulingprovisions. The substances are 1-pentyl­3-(1-naphthoyl)indole (]WH-018), 1­butyl-3-(1-naphthoyl)indole (]WH-073),1-[2-( 4-morpholinyl)ethyl]-3-( 1­naphthoyl)indole (]WH-200), 5-(1,1­dimethylheptyl)-2-[( lR,3S)-3­hydroxycyclohexyl]-phenol (CP­47,497), and 5-(l,l-dimethyloctyl)-2-I(lR,3S)-3-hydroxycyclohexyl]-phenol(cannabicyclohexanol; CP-47,497 C8homologue). This action is based on afinding by the Administrator that theplacement of these syntheticcannabinoids into Schedule I of the CSAis necessary to avoid an imminenthazard to the public safety. As a resultofthis order, the full effect of the CSAand its implementing regulationsincluding criminal, civil andadministrative penalties, sanctions andregulatory controls of Schedule Isubstances will be imposed on themanufacture, distribution, possession,importation, and exportation of thesesynthetic cannabinoids.FOR FURTHER INFORMATION CONTACT:

Christine A. Sannemd, PhD, Chief, Drugand Chemical Evaluation Section. Office

of Diversion Control, Drug EnforcementAdministration, 8701 Morrissette Drive,Springfield, VA 22152, telephone (202)307-7183, fax (202) 353-1263, or [email protected]: Effective Date: March I, 2011.SUPPLEMENTARY INFORMATION:

Background

The Comprehensive Crime ControlAct of 1984 (Pub. L; 98-473), which wassigned into law on October 12, 1984,amended section 201 of the CSA (21U.S.C. 811) to give the Attorney Generalthe authority to temporarily place asubstance into Schedule I of the CSA forone year without regard to therequirements of 21 U.S.C. 811(b) if hefinds that such action is necessary toavoid imminent hazard to the publicsafety. The Attorney General mayextend the temporary scheduling up tosix months during pendency ofproceedings under 21 U.S.C. 811(a)(1).A substance may be temporarilyscheduled under the emergencyprovisions of the CSA if it is not listedin any other schedule under section 202of the CSA (21 U.S.C. 812) or ifthere isno exemption or approval in effectunder 21 U.S.C. 355 for the substance.The Attorney General has delegated hisauthority under 21 U.S.C. 811 to theDEA Administrator (28 CFR 0.100).

As per section 201(h)(4) of the CSA(21 U.S.C. 811(h)(4)), the DeputyAdministrator, now Administrator,transmitted notice of her intention totemporarily place ]WH-018, ]WH-073,]WH-200, CP-47,497, andcannabicyclohexanol into Schedule I ofthe CSA to the Assistant Secretary forHealth of the Department of Health andHuman Services (HHS) in a letter datedOctober 6, 2010. In response to thisnotification, the Assistant Secretary ofHealth, HHS communicated in a letterdated November 22, 2010, to the then­DEA Acting Administrator that there areno exemptions or approvals in effect for~-o18,]VVH-073,~-200,CP­47,497, and cannabicyclohexanol underSection 505 of the Federal Food. Drugand Cosmetic Act (21 U.S.C. 355). Thesubstances are not listed in any otherschedule in 21 V.S.C. 812.

A notice of intent to temporarily place]WH-018,]WH-o73,]WH-200,CP­47,497, and cannabicyclohexanol intoSchedule I of the CSA was published inthe Federal Register on November 24,2010 (75 FR 71635). Before making a

finding that temporarily placing asubstance into Schedule I of the CSA is

necessary to avoid an imminent hazardto the public safety, the Administratormust consider three of the eight factors(factors 4, 5, and 6) set forth in section201(c) of the CSA (21 U.S.C. 8U(c)).These factors are the history and currentpattern of abuse, the scope, duration,and significance of abuse. and what, ifany, risk there is to the public health,including actual abuse, diversion fromlegitimate channels, and clandestineimportation, manufacture, ordistribution. 21 U.S.C. 811(h)(3).

The temporary placement of these fivesynthetic cannabinoids into Schedule Iof the CSA is necessary in order to avoidan imminent hazard to the public safety.First, these substances are not intendedfor human consumption, but there hasbeen a rapid and significant increase inabuse of these substances in the UnitedStates. As a result of this abuse,synthetic cannabinoids are banned in atleast 18 states in the United States andseveral countries, and all five branchesof the U.S. military prohibit militarypersonnel from possessing or usingsynthetic cannabinoids. Second, lawenforcement has seized syntheticcannabinoids in conjunction withcontrolled substances and based on self­reports to law enforcement and healthcare professionals, syntheticcannabinoids are abused for theirpsychoactive properties. Third,numerous state and local public healthdepartments and poison control centershave issued health warnings describingthe adverse health effects associatedwith synthetic cannabinoids. Based onscientific data currently available, thesefive substances have the potential to beextremely harmful and, therefore, posean imminent hazard to the public safety.

History and Current Pattern of Abuse

A "cannabinoid" is a class of chemicalcompounds in the marijuana plant thatare structurally related. Thecannabinoid il9-tetrahydrocannabinol(THC) is the primary psychoactiveconstituent of marijuana. "Syntheticcannabinoids" are a large family ofchemically unrelated structuresfunctionally (biologically) similar toTHC, the active principle of marijuana.

Two oftha five syntheticcannabinoids (CP-47,497 andcannabicyclohexanol) were synthesizedin the early 1980s for research purposes

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11076 Federal Register/Vol. 76; No. 40/Tuesday, March 1, 2011/Rules and Regulations

in the investigation of the cannabinoidsystem. ]WH-{)18, IWH-073, and ]WH­200 were prepared in the mid-1990s andevaluated to further advance

. understanding of drug-receptorinteractions regarding the cannabinoidsystem. Developed and evaluated asresearch tools, no other knownlegitimate uses have been identified forthese five synthetic cannabinoids.Furthennore, these five syntheticcannabinoids are not intended forhwnan conswnption.

The emergence of these five syntheticcannabinoids represents a recent .phenomenon in the U.S. designer drugmarket. Since the initial identificationof ]WH-018 by U.S. forensiclaboratories, many additional syntheticcannabinoids including ]WH-{)73,IWH-200, CP-47,497, and

cannabicyclohexanol have beenidentified in related herbal incenseproducts and plant food. Thesesynthetic cannabinoids have purportedpsychotropic effects when smoked oringested. These substances are typicallyfound in powder fonn or are dissolvedin appropriate solvents, such as acetone.before being sprayed on the plantmaterial contained in the herbal incenseproducts.

The popularity of these THC-likesynthetic cannabinoids has significantlyincreased throughout the United States,and they are being abused for theirpsychoactive properties as reported bylaw enforcement, the medicalcommunity, and through scientificliterature.

Some of the product names include,but are not limited to, "Spice," "K2," andmany more. Due to sophisticatedmarketing, the products that containthese five THC-like syntheticcannabinoids are perceived as "legal"alternatives to marijuana despite the factthat they are typically advertised asherbal incense or plant food (Bonsai-18)by Internet retailers, tobacco shops,head shops, and other domestic brickand mortar retail venues, and labeled"Not For Hwnan Conswnption." Noevidence exists that these syntheticcannabinoids have value as an additiveto herbal incense products due to theabsence of odor associated with thesubstances.

Based on law enforcementencounters, these five substances aretypically found laced on plant material.The plant material is packaged in smallpouches or packets, and is being soldover the Internet, in tobacco and smokeshops, drug paraphernalia shops, gasstations, and convenience stores asherbal incense products, givingcustomers of all ages direct access tothese five substances. Research articles

propose that the packaging isprofessional and conspicuous, targetingyoung people, possibly eager to usecannabis, but who are afraid of thejudicial consequences and! orassociation with illicit drugs.

According to Internet discussionboards and law enforcement encountersreported directly to DEA, these fivesynthetic cannabinoids are being bothabused alone and/or being sprayed onplant material (which is then smoked).The most common route ofadministration of these syntheticcannabinoids is by smoking (using apipe, a water pipe, or rolling the drug­spiked plant material in cigarettepapers).

These five synthetic cannabinoidsalone or spiked on plant material havethe potential to be extremely harmfuldue to their method of manufacture andhigh pharmacological potency. There islittle infonnation regarding thepharmacology, toxicology, and safety ofthese substances in hwnans given theminimal amount of pre-clinicalinvestigations undertaken regardingthese substances; therefore. the fulldanger of these drugs has not yet beendetennined.

As of January 31, 2011, 18 states inthe United States and other countrieshave controlled one or more of the fivesynthetic cannabinoids. Moreover, allfive branches of the military prohibittheir personnel from possessing or usingsynthetic cannabinoids associated withproducts such as Spice and K2.

Scope, Duration, and Significance ofAbuse

According to forensic laboratoryreports, the initial appearance of thesesynthetic cannabinoids in herbalincense products in the United Statesoccurred in November 2008 when U.S.Customs and Border Protection firstencountered products such as Spice.

The increasing abuse of the fivesynthetic cannabinoids is demonstratedby the increase in federal, state, andlocal law enforcement activityassociated with these substances. TheNational Forensic LaboratoryInformation System, a nationalrepository for drug evidence analysesfrom forensic laboratories across theUnited States, has reported in excess of500 exhibits containing syntheticcannabinoid from January 2010 throughSeptember 2010. These exhibits camefrom numerous states across the nation

including Alabama, Arkansas.California, Florida, Hawaii, Iowa,Indiana, Kansas, Kentucky, Louisiana,Minnesota, Missouri, North Dakota,Nebraska, Nevada, Oklahoma,

Pennsylvania, South Carolina,Tennessee, and Virginia.

Even though there is no evidence oflegitimate non-research related use forthese synthetic cannabinoids, multipleshipments of IWH-018 and IWH-{)73have been encountered by U.S. Customsand Border Protection in 2010. Oneenforcement operation encountered fiveshipments of IWH-018 totaling over 50kilograms (110.2 pounds) of powder. Inaddition, bulk loads of IWH-018 andIWH-200 have been encountered by lawenforcement in 2010. For example, inCasper, Wyoming, DEA agentsencountered large quantities of herbalincense products laced with thesynthetic cannabinoid IWH-018 inconjunction with methamphetamineand other illegal drugs in execution ofsearch and arrest warrants.

On March 24, 2010, the AmericanAssociation of Poison Control Centersreported receiving 112 calls from 15states related to synthetic cannabinoidsto U.S. poison centers since 2009. Justnine months later, the number of callsincreased to over 2,700 from 49 statesand the District of Columbia.

What, If Any, Risk There Is to thePublic Health

Health warnings have been issued bynumerous state and local public healthdepartments and poison control centersdescribing the adverse health effectsassociated with these syntheticcannabinoids and their related products,including agitation, anxiety, nausea,vomiting, tachycardia (fast, racingheartbeat), elevated blood pressure,tremor, seizures, hallucinations,paranoid behavior, and non­responsiveness ..

Smoking these synthetic cannabinoidsfor the purpose of achievingintoxication and experiencing thepsychoactive effects has been identifiedas a reason for emergency room visitsand calls to poison control centers. In afact sheet by the National Drug CourtInstitute, the problem of syntheticcannabinoid abuse is described as"significant and disturbing." This issupported by information that wascommunicated to DEA from one of themajor private toxicology laboratories.Based on laboratory findings from drugscreens for the period of July 2010through November 2010, over 3,700specimens tested positive for eitherJWH-018 or ]WH-{)73. They alsoindicated that they were finding 30­35% positivity for specimens submitted

by juvenile probation departments.Case reports describe psychoticepisodes. withdrawal, and dependenceassociated with use of these syntheticcannabinoids, similar to syndromes

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Federal Register/Vol. 76, No. 40/Tuesday, March 1, 2011/Rules and Regulations 11077

observed in marijuana abuse. Inaddition, based on law enforcementencounters reported directly to DEA,when responding to incidents involvingindividuals who have reportedlysmoked these synthetic cannabinoids,first responders report that theseindividuals have suffered from intensehallucinations. Moreover, emergencydepartment physicians and toxicologistshave reported the adverse health effectsassociated with smoking herbal incenseproducts laced with these substances.Furthermore, based on law enforcementencounters, suspected Driving Underthe Influence of Drug incidents areattributed to the smoking of syntheticcannabinoids. For example, inSeptember 2010, police in Nebraskaresponded to an incident involving ateenage male who had careened histruck into the side of a residence. Afterstriking the residence and several moreitems, the teen continued several moreyards before coming to a complete stop.Prior to crashing the truck, theindividual had driven past a junior highschool and nearly struck a child. Uponfurther investigation, the driver of thevehicle admitted to smoking "WickedX," a product marketed as "herbalincense" and known to containsynthetic cannabinoids, prior to theaccident. Preliminary toxicology reportsindicated that the individual did nothave any alcohol or other illegalsubstances in his system.

Detailed chemical analyses by DEAand other investigators have found thesesynthetic cannabinoids spiked on plantmaterial in herbal incense productsmarketed to the general public. Productanalyses have found variations in boththe synthetic cannabinoid found on theplant material and the amount. Asproposed in scientific literature, the riskof adverse health effects is furtherincreased by the fact that similarproducts vary in the composition andconcentration of synthetic cannabinoids

spiked on the plant material.Self-reported abuse of these THC-likesynthetic cannabinoids either alone(e.g., in pills with the substance inpowder form) or spiked on plantmaterial appear extensively on Internetdiscussion boards, and abuse has beenreported to public health officials andlaw enforcement. The abuse of thesesubstances spiked on plant material iscorroborated by forensic laboratoryanalysis of products encountered by lawenforcement.

According to the U.S. Customs andBorder Protection, a number of theproducts and synthetic cannabinoidsappear to originate from foreign sources.Product manufacturing operationsencountered by law enforcement

corroborate that the herbal incense

products are manufactured in theabsence of quality controls and devoidof regulatory oversight. Lawenforcement has encountered themanufacture of herbal incense productsoccurring in such places as residentialneighborhoods. These products andassociated synthetic cannabinoids arereadily accessible via the Internet.

Based on the above data, thecontinued uncontrolled manufacture,distribution, importation, exportation,and possession ofJWH-018, JWH-073,JWH-200, CP-47,497, andcannabicyclohexanol pose an imminenthazard to the public safety. DEA is notaware of any recognized therapeuticuses of these synthetic cannabinoids inthe United States.

DEA has considered the three criteriafor placing a substance into Schedule Iof the CSA (21 U.S.C. 812). The dataavailable and reviewed for JWH-073 ,JWH-018, JWH-200, CP47,497, andcannabicyclohexanol indicate that thesesynthetic cannabinoids each has a highpotential for abuse, no currentlyaccepted medical use in treatment in theUnited States and a lack of acceptedsafety for use under medicalsupervision.

In accordance with the provisions ofsection 201(h) of the CSA (21 U.S.C.811(h)) and 28 CFR 0.100, theAdministrator has considered theavailable data and the three factorsrequired to support a determination totemporarily schedule five syntheticcannabinoids: I-butyl-3-(1­naphthoyl)indole,l-pentyl-3-(1­naphthoyl)indole, 1-[2-(4­morpholinyl)ethy 1)-3-(1­naphthoyl)indole, 5-(1,1-dimethy lheptyl)-2-[ (lR,3S)-3­hydroxycyclohexyl]-phenol. and 5-(1,1­dimethy locty 1)-2-[(lR.3S)-3­hydroxycyclohexyl]-phenol in ScheduleI of the CSA and finds that temporaryplacement of these syntheticcannabinoids into Schedule I of the CSAis necessary to avoid an imminenthazard to the public safety.

Regulatory RequirementsWith the issuance ofthis final order,

JWH-018 , JWH-073 , JWH-200, CP­47,497, and cannabicyclohexanolbecome subject to the regulatorycontrols and administrative, civil andcriminal sanctions applicable to themanufacture, distribution, possession,importation, and exportation of aSchedule I controlled substance underthe CSA.

1. Registration. Any person whomanufactures, distributes, dispenses,imports, exports, or possesses JWH-018,JWH-073, ]WH-200, CP-47,497, or

cannabicyclohexanol or who engages inresearch or conducts instructionalactivities with respect to JWH-018,JWH-073, JWH-200, CP-47,497, orcannabicyclohexanol, or who proposesto engage in such activities, must beregistered to conduct such activities inaccordance with 21 U.S.C. 823 and 958.

Any person who is currently engaged inany of the above activities and is notregistered with DEA must submit anapplication for registration and may notcontinue their activities until DEA hasapproved that application. Retail salesof Schedule I controlled substances to

the general public are not allowed underthe Controlled Substances Act.

2. Security. JWH-018 , lWH-073,JWH-200, CP-47,497, andcannabicyclohexanol are subject toSchedule I security requirements.Accordingly, appropriately registeredDEA registrants must manufacture,distribute and store these substances inaccordance with 1301.71; 1301.72(a).(c), and (d); 1301.73; 1301.74; 1301.75(a)and (c); and 1301.76 of Title 21 of theCode of Federal Regulations as of MarchI, 2011.

3. Labeling and packaging. Alllabeling and packaging requirements forcontrolled substances set forth in Part1302 of Title 21 ofthe Code of FederalRegulations shall apply to commercialcontainers of lWH-018 , lWH-073, JWH­200, CP-47,497, andcannabicyclohexanol. Current DEAregistrants shall have thirty (30)calendar days from the effective date ofthis Final Order to be in compliancewith all labeling and packagingrequirements.

4. Quotas. Quotas for JWH-018, JWH­073, JWH-200, CP-47,497, andcannabicyclohexanol will be establishedbased on registrations granted and quotaapplications received pursuant to part1303 of Title 21 of the Code of FederalRegulations.

5. Inventory. Every DEA registrantwho possesses any quantity of JWH­018, JWH-073, JWH-200, CP-47,497, orcannabicyclohexanol is required to keepinventory of all stocks of thesesubstances on hand pursuant to1304.03,1304.04, and 1304.11 of Title21 of the Code of Federal Regulations.Every current DEA registrant whodesires registration in Schedule I forJWH-018,rNH-o73,JWH-200,CP­47,497, or cannabicyclohexanol shallconduct an inventory of all stocks ofthese substances. Current DEA

registrants shall have thirty (30)calendar days from the effective date ofthis Final Order to be in compliancewith all inventory requirements.

6. Records. All registrants who handle]WH-OIB, ]WH-073, ]WH-200, CP-

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11078 Federal Register/Vol. 76, No. 40/Tuesday, March 1, 20n/Rules and Regulations

Bureau of Prisons

DEPARTMENT OF JUSTICE

PART 1308-SCHEDULES OFCONTROLLED SUBSTANCES

• 1. The authority citation for part 1308continues to read as follows:

Authority: 21 V.S.C. 811, 812, 871(b),unless otherwise noted.

****

SUMMARY: In this document, the Bureauof Prisons delays the effective date ofthe final rule that appeared in theFederal Register on December 8, 2010,(75 FR 76263) and the subsequentcorrection which appeared in the

28 CFR Part 541

[Docket No. BOP-1118-F]

RIN 1120-AB18

Inmate Discipline ProgramlSpecialHousing Units: Subpart Revision andClarification

AGENCY: Bureau of Prisons, Justice.

ACTION: Final rule; delay of effectivedate.

(g)***(1) 5-(l,l-Dimethylheptyl)-2-[(lR,3S)­

3-hydroxycyclohexyl]-phenol, itsoptical, positional, and geometricisomers, salts and salts of isomers­7297 (Other names: CP-47,497)

(2) 5-( l,l-Dimethyloctyl)-2-[( lR,3S)-3­hydroxycyclohexyl]-phenol. its optical.positional, and geometric isomers, saltsand salts of isomers-7298 (Othernames: cannabicyclohexanol and CP­47,497 C8 homologue)

(3) I-Butyl-3-(1-naphthoyl)indole, itsoptical, positional, and geometricisomers, salts and salts of isomers­7173 (Other names: JWH-073)

(4) 1-[2-(4-Morpholinyl)ethyl]-3-(1­naphthoyl)indole, its optical, positional,and geometric isomers, salts and salts ofisomers-7200 (Other names: ]WH-200)

(5) 1-Pentyl-3-(1-naphthoyl)indole, itsoptical, positional, and geometricisomers, salts and salts of isomers­7118 (Other names: ]WH-018 andAM678)

Dated: February 18, 201loMichele M. Leonhart,Administrator.

[FR Doc. 2011-4426 Filed 2-26-11; 6:45 amI

SILLING CODe 441()"'()&-P

.2. Section 1308.11 is amended byadding new paragraphs (g)(l), (2), (3),(4), and (5) to read as follows:

§1308.11 Schedule I.

and public procedure thereon areimpracticable, unnecessary, or contraryto the public interest. It is in the publicinterest to schedule these cannabinoidsimmediately because they pose a publichealth risk. Use of materials spiked withthese cannabinoids has been the causeof emergency room visits and calls topoison control centers. The adversehealth effects associated with thesesynthetic cannabinoids and their relatedproducts include agitation, anxiety,nausea, vomiting, tachycardia (fast,racing heartbeat), elevated bloodpressure, tremor. seizures,hallucinations, paranoid behavior, andnon-responsiveness. The.materials havebeen marketed on products that areavailable to the general public, and theirmanufacture is devoid of qualitycontrols and unregulated.

This temporary scheduling action istaken pursuant to section 811(h). whichis specifically designed to enable DEAto act in an expeditious manner to avoidan imminent hazard to the public safetyfrom new or designer drugs or abuse ofthose drugs. Section 811(h) exempts thetemporary scheduling order fromstandard notice and commentrulemaklng procedures to ensure thatthe process moves swiftly. For the samereasons that underl ie section 811 (h),that is. DENs need to move quickly toplace these five cannabinoids intoSchedule 1 because they pose a threatto public health, it would be contrary tothe public interest to delayimplementation of the temporaryscheduling order by requiring DEA toundertake the procedures necessary tocomply with the Congressional ReviewAct prior to the order taking effect.

Unfunded Mandates Reform Act of 1995

This final temporary scheduling orderwill not result in the expenditure byState, local and tribal governments, inthe aggregate, or by the private sector, of$126,400.000 or more (adjusting forinflation) in anyone year. and it willnot significantly or uniquely affect smallgovernments. Therefore, no actions weredeemed necessary under the provisionsof the Unfunded Mandates Reform Actof 1995.

List of Subjects in 21 CFR Part 1308

Administrative practice andprocedure, Drug traffic control,Reporting and recordkeepingrequirements.

Under the authority vested in theAttorney General by section z(:n(h) ofthe CSA (21 U.S.C. 811 (h)). theAdministrator hereby amends 21 CFRpart 1308 as follows:

47,497, or cannabicyclohexanol arerequired to keep records pursuant to1304.03, 1304.04, 1304.21, 1304.22, and1304.23 of Title 21 of the Code ofFederal Regulations. CurrentDEAregistrants shall have thirty (30)calendar days from the effective date ofthis Final Order to be in compliancewith all recordkeeping requirements.

7. Reports. All registrants are requiredto submit reports in accordance with1304.33 of Title 21 of the Code of

Federal Regulations. Registrants whomanufacture or distribute IWH-018,]WH-073, ]WH-200, CP-47,497, orcannabicyclohexanol are required tocomply with these reportingrequirements and shall do so as ofMarch 1,2011.

8. Order Forms. All registrantsinvolved in the distribution of]WH­018, IWH-073 , ]WH-200, CP-47,497, orcannabicyclohexanol must comply withorder form requirements of part 1305 ofTitle 21 of the Code of Federal

Regulations as of March 1, 2011.9. Importation and Exportation. All

importation and exportation of IWH­018, IWH-073, ]WH-200, CP-47,497, orcannabicyclohexanol must beconducted by appropriately registeredDEA registrants in compliance with part1312 of Title 21 of the Code of FederalRegulations on or after March 1, 2011.

10. CriminalLJability. Themanufacture, distribution, dispensation,or possession with the intent to conductthese activities; possession; importation;or exportation of ]WH-018, ]WH-073,]WH-200, CP-47,497, orcannabicyclohexanol not authorized by,or in violation of the CSA or theControlled Substances Import andExport Act occurring as of March 1,2011 is unlawful.

Executive Order 12988

This fmal temporary scheduling ordermeets the applicable standards set forthin sections 3(a) and 3(b)(2) of ExecutiveOrder 12988 Civil Justice Reform.

Executive Order 13132

This final temporary scheduling orderdoes not preempt or modify anyprovision of State law; nor does itimpose enforcement responsibilities onany State; nor does it diminish thepower of any State to enforce its ownlaws. Accordingly, this order does nothave federalism implications warrantingthe application of Executive Order13132.

Congressional Review ActPursuant to section 808(2) of the

Congressional Review Act, the agency isnot required to comply with the Act ifit makes a good faith finding that notice