Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 27611 

telephone +33 5 61 93 36 96; fax +33 5 61 

93 44 51; email account.airworth-eas@

airbus.com; Internet http://www.airbus.com. 

You may view this service information at the 

FAA, Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on April 30, 

2015. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–11554 Filed 5–13–15; 8:45 am] 

BILLING CODE 4910–13–P 

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-indol3-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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
27612 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 

1As 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. 

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. 

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-indol3-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 

(D 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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 27613 

2Comprehensive 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. 

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 D 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

(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 D 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 

D 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 D 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-9bhydroxyhexahydrocannabinol (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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
27614 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 

3NFLIS is a program of the DEA that collects drug 

identification results from drug cases analyzed by 

other Federal, State, and local forensic laboratories. 

4STRIDE 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. 

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 longterm 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. 

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 (D 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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 27615 

5UR–144, XLR11, and AKB48 are currently 

subject to schedule I controls on a temporary basis, 

pursuant to 21 U.S.C. 811(h). 

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-indol3-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 (D 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-indol3-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-indol3-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-indol3-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: 

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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
27616 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Proposed Rules 

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 

■ 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. 

■ 2. Amend § 1308.11 by: 

■ a. Adding paragraphs (g)(16) through 

(18); and 

■ 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: 

§ 1308.11 Schedule I. 

* * * * * 

(g) * * * 

(16) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR–144) ......................................................................... (7144) 

(17) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR–144, XLR11) ............................. (7011) 

(18) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) .............................................................................. (7048) 

* * * * * 

Dated: May 12, 2015. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2015–11762 Filed 5–13–15; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2015–0045] 

RIN 1625–AA08 

Special Local Regulation; Southeast 

Drag Boat Championships, Atlantic 

Intracoastal Waterway; Bucksport, SC 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish a special local regulation on 

the Atlantic Intracoastal Waterway in 

Bucksport, South Carolina during the 

Southeast Drag Boat Championships, a 

series of high-speed boat races. The 

event is scheduled to take place from 10 

a.m. on July 24, 2015, through 6 p.m. on 

July 26, 2015. Approximately 50 highspeed race boats are anticipated to 

participate in the races. This special 

local regulation is necessary to provide 

for the safety of life and property on 

navigable waters of the United States 

during the event. This special local 

regulation would temporarily restrict 

vessel traffic in a portion of the Atlantic 

Intracoastal Waterway. Persons and 

vessels that are not participating in the 

races would be prohibited from 

entering, transiting through, anchoring 

in, or remaining within the restricted 

area unless authorized by the Captain of 

the Port Charleston or a designated 

representative. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before June 15, 2015. Requests for 

public meetings must be received by the 

Coast Guard on or before May 29, 2015. 

ADDRESSES: You may submit comments 

identified by docket number using any 

one of the following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail or Delivery: Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Deliveries 

accepted between 9 a.m. and 5 p.m., 

Monday through Friday, except federal 

holidays. The telephone number is 202– 

366–9329. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for further instructions on 

submitting comments. To avoid 

duplication, please use only one of 

these three methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Chief Warrant Officer Christopher 

Ruleman, Sector Charleston Office of 

Waterways Management, Coast Guard; 


tkelley on DSK3SPTVN1PROD with PROPOSALS