1776 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules 

1Because the Secretary of the HHS has delegated 

to the Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations, for purposes of this Notice of 

Intent, all subsequent references to ‘‘Secretary’’ 

have been replaced with ‘‘Assistant Secretary.’’ As 

set forth in a memorandum of understanding 

entered into by HHS, the Food and Drug 

Administration (FDA), and the National Institute on 

Drug Abuse (NIDA), FDA acts as the lead agency 

within HHS in carrying out the Assistant 

Secretary’s scheduling responsibilities under the 

CSA, with the concurrence of NIDA. 50 FR 9518, 

Mar. 8, 1985. 

Austro Engine GmbH Engines: Docket No. 

FAA–2013–0164; Directorate Identifier 

2013–NE–10–AD. 

(a) Comments Due Date 

The FAA must receive comments on this 

AD action by March 11, 2014. 

(b) Affected ADs 

This AD supersedes AD 2013–14–08, 

Amendment 39–17513 (78 FR 42677, July 17, 

2013). 

(c) Applicability 

This AD applies to all Austro Engine 

GmbH model E4 engines, with a waste gate 

controller, part number (P/N) E4A–41–120– 

000, Revision 060, or lower revision; or a 

waste gate controller, P/N E4B–41–120–000, 

Revision 010, or lower revision, installed. 

(d) Unsafe Condition 

This AD was prompted by engine power 

loss events due to fracture of the waste gate 

controller lever. We are issuing this AD to 

prevent failure of the waste gate controller 

lever, which could lead to damage to one or 

more engines, loss of thrust control, and 

damage to the airplane. 

(e) Compliance 

(1) Comply with this AD within the 

compliance times specified, unless already 

done. 

(2) At the next maintenance action for any 

reason, or within 110 flight hours after the 

effective date of this AD, or within three 

months after the effective date of this AD, 

whichever occurs first, remove from service 

waste gate controller, P/N E4A–41–120–000, 

Revision 060, or lower revision, and waste 

gate controller, P/N E4B–41–120–000, 

Revision 010 or lower revision. 

(f) Installation Prohibition 

After the effective date of this AD, do not 

install any waste gate controller, P/N E4A– 

41–120–000, Revision 060, or lower revision, 

or waste gate controller, P/N E4B–41–120– 

000, Revision 010, or lower revision, onto 

any engine, nor approve for return to service 

any engine that has either waste gate 

controller installed. 

(g) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

may approve AMOCs for this AD. Use the 

procedures found in 14 CFR 39.19 to make 

your request. 

(h) Related Information 

(1) For more information about this AD, 

contact Frederick Zink, Aerospace Engineer, 

Engine Certification Office, FAA, Engine & 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7779; fax: 781–238–7199; 

email: frederick.zink@faa.gov. 

(2) Refer to MCAI European Aviation 

Safety Agency AD 2013–0213, dated 

September 13, 2013, for more information. 

You may examine the MCAI on the Internet 

at http://www.regulations.gov/

#!documentDetail;D=FAA-2013-0164-0002. 

(3) Austro Engine Mandatory Service 

Bulletin No. MSB–E4–007/6, Revision 6, 

dated September 18, 2013, which is not 

incorporated by reference in this AD, can be 

obtained from Austro Engine GmbH, using 

the contact information in paragraph (h)(4) of 

this AD. 

(4) For service information identified in 

this AD, contact Austro Engine GmbH, 

Rudolf-Diesel-Strasse 11, A–2700 Weiner 

Neustadt, Austria; phone: +43 2622 23000; 

fax: +43 2622 23000–2711; Internet: 

www.austroengine.at. 

(5) You may view this service information 

at the FAA, Engine & Propeller Directorate, 

12 New England Executive Park, Burlington, 

MA. For information on the availability of 

this material at the FAA, call 781–238–7125. 

Issued in Burlington, Massachusetts, on 

December 31, 2013. 

Colleen M. D’Alessandro, 

Assistant Directorate Manager, Engine & 

Propeller Directorate, Aircraft Certification 

Service. 

[FR Doc. 2014–00169 Filed 1–9–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–385] 

Schedules of Controlled Substances: 

Temporary Placement of Four 

Synthetic Cannabinoids Into 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of Intent. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this notice of intent to 

temporarily schedule four synthetic 

cannabinoids into Schedule I pursuant 

to the temporary scheduling provisions 

of the Controlled Substances Act (CSA). 

The substances are: quinolin-8-yl 1- 

pentyl-1H-indole-3-carboxylate (PB–22; 

QUPIC); quinolin-8-yl 1-(5- 

fluoropentyl)-1H-indole-3-carboxylate 

(5-fluoro-PB–22; 5F–PB–22); N-(1- 

amino-3-methyl-1-oxobutan-2-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (AB–FUBINACA); and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB–PINACA). This action is based on 

a finding by the Deputy 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. Any final 

order will impose the administrative, 

civil, and criminal sanctions and 

regulatory controls applicable to 

Schedule I substances under the CSA on 

the manufacture, distribution, 

possession, importation, exportation, 

research, and conduct of instructional 

activities of these synthetic 

cannabinoids. 

DATES: January 10, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Acting Chief, Policy 

Evaluation and Analysis Section, Office 

of Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone (202) 598–6812. 

SUPPLEMENTARY INFORMATION: Any final 

order will be published in the Federal 

Register and may not be effective prior 

to February 10, 2014. 

Background 

Section 201 of the CSA, 21 U.S.C. 811, 

provides the Attorney General with the 

authority to temporarily place a 

substance into Schedule I of the CSA for 

two years 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. 21 U.S.C. 811(h). In addition, if 

proceedings to control a substance are 

initiated under 21 U.S.C. 811(a)(1), the 

Attorney General may extend the 

temporary scheduling for up to one 

year. 21 U.S.C. 811(h)(2). 

Where the necessary findings are 

made, a substance may be temporarily 

scheduled if it is not listed in any other 

schedule under section 202 of the CSA, 

21 U.S.C. 812, or if there is no 

exemption or approval in effect for the 

substance under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(FDCA), 21 U.S.C. 355. 21 U.S.C. 

811(h)(1); 21 CFR part 1308. The 

Attorney General has delegated his 

authority under 21 U.S.C. 811 to the 

Administrator of the DEA, who in turn 

has delegated her authority to the 

Deputy Administrator of the DEA. 28 

CFR 0.100, 0.104, Appendix to Subpart 

R of Part 0, Sec. 12. 

Section 201(h)(4) of the CSA (21 

U.S.C. 811(h)(4)) requires the Deputy 

Administrator to notify the Secretary of 

the Department of Health and Human 

Services (HHS) of his intention to 

temporarily place a substance into 

Schedule I of the CSA.1 As PB–22, 5F– 

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2STRIDE is a database of drug exhibits sent to 

DEA laboratories for analysis. Exhibits from the 

database are from the DEA, other federal agencies, 

and local law enforcement agencies. 

3NFLIS is a national drug forensic laboratory 

reporting system that systematically collects results 

from drug chemistry analyses conducted by state 

and local forensic laboratories across the country. 

PB–22, AB–FUBINACA, and ADB– 

PINACA are not currently listed in any 

schedule under the CSA, the DEA 

believes that the conditions of 21 U.S.C. 

811(h)(1) have been satisfied. Any 

comments submitted by the Assistant 

Secretary in response to the notice 

transmitted to the Assistant Secretary on 

November 7, 2013, shall be taken into 

consideration before a final order is 

published. 21 U.S.C. 811(h)(4). 

To make a finding that placing a 

substance temporarily into Schedule I of 

the CSA is necessary to avoid an 

imminent hazard to the public safety, 

the Deputy Administrator is required to 

consider three of the eight factors set 

forth in section 201(c) of the CSA, 21 

U.S.C. 811(c): the substance’s history 

and current pattern of abuse; the scope, 

duration and significance of abuse; and 

what, if any, risk there is to the public 

health. 21 U.S.C. 811(h)(3). 

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution. 21 U.S.C. 

811(h)(3). 

A substance meeting the statutory 

requirements for temporary scheduling 

may only be placed in Schedule I. 21 

U.S.C. 811(h)(1). Substances in 

Schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. 21 U.S.C. 812(b)(1). 

Available data and information for PB– 

22, 5F–PB–22, AB–FUBINACA, and 

ADB–PINACA indicate that these four 

synthetic cannabinoids have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. 

Synthetic Cannabinoids 

Synthetic cannabinoids are a large 

family of compounds that are 

functionally (biologically) similar to 

delta9-tetrahydrocannabinol (THC), the 

main active ingredient in marijuana. 

Synthetic cannabinoids, however, are 

not organic but are chemicals created in 

a laboratory. Two of the synthetic 

cannabinoids currently controlled (CP– 

47,497 and cannabicyclohexanol) were 

first synthesized in the early 1980’s for 

research purposes in the investigation of 

the cannabinoid system. JWH–018, 

JWH–073, and JWH–200 (temporarily 

scheduled on March 1, 2011 at 76 FR 

11075 and permanently scheduled on 

July 9, 2012, by Section 1152 of the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), Pub. L. 

112–144) were synthesized in the mid1990s and studied to further advance 

the understanding of drug-receptor 

interactions regarding the cannabinoid 

system. Synthesized as research tools, 

no other known legitimate uses have 

been identified for these five synthetic 

cannabinoids. 

According to forensic laboratory 

reports, the initial appearance of 

synthetic cannabinoids in herbal 

incense products in the United States 

occurred in November 2008 when U.S. 

Customs and Border Protection (CBP) 

first encountered products using brand 

names such as ‘‘Spice.’’ Prior to 

appearing on the U.S. market, synthetic 

cannabinoids were marketed in herbal 

incense products in several European 

countries. After experiencing numerous 

health-related incidents, some European 

countries banned these products/

chemicals. According to CBP, a number 

of the synthetic cannabinoids appeared 

to originate from foreign sources. 

Detailed chemical analyses by DEA 

and other agencies have found synthetic 

cannabinoids applied on plant material 

in herbal incense products marketed to 

the general public. Product analyses 

have found variations in both the type 

of synthetic cannabinoid and the 

amount of the substance found on the 

plant material. 

The vast majority of cannabinoids are 

manufactured in Asia by individuals 

who are not bound by any 

manufacturing requirements or quality 

control standards. The bulk products are 

smuggled into the United States 

typically as misbranded imports. These 

chemicals are generally found in 

powder form or are dissolved in 

solvents, such as acetone, before being 

applied to the plant material comprising 

the ‘‘herbal incense’’ products. After 

local distributors apply the drug to the 

leafy material, they package it for retail 

distribution, ignoring any control 

mechanisms to prevent contamination 

or to ensure a consistent, uniform 

concentration of drug in each package. 

According to Internet discussion boards 

and law enforcement encounters, 

spraying or mixing the synthetic 

cannabinoids on plant material provides 

a vehicle for the most common route of 

administration- smoking (using a pipe, a 

water pipe, or rolling the drug-spiked 

plant material in cigarette papers). They 

are sold under hundreds of different 

brand names, including ‘‘Spice,’’ ‘‘K2,’’ 

‘‘Blaze,’’ ‘‘Red X Dawn,’’ ‘‘Paradise,’’ 

‘‘Demon,’’ ‘‘Black Magic,’’ ‘‘Spike,’’ ‘‘Mr. 

Nice Guy,’’ ‘‘Ninja,’’ ‘‘Zohai,’’ ‘‘Dream,’’ 

‘‘Genie,’’ ‘‘Sence,’’ ‘‘Smoke,’’ ‘‘Skunk,’’ 

‘‘Serenity,’’ ‘‘Yucatan,’’ ‘‘Fire,’’ and 

‘‘Crazy Clown.’’ 

Law enforcement personnel have 

encountered dosage form and packaging 

operations in residential neighborhoods, 

garages, and warehouses. Throughout 

this process, there is no concern for 

preventing contamination of the 

product, consistent dosage, or the 

adverse health consequences that may 

occur from ingesting the drug. As 

proposed in the scientific literature, the 

risk of adverse health effects is further 

increased by the fact that similarly 

labeled products vary in the 

composition and concentration of 

synthetic cannabinoids applied on the 

plant material. 

There is an incorrect assumption that 

these products are safe. Numerous 

states, local jurisdictions, and the 

international community have 

controlled many synthetic 

cannabinoids. These substances have no 

accepted medical use in the United 

States and have been reported to 

produce adverse health effects in those 

who abuse them. 

PB–22, 5F–PB–22, AB–FUBINACA 

and ADB–PINACA are synthetic 

cannabinoids that have pharmacological 

effects similar to the Schedule I 

hallucinogen delta-9- 

tetrahydrocannabinol (THC). PB–22 and 

5F–PB–22 were not reported in the 

scientific literature prior to their 

appearance on the illicit drug market. 

First appearing in a 2009 patent filed by 

the pharmaceutical manufacturer Pfizer, 

AB–FUBINACA was most recently 

reported in the scientific literature as a 

component of so-called ‘‘herbal 

products’’ purchased via the Internet in 

July 2012. ADB–PINACA was first 

encountered by law enforcement 

following reports of serious adverse 

events in Georgia and Colorado in 

August and September 2013, 

respectively. 

From January through November 

2013, according to the System to 

Retrieve Information from Drug 

Evidence (STRIDE)2 there were 189 

reports involving PB–22, 155 reports 

involving 5F–PB–22, and 42 reports 

involving AB–FUBINACA (Queried on 

December 18, 2013). From January 

through November 2013, the National 

Forensic Laboratory Information System 

(NFLIS)3 registered 1,092 reports 

containing PB–22 in 29 states, 1,058 

reports containing 5F–PB–22 in 25 

states, 458 reports containing AB– 

FUBINACA in 17 states and 9 reports 

containing ADB–PINACA in one state 

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(Queried on December 18, 2013). No 

reports in NFLIS or STRIDE were 

identified for PB–22 or 5F–PB–22 prior 

to February 2013. No reports in NFLIS 

or STRIDE were identified for AB– 

FUBINACA prior to June 2013 or for 

ADB–PINACA prior to August 2013. 

Factor 4. History and Current Pattern of 

Abuse 

Synthetic cannabinoids have been 

developed over the last 30 years as tools 

for investigating the cannabinoid 

system. Synthetic cannabinoids 

intended for illicit use were first 

reported in the United States in a 

November 2008 encounter, where a 

shipment of ‘‘Spice’’ was seized and 

analyzed by CBP in Dayton, Ohio. 

Additionally around the same time, in 

December 2008, JWH–018 and 

cannabicyclohexanol (CP–47,497 C8 

homologue) were identified by German 

forensic laboratories. Since the initial 

identification of JWH–018, many 

additional synthetic cannabinoids have 

been found applied on plant material 

and encountered as designer drug 

products. The majority of the substances 

encountered on the illicit market have 

not been tested beyond preliminary preclinical laboratory screens before 

clandestine operators apply them on 

plant material. 

JWH–018 was the first synthetic 

cannabinoid to be identified as a 

product adulterant in Germany in 2008. 

This substance was initially synthesized 

as a research tool to investigate the 

cannabinoid system. Since then, 

numerous other synthetic cannabinoids 

have been identified as product 

adulterants and law enforcement has 

seized bulk amounts of these 

substances. The first synthetic 

cannabinoids identified as being abused 

included JWH–018, JWH–200, JWH– 

073, CP–47,497 and CP–47,497 C8 

homologue, followed shortly thereafter 

by new generations of synthetic 

cannabinoids that included AM2201 

and others, and eventually UR–144, 

XLR11 and AKB48. JWH–018, JWH– 

073, JWH–200, CP–47,497, and CP– 

47,497 C8 were temporarily scheduled 

on March 1, 2011 (76 FR 11075), and 

later permanently placed in Schedule I 

by Section 1152 of FDASIA on July 9, 

2012. Section 1152 of FDASIA amended 

the CSA by placing cannabimimetic 

agents and 26 specific substances 

(including 15 synthetic cannabinoids, 2 

synthetic cathinones, and 9 synthetic 

phenethylamines of the 2C-series) in 

Schedule I. UR–144, XLR11 and AKB– 

48 were temporarily scheduled on May 

16, 2013 (78 FR 28735). The most recent 

synthetic cannabinoids emerging as 

drugs of abuse include PB–22, 5F–PB– 

22, AB–FUBINACA, and ADB–PINACA. 

These four synthetic cannabinoids, 

along with UR–144, XLR11 and AKB– 

48, were not included among the 15 

specific named synthetic cannabinoids, 

and do not fall under the definition of 

cannabimimetic agents, under FDASIA. 

Synthetic cannabinoid products are 

marketed directly to adolescents and 

youth who appear to be the primary 

abusers of synthetic cannabinoids and 

synthetic cannabinoid-containing 

products. This is supported by law 

enforcement encounters and reports 

from emergency rooms; however, all age 

groups have been reported by media as 

abusing these substances and related 

products. 

According to recent testimony given 

by the Deputy Director of the Office of 

National Drug Control Policy (ONDCP) 

to the United States Senate Caucus on 

International Narcotics Control 

(September 25, 2013), current drug 

testing misses significant populations of 

synthetic cannabinoid users. This 

testimony describes a study showing 

that in a sample of men 30 years old or 

younger within the District of Columbia 

parole and probation system, 39 percent 

of those who cleanly passed a 

traditional drug screen tested positive 

for synthetic cannabinoids. The study 

continued that between one-quarter and 

one-third of young men who were tested 

in the Washington, DC criminal justice 

system had positive test results for 

synthetic cannabinoids, regardless of 

whether they had failed or passed a 

traditional drug screen. 

Factor 5. Scope, Duration and 

Significance of Abuse 

Recently, increased exposure 

incidents have been documented by 

poison control centers in the United 

States as the abuse of synthetic 

cannabinoids has been associated with 

both acute and long-term public health 

and safety concerns. From January 

through November 2013, according to 

STRIDE there were 189 reports 

involving PB–22; 155 reports involving 

5F–PB–22; and 42 reports involving 

AB–FUBINACA (Queried on December 

18, 2013). From January through 

November 2013, NFLIS registered 1,092 

reports containing PB–22 in 29 states 

(Arkansas, Arizona, Colorado, 

Connecticut, Florida, Georgia, Hawaii, 

Iowa, Kansas, Kentucky, Louisiana, 

Maryland, Minnesota, Missouri, North 

Dakota, Nebraska, New Hampshire, New 

Jersey, New Mexico, Ohio, Oklahoma, 

Oregon, Pennsylvania, South Carolina, 

Texas, Utah, Virginia, Wisconsin and 

Wyoming); 1,058 reports containing 5F– 

PB–22 in 25 states (Arkansas, Arizona, 

Colorado, Florida, Georgia, Iowa, 

Indiana, Kansas, Louisiana, Minnesota, 

Missouri, North Dakota, New Jersey, 

New Mexico, Nevada, Ohio, Oregon, 

Pennsylvania, South Carolina, 

Tennessee, Texas, Utah, Virginia, 

Wisconsin and Wyoming); 458 reports 

containing AB–FUBINACA in 17 states 

(Arizona, Colorado, Florida, Georgia, 

Iowa, Indiana, Kansas, Louisiana, 

Minnesota, Missouri, North Dakota, 

New Jersey, Nevada, Ohio, Oklahoma, 

Pennsylvania and Texas); and 9 reports 

containing ADB–PINACA in one state 

(Colorado) (Queried on December 18, 

2013). No reports in NFLIS or STRIDE 

were identified for PB–22 or 5F–PB–22 

prior to February 2013. No reports in 

NFLIS or STRIDE were identified for 

AB–FUBINACA prior to June 2013 or 

for ADB–PINACA prior to August 2013. 

ADB–PINACA was first encountered 

in the United States following reports of 

serious adverse events in Georgia on 

August 23, 2013. Reports of ADB– 

PINACA were not found in the scientific 

literature prior to its emergence on the 

designer drug market. The Georgia 

Bureau of Investigation (GBI) reported 

on September 12, 2013 that ADB– 

PINACA was detected in ‘‘herbal 

incense’’ products sold under the brand 

name ‘‘Crazy Clown.’’ It was later 

confirmed by the Centers for Disease 

Control and Prevention (CDC) as the 

substance responsible for severe adverse 

events in at least 22 persons who 

consumed the product. In addition, on 

August 30, 2013, the Colorado 

Department of Public Health and 

Environment (CDPHE) was notified by 

several hospitals of an increase in the 

number of patients visiting their 

emergency departments (EDs) with 

altered mental status after using 

synthetic marijuana. On September 8, 

2013, CDPHE, with the assistance of 

CDC, began an epidemiologic 

investigation whereby 221 cases of 

severe illness due to ingestion of a 

synthetic cannabinoid were identified. 

Those that presented at emergency 

rooms in the Denver, Colorado area 

around September 1, 2013, had 

symptoms similar to those found in the 

August 2013 Georgia incident. 

Laboratory analysis of samples from the 

Colorado incident confirmed that the 

substance abused in the ‘‘herbal 

incense’’ products was ADB–PINACA. 

The American Association of Poison 

Control Centers (AAPCC) reported 

receiving over 2,436 calls from January 

to November 2013, regarding exposures 

to products purportedly containing 

synthetic cannabinoids, although the 

data provided does not generally 

include biological sample testing that 

would confirm to which cannabinoids 

the user was exposed. A majority of 

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these exposure incidents resulted in 

individuals seeking medical attention at 

health care facilities. 

Factor 6. What, if Any, Risk There is to 

the Public Health 

The earliest reported encounter of 

PB–22 was by Finnish Customs (Tulli) 

in Helsinki who intercepted a 

consignment of 54 kilograms en route 

from China to Russia on October 27, 

2012. From January through November 

2013, CBP shared information related to 

synthetic cannabinoid shipments 

encountered at United States Ports of 

Entry and intended for destinations 

within the United States: PB–22—25 

encounters involving 69.6 kg; 5F–PB– 

22—23 encounters involving 32.9 kg; 

and AB–FUBINACA—9 encounters 

involving 16.1 kg. The DEA has reported 

multiple encounters of large quantities 

of PB–22, 5F–PB–22 and/or AB– 

FUBINACA that have been confirmed 

by forensic laboratories (STRIDE). 

In late August 2013, local law 

enforcement in Brunswick, Georgia 

reported that 22 persons ranging in age 

from 16 to 57 presented to emergency 

departments with severe adverse 

reactions after consuming a synthetic 

product called ‘‘Crazy Clown.’’ Adverse 

effects included the inability to stand, 

foaming at the mouth, violence towards 

police and paramedics and memory 

lapse. The substance responsible for 

these effects was later identified by the 

GBI as ADB–PINACA. In early 

September 2013, 221 patients presented 

to emergency departments in Colorado 

after having adverse reactions to a 

synthetic product labeled as ‘‘Black 

Mamba.’’ Adverse effects included 

having no gag reflex, inability to breathe 

on their own, hallucinations and 

psychotic episodes as described by 

nurses and attending physicians. The 

substance in the product consumed was 

identified as ADB–PINACA. In addition 

to the incidents in Georgia and 

Colorado, ADB–PINACA was also 

identified in exhibits of plant material 

labeled ‘‘10X’’ and ‘‘20X’’ submitted to 

a laboratory in Illinois on October 7, 

2013. 

Health warnings have been issued by 

numerous state public health 

departments and poison control centers 

describing adverse health effects 

associated with smoking (inhaling) 

synthetic cannabinoid products 

including, agitation, vomiting, 

tachycardia, elevated blood pressure, 

seizures, hallucinations, and nonresponsiveness. 

Medical examiner and postmortem 

toxicology reports demonstrate the 

involvement of 5F–PB–22 in the death 

of at least five individuals. These 

reports demonstrated that 5F–PB–22 

was qualitatively identified in the blood 

and/or urine of all five of the deceased 

individuals. In addition, 5F–PB–22 

intoxication was the sole cause of death 

in one case, while a second case stated 

that the cause of death was a fatal 

cardiac arrhythmia and/or fatal seizure 

in association with the use of 5F–PB–22. 

Since abusers obtain these drugs 

through unknown sources, the identity, 

purity, and quantity of these substances 

is uncertain and inconsistent, thus 

posing significant adverse health risks 

to users. There are no recognized 

therapeutic uses of these substances in 

the United States. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

Based on the above summarized data 

and information, the continued 

uncontrolled manufacture, distribution, 

importation, exportation, and abuse of 

PB–22, 5F–PB–22, AB–FUBINACA and 

ADB–PINACA pose an imminent hazard 

to the public safety. The DEA is not 

aware of any currently accepted medical 

uses for these synthetic cannabinoids in 

the United States. A substance meeting 

the statutory requirements for temporary 

scheduling, 21 U.S.C. 811(h)(1), may 

only be placed in Schedule I. 

Substances in Schedule I are those that 

have a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. Available data and 

information for PB–22, 5F–PB–22, AB– 

FUBINACA, and ADB–PINACA indicate 

that these four synthetic cannabinoids 

have a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. As required by 

section 201(h)(4) of the CSA, 21 U.S.C. 

811(h), the Deputy Administrator, 

through a letter dated November 7, 

2013, notified the Assistant Secretary of 

the DEA’s intention to temporarily place 

these four synthetic cannabinoids in 

Schedule I. 

Conclusion 

This notice of intent initiates an 

expedited temporary scheduling action 

and provides the 30-day notice pursuant 

to section 201(h) of the CSA, 21 U.S.C. 

811(h). In accordance with the 

provisions of section 201(h) of the CSA, 

21 U.S.C. 811(h), the Deputy 

Administrator considered available data 

and information, herein set forth the 

grounds for his determination that it is 

necessary to temporarily schedule four 

synthetic cannabinoids, quinolin-8-yl 1- 

pentyl-1H-indole-3-carboxylate (PB–22; 

QUPIC); quinolin-8-yl 1-(5- 

fluoropentyl)-1H-indole-3-carboxylate 

(5-fluoro-PB–22; 5F–PB–22); N-(1- 

amino-3-methyl-1-oxobutan-2-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (AB–FUBINACA); and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB–PINACA), in Schedule I of the 

CSA, and finds that placement of these 

synthetic cannabinoids into Schedule I 

of the CSA is warranted in order to 

avoid an imminent hazard to the public 

safety. 

Because the Deputy Administrator 

hereby finds that it is necessary to 

temporarily place these synthetic 

cannabinoids into Schedule I to avoid 

an imminent hazard to the public safety, 

any subsequent final order temporarily 

scheduling these substances will be 

effective on the date of publication in 

the Federal Register, and will be in 

effect for a period of two years, with a 

possible extension of one additional 

year, pending completion of the regular 

(permanent) scheduling process. 21 

U.S.C. 811(h)(1) and (2). It is the 

intention of the Deputy Administrator to 

issue such a final order as soon as 

possible after the expiration of 30 days 

from the date of publication of this 

notice. PB–22, 5F–PB–22, AB– 

FUBINACA and ADB–PINACA will 

then be subject to the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to the 

manufacture, distribution, possession, 

importation, exportation, research, and 

conduct of instructional activities of a 

Schedule I controlled substance. 

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Regular scheduling actions in 

accordance with 21 U.S.C. 811(a) are 

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing’’ conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557. 

21 U.S.C. 811. The regular scheduling 

process of formal rulemaking affords 

interested parties with appropriate 

process and the government with any 

additional relevant information needed 

to make a determination. Final 

decisions that conclude the regular 

scheduling process of formal 

rulemaking are subject to judicial 

review. 21 U.S.C. 877. Temporary 

scheduling orders are not subject to 

judicial review. 21 U.S.C. 811(h)(6). 

Regulatory Matters 

Section 201(h) of the CSA, 21 U.S.C. 

811(h), provides for an expedited 

temporary scheduling action where 

such action is necessary to avoid an 

imminent hazard to the public safety. 

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1780 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules 

As provided in this subsection, the 

Attorney General may, by order, 

schedule a substance in Schedule I on 

a temporary basis. Such an order may 

not be issued before the expiration of 30 

days from (1) the publication of a notice 

in the Federal Register of the intention 

to issue such order and the grounds 

upon which such order is to be issued, 

and (2) the date that notice of the 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary. 

21 U.S.C. 811(h)(1). 

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of 

section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 553, do 

not apply to this notice of intent. In the 

alternative, even assuming that this 

notice of intent might be subject to 

section 553 of the APA, the Deputy 

Administrator finds that there is good 

cause to forgo the notice and comment 

requirements of section 553, as any 

further delays in the process for 

issuance of temporary scheduling orders 

would be impracticable and contrary to 

the public interest in view of the 

manifest urgency to avoid an imminent 

hazard to the public safety. 

Although the DEA believes this notice 

of intent to issue a temporary 

scheduling order is not subject to the 

notice and comment requirements of 

section 553 of the APA, the DEA notes 

that in accordance with 21 U.S.C. 

811(h)(4), the Deputy Administrator will 

take into consideration any comments 

submitted by the Assistant Secretary 

with regard to the proposed temporary 

scheduling order. 

Further, the DEA believes that this 

temporary scheduling action is not a 

‘‘rule’’ as defined by 5 U.S.C. 601(2), 

and, accordingly, is not subject to the 

requirements of the Regulatory 

Flexibility Act (RFA). The requirements 

for the preparation of an initial 

regulatory flexibility analysis in 5 U.S.C. 

603(a) are not applicable where, as here, 

the DEA is not required by section 553 

of the APA or any other law to publish 

a general notice of proposed 

rulemaking. 

Additionally, this action is not a 

significant regulatory action as defined 

by Executive Order 12866 (Regulatory 

Planning and Review), section 3(f), and, 

accordingly, this action has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This action will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, in 

accordance with Executive Order 13132 

(Federalism) it is determined that this 

action does not have sufficient 

federalism implications to warrant the 

preparation of a Federalism Assessment. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Under the authority vested in the 

Attorney General by section 201(h) of 

the CSA, 21 U.S.C. 811(h), and 

delegated to the Deputy Administrator 

of the DEA by Department of Justice 

regulations (28 CFR 0.100, Appendix to 

Subpart R of Part 0), the Deputy 

Administrator hereby proposes that 21 

CFR part 1308 be amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for Part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

adding paragraphs (h)(15) through (18) 

to read as follows: 

§ 1308.11 Schedule I 

* * * * * 

(h) * * * 

(15) quinolin-8-yl 1-pentyl-1H-indole3-carboxylate, its optical, positional, 

and geometric isomers, salts and salts of 

isomers—7222 (Other names: PB–22; 

QUPIC) 

(16) quinolin-8-yl 1-(5-fluoropentyl)- 

1H-indole-3-carboxylate, its optical, 

positional, and geometric isomers, salts 

and salts of isomers—7225 (Other 

names: 5-fluoro-PB–22; 5F–PB–22) 

(17) N-(1-amino-3-methyl-1-oxobutan2-yl)-1-(4-fluorobenzyl)-1H-indazole-3- 

carboxamide, its optical, positional, and 

geometric isomers, salts and salts of 

isomers—7012 (Other names: AB– 

FUBINACA) 

(18) N-(1-amino-3,3-dimethyl-1- 

oxobutan-2-yl)-1-pentyl-1H-indazole-3- 

carboxamide, its optical, positional, and 

geometric isomers, salts and salts of 

isomers—7035 (Other names: ADB– 

PINACA) 

Dated: January 6, 2014. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2014–00217 Filed 1–9–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 140 and 146 

46 CFR Parts 4 and 109 

[Docket No. USCG–2013–1057] 

RIN 1625–AB99 

Marine Casualty Reporting on the 

Outer Continental Shelf 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes 

broadening the regulatory requirements 

for reporting marine casualties that 

occur on the U.S. Outer Continental 

Shelf (OCS). The limited reporting 

requirements currently applicable to 

foreign-flag OCS units in those waters 

would be replaced with the broader 

requirements currently applicable to 

U.S.-flag OCS units and to marine 

casualties occurring elsewhere in U.S. 

waters. The proposed changes would 

improve the Coast Guard’s ability to 

collect and analyze casualty data for 

incidents on the OCS, in the interest of 

maintaining and improving safety on 

the OCS. This proposed rule would 

support the Coast Guard’s maritime 

safety and stewardship missions. 

DATES: Comments and related material 

must either be submitted to our online 

docket via http://www.regulations.gov 

on or before April 10, 2014 or reach the 

Docket Management Facility by that 

date. Comments sent to the Office of 

Management and Budget (OMB) on 

collection of information must reach 

OMB on or before April 10, 2014. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2013–1057 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail: 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. 

(4) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

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