5042 Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 97 

Air Traffic Control, Airports, 

Incorporation by reference, Navigation 

(air). 

Issued in Washington, DC, on January 2, 

2015. 

John Duncan, 

Director, Flight Standards Service. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, Title 14, 

Code of Federal Regulations, Part 97 (14 

CFR part 97) is amended by 

establishing, amending, suspending, or 

removing Standard Instrument 

Approach Procedures and/or Takeoff 

Minimums and Obstacle Departure 

Procedures effective at 0901 UTC on the 

dates specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 5 February 2015 

Fort Lauderdale, FL, Fort Lauderdale 

Executive, ILS OR LOC RWY 9, Amdt 5A 

Fort Lauderdale, FL, Fort Lauderdale 

Executive, RNAV (GPS) RWY 9, Amdt 2A 

Fort Lauderdale, FL, Fort Lauderdale 

Executive, RNAV (GPS) RWY 27, Amdt 2B 

Orlando, FL, Orlando Intl, ILS OR LOC RWY 

17L, ILS RWY 17L (CAT II), ILS RWY 17L 

(SA CAT I), Amdt 2 

Orlando, FL, Orlando Intl, ILS OR LOC RWY 

18R, Amdt 10 

Orlando, FL, Orlando Intl, ILS OR LOC RWY 

35L, ILS RWY 35L (CAT II), ILS RWY 35L 

(CAT III), ILS RWY 35L (SA CAT I), Amdt 

7 

Orlando, FL, Orlando Intl, ILS OR LOC RWY 

35R, ILS RWY 35R (CAT II), ILS RWY 35R 

(SA CAT I), Amdt 2 

Orlando, FL, Orlando Intl, ILS OR LOC RWY 

36R, ILS RWY 36R (CAT II), ILS RWY 36R 

(CAT III), ILS RWY 36R (SA CAT I), Amdt 

10 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

17L, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

17R, Orig-C 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

18L, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

18R, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

35L, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

35R, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

36L, Amdt 1 

Orlando, FL, Orlando Intl, RNAV (GPS) RWY 

36R, Amdt 1 

Punta Gorda, FL, Punta Gorda, VOR RWY 4, 

Orig 

Fort Stewart (Hinesville), GA, Wright AAF 

(Fort Stewart)/Midcoast Rgnl, NDB RWY 

33R, Orig-B 

Fort Stewart (Hinesville), GA, Wright AAF 

(Fort Stewart)/Midcoast Rgnl, RNAV (GPS) 

RWY 6L, Orig-B 

Fort Stewart (Hinesville), GA, Wright AAF 

(Fort Stewart)/Midcoast Rgnl, RNAV (GPS) 

RWY 33R, Orig-B 

Helena, MT, Helena Rgnl, ILS OR LOC Z 

RWY 27, Amdt 2 

Brookneal, VA, Brookneal/Campbell County, 

RNAV (GPS) RWY 6, Orig 

Brookneal, VA, Brookneal/Campbell County, 

RNAV (GPS) RWY 24, Amdt 1 

Effective 5 March 2015 

Webster City, IA, Webster City Muni, RNAV 

(GPS) RWY 14, Orig 

Webster City, IA, Webster City Muni, RNAV 

(GPS) RWY 32, Amdt 2 

Frederick, MD, Frederick Muni, Takeoff 

Minimums and Obstacle DP, Amdt 4 

Memphis, TN, Memphis Intl, ILS OR LOC 

RWY 18R, Amdt 14C 

Memphis, TN, Memphis Intl, RNAV (GPS) Z 

RWY 18R, Amdt 2C 

Memphis, TN, Memphis Intl, RNAV (RNP) X 

RWY 18R, Orig-D 

Memphis, TN, Memphis Intl, RNAV (RNP) Y 

RWY 18R, Orig-D 

Denton, TX, Denton Muni, RNAV (GPS) RWY 

18, Orig-A 

[FR Doc. 2015–01034 Filed 1–29–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–402] 

Schedules of Controlled Substances: 

Temporary Placement of Three 

Synthetic Cannabinoids Into Schedule 

I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this final order to temporarily schedule 

three synthetic cannabinoids (SCs) into 

schedule I pursuant to the temporary 

scheduling provisions of the Controlled 

Substances Act (CSA). The substances 

are: (1) N-(1-amino-3-methyl-1- 

oxobutan-2-yl)-1-(cyclohexylmethyl)- 

1H-indazole-3-carboxamide (‘‘AB– 

CHMINACA’’); (2) N-(1-amino-3-methyl1-oxobutan-2-yl)-1-pentyl-1H-indazole3-carboxamide (‘‘AB–PINACA’’); and (3) 

[1-(5-fluoropentyl)-1H-indazol-3- 

yl](naphthalen-1-yl)methanone (‘‘THJ– 

2201’’). This action is based on a finding 

by the Administrator that the placement 

of these synthetic cannabinoids and 

their optical, positional, and geometric 

isomers, salts, and salts of isomers into 

schedule I of the CSA is necessary to 

avoid an imminent hazard to the public 

safety. As a result of this order, the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule I controlled substances will 

be imposed on persons who handle 

(manufacture, distribute, import, export, 

engage in research, or possess), or 

propose to handle these SCs. 

DATES: This final order is effective 

January 30, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 

enforces titles II and III of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, as amended. 

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 purpose 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, and the degree of dependence the 

drug or other 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 all scheduled 

substances is published at 21 CFR part 

1308. 

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

provides the Attorney General with the 

authority to temporarily place a 


rljohnson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 5043 

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 Final Order, 

all subsequent references to ‘‘Secretary’’ have been 

replaced with ‘‘Assistant Secretary.’’ As set forth 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 Assistant Secretary’s scheduling 

responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, March 8, 1985. 

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 an 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, 28 CFR 

0.100. 

Background 

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

U.S.C. 811(h)(4)) requires the DEA to 

notify the Department of Health and 

Human Services (HHS) of the intent to 

temporarily place a substance into 

schedule I of the CSA.1 The DEA 

transmitted notice of the intent to place 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 in schedule I on a temporary 

basis to the Assistant Secretary by letter 

dated September 17, 2014. The 

Assistant Secretary responded to this 

notice by letter dated September 30, 

2014, and advised that based on a 

review by the Food and Drug 

Administration (FDA), there are 

currently no investigational new drug 

applications or approved new drug 

applications for AB–CHMINACA, AB– 

PINACA, or THJ–2201. The Assistant 

Secretary also stated that HHS has no 

objection to the temporary placement of 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 into schedule I of the CSA. 

The DEA has taken into consideration 

the Assistant Secretary’s comments as 

required by 21 U.S.C. 811(h)(4). AB– 

CHMINACA, AB–PINACA, and THJ– 

2201 are not currently listed in any 

schedule under the CSA, and no 

exemptions or approvals are in effect for 

AB–CHMINACA, AB–PINACA, or THJ– 

2201 under section 505 of the FDCA, 21 

U.S.C. 355. The DEA has found that the 

scheduling of AB–CHMINACA, AB– 

PINACA, and THJ–2201 in schedule I 

on a temporary basis is necessary to 

avoid an imminent hazard to public 

safety, and as required by 21 U.S.C. 

811(h)(1)(A), a notice of intent to 

temporarily schedule these three 

synthetic cannabinoids (SCs) was 

published in the Federal Register on 

December 19, 2014. 79 FR 75767. 

To find that placing a substance 

temporarily into schedule I of the CSA 

is necessary to avoid an imminent 

hazard to the public safety, the 

Administrator is required to consider 

three of the eight factors set forth in 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 AB–CHMINACA, AB– 

PINACA, and THJ–2201 indicate that 

these three SCs 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 

SCs are chemicals synthesized in 

laboratories and mimic the biological 

effects of delta-9-tetrahydrocannabinol 

(THC), the main psychoactive ingredient 

in marijuana. These chemicals, such as 

CP–47,497 and cannabicyclohexanol 

(both designed in the 1980s and 

currently controlled pursuant to the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), Pub. L. 

112–144), were initially used as 

research tools to investigate the 

biological mechanisms in the 

cannabinoid system and to develop 

novel therapies for various clinical 

conditions. Other SCs including JWH– 

018, JWH–073, and JWH–200 (all 

permanently controlled pursuant to 

FDASIA) were synthesized in the mid1990s and studied to advance the 

understanding of drug-receptor 

interactions in the cannabinoid system. 

SCs were marketed in several 

European countries as ‘‘herbal incense’’ 

before the initial encounter in the 

United States by U.S. Customs and 

Border Protection (CBP) in November 

2008. In 2009, their use began 

increasing in the United States, with 

law enforcement encounters describing 

SCs laced on plant material and being 

abused for their psychoactive 

properties. Forensic analyses by the 

DEA and other Federal, State, and local 

laboratories have identified multiple 

variations in both the type and amount 

of SCs applied to the plant material. 

As observed by the DEA and CBP, SCs 

originate from foreign sources, 

including China and other countries in 

Southeast Asia. Bulk substances are 

smuggled via common carrier into the 

United States and find their way to 

clandestine manufacturing operations 

located in residential neighborhoods, 

garages, warehouses, and other similar 

destinations throughout the country. 

The powder form of SCs is typically 

dissolved in solvents (e.g., acetone) 

before being applied to a green plant 

material or dissolved in a propellant 

intended for use in e-cigarette devices. 

SCs are marketed under hundreds of 

different brand names, including 

‘‘Spice,’’ ‘‘K2,’’ ‘‘Blaze,’’ ‘‘Red X Dawn,’’ 

‘‘Paradise,’’ ‘‘Demon,’’ ‘‘Black Magic,’’ 

‘‘Spike,’’ ‘‘Mr. Nice Guy,’’ ‘‘Ninja,’’ 

‘‘Zohai,’’ ‘‘Yucatan,’’ ‘‘Fire,’’ ‘‘Crazy 

Clown,’’ ‘‘Mojo,’’ ‘‘Black Mamba,’’ 

‘‘Black Voodoo,’’ ‘‘Scooby Snax,’’ 

‘‘Bizzaro,’’ and many others. In 

addition, various ‘‘new generations’’ of 

SCs reflect the same or similar product 

labels while yielding a higher intensity 

and longer-lasting highs while the user 

remains unaware of the package’s exact 

contents. 

The drug products laced with SCs are 

often sold under the guise of ‘‘herbal 

incense,’’ ‘‘potpourri,’’ etc., using 

various product names and routinely 

labeled ‘‘not for human consumption.’’ 

Additionally, these products are 

marketed as a ‘‘legal high’’ or ‘‘legal 

alternative to marijuana’’ and are readily 

available over the Internet, in head 

shops, and in convenience stores. There 

is an incorrect assumption that these 

products are safe and further, that 

mislabeling these products as ‘‘not for 

human consumption’’ is a legal defense 

to criminal prosecution. 

These substances have no accepted 

medical use in the United States and 

have been reported to produce adverse 

health effects in humans while having a 

negative effect on communities. Acute 

and chronic abuse of SCs in general 

have been linked to adverse health 


rljohnson on DSK4SPTVN1PROD with RULES
5044 Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 

2While seizure evidence is not direct evidence of 

abuse, it can lead to an inference that a drug has 

been diverted and abused. See 76 FR 77330, 77332, 

December 12, 2011. 

3System to Retrieve Information from Drug 

Evidence (STRIDE) is a database of drug exhibits 

sent to DEA laboratories for analysis. Exhibits from 

the database are from the DEA, other Federal 

agencies, and law enforcement agencies. STRIDE 

was last queried on October 1, 2014. Note that 

reporting via STRIDE ceased on September 30, 

2014. 

4National Forensic Laboratory Information 

System (NFLIS) is a national drug forensic 

laboratory reporting system that systematically 

collects results from drug chemistry analyses 

conducted by state and local forensic laboratories 

in the United States. NFLIS was last queried on 

November 25, 2014. 

5Supra note 2. 

effects including signs of addiction and 

withdrawal, numerous reports of 

emergency room admissions resulting 

from their abuse, overall toxicity, and 

death. 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 are SCs that have 

pharmacological effects similar to the 

schedule I hallucinogen THC and other 

temporarily and permanently controlled 

schedule I substances. With no 

approved medical use in treatment in 

the United States and limited safety or 

toxicological information, AB– 

CHMINACA, AB–PINACA, and THJ– 

2201 have emerged on the illicit drug 

market and are being abused for their 

psychoactive properties. The DEA’s 

analysis is available in its entirety under 

‘‘Supporting and Related Material’’ of 

the public docket for this action at 

www.regulations.gov under docket 

number DEA–402. 

Factor 4. History and Current Pattern of 

Abuse 

SCs were initially developed over the 

last 30 years as part of research efforts 

to investigate the cannabinoid system. 

SCs intended for illicit use were first 

reported in the United States in a 

November 2008 encounter, when a 

shipment of ‘‘Spice’’ was seized and 

analyzed by CBP in Dayton, Ohio, and 

later identified as containing JWH–018. 

At approximately the same time, in 

December 2008, JWH–018 and 

cannabicyclohexanol (CP–47,497 C8 

homologue) were identified by German 

forensic laboratories. Since then, many 

other SCs have been found applied on 

plant material and encountered as drug 

products. Beginning in January 2010, 

the popularity of these cannabinoids 

and their associated products appears to 

have increased in the United States as 

evidenced by seizure exhibits and 

public health and media reports. 

Numerous SCs have previously been 

identified as product adulterants, and 

law enforcement officials have seized 

bulk amounts of these substances.2 The 

first SCs identified as being abused 

include JWH–018, JWH–073, JWH–200, 

CP–47,497, and CP–47,497 C8 

homologue, followed shortly thereafter 

by new generations of SCs including 

UR–144, XLR11, AKB48, PB–22, 5F– 

PB–22, AB–FUBINACA, ADB–PINACA, 

and numerous others that vary only 

slightly in chemical structure. JWH–018, 

JWH–073, JWH–200, CP–47,497, and 

CP–47,497 C8 homologue were 

temporarily scheduled on March 1, 

2011, 76 FR 11075, and later 

permanently placed into 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 

SCs, 2 synthetic cathinones, and 9 

synthetic phenethylamines of the 2Cseries) into schedule I. UR–144, XLR11, 

and AKB48 were temporarily scheduled 

on May 16, 2013. 78 FR 28735. PB–22, 

5F–PB–22, AB–FUBINACA, and ADB– 

PINACA were temporarily scheduled on 

February 10, 2014. 79 FR 7577. 

Recently, another generation of SCs 

including AB–CHMINACA, AB– 

PINACA, and THJ–2201 has been 

encountered. AB–CHMINACA, AB– 

PINACA, and THJ–2201 are not 

included among the 15 SCs that are 

specifically controlled under FDASIA, 

and do not fall under the definition of 

‘‘cannabimimetic agents’’ as provided 

under FDASIA. Furthermore, as detailed 

in reports, law enforcement and public 

health officials are encountering the 

abuse of these substances and products 

laced with these substances, which are 

commonly marketed under the guise of 

being a ‘‘legal high’’ with a disclaimer 

that the products are ‘‘not for human 

consumption.’’ 

As with the older generation of SCs, 

the major concern of public health 

officials and medical professionals 

regarding these new products is the 

targeting and direct marketing toward 

adolescents and youth. This is 

supported by law enforcement 

encounters and reports from emergency 

rooms (see Factor 6 of Background 

Information and Evaluation of ‘‘Three 

Factor Analysis’’ (Factors 4, 5, and 6) for 

Temporary Scheduling). However, 

media reports indicate that all age 

groups abuse these substances and 

related products. Additionally, law 

enforcement has been encountering new 

variations of SCs in liquid form. The 

liquids contain one or more SCs, 

including AB–CHMINACA and AB– 

PINACA. Users have been identified 

applying the liquid to hookahs (an 

instrument for vaporizing and smoking 

a given material whereby the smoke or 

vapor passes through a water basin prior 

to inhalation), vaporizers (also known as 

‘‘vaping’’ or using an ‘‘e-cigarette,’’ 

which allows the user to administer a 

liquid to be aerosolized and then 

inhaled), and hookah pens (a type of 

vaporizer, often much smaller and 

intended for increased discretion while 

smoking). As with conventional illicit 

manufacturing of SC products, liquid 

preparations of these substances do not 

adhere to any manufacturing standards 

with regard to dosage, the substance(s) 

included, purity, or contamination. It is 

therefore important to note that 

following manufacturing principles or 

standards would not eliminate the 

adverse effects observed with SC 

products and SCs would still be 

considered a threat to public safety. 

Factor 5. Scope, Duration and 

Significance of Abuse 

Despite multiple scheduling actions 

undertaken by the DEA in an attempt to 

safeguard the public from the adverse 

effects and safety issues associated with 

SCs, encounters by law enforcement and 

health care professionals demonstrate 

the continued abuse of these substances 

and their associated products. With the 

passing of each Federal control action, 

clandestine drug manufacturers and 

suppliers are adapting at an alarmingly 

quick pace to switch the ingredients to 

new, non-controlled variations of SCs. 

Exposure incidents involving SCs 

continue to be documented by poison 

control centers in the United States as 

the abuse of these substances remain a 

threat to both the short- and long-term 

public health and safety. Exposures to 

SCs were first reported to the American 

Association of Poison Control Centers 

(AAPCC) in 2011. Recently, the number 

of AAPCC exposure reports has begun to 

increase, demonstrating the dangerous 

health effects observed involving these 

chemicals. Exposures for August 2014 

(442) were the highest received in a 

monthly period by the AAPCC since 

July 2012 (when there were 459). As of 

November 30, 2014, the AAPCC has 

received approximately 3,359 calls 

involving exposure to SCs for 2014. 

The following information details 

information obtained through STRIDE 3

and NFLIS,4 including the number of 

exhibits/reports, dates of first encounter, 

and locations of those encounters where 

available: 5

For AB–CHMINACA, STRIDE 

contained 21 exhibits, with the first 

encounter in March 2014. NFLIS 

contained 586 reports, with the first 

encounter in February 2014, and 

locations of all encounters spanning 

Arkansas, Arizona, California, Colorado, 

Georgia, Iowa, Indiana, Kansas, 


rljohnson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 5045 

Kentucky, Louisiana, Missouri, North 

Dakota, New Jersey, Ohio, Oklahoma, 

Pennsylvania, Tennessee, Texas, and 

Wisconsin. 

For AB–PINACA, STRIDE contained 

245 exhibits, with the first encounter in 

June 2013. NFLIS contained 3,783 

reports, with the first encounter in 

March 2013, and locations of all 

encounters spanning Alabama, 

Arkansas, Arizona, California, Colorado, 

Connecticut, Florida, Georgia, Iowa, 

Idaho, Illinois, Indiana, Kansas, 

Kentucky, Louisiana, Massachusetts, 

Michigan, Minnesota, Missouri, 

Mississippi, North Dakota, Nebraska, 

New Hampshire, New Jersey, Nevada, 

New York, Ohio, Oklahoma, Oregon, 

Pennsylvania, South Carolina, 

Tennessee, Texas, Utah, Virginia, 

Washington, Wisconsin, West Virginia, 

and Wyoming. 

For THJ–2201, STRIDE contained 65 

exhibits, with the first encounter in 

September 2013. NFLIS contained 220 

reports, with the first encounter in 

January 2014, and locations of all 

encounters spanning Arkansas, Arizona, 

Connecticut, Georgia, Iowa, Illinois, 

Indiana, Kansas, Kentucky, Minnesota, 

Missouri, North Dakota, Nebraska, New 

Hampshire, New Jersey, Ohio, 

Pennsylvania, Tennessee, and 

Wisconsin. 

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

the Public Health 

AB–PINACA has been for sale on the 

illicit drug market as early as March 

2013. Meanwhile, THJ–2201 was first 

observed in September 2013, and AB– 

CHMINACA was first observed in 

February 2014. From December 2013 

through September 2014, CBP reported 

select encounters of these substances 

with most shipments originating in 

China and intended for destinations 

within the United States. Specifically, 

there were 17 seizures of AB– 

CHMINACA involving 15.825 kilograms 

total; 4 seizures of AB–PINACA 6 

kilograms total; and 6 seizures of THJ– 

2201 involving 5.5 kilograms total (see 

Three Factor Analysis). Additionally, 

the DEA has reported multiple 

encounters of large quantities of AB– 

CHMINACA, AB–PINACA and THJ– 

2201 that have been confirmed by 

forensic laboratories (STRIDE and/or 

NFLIS). 

From October 2013 to September 

2014, multiple deaths and severe 

overdoses occurred involving AB– 

CHMINACA and AB–PINACA. Adverse 

effects reported from these incidences 

have included: Seizures, coma, severe 

agitation, loss of motor control, loss of 

consciousness, difficulty breathing, 

altered mental status, and convulsions 

that in some cases resulted in death. 

There have been multiple overdose 

reports involving AB–CHMINACA, AB– 

PINACA, or a combination of both 

substances. In addition, there have been 

at least four documented deaths 

involving AB–CHMINACA and three 

documented deaths involving AB– 

PINACA. 

Since abusers obtain these drugs 

through unknown sources, the identity 

and purity of these substances is 

uncertain and inconsistent, thus posing 

significant adverse health risks to users. 

Because the three SCs share 

pharmacological similarities with 

schedule I substances such as D9–THC, 

JWH–018, and other temporarily and 

permanently controlled schedule I 

substances, AB–CHMINACA, AB– 

PINACA, and THJ–2201 pose a risk to 

the abuser. Furthermore, despite being 

encountered on the illicit drug market 

and having no accepted medical use in 

treatment within the United States, 

these products continue to be easily 

available and abused across age groups. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

Based on the data and information 

summarized above, the continued 

uncontrolled manufacturing, 

distribution, importation, exportation, 

and abuse of AB–CHMINACA, AB– 

PINACA, and THJ–2201 pose an 

imminent hazard to the public safety. 

Furthermore, the DEA is not aware of 

any currently accepted medical uses for 

these SCs in the United States. 

A substance meeting the statutory 

requirements for temporary scheduling 

under 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 AB–CHMINACA, AB– 

PINACA, and THJ–2201 indicate that 

these three SCs 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)(4), the DEA, through a 

letter dated September 17, 2014, 

notified the Assistant Secretary of the 

DEA’s intention to temporarily place 

these three SCs in schedule I. 

Conclusion 

In accordance with the provisions of 

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

811(h), the Administrator considered 

available data and information, herein 

set forth the grounds for her 

determination that it is necessary to 

temporarily place three synthetic 

cannabinoids, AB–CHMINACA, AB– 

PINACA, and THJ–2201 into schedule I 

of the CSA, and hereby 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 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, the 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). 

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). 

Requirements for Handling 

Upon the effective date of this final 

order, AB–CHMINACA, AB–PINACA, 

and THJ–2201 are subject to the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, 

importation, exportation, conduct of 

instructional activities, and possession 

of schedule I controlled substances 

including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

imports, exports, engages in research, 

conducts instructional activities with, or 

possesses), or desires to handle, AB– 

CHMINACA, AB–PINACA, or THJ– 

2201, must 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 as of January 30, 2015. Any person 

who currently handles AB–CHMINACA, 

AB–PINACA, or THJ–2201, and is not 


rljohnson on DSK4SPTVN1PROD with RULES
5046 Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 

registered with the DEA, must submit an 

application for registration and may not 

continue to handle AB–CHMINACA, 

AB–PINACA, or THJ–2201 as of January 

30, 2015, unless the DEA has approved 

that application for registration, 

pursuant to 21 U.S.C. 822, 823, 957, 

958, and in accordance with 21 CFR 

parts 1301 and 1312. Retail sales of 

schedule I controlled substances to the 

general public are not allowed under the 

CSA. 

2. Security. AB–CHMINACA, AB– 

PINACA, and THJ–2201are subject to 

schedule I security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 821, 823, 871(b), and in 

accordance with 21 CFR 1301.71– 

1301.93, as of January 30, 2015. 

3. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of AB–CHMINACA, AB– 

PINACA, and THJ–2201 must be in 

compliance with 21 U.S.C. 825, 958(e), 

and be in accordance with 21 CFR part 

1302 as of January 30, 2015. Current 

DEA registrants shall have 30 calendar 

days from January 30, 2015, to comply 

with all labeling and packaging 

requirements. 

4. Inventory. Every DEA registrant 

who possesses any quantity of AB– 

CHMINACA, AB–PINACA, or THJ–2201 

on the effective date of this order, must 

take an inventory of all stocks of these 

substances on hand as of January 30, 

2015, pursuant to 21 U.S.C. 827 and 

958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11 (a) and 

(d). Current DEA registrants shall have 

30 calendar days from the effective date 

of this order to be in compliance with 

all inventory requirements. 

After the initial inventory, every DEA 

registrant must take an inventory of all 

controlled substances (including AB– 

CHMINACA, AB–PINACA, and THJ– 

2201) on hand on a biennial basis, 

pursuant to 21 U.S.C. 827 and 958, and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

5. Records. All DEA registrants must 

maintain records with respect to AB– 

CHMINACA, AB–PINACA, or THJ–2201 

pursuant to 21 U.S.C. 827 and 958, and 

in accordance with 21 CFR parts 1304, 

1307, and 1312 as of January 30, 2015. 

Current DEA registrants authorized to 

handle AB–CHMINACA, AB–PINACA, 

or THJ–2201 shall have 30 calendar 

days from the effective date of this order 

to be in compliance with all 

recordkeeping requirements. 

6. Reports. All DEA registrants who 

manufacture or distribute AB– 

CHMINACA, AB–PINACA, or THJ– 

2201must submit reports pursuant to 21 

U.S.C. 827 and in accordance with 21 

CFR 1304, 1307, and 1312 as of January 

30, 2015. 

7. Order Forms. All registrants who 

distribute AB–CHMINACA, AB– 

PINACA, or THJ–2201must comply with 

order form requirements pursuant to 21 

U.S.C. 828 and in accordance with 21 

CFR part 1305 as of January 30, 2015. 

8. Importation and Exportation. All 

importation and exportation of AB– 

CHMINACA, AB–PINACA, or THJ– 

2201must be in compliance with 21 

U.S.C. 952, 953, 957, 958, and in 

accordance with 21 CFR part 1312 as of 

January 30, 2015. 

9. Quota. Only registered 

manufacturers may manufacture AB– 

CHMINACA, AB–PINACA, or THJ–2201 

in accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303. 

10. Liability. Any activity involving 

AB–CHMINACA, AB–PINACA, or THJ– 

2201 not authorized by, or in violation 

of the CSA, occurring as of January 30, 

2015, is unlawful, and may subject the 

person to administrative, civil, and/or 

criminal sanctions. 

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. 

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 temporary scheduling 

action. In the alternative, even assuming 

that this action might be subject to 

section 553 of the APA, the 

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. Further, the 

DEA believes that this temporary 

scheduling action final order 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. 

Pursuant to section 808(2) of the 

Congressional Review Act (CRA), ‘‘any 

rule for which an agency for good cause 

finds . . . that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest, shall take effect at such time as 

the Federal agency promulgating the 

rule determines.’’ 5 U.S.C. 808(2). It is 

in the public interest to schedule these 

substances immediately because they 

pose a public health risk. This 

temporary scheduling action is taken 

pursuant to 21 U.S.C. 811(h), which is 

specifically designed to enable the DEA 

to act in an expeditious manner to avoid 

an imminent hazard to the public safety. 

21 U.S.C. 811(h) exempts the temporary 

scheduling order from standard notice 

and comment rulemaking procedures to 

ensure that the process moves swiftly. 

For the same reasons that underlie 21 

U.S.C. 811(h), that is, the DEA’s need to 

move quickly to place these substances 

into schedule I because they pose an 

imminent hazard to public safety, it 

would be contrary to the public interest 

to delay implementation of the 

temporary scheduling order. Therefore, 

in accordance with section 808(2) of the 

CRA, this order shall take effect 

immediately upon its publication. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 


rljohnson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Rules and Regulations 5047 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, the DEA 

amends 21 CFR part 1308 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. Amend § 1308.11, by adding 

paragraphs (h)(29) through (31) to read 

as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(29) N-(1-amino-3-methyl-1-oxobutan2-yl)-1-(cyclohexylmethyl)-1H-indazole3-carboxamide, its optical, positional, 

and geometric isomers, salts, and salts 

of isomers—7031 (Other names: AB– 

CHMINACA). 

(30) N-(1-amino-3-methyl-1-oxobutan2-yl)-1-pentyl-1H-indazole-3- 

carboxamide, its optical, positional, and 

geometric isomers, salts, and salts of 

isomers—7023 (Other names: AB– 

PINACA). 

(31) [1-(5-fluoropentyl)-1H-indazol-3- 

yl](naphthalen-1-yl)methanone, its 

optical, positional, and geometric 

isomers, salts, and salts of isomers— 

7024 (Other names: THJ–2201). 

Dated: January 23, 2015. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2015–01776 Filed 1–29–15; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF TRANSPORTATION 

Saint Lawrence Seaway Development 

Corporation 

33 CFR Part 402 

RIN 2135–AA37 

Tariff of Tolls 

AGENCY: Saint Lawrence Seaway 

Development Corporation, DOT. 

ACTION: Final rule. 

SUMMARY: The Saint Lawrence Seaway 

Development Corporation (SLSDC) and 

the St. Lawrence Seaway Management 

Corporation (SLSMC) of Canada, under 

international agreement, jointly publish 

and presently administer the St. 

Lawrence Seaway Tariff of Tolls in their 

respective jurisdictions. The Tariff sets 

forth the level of tolls assessed on all 

commodities and vessels transiting the 

facilities operated by the SLSDC and the 

SLSMC. The SLSDC is revising its 

regulations to reflect the fees and 

charges currently being levied by the 

SLSMC in Canada. The changes affect 

the tolls for commercial vessels and are 

applicable only in Canada. For 

consistency, because these are under 

international agreement joint 

regulations, and to avoid confusion 

among users of the Seaway, the SLSDC 

finds that there is good cause to make 

the U.S. version of the amendments 

effective upon publication. (See 

SUPPLEMENTARY INFORMATION.) 

DATES: This rule is effective on January 

30, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Carrie Mann Lavigne, Chief Counsel, 

Saint Lawrence Seaway Development 

Corporation, 180 Andrews Street, 

Massena, New York 13662; 315/764– 

3200. 

SUPPLEMENTARY INFORMATION: The Saint 

Lawrence Seaway Development 

Corporation (SLSDC) and the St. 

Lawrence Seaway Management 

Corporation (SLSMC) of Canada, under 

international agreement, jointly publish 

and presently administer the St. 

Lawrence Seaway Tariff of Tolls 

(Schedule of Fees and Charges in 

Canada) in their respective jurisdictions. 

The Tariff sets forth the level of tolls 

assessed on all commodities and vessels 

transiting the facilities operated by the 

SLSDC and the SLSMC. The SLSDC is 

revising 33 CFR 402.11, ‘‘Schedule of 

tolls’’, to reflect the fees and charges 

levied by the SLSMC in Canada and to 

make corrections to various sections. 

The changes affect the tolls for 

commercial vessels and are applicable 

only in Canada. The collection of tolls 

by the SLSDC on commercial vessels 

transiting the U.S. locks is waived by 

law (33 U.S.C. 988a(a)). Accordingly, no 

notice or comment is necessary on these 

amendments. 

Regulatory Notices: Privacy Act: 

Anyone is able to search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review DOT’s 

complete Privacy Act Statement in the 

Federal Register published on April 11, 

2000 (65 FR 19477–19478) or you may 

visit www.regulations.gov. 

Regulatory Evaluation 

This regulation involves a foreign 

affairs function of the United States and 

therefore Executive Order 12866 does 

not apply and evaluation under the 

Department of Transportation’s 

Regulatory Policies and Procedures is 

not required. 

Regulatory Flexibility Act 

Determination 

I certify this regulation will not have 

a significant economic impact on a 

substantial number of small entities. 

The St. Lawrence Seaway Tariff of Tolls 

primarily relate to commercial users of 

the Seaway, the vast majority of whom 

are foreign vessel operators. Therefore, 

any resulting costs will be borne mostly 

by foreign vessels. 

Environmental Impact 

This regulation does not require an 

environmental impact statement under 

the National Environmental Policy Act 

(49 U.S.C. 4321, et seq.) because it is not 

a major federal action significantly 

affecting the quality of the human 

environment. 

Federalism 

The Corporation has analyzed this 

rule under the principles and criteria in 

Executive Order 13132, dated August 4, 

1999, and has determined that this rule 

does not have sufficient federalism 

implications to warrant a Federalism 

Assessment. 

Unfunded Mandates 

The Corporation has analyzed this 

rule under Title II of the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4, 109 Stat. 48) and determined that 

it does not impose unfunded mandates 

on State, local, and tribal governments 

and the private sector requiring a 

written statement of economic and 

regulatory alternatives. 

Paperwork Reduction Act 

This regulation has been analyzed 

under the Paperwork Reduction Act of 

1995 and does not contain new or 

modified information collection 

requirements subject to the Office of 

Management and Budget review. 

List of Subjects in 33 CFR Part 402 

Vessels, Waterways. 

Accordingly, the Saint Lawrence 

Seaway Development Corporation is 

amending 33 CFR part 402, Tariff of 

Tolls, as follows: 

PART 402—TARIFF OF TOLLS 

■ 1. The authority citation for part 402 

continues to read as follows: 

Authority: 33 U.S.C. 983(a), 984(a)(4) and 

988, as amended; 49 CFR 1.52. 

■ 2. In § 402.5, revise paragraph (c) to 

read as follows: 


rljohnson on DSK4SPTVN1PROD with RULES