Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Proposed Rules 75767 

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 the HHS, 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, 

Mar. 8, 1985. 

Dated: December 12, 2014. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

[FR Doc. 2014–29701 Filed 12–18–14; 8:45 am] 

BILLING CODE 6717–01–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: Notice of intent. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration is 

issuing this notice of intent to 

temporarily schedule three synthetic 

cannabinoids into schedule I pursuant 

to the temporary scheduling provisions 

of the Controlled Substances Act. The 

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

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

1H-indazole-3-carboxamide (common 

name: AB-CHMINACA), N-(1-amino-3- 

methyl-1-oxobutan-2-yl)-1-pentyl-1Hindazole-3-carboxamide (common 

name: AB-PINACA) and [1-(5- 

fluoropentyl)-1H-indazol-3- 

yl](naphthalen-1-yl)methanone 

(common name: THJ-2201). 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: December 19, 2014. 

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: Any final 

order will be published in the Federal 

Register and may not be effective prior 

to January 20, 2015. 

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. 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 

purpose of this action. The DEA 

publishes the implementing regulations 

for these statutes in title 21 of the Code 

of Federal Regulations (CFR), parts 1300 

to 1321. 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, every 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 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. 21 

U.S.C. 812(a). 

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 

scheduling authority under 21 U.S.C. 

811 to the Administrator of the DEA, 28 

CFR 0.100, who in turn has redelegated 

that authority to the Deputy 

Administrator of the DEA, 28 CFR part 

0, appendix to subpart R. 

Background 

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 The Deputy 

Administrator transmitted notice of his 

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. 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 are not currently listed in any 

schedule under the CSA, a condition of 

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

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 Deputy 

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 

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75768 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Proposed Rules 

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 synthetic cannabinoids (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. In addition, forensic 

analyses by the DEA and other Federal, 

State, and local laboratories have 

identified multiple variations in both 

the type and amount of SC 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 designer drug product 

manufacturing operations located in 

residential neighborhoods, garages, 

warehouses, and other similar 

destinations throughout the country. 

The powder form of SCs are 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, but with the 

user still being deprived of knowledge 

as to exactly what is contained inside 

the packaging. 

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, or sold 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 

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 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 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. At 

approximately 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 (November 

2008), many other SCs have been found 

applied on plant material and 

encountered as drug products. The 

popularity of these cannabinoids and 

their associated products appears to 

have increased since January 2010 in 

the United States based on seizure 

exhibits and public health and media 

reports. 

Numerous SCs have been identified as 

product adulterants, and law 

enforcement has seized bulk amounts of 

these substances. 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 drugs such 

as UR–144, XLR11, AKB48, PB–22, 5F– 

PB–22, AB–FUBINACA, ADB–PINACA, 

and numerous other SCs varying only 

by slight modifications to their 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 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) 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). 

Another generation of SCs including 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 has recently been 

encountered. AB–CHMINACA, AB– 

PINACA, and THJ–2201 are not 

included among the 15 SCs that are 

specifically named under FDASIA, and 

do not fall under the legal definition of 

cannabimimetic agents as provided 

under FDASIA. These substances and 

products laced with these substances 

are commonly marketed under the guise 

of being a ‘‘legal high’’ with a disclaimer 

of ‘‘not for human consumption.’’ As 

detailed in reports, law enforcement and 

public health officials are encountering 

the abuse of these substances. 

A major concern as reiterated by 

public health officials and medical 

professionals remains the targeting and 

direct marketing of SCs and SCmstockstill on DSK4VPTVN1PROD with PROPOSALS

Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Proposed Rules 75769 

2System 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. 

3National 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. 

containing products to 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, all age groups have been 

reported by media as abusing these 

substances and related products. 

Recently, 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 

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). Similar to 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 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 

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, noncontrolled 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, AAPCC exposure 

reports have begun to increase. The 

number of exposures reported 

demonstrates 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 (459). As of October 31, 2014, 

the AAPCC has received approximately 

2,996 calls involving exposure to SCs 

for 2014. 

The following information details 

information obtained through STRIDE 2

and NFLIS 3 (queried on October 1, 2014 

(STRIDE); November 25, 2014 (NFLIS)), 

including dates of first encounter, 

exhibits/reports, and locations. 

AB–CHMINACA: STRIDE –21 

exhibits, first encountered in March 

2014; NFLIS–586 reports, first 

encountered in February 2014, locations 

include Arkansas, Arizona, California, 

Colorado, Georgia, Iowa, Indiana, 

Kansas, Kentucky, Louisiana, Missouri, 

North Dakota, New Jersey, Ohio, 

Oklahoma, Pennsylvania, Tennessee, 

Texas and Wisconsin. 

AB–PINACA: STRIDE–245 exhibits, 

first encountered in June 2013; NFLIS– 

3,783 reports, first encountered in 

March 2013, locations include 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. 

THJ–2201: STRIDE–65 exhibits, first 

encountered in September 2013; NFLIS– 

220 reports, first encountered in January 

2014, locations include 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 

THJ–2201 was first observed in 

September 2013 while AB–CHMINACA 

was first observed in February 2014. 

AB–PINACA has been for sale on the 

illicit drug market as early as March 

2013. 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: AB–CHMINACA–17 

seizures involving 15.825 kg; AB– 

PINACA–4 seizures involving 6 kg; 

THJ–2201–6 seizures involving 5.5 kg 

(see Three Factor Analysis). 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 the present, 

multiple deaths and severe overdoses 

have occurred involving AB– 

CHMINACA and AB–PINACA. Adverse 

effects reported from these incidences 

have included a variety of the following 

effects: 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. 

By sharing pharmacological similarities 

with schedule I substances (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. AB–CHMINACA, AB– 

PINACA, and THJ–2201 are being 

encountered on the illicit drug market 

and have no accepted medical use 

within the United States. Regardless, 

these products continue to be easily 

available and abused by diverse 

populations. 

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 

AB–CHMINACA, AB–PINACA, and 

THJ–2201 pose an imminent hazard to 

the public safety. 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, 

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, 

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75770 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Proposed Rules 

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 Deputy Administrator, 

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 

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 three 

SCs, N-(1-amino-3-methyl-1-oxobutan-2- 

yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (AB–CHMINACA), N-(1- 

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

pentyl-1H-indazole-3-carboxamide (AB– 

PINACA) and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ–2201) in schedule I 

of the CSA, and finds that placement of 

these SCs into schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety. 

Because the Deputy Administrator 

hereby finds that it is necessary to 

temporarily place these SCs 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. AB–CHMINACA, AB– 

PINACA, and THJ–2201 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. 

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). 

In as much 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. 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. 

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. 

For the reasons set out above, the DEA 

proposes to amend 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. In § 1308.11, add 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) 

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Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Proposed Rules 75771 

(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: December 12, 2014. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2014–29651 Filed 12–18–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF EDUCATION 

34 CFR Chapter VI 

[Docket ID ED–2014–OPE–0161] 

RIN 1840–AD18 

Negotiated Rulemaking Committee; 

Negotiator Nominations and Schedule 

of Committee Meetings—William D. 

Ford Federal Direct Loan Program 

AGENCY: Office of Postsecondary 

Education, Department of Education. 

ACTION: Notice of intent to establish 

negotiated rulemaking committee. 

SUMMARY: We announce our intention to 

establish a negotiated rulemaking 

committee to prepare proposed 

regulations governing the William D. 

Ford Federal Direct Loan (Federal Direct 

Loan) Program authorized under title IV 

of the Higher Education Act of 1965, as 

amended (HEA). The committee will 

include representatives of organizations 

or groups with interests that are 

significantly affected by the topics 

proposed for negotiations. We request 

nominations for individual negotiators 

who represent key stakeholder 

constituencies for the issues to be 

negotiated to serve on the committee, 

and we set a schedule for committee 

meetings. 

DATES: We must receive your 

nominations for negotiators to serve on 

the committee on or before January 20, 

2015. The dates, times, and locations of 

the committee meetings are set out in 

the Schedule for Negotiations section in 

the SUPPLEMENTARY INFORMATION section. 

ADDRESSES: Please send your 

nominations for negotiators to Wendy 

Macias, U.S. Department of Education, 

1990 K Street NW., Room 8017, 

Washington, DC 20006. Telephone: 

(202) 502–7526 or by email: 

wendy.macias@ed.gov. 

FOR FURTHER INFORMATION CONTACT: For 

information about the content of this 

notice, including information about the 

negotiated rulemaking process or the 

nomination submission process, 

contact: Wendy Macias, U.S. 

Department of Education, 1990 K Street 

NW., Room 8017, Washington, DC 

20006. Telephone: (202) 502–7526 or by 

email: wendy.macias@ed.gov. 

For information about negotiated 

rulemaking in general, see The 

Negotiated Rulemaking Process for Title 

IV Regulations, Frequently Asked 

Questions at http://www2.ed.gov/policy/ 

highered/reg/hearulemaking/hea08/negreg-faq.html. 

If you use a telecommunications 

device for the deaf (TDD) or text 

telephone (TTY), call the Federal Relay 

Service (FRS) toll free at 1–800–877– 

8339. 

SUPPLEMENTARY INFORMATION: On 

September 3, 2014, we published a 

notice in the Federal Register (79 FR 

52273) announcing our intent to 

establish a negotiated rulemaking 

committee under section 492 of the HEA 

to develop proposed regulations to 

allow more student borrowers of Federal 

Direct Loans to use a ‘‘Pay as You Earn’’ 

repayment plan in accordance with the 

Presidential Memorandum issued on 

June 9, 2014 (available at 

www.whitehousce.gov/the-press-office/

2014/06/09/presidential-memorandumfederal-student-loan-repayments). We 

also announced two public hearings at 

which interested parties could comment 

on the topic suggested by the U.S. 

Department of Education (Department) 

and suggest additional topics for 

consideration for action by the 

negotiated rulemaking committee. 

Those hearings were held on October 

23, 2014, in Washington, DC, and on 

November 4, 2014, in Anaheim, 

California. We invited parties to 

comment and submit topics for 

consideration in writing as well. 

Transcripts from the public hearings are 

available at http://www2.ed.gov/policy/

highered/reg/hearulemaking/2015/

index.html. Written comments 

submitted in response to the September 

3, 2014, notice may be viewed through 

the Federal eRulemaking Portal at 

www.regulations.gov. Instructions for 

finding comments are available on the 

site under ‘‘How to Use 

Regulations.gov’’ in the Help section. 

Individuals can enter docket ID ED– 

2014–OPE–0124 in the search box to 

locate the appropriate docket. 

Regulatory Issues: After considering 

the information received at the regional 

hearings and the written comments, we 

have decided to establish a negotiating 

committee to (1) prepare proposed 

regulations to establish a new Pay as 

You Earn repayment plan for those not 

covered by the existing Pay as You Earn 

Repayment Plan in the Federal Direct 

Loan Program, and (2) establish 

procedures for Federal Family 

Education Loan (FFEL) Program loan 

holders to use to identify U.S. military 

servicemembers who may be eligible for 

a lower interest rate on their FFEL 

Program loans under section 527 of the 

Servicemembers Civil Relief Act 

(SCRA). 

Under the Department’s current 

regulations, once a loan holder (the 

Secretary or a FFEL loan holder) 

receives a servicemember’s written 

request and a copy of the 

servicemember’s military orders, the 

maximum interest rate on any Federal 

Direct Loan or FFEL program loan made 

prior to the borrower entering activeduty status is six percent while the 

borrower is on active-duty status. (See 

34 CFR 685.202(a)(4) and 682.202(a)(8)). 

On August 25, 2014, the Department 

published Dear Colleague Letter GEN– 

14–16 (available at http://ifap.ed.gov/

dpcletters/GEN1416.html) announcing 

that the Department had adopted new 

procedures for determining a borrower’s 

eligibility for benefits under the SCRA 

and authorizing FFEL loan holders to 

adopt similar procedures. The 

Department now seeks to include those 

procedures in the regulations and to 

require FFEL loan holders to use those 

procedures. 

These topics are tentative. Topics may 

be added or removed as the process 

continues. 

We intend to select negotiators for the 

committee who represent the interests 

significantly affected by the topics 

proposed for negotiations. In so doing, 

we will follow the requirement in 

section 492(b)(1) of the HEA that the 

individuals selected must have 

demonstrated expertise or experience in 

the relevant topics proposed for 

negotiations. We will also select 

individual negotiators who reflect the 

diversity among program participants, 

in accordance with section 492(b)(1) of 

the HEA. Our goal is to establish a 

committee that will allow significantly 

affected parties to be represented while 

keeping the committee size manageable. 

We generally select a primary and 

alternate negotiator for each 

constituency represented on the 

committee. The primary negotiator 

participates for the purpose of 

determining consensus. The alternate 

participates for the purpose of 

determining consensus in the absence of 

the primary. Either the primary or the 

alternate may speak during the 

negotiations. 

The committee may create subgroups 

on particular topics that may involve 

individuals who are not members of the 

committee. Individuals who are not 

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