Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 7577 

1 42 U.S.C. 902(a)(5). 

2 5 U.S.C. 553(b)(B). 

when developing our regulations.1 The 

APA provides exceptions to its prior 

notice and public comment procedures 

when an agency finds good cause for 

dispensing with such procedures on the 

basis that they are impracticable, 

unnecessary, or contrary to the public 

interest. In the case of this final rule, we 

have determined that good cause exists 

for dispensing with the notice and 

public comment procedures because 

such procedures are unnecessary.2

Executive Order 12866 

We consulted with the Office of 

Management and Budget and 

determined that this final rule does not 

meet the criteria for a significant 

regulatory action under Executive Order 

12866, as supplemented by Executive 

Order 13563. 

Regulatory Flexibility Act 

We certify that this final rule will not 

have a significant economic impact on 

a substantial number of small entities 

because it only affects individuals. 

Therefore, a regulatory flexibility 

analysis is not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

This rule does not create any new or 

affect any existing collections and, 

therefore, does not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Program Nos. 

96.001, Social Security—Disability 

Insurance; 96.002, Social Security— 

Retirement Insurance; 96.004, Social 

Security—Survivors Insurance; 96.006, 

Supplemental Security Income; 96.007, 

Social Security—Research and 

Demonstration; 96.008, Social Security— 

Work Incentives Planning and Assistance 

Program; 96.009 Social Security State Grants 

for Work Incentives Assistance to Disabled 

Beneficiaries; 96.020, Special Benefits for 

Certain World War II Veterans; and 96.021 

Social Security Economic Recovery Act 

Payments) 

List of Subjects 

20 CFR Part 403 

Courts, Government employees, 

Reporting and recordkeeping 

requirements. 

20 CFR Part 429 

Administrative practice and 

procedure, Claims, Government 

employees, Penalties. 

Dated: February 4, 2014. 

Carolyn W. Colvin, 

Acting Commissioner of Social Security. 

For the reasons set out in the 

preamble, we amend 20 CFR chapter III, 

parts 403 and 429 as follows: 

PART 403—TESTIMONY BY 

EMPLOYEES AND THE PRODUCTION 

OF RECORDS AND INFORMATION IN 

LEGAL PROCEEDINGS 

■ 1. The authority citation for part 403 

continues to read as follows: 

Authority: Secs. 702(a)(5) and 1106 of the 

Act, (42 U.S.C. 902(a)(5) and 1306); 5 U.S.C. 

301; 31 U.S.C. 9701. 

■ 2. Amend § 403.120 to revise 

paragraph (c) to read as follows: 

§ 403.120 How do you request testimony? 

* * * * * 

(c) You must send your application 

for testimony to: Social Security 

Administration, Office of the General 

Counsel, Office of General Law, 6401 

Security Boulevard, Room 617 Altmeyer 

Building, Baltimore, Maryland, 21235– 

6401, Attn: Touhy Officer. (If you are 

requesting testimony of an employee of 

the Office of the Inspector General, send 

your application to the address in 

§ 403.125.) 

* * * * * 

PART 429—ADMINISTRATIVE CLAIMS 

UNDER THE FEDERAL TORT CLAIMS 

ACT AND RELATED STATUTES 

■ 3. The authority citation for part 429 

continues to read as follows: 

Authority: Secs. 702(a)(5) of the Social 

Security Act (42 U.S.C. 902(a)(5)); 28 U.S.C. 

2672; 28 CFR 14.11; 31 U.S.C. 3721. 

Subpart A—Claims Against the 

Government Under the Federal Tort 

Claims Act 

■ 4. Amend § 429.102 to revise 

paragraph (c) to read as follows: 

§ 429.102 How do I file a claim under this 

subpart? 

* * * * * 

(c) Where to obtain claims forms and 

file claims. You can obtain claims forms 

by writing to the Social Security 

Administration, Office of the General 

Counsel, Office of General Law, 6401 

Security Boulevard, Room 617 Altmeyer 

Building, Baltimore, Maryland 21235– 

6401. You may also file your claim with 

the Social Security Administration at 

this same address. 

Subpart B—Claims Under the Military 

Personnel and Civilian Employees’ 

Claims Act of 1964 

■ 5. Amend § 429.202 to revise 

paragraph (b) to read as follows: 

§ 429.202 How do I file a claim under this 

subpart? 

* * * * * 

(b) Where to file. You must file your 

claim with the Social Security 

Administration, Office of the General 

Counsel, Office of General Law, 6401 

Security Boulevard, Room 617 Altmeyer 

Building, Baltimore, Maryland 21235– 

6401. 

* * * * * 

[FR Doc. 2014–02853 Filed 2–7–14; 8:45 am] 

BILLING CODE 4191–02–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: Final order. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this final order 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-amino3-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 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, 


emcdonald on DSK67QTVN1PROD with RULES
7578 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 

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 HHS, the Food and Drug Administration (FDA), 

and the National Institute on Drug Abuse (NIDA), 

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. 

engage in research, conduct 

instructional activities, and possess), or 

propose to handle these synthetic 

cannabinoids. 

DATES: This final order is effective 

February 10, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The 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), 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, controlled substances 

are classified into one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of 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 

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, who in turn 

has delegated her authority to the 

Deputy Administrator of the DEA. 28 

CFR 0.100, Appendix to Subpart R of 

Part 0, Sec. 12. 

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 PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA into 

schedule I on a temporary basis to the 

Assistant Secretary by letter dated 

November 7, 2013. The Assistant 

Secretary responded to this notice by 

letter dated January 27, 2014, and 

advised that based on review by the 

FDA, there are currently no 

investigational new drug applications or 

approved new drug applications for PB22, 5F-PB-22, AB-FUBINACA, or ADBPINACA. The Assistant Secretary also 

stated that the HHS has no objection to 

the temporary placement of PB-22, 5FPB-22, AB-FUBINACA, and ADBPINACA 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). As PB22, 5F-PB-22, AB-FUBINACA, and ADBPINACA are not currently listed in any 

schedule under the CSA, and as no 

exemptions or approvals are in effect for 

PB-22, 5F-PB-22, AB-FUBINACA, and 

ADB-PINACA under section 505 of the 

FDCA, 21 U.S.C. 355, the conditions of 

21 U.S.C. 811(h)(1) have been satisfied. 

As required by 21 U.S.C. 811(h)(1)(A), a 

notice of intent to temporarily schedule 

these four synthetic cannabinoids was 

published in the Federal Register on 

January 10, 2014. 79 FR 1776. 

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 

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, ABFUBINACA, 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 1980s 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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 7579 

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. 

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 December 

2013, according to the System to 

Retrieve Information from Drug 

Evidence (STRIDE) 2 there were 211 

reports involving PB–22, 168 reports 

involving 5F–PB–22, and 74 reports 

involving AB–FUBINACA (Queried on 

January 22, 2014). From January through 

December 2013, the National Forensic 

Laboratory Information System 

(NFLIS) 3 registered 1,318 reports 

containing PB–22 in 29 states, 1,294 

reports containing 5F–PB–22 in 29 

states, 822 reports containing AB– 

FUBINACA in 21 states and 40 reports 

containing ADB–PINACA in three states 

(Queried on January 22, 2014). No 

reports in NFLIS or STRIDE were 

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

to January 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 AKB48 

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 AKB48, 

were not included among the 15 specific 

named synthetic cannabinoids, and do 

not fall under the definition of 

cannabimimetic agents, under FDASIA. 


emcdonald on DSK67QTVN1PROD with RULES
7580 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 

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 December 2013, according to 

STRIDE there were 211 reports 

involving PB–22; 168 reports involving 

5F–PB–22; and 74 reports involving 

AB–FUBINACA (Queried on January 22, 

2014). From January through December 

2013, NFLIS registered 1,318 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); 1,294 reports containing 5F– 

PB–22 in 29 states (Arkansas, Arizona, 

California, Colorado, Connecticut, 

Florida, Georgia, Iowa, Indiana, Kansas, 

Kentucky, Louisiana, Minnesota, 

Missouri, North Dakota, New 

Hampshire, New Jersey, New Mexico, 

Nevada, Ohio, Oregon, Pennsylvania, 

South Carolina, Tennessee, Texas, Utah, 

Virginia, Wisconsin and Wyoming); 822 

reports containing AB–FUBINACA in 21 

states (Arizona, Colorado, Connecticut, 

Florida, Georgia, Iowa, Indiana, Kansas, 

Louisiana, Minnesota, Missouri, North 

Dakota, New Hampshire, New Jersey, 

Nevada, Ohio, Oklahoma, Pennsylvania, 

South Carolina, Texas and Wisconsin); 

and 40 reports containing ADB– 

PINACA in three states (Colorado, 

Georgia and Wisconsin) (Queried on 

January 22, 2014). No reports in NFLIS 

or STRIDE were identified for PB–22 or 

5F–PB–22 prior to January 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.’’ CDC 2013. 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 2,639 calls from January 

to December 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 

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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 7581 

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 into 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)(4), the Deputy Administrator, 

through a letter dated November 7, 

2013, notified the Assistant Secretary of 

the intention to temporarily place these 

four synthetic cannabinoids in schedule 

I. 

Conclusion 

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 place four 

synthetic cannabinoids, PB–22, 5F–PB– 

22, AB–FUBINACA, and ADB–PINACA 

into 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, 

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, PB–22, 5F–PB–22, AB– 

FUBINACA, and ADB–PINACA become 

subject to the regulatory controls and 

administrative, civil and criminal 

sanctions applicable to the manufacture, 

distribution, importing, exporting, 

research, 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, PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

PINACA, 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 February 10, 2014. Any 

person who currently handles PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

PINACA, and is not registered with the 

DEA, must submit an application for 

registration and may not continue to 

handle PB–22, 5F–PB–22, AB– 

FUBINACA, or ADB–PINACA as of 

February 10, 2014 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. PB–22, 5F–PB–22, AB– 

FUBINACA, and ADB–PINACA are 

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 February 10, 

2014. 

3. Labeling and Packaging. All labels 

and labeling for commercial containers 

of PB–22, 5F–PB–22, AB–FUBINACA, 

and ADB–PINACA must be in 

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

and be in accordance with 21 CFR part 

1302 as of February 10, 2014. Current 

DEA registrants shall have 30 calendar 

days from February 10, 2014 to comply 

with all labeling and packaging 

requirements. 

4. Inventory. Every DEA registrant 

who possesses any quantity of PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

PINACA on the effective date of this 

order, must take an inventory of all 

stocks of these substances on hand as of 

February 10, 2014, pursuant to 21 U.S.C. 

827, 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 PB–22, 

5F–PB–22, AB–FUBINACA, and ADB– 

PINACA) on hand on a biennial basis, 

pursuant to 21 U.S.C. 827, 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 PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

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

and in accordance with 21 CFR parts 

1304, 1307, and 1312 as of February 10, 

2014. Current DEA registrants 

authorized to handle PB–22, 5F–PB–22, 

AB–FUBINACA, or ADB–PINACA 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 PB–22, 5F– 

PB–22, AB–FUBINACA, or ADB– 

PINACA must submit reports pursuant 

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

21 CFR 1304.33 as of February 10, 2014. 

7. Order Forms. All registrants who 

distribute PB–22, 5F–PB–22, AB– 

FUBINACA, or ADB–PINACA must 

comply with order form requirements 

pursuant to 21 U.S.C. 828 and in 

accordance with 21 CFR part 1305 as of 

February 10, 2014. 


emcdonald on DSK67QTVN1PROD with RULES
7582 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Rules and Regulations 

8. Importation and Exportation. All 

importation and exportation of PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

PINACA must be in compliance with 21 

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

accordance with 21 CFR part 1312 as of 

February 10, 2014. 

9. Quota. Only registered 

manufacturers may manufacture PB–22, 

5F–PB–22, AB–FUBINACA, or ADB– 

PINACA in accordance with a quota 

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

in accordance with 21 CFR part 1303. 

10. Criminal Liability. Any activity 

involving PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA not 

authorized by, or in violation of the 

CSA, occurring as of February 10, 2014 

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 a 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary of 

HHS. 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 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. 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 

from new or designer drugs or abuse of 

those drugs. 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 a threat to public 

health, 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, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

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

unless otherwise noted. 

■ 2. Amend § 1308.11 by adding 

paragraphs (h)(15) through (h)(18) to 

read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(15) Quinolin-8-yl 1-pentyl-1Hindole-3-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: ABFUBINACA) 

(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: ADBPINACA) 

Dated: February 5, 2014. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2014–02848 Filed 2–7–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice 8627] 

RIN 1400–AD29 

Visas: Documentation of 

Nonimmigrants Under the Immigration 

and Nationality Act, as Amended; TN 

Visas From NAFTA Countries 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: The Department of State 

amends its regulation pertaining to The 

North American Free Trade Agreement 

(NAFTA), by removing the petition 

requirement for citizens of Mexico 

applying for nonimmigrant visa 

classification as NAFTA professionals. 

The rule reflects changes to 

documentary requirements authorized 

under the Immigration and Nationality 

Act, in implementation of NAFTA. 


emcdonald on DSK67QTVN1PROD with RULES