67166 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Proposed Rules 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2018–1028; Airspace 

Docket No. 17–ASO–6.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

All communications received on or 

before the specified comment closing 

date will be considered before taking 

action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. A report summarizing each 

substantive public contact with FAA 

personnel concerned with this 

rulemaking will be filed in the docket. 

Availability of NPRM’s 

An electronic copy of this document 

may be downloaded through the 

internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s web page at http://

www.faa.gov/air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9:00 a.m. and 

5:00 p.m., Monday through Friday, 

except federal holidays. An informal 

docket may also be examined during 

normal business hours at the office of 

the Eastern Service Center, Federal 

Aviation Administration, Room 210, 

1701 Columbia Ave., College Park, GA 

30337. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document proposes to amend 

FAA Order 7400.11C, Airspace 

Designations and Reporting Points, 

dated August 13, 2018 and effective 

September 15, 2018. FAA Order 

7400.11C is publicly available as listed 

in the ADDRESSES section of this 

proposed rule. FAA Order 7400.11C 

lists Class A, B, C, D, and E airspace 

areas, air traffic service routes, and 

reporting points. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) part 71 to modify the 

description of VOR Federal airway V– 

18, in the vicinity of Talladega, AL, due 

to the planned decommissioning of the 

Talladega, AL, VOR/DME. The proposed 

route change is described below. 

V–18: V–18 currently extends 

between the Guthrie, TX, VORTAC and 

the Charleston, SC, VORTAC. The FAA 

proposes to remove the airway segments 

between the Vulcan, AL, VORTAC and 

the Colliers, SC, VORTAC. This would 

result in a gap in the airway between 

Vulcan, AL, and Colliers, SC. Therefore, 

proposed amended V–18 route would 

consist of two separate sections: First, 

between the Guthrie, TX, VORTAC and 

the Vulcan, AL, VORTAC; and second, 

after the gap, the airway would resume 

between the Colliers, SC, VORTAC and 

the Charleston, SC, VORTAC. 

Domestic VOR Federal airways are 

published in paragraph 6010(a) of FAA 

Order 7400.11C, dated August 13, 2018, 

and effective September 15, 2018, which 

is incorporated by reference in 14 CFR 

71.1. The VOR Federal airway listed in 

this document would be subsequently 

published in the Order. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore: (1) Is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this proposed rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

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

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.11C, 

Airspace Designations and Reporting 

Points, dated August 13, 2018, and 

effective September 15, 2018, is 

amended as follows: 

Paragraph 6010(a) Domestic VOR Federal 

Airways. 

* * * * * 

V–18 [Amended] 

From Guthrie, TX, via INT Guthrie 156° 

and Millsap, TX, 274° radials; Millsap; Glen 

Rose, TX; Cedar Creek, TX; Quitman, TX; 

Belcher, LA; Monroe, LA; Magnolia, MS; 

Meridian, MS; Crimson, AL; to Vulcan, AL. 

From Colliers, SC; to Charleston, SC. 

* * * * * 

Issued in Washington, DC, on December 

17, 2018. 

Scott M. Rosenbloom, 

Acting Manager, Airspace Policy Group. 

[FR Doc. 2018–28107 Filed 12–27–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–491] 

Schedules of Controlled Substances: 

Temporary Placement of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144 in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Proposed amendment; notice of 

intent. 

SUMMARY: The Acting Administrator of 

the Drug Enforcement Administration is 

issuing this notice of intent to publish 

a temporary order to schedule the 

synthetic cannabinoids (SCs), ethyl 2-(1- 

(5-fluoropentyl)-1H-indazole-3- 

carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-EDMB-PINACA); 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-MDMB-PICA); N- 

(adamantan-1-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide (trivial name: 

FUB-AKB48; FUB-APINACA; AKB48 N- 

(4-FLUOROBENZYL)); 1-(5- 

fluoropentyl)-N-(2-phenylpropan-2-yl)- 

1H-indazole-3-carboxamide (trivial 

names: 5F-CUMYL-PINACA; SGT-25); 

and (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3-tetramethylcyclopropyl) 


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1Though DEA has used the term ‘‘final order’’ 

with respect to temporary scheduling orders in the 

past, this notice of intent adheres to the statutory 

language of 21 U.S.C. 811(h), which refers to a 

‘‘temporary scheduling order.’’ No substantive 

change is intended. 

2 21 U.S.C. 811(h)(1). 

3 Id. at 811(h)(2). 

4 21 U.S.C. 812. 

5 21 U.S.C. 811(h)(1); 21 CFR part 1308(h). 

6 28 CFR 0.100. 

7 21 U.S.C. 811(h)(4); As discussed in a 

memorandum of understanding entered into by the 

FDA and the National Institute on Drug Abuse 

(NIDA), the FDA acts as the lead agency within the 

HHS in carrying out the Secretary’s scheduling 

responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518 (Mar. 8, 1985). 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460 (July 1, 1993). 

8 21 U.S.C. 355. 

9 21 U.S.C. 811(h)(3). 

10 Id. 

11 21 U.S.C. 811(h)(1). 

12 21 U.S.C. 812(b)(1). 

methanone (trivial name: FUB-144), in 

schedule I. This action is based on a 

finding by the Acting Administrator that 

the placement of these SCs in schedule 

I of the Controlled Substances Act (CSA) 

is necessary to avoid an imminent 

hazard to the public safety. When it is 

issued, the temporary scheduling order 

will impose regulatory requirements 

under the CSA on the manufacture, 

distribution, reverse distribution, 

possession, importation, exportation, 

research, and conduct of instructional 

activities, and chemical analysis of 

these SCs, as well as administrative, 

civil, and criminal remedies with 

respect to persons who fail to comply 

with such requirements or otherwise 

violate the CSA with respect to these 

substances. 

DATES: December 28, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Kathy L. Federico, Regulatory Drafting 

and Policy Support Section (DPW), 

Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone: 

(202) 598–6812. 

SUPPLEMENTARY INFORMATION: This 

notice of intent contained in this 

document is issued pursuant to the 

temporary scheduling provisions of 21 

U.S.C. 811(h). The Drug Enforcement 

Administration (DEA) intends to issue a 

temporary scheduling order (in the form 

of a temporary amendment) placing 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 in schedule I of the Controlled 

Substances Act (CSA).1 The temporary 

scheduling order will be published in 

the Federal Register on or after January 

28, 2019. 

Legal Authority 

Section 201 of the CSA provides the 

Attorney General with the authority to 

temporarily place a substance in 

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.2 In addition, 

if proceedings to control a substance 

permanently are initiated under 21 

U.S.C. 811(a)(1) while the substance is 

temporarily controlled under section 

811(h), the Attorney General may 

extend the temporary scheduling for up 

to one year.3

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,4

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).5 The Attorney 

General has delegated scheduling 

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

Administrator of the DEA.6

Background 

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

the Administrator to notify the Secretary 

of the Department of Health and Human 

Services (HHS) of his intention to 

temporarily place a substance in 

schedule I of the CSA.7 The Acting 

Administrator transmitted notice of his 

intent to place 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 in schedule I on 

a temporary basis to the Assistant 

Secretary for Health of HHS by letter 

dated August 24, 2018. The Assistant 

Secretary responded to this notice of 

intent by letter dated September 6, 2018, 

and advised that based on a review by 

the Food and Drug Administration 

(FDA), there are currently no approved 

new drug applications or investigational 

new drug applications for 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA and FUB-144. The 

Assistant Secretary also stated that HHS 

has no objection to the temporary 

placement of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA or FUB-144 in schedule I of the 

CSA. 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA 

or FUB-144 are not currently listed in 

any schedule under the CSA, and no 

exemptions or approvals are in effect for 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA and 

FUB-144 under section 505 of the 

FDCA.8

In order to place a substance 

temporarily in schedule I of the CSA 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): (1) The 

substance’s history and current pattern 

of abuse; (2) the scope, duration and 

significance of abuse; and (3) what, if 

any, risk there is to the public health.9

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution.10

A substance meeting the statutory 

requirements for temporary scheduling 

may only be placed in schedule I.11

Substances in schedule I are those that 

have a high potential for abuse, no 

currently accepted medical use for 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision.12

Synthetic Cannabinoids 

The illicit use of SCs continues to 

cause severe adverse effects, overdoses 

and deaths in the United States. SCs are 

substances synthesized in laboratories 

that mimic the biological effects of 

delta-9-tetrahydrocannabinol (THC), the 

main psychoactive ingredient in 

marijuana. SCs were introduced to the 

designer drug market 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. From 2009, misuse of SCs has 

escalated in the United States as 

evidenced by large numbers of law 

enforcement encounters of SCs applied 

onto plant material and in other 

designer drug products intended for 

human consumption. Recent hospital 

reports, scientific publications, and/or 

law enforcement reports demonstrate 

that 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYLPINACA, FUB-144, and their associated 

designer drug products are being abused 

for their psychoactive properties (see 

DEA 3-Factor Analysis). As with many 

generations of SCs encountered since 

2009, the abuse of 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA and FUB-144 is 

negatively impacting communities in 

the United States. 

As noted by the DEA and CBP, SCs 

originate from foreign sources, such as 

China. Bulk powder 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, 


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warehouses, and other similar 

destinations throughout the country. 

According to online discussion boards 

and law enforcement encounters, 

spraying or mixing the SCs with plant 

material provides a vehicle for the most 

common route of administration— 

smoking (using a pipe, a water pipe, or 

rolling the drug-laced plant material in 

cigarette papers). 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA and 

FUB-144 have no accepted medical use 

in the United States. Use of 5F-MDMBPICA, 5F-EDMB-PINACA, FUB-AKB48, 

5F-CUMYL-PINACA and FUB-144 has 

been reported to result in adverse effects 

in humans in the United States (see 

DEA 3-Factor Analysis). In addition, 

there have been multiple law 

enforcement seizures of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA and FUB-144 in 

the United States. Use of other SCs has 

resulted in signs of addiction and 

withdrawal. Based on the 

pharmacological similarities between 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA and 

FUB-144 and other SCs, these five SCs 

are likely to produce signs of addiction 

and withdrawal similar to those 

produced by other SCs. 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA and 

FUB-144 are SCs that have 

pharmacological effects similar to the 

schedule I hallucinogen THC, and other 

temporarily and permanently controlled 

schedule I SCs. In addition, the misuse 

of 5F-CUMYL-PINACA, 5F-EDMBPINACA and FUB-144 has been 

associated with multiple overdoses 

requiring emergency medical 

intervention (see DEA 3-Factor 

Analysis) while deaths have been 

reported that involved FUB-AKB48. 

With no approved medical use and 

limited safety or toxicological 

information, 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 have emerged in 

the designer drug market, and the abuse 

of these substances for their 

psychoactive properties is concerning. 

Factor 4. History and Current Pattern of 

Abuse 

SCs have been developed by 

researchers over the last 30 years as 

tools for investigating the 

endocannabinoid system (e.g., 

determining CB1 and CB2 receptor 

activity). The first encounter of SCs 

intended for illicit use within the 

United States occurred in November 

2008 by CBP. Since then, the popularity 

of SCs as product adulterants and 

objects of abuse has increased as 

evidenced by law enforcement seizures, 

public health information, and media 

reports. 

Numerous SCs have been identified as 

product adulterants, and law 

enforcement has seized bulk amounts of 

these substances. As successive 

generations of SCs have been identified 

and controlled as schedule I substances, 

illicit distributors have developed new 

SC substances that vary only by slight 

modifications to their chemical 

structure while retaining 

pharmacological effects related to their 

abuse potential. These substances, and 

products laced with these substances, 

are marketed under the guise of ‘‘herbal 

incense’’ and promoted as a ‘‘legal high’’ 

with a disclaimer that they are ‘‘not for 

human consumption.’’ Thus, after 

section 1152 of the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), Public Law 112-144, 

placed cannabimimetic agents and 26 

specific substances (15 of these are SCs) 

into schedule I, law enforcement 

documented the emergence of new SCs 

including UR-144, XLR11, AKB48, PB22, 5F-PB-22, AB-FUBINACA, and ADBPINACA. After these substances were 

temporarily scheduled (78 FR 28735, 

May 16, 2013; 79 FR 7577, February 10, 

2014) other generations of SCs appeared 

and were temporarily controlled, 

including AB-CHMINACA, ABPINACA, THJ-2201 (80 FR 5042, January 

30, 2015), MAB-CHMINACA (81 FR 

6171, February 5, 2016), 5F-ADB, 5FAMB, 5F-ABK48, ADB-FUBINACA, 

MDMB-CHMICA, MDMB-FUBINACA 

(82 FR 17119, April 10, 2017), FUBAMB (82 FR 51154, November 3, 2017) 

NM2201, 5F-AB-PINACA, 4-CNCUMYL-BUTINACA, MMB-CHMICA 

and 5F-CUMYL-P7AICA (83 FR 31877, 

July 10, 2018). 

FUB-AKB48 was first identified in 

seized drug evidence in October 2013, 

followed by FUB-144 (January 2014), 

5F-MDMB-PICA (October 2016), 5FEDMB-PINACA (October 2017) and 5FCUMYL-PINACA (February 2018). 

Following their manufacture in China, 

SCs are often encountered in countries 

including New Zealand, Australia, and 

Russia before appearing throughout 

Europe, and eventually in the United 

States. 5F-CUMYL-PINACA was first 

reported in the German and Swiss illicit 

drug market in 2015 but didn’t show up 

in the United States until February 

2018; 5F-EDMB-PINACA was reported 

in China in 2016 but didn’t appear in 

the United States until October 2017; 

and 5F-MDMB-PICA was reported in 

Germany in August 2016 and November 

2016 in Belgium, a few months before 

showing up in the United States. These 

data further support that based upon 

trends, SCs appear in the illicit drug 

markets of other countries including 

those in Europe, often before being 

trafficked in the United States. The 

misuse of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 has been 

associated with law enforcement 

seizures, overdoses requiring emergency 

medical intervention, or both (see DEA 

3-Factor Analysis). 

The powder form of SCs is typically 

dissolved in solvents (e.g., acetone) 

before being applied to plant material, 

or dissolved in a propellant intended for 

use in electronic cigarette devices. In 

addition, 5F-EDMB-PINACA was 

identified as an adulterant on pieces of 

paper that were smuggled into a 

detention facility and later found 

partially burned (see DEA 3- Factor 

Analysis). Law enforcement personnel 

have encountered various application 

methods including buckets or cement 

mixers in which plant material and one 

or more SCs are mixed together, or in 

large areas where the plant material is 

spread out so that a dissolved SC 

mixture can be applied directly. Once 

mixed, the SC plant material is then 

allowed to dry before manufacturers 

package the product for distribution, 

ignoring any control mechanisms to 

prevent contamination or to ensure a 

uniform concentration of the substance 

in each package. Adverse health 

consequences may also occur from 

directly ingesting the drug during the 

manufacturing process. The failure to 

adhere to any manufacturing standards 

with regard to amounts, the substance(s) 

included, purity, or contamination may 

increase the risk of adverse events. 

However, it is important to note that 

adherence to manufacturing standards 

would not eliminate their potential to 

produce adverse effects because the 

toxicity and safety profile of these SCs 

have not been studied. 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA and 

FUB-144, similar to other SCs, have 

been found in powder form or mixed 

with dried leaves or herbal blends that 

were marketed for human use. 

Presentations at emergency departments 

directly linked to the abuse of 5FEDMB-PINACA and FUB-144 have 

included seizures, agitation, vomiting, 

tachycardia and elevated blood pressure 

(see DEA 3-Factor Analysis). 

Factor 5. Scope, Duration and 

Significance of Abuse 

SCs continue to be encountered in the 

illicit market despite scheduling actions 

that attempt to safeguard the public 

from the adverse effects and safety 

issues associated with these substances 


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13STARLiMS is a laboratory information 

management system that systematically collects 

results from drug chemistry analyses conducted by 

DEA laboratories. On October 1, 2014, STARLiMS 

replaced System to Retrieve Information from Drug 

Evidence (STRIDE) as the DEA laboratory drug 

evidence data system of record. 

14STRIDE is a database of drug exhibits sent to 

DEA laboratories for analysis. Exhibits from the 

database are from the DEA, other federal agencies, 

and some local law enforcement agencies. 

15The National Forensic Laboratory Information 

System (NFLIS) is a national forensic laboratory 

reporting system that systematically collects results 

from drug chemistry analyses conducted by State 

and local forensic laboratories in the United States. 

16At the time of query, 2017 data were still 

reporting. 

(see DEA 3-Factor Analysis). Novel 

substances continue to be encountered, 

differing only by small chemical 

structural modifications intended to 

avoid prosecution while maintaining 

the pharmacological effects. Law 

enforcement and health care 

professionals continue to report the 

abuse of these substances and their 

associated products. 

As described by NIDA, many 

substances being encountered in the 

illicit market, specifically SCs, have 

been available for years but have 

reentered the marketplace due to a 

renewed popularity. The threat of 

serious injury to the individual and the 

imminent threat to public safety 

following the ingestion of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA and FUB-144 and 

other SCs persist. 

Full reports of information obtained 

through STARLiMS,13 STRIDE,14 and 

NFLIS 15 for the past five years may be 

found in the DEA 3-Factor Analysis. 

According to NFLIS data, state and local 

forensic laboratories have detected the 

following information about the SCs in 

question: 

• 5F-EDMB-PINACA was identified 

in 205 different NFLIS reports from five 

states since 2017,16 and 16 STRIDE/ 

STARLiMS reports from one state since 

2017. 

• 5F-MDMB–PICA was identified in 

115 NFLIS reports from 18 states since 

2016. 

• FUB-AKB48 was identified in 342 

NFLIS reports from 20 states since 2014, 

and 36 STRIDE/STARLiMS reports from 

eight states since 2013. 

• 5F-CUMYL-PINACA was identified 

in three NFLIS reports from two states 

since 2018. 

• FUB-144 was identified in 346 

NFLIS reports from 26 states since 2014, 

71 STARLiMS reports from 13 states 

plus Washington, DC since 2014. 

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

the Public Health 

Since first being identified in the 

United States in 2008, the ingestion of 

SCs continues to result in serious 

adverse effects. Details of these events 

involving 5F-CUMYL-PINACA, 5FEDMB-PINACA, FUB-144, FUB-AKB48, 

and 5F-MDMB-PICA are summarized 

below. 

1. In 2015, in London (United 

Kingdom), a 34 year-old male was 

hospitalized after ingesting a synthetic 

cannabinoid product. Toxicological 

analysis identified 5F-AKB48 and 5FCUMYL-PINACA in biological samples. 

2. In September 2018, law 

enforcement in Georgia seized multiple 

electronic cigarettes with various 

colored viscous liquids following the 

reports of overdoses. Laboratory 

analysis on the seized evidence 

determined the substance to be 5FCUMYL-PINACA. 

3. In late November and early 

December 2015, in Jackson, MS, five 

individuals presented at local 

emergency facilities following ingestion 

of a synthetic cannabinoid-containing 

product. Evidence collected from the 

individuals tested positive for THC, 

MAB-CHMINACA and FUB-144. 

Toxicological analysis of biological 

samples in all five patients identified 

THC, MAB-CHMINACA, and FUB-144. 

4. In March 2017, in Chaves, NM, a 

14 year-old female was found in the 

bathroom of her home with seizure-like 

activity. Following transport to a local 

hospital by family members, she was 

pronounced dead approximately 20 

minutes later. Toxicological analysis 

upon autopsy identified three SCs: FUBAKB48, AB-CHMINACA, and ADBCHMINACA (MAB-CHMINACA). The 

cause of death was determined to be 

toxic effects of synthetic cannabinoids 

(FUB-AKB48, AB-CHMINACA, and 

ADB-CHMINACA). 

5. In January 2018, in Pittsburgh, PA, 

13 correctional facility workers were 

treated for overdose symptoms 

including diaphoresis, hypertension and 

tachycardia following ingestion of an 

airborne substance while conducting 

cell searches for contraband. In response 

to the overdose events, evidence 

retrieved from the searches tested 

positive for the synthetic cannabinoids 

5F-ADB, 5F-EDMB-PINACA, and 4-CNCUMYL-BUTINACA. 

6. In March 2018, in Chicago, IL, a 22 

year-old male expired at a local 

hospital. Toxicological analysis 

confirmed buprenorphine, brodifacoum, 

bromadiolone, FUB-AMB and FUBAKB48 in biological samples of this 

decedent. 

7. In April 2018, in Harrisburg, PA, a 

38-year old male presented at a local 

hospital due to repeated nosebleeds, 

gastrointestinal bleeding with anemia 

and bruising on his arms. Toxicological 

analysis confirmed brodifacoum, FUBAMB, and FUB-AKB48 in biological 

samples. 

8. In April 2018, in Harrisburg, PA, 

another patient presented at a local 

hospital due to significant bleeding and 

anemia requiring a transfusion. 

Toxicological analysis confirmed 

brodifacoum, FUB-AMB, and FUBAKB48 in biological samples. 

9. In June 2018, in Chicago, IL, a 25- 

year old male expired at a local hospital. 

Toxicological analysis confirmed 

brodifacoum, bromadiolone, FUB-AMB 

and FUB-AKB48 in biological samples 

of this decedent. 

10. In July 2018, in Washington, DC, 

in excess of 260 overdoses and four 

deaths were reported following use of a 

synthetic cannabinoid product. Analysis 

of drug evidence from the overdose 

event confirmed the presence of the 

synthetic cannabinoids FUB-AMB, 

EMB-FUBINACA and FUB-144. 

11. In August 2018, in New Haven, 

CT, in excess of 47 overdoses were 

reported following the use of a synthetic 

cannabinoid product. Analysis of drug 

evidence from the overdose event 

confirmed the presence of the synthetic 

cannabinoids 5F-ADB, FUB-AMB and 

5F-MDMB-PICA. 

12. From September 10–16, 2018, in 

Washington, DC, at least 244 overdoses 

were reported following use of a 

synthetic cannabinoid product. Analysis 

of drug evidence from the overdose 

event confirmed the presence of the 

synthetic cannabinoids FUB-AMB and 

5F-MDMB-PICA. 

Because they share pharmacological 

similarities with schedule I substances 

(D9-THC, JWH-018 and other 

temporarily and permanently controlled 

schedule I SCs), 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 pose serious 

risks to an abuser. Tolerance to SCs may 

develop fairly rapidly with larger doses 

being required to achieve the desired 

effect. 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 department 

admissions, and overall toxicity and 

deaths. Psychiatric case reports have 

been reported in the scientific literature 

detailing the SC abuse and associated 

psychoses. As abusers obtain these 

drugs through unknown sources, the 

identity and purity of these substances 

is uncertain and inconsistent, thus 


amozie on DSK3GDR082PROD with PROPOSALS1
67170 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Proposed Rules 

17 21 U.S.C. 811(h)(1). 

18 21 U.S.C. 812(b)(1). 

19 21 U.S.C. 811(h)(4). 

20 21 U.S.C. 811(h). 21 21 U.S.C. 811(h)(1) and (2). 

22 21 U.S.C. 811. 

23 21 U.S.C. 877. 

24 21 U.S.C. 811(h)(6). 

25 21 U.S.C. 811(h)(1). 

26 5 U.S.C. 553. 

posing significant adverse health risks 

to users. 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA, and 

FUB-144 are being encountered on the 

illicit drug market and have no accepted 

medical use in 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 

In accordance with 21 U.S.C. 

811(h)(3) and based on the data and 

information summarized above, the 

continued uncontrolled manufacture, 

distribution, reverse distribution, 

importation, exportation, conduct of 

research and chemical analysis, 

possession, and/or abuse of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144, 

resulting from the lack of control of 

these substances, pose an imminent 

hazard to the public safety. The DEA is 

not aware of any currently accepted 

medical uses for 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 in the United 

States. A substance meeting the 

statutory requirements for temporary 

scheduling may only be placed in 

schedule I.17 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.18 Available 

data and information for 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144 

indicate that these 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,19 the Acting 

Administrator, through a letter dated 

August 24, 2018, notified the Assistant 

Secretary for Health of the DEA’s 

intention to temporarily place 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 in schedule I and considered the 

Assistant Secretary’s response. 

Conclusion 

This notice of intent provides the 30- 

day notice, pursuant to section 201(h) of 

the CSA,20 of the DEA’s intent to issue 

a temporary scheduling order. In 

accordance with the provisions of 

section 201(h) of the CSA, the Acting 

Administrator considered available data 

and information, and herein sets forth 

the grounds for his determination that it 

is necessary to temporarily schedule 

ethyl 2-(1-(5-fluoropentyl)-1H-indazole3-carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-EDMB-PINACA); 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-MDMB-PICA); N- 

(adamantan-1-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide (trivial name: 

FUB-AKB48; FUB-APINACA; AKB48 N- 

(4-FLUOROBENZYL)); 1-(5- 

fluoropentyl)-N-(2-phenylpropan-2-yl)- 

1H-indazole-3-carboxamide (trivial 

names: 5F-CUMYL-PINACA; SGT-25); 

and (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3-tetramethylcyclopropyl) 

methanone (trivial name: FUB-144) in 

schedule I of the CSA and finds that 

placement of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 in schedule I of 

the CSA on a temporary basis is 

necessary to avoid an imminent hazard 

to the public safety. 

The temporary placement of 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 in schedule I of the CSA will take 

effect pursuant to a temporary 

scheduling order, which will not be 

issued before January 28, 2019. Because 

the Acting Administrator hereby finds 

that it is necessary to temporarily place 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA, and 

FUB-144 in schedule I to avoid an 

imminent hazard to the public safety, 

the temporary order scheduling these 

substances will be effective on the date 

that order is published 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 It is 

the intention of the Acting 

Administrator to issue a temporary 

scheduling order as soon as possible 

after the expiration of 30 days from the 

date of publication of this document. 

Upon publication of the temporary 

order, 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA 

and FUB-144 will be subject to the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, reverse 

distribution, importation, exportation, 

research, conduct of instructional 

activities and chemical analysis, and 

possession 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 

557.22 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.23 Temporary 

scheduling orders are not subject to 

judicial review.24

Regulatory Matters 

Section 201(h) of the CSA provides 

for a 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 of 

HHS.25

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) 26 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 Acting 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 


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Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Proposed Rules 67171 

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 Acting Administrator took 

into consideration comments submitted 

by the Assistant Secretary in response to 

the notice that DEA transmitted to the 

Assistant Secretary pursuant to section 

811(h)(4). 

Further, the DEA believes that this 

temporary scheduling action is not a 

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

and, accordingly, is not subject to the 

requirements of the Regulatory 

Flexibility Act (RFA). The requirements 

for the preparation of an initial 

regulatory flexibility analysis in 5 U.S.C. 

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

the DEA is not required by section 553 

of the APA or any other law to publish 

a general notice of proposed 

rulemaking. 

Additionally, this action is not a 

significant regulatory action as defined 

by Executive Order 12866 (Regulatory 

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

accordingly, this action has not been 

reviewed by the Office of Management 

and Budget. 

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), 

956(b), unless otherwise noted. 

■ 2. In § 1308.11, add paragraphs (h)(37) 

through (41) to read as follows: 

§ 1308.11 Schedule I 

* * * * * 

(h) * * * 

(37) thyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3- 

dimethylbutanoate, its optical, 

positional, and geometric isomers, salts 

and salts of isomers (trivial name: 5FEDMB-PINACA)-(7036) 

(38) methyl 2-(1-(5-fluoropentyl)-1Hindole-3-carboxamido)-3,3- 

dimethylbutanoate, its optical, 

positional, and geometric isomers, salts 

and salts of isomers (trivial name: 5FMDMB-PICA)-(7041) 

(39) N-(adamantan-1-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide, its optical, positional, and 

geometric isomers, salts and salts of 

isomers (trivial name: FUB-AKB48; 

FUB-APINACA; AKB48 N-(4- 

FLUOROBENZYL))-(7047) 

(40) 1-(5-fluoropentyl)-N-(2- 

phenylpropan-2-yl)-1H-indazole-3- 

carboxamide, its optical, positional, and 

geometric isomers, salts and salts of 

isomers (trivial names: 5F-CUMYLPINACA; SGT-25)-(7083) 

(41) (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers 

(trivial name: FUB-144)-(7014) 

Dated: December 20, 2018. 

Uttam Dhillon, 

Acting Administrator. 

[FR Doc. 2018–28110 Filed 12–27–18; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–115420–18] 

RIN 1545–BP03 

Investing in Qualified Opportunity 

Funds; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to a notice of 

proposed rulemaking and notice of 

public hearing. 

SUMMARY: This document contains a 

correction to notice of proposed 

rulemaking and notice of public hearing 

(REG–115420–18) that was published in 

the Federal Register on Monday, 

October 29, 2018. The proposed 

regulations are providing guidance 

under new section 1400Z–2 of the 

Internal Revenue Code relating to gains 

that may be deferred as a result of a 

taxpayer’s investment in a qualified 

opportunity fund. 

DATES: Written or electronic comments 

and request for a public hearing for the 

notice of proposed rulemaking at 83 FR 

54279, October 29, 2018, are still being 

accepted and must be received by 

December 28, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Erika C. Reigle of the Office of Associate 

Chief Counsel (Income Tax and 

Accounting), (202) 317–7006 and Kyle 

C. Griffin of the Office of Associate 

Chief Counsel (Income Tax and 

Accounting), (202) 317–4718; 

concerning the submission of 

comments, the hearing, or to be placed 

on the building access list to attend the 

hearing, Regina L. Johnson, (202) 317- 

6901 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

The notice of proposed rulemaking 

and notice of public hearing that is 

subject of this document is under 

section 1400Z–2 of the Internal Revenue 

Code. 

Need for Correction 

As published, the notice of proposed 

rulemaking and notice of public hearing 

(REG–115420–18) contains errors that 

may prove to be misleading and are in 

need of clarification. 

Correction of Publication 

Accordingly, the notice of proposed 

rulemaking and notice of public 

hearing, FR Doc. 2018–23382, published 

at 83 FR 54279, October 29, 2018, is 

corrected as follows: 

1. On page 54285, second column, in 

the preamble, the twelfth line of the first 

full paragraph, the language ‘‘1400Z– 

2(d)](2)(D)). is corrected to read 

‘‘1400Z–2(d)(2)(D)).’’. 

2. On page 54285, second column, in 

the preamble, the last line of the first 

full paragraph, the language ‘‘section 

1400Z–2(d)(2)(B)(ii)(III).’’ is corrected to 

read ‘‘section 1400Z–2(d)(2)(B)(i)(III) 

and section 1400Z–2(d)(2)(C)(iii).’’. 

§ 1.400Z2(e)–1 [Corrected] 

3. On page 54296, third column, the 

eleventh line of paragraph (a)(3)(i), the 

language ‘‘§ 1.752–3(a)’’ is corrected to 

read ‘‘section 752 and the regulations 

thereunder,’’ 

Martin V. Franks, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. 2018–28207 Filed 12–27–18; 8:45 am] 

BILLING CODE 4830–01–P 


amozie on DSK3GDR082PROD with PROPOSALS1