12938 Federal Register / Vol. 79, No. 45 / Friday, March 7, 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 

HHS, the Food and Drug Administration (FDA), and 

the National Institute on Drug Abuse (NIDA), FDA 

acts as the lead agency within HHS in carrying out 

the Assistant Secretary’s scheduling responsibilities 

under the CSA, with the concurrence of NIDA. 50 

FR 9518, Mar. 8, 1985. 

14 CFR part or section identified and described Current OMB control number 

*******

Part 121 .................................................................................................... 2120–0008, 2120–0028, 2120–0535, 2120–0571, 2120–0600, 2120– 

0606, 2120–0614, 2120–0616, 2120–0631, 2120–0651, 2120–0653, 

2120–0691, 2120–0702, 2120–0739 

*******

Issued in Washington, DC, under the 

authority provided by 49 U.S.C. 106(f) and 

44701(a) on February 28, 2014. 

Lirio Liu, 

Director, Office of Rulemaking. 

[FR Doc. 2014–04902 Filed 3–6–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–386] 

Schedules of Controlled Substances: 

Temporary Placement of 10 Synthetic 

Cathinones 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 10 synthetic 

cathinones into schedule I pursuant to 

the temporary scheduling provisions of 

the Controlled Substances Act (CSA). 

The 10 substances are: 4-methyl-Nethylcathinone (‘‘4-MEC’’); 4-methylalpha-pyrrolidinopropiophenone (‘‘4- 

MePPP’’); alphapyrrolidinopentiophenone (‘‘a-PVP’’); 1- 

(1,3-benzodioxol-5-yl)-2- 

(methylamino)butan-1-one (‘‘butylone’’); 

2-(methylamino)-1-phenylpentan-1-one 

(‘‘pentedrone’’); 1-(1,3-benzodioxol-5- 

yl)-2-(methylamino)pentan-1-one 

(‘‘pentylone’’); 4-fluoro-Nmethylcathinone (‘‘4–FMC’’); 3-fluoroN-methylcathinone (‘‘3–FMC’’); 1- 

(naphthalen-2-yl)-2-(pyrrolidin-1- 

yl)pentan-1-one (‘‘naphyrone’’); and 

alpha-pyrrolidinobutiophenone (‘‘aPBP’’). This action is based on a finding 

by the Deputy Administrator that the 

placement of these synthetic cathinones 

and their optical, positional, and 

geometric isomers, salts and salts of 

isomers into schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety. As a result of this 

order, the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances will be imposed 

on persons who handle (manufacture, 

distribute, import, export, engage in 

research, conduct instructional 

activities, and possess), or propose to 

handle these synthetic cathinones. 

DATES: This final order is effective 

March 7, 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 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP 

into schedule I on a temporary basis to 

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Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Rules and Regulations 12939 

2STRIDE is a database of drug exhibits sent to the 

DEA laboratories for analysis. Exhibits from the 

database are from the DEA, other Federal agencies, 

and some local law enforcement agencies. STRIDE 

data was queried on 2/5/2014 by date submitted to 

Federal forensic laboratories. 

3FMC refers to both 3-FMC and 4-FMC. 

4NFLIS 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. 

NFLIS State and local forensic drug reports were 

queried on 2/6/2014. 

5FMC refers to both 3-FMC and 4-FMC. 

the Assistant Secretary by letter dated 

November 7, 2013. The Assistant 

Secretary responded to this notice by 

letter dated December 4, 2013, and 

advised that based on review by the 

FDA, there are currently no 

investigational new drug applications or 

approved new drug applications for 4- 

MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, or a-PBP. The Assistant 

Secretary also stated that the HHS has 

no objection to the temporary placement 

of 4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP 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 4- 

MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP are not currently 

listed in any schedule under the CSA, 

and as no exemptions or approvals are 

in effect for 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP 

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 10 synthetic cathinones was 

published in the Federal Register on 

January 28, 2014. 79 FR 4429. 

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 4-MEC, 4-MePPP, aPVP, butylone, pentedrone, pentylone, 

4-FMC, 3-FMC, naphyrone, and a-PBP 

indicate that these 10 synthetic 

cathinones 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 Cathinones 

Synthetic cathinones are b-ketophenethylamine derivatives of the larger 

phenethylamine structural class 

(amphetamines, cathinones, 2C 

compounds, aminoindanes, etc.). 

Synthetic cathinones share a core 

phenethylamine structure with 

substitutions at the b-position, aposition, phenyl ring, or nitrogen atom. 

The addition of a beta-keto (b-keto) 

substituent (i.e., carbonyl (C=O)) to the 

phenethylamine core structure along 

with substitutions on the alpha (a) 

carbon (C) atom or the nitrogen (N) atom 

produce a variety of substances called 

cathinones or synthetic cathinones. 

Many synthetic cathinones produce 

pharmacological effects substantially 

similar to the schedule I substances 

cathinone, methcathinone, and 3,4- 

methylenedioxymethamphetamine 

(MDMA) and schedule II stimulants 

amphetamine, methamphetamine, and 

cocaine. 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP are 

synthetic cathinones and are 

structurally and pharmacologically 

similar to amphetamine, MDMA, 

cathinone, and other related substances. 

Accordingly, these synthetic cathinone 

substances share substantial similarities 

with schedule I and schedule II 

substances with respect to desired and 

adverse effects. In general, desired 

effects reported by abusers of synthetic 

cathinone substances include euphoria, 

sense of well-being, increased 

sociability, energy, empathy, increased 

alertness, and improved concentration 

and focus. Abusers also report 

experiencing unwanted effects such as 

tremor, vomiting, agitation, sweating, 

fever, and chest pain. Other adverse or 

toxic effects that have been reported 

with the abuse of synthetic cathinones 

include tachycardia, hypertension, 

hyperthermia, mydriasis, 

rhabdomyolysis, hyponatremia, 

seizures, altered mental status 

(paranoia, hallucinations, delusions), 

and even death. These synthetic 

cathinone substances have no known 

medical use in the United States but 

evidence demonstrates that these 

substances are being abused by 

individuals. There have been 

documented reports of emergency room 

admissions and deaths associated with 

the abuse of synthetic cathinone 

substances. 

Products that contain synthetic 

cathinones have been falsely marketed 

as ‘‘research chemicals,’’ ‘‘jewelry 

cleaner,’’ ‘‘stain remover,’’ ‘‘plant food 

or fertilizer,’’ ‘‘insect repellants,’’ or 

‘‘bath salts.’’ These products are sold at 

smoke shops, head shops, convenience 

stores, adult book stores, and gas 

stations and can also be purchased on 

the Internet. These substances are 

commonly encountered in the form of 

powders, crystals, resins, tablets, and 

capsules. 

From January 2010 through December 

2013, according to the System to 

Retrieve Information from Drug 

Evidence 2 (STRIDE) data, there are 377 

exhibits for 4-MEC; 125 exhibits for 4- 

MePPP; 689 exhibits for a-PVP; 75 

exhibits for butylone; 304 exhibits for 

pentedrone; 121 exhibits for pentylone; 

37 exhibits for FMC 3; 24 exhibits for 

naphyrone; and 37 exhibits for a-PBP. 

From January 2010 through December 

2013, the National Forensic Laboratory 

Information System 4 (NFLIS) registered 

9,113 reports containing these synthetic 

cathinones (4-MEC—1,952 reports; 4- 

MePPP—289 reports; a-PVP—4,536 

reports; butylone—495 reports; 

pentedrone—1,167 reports; pentylone— 

238 reports; FMC5—292 reports; 

naphyrone—44 reports; a-PBP—100 

reports) across 42 States. 

Factor 4. History and Current Pattern of 

Abuse 

4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP are synthetic 

cathinones that emerged on the United 

States’ illicit drug market around the 

time of the temporary scheduling of 

mephedrone, MDPV, and methylone on 

October 21, 2011. 76 FR 65371. 

Mephedrone and MDPV were 

permanently placed in schedule I on 

July 9, 2012, by the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144), and methylone 

was permanently placed in schedule I 

by the DEA on April 12, 2013 (78 FR 

21818). These synthetic cathinone 

substances, like the schedule I synthetic 

cathinones (mephedrone, methylone, 

and MDPV), are promoted as being a 

‘‘legal’’ alternative to cocaine, 

methamphetamine, and MDMA. 

Products that contain 4-MEC, 4-MePPP, 

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12940 Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Rules and Regulations 

6MTF is a research program conducted by the 

University of Michigan’s Institute for Social 

Research under grants from NIDA. MTF tracks drug 

use trends among American adolescents in the 8th, 

10th, and 12th grades and high school graduates 

into adulthood by conducting nationwide surveys. 

7STRIDE data was queried on 2/5/2014 by date 

submitted to Federal forensic laboratories. 

8NFLIS State and local forensic drug reports were 

queried on 2/6/2014. 9FMC refers to both 3-FMC and 4-FMC. 

a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

and a-PBP are falsely marketed as 

‘‘research chemicals,’’ ‘‘jewelry 

cleaner,’’ ‘‘stain remover,’’ ‘‘plant food 

or fertilizer,’’ ‘‘insect repellants,’’ or 

‘‘bath salts.’’ They are sold at smoke 

shops, head shops, convenience stores, 

adult book stores, and gas stations, and 

can also be purchased on the Internet 

under a variety of product names (e.g., 

‘‘White Dove,’’ ‘‘Explosion,’’ and 

‘‘Tranquility’’). They are commonly 

encountered in the form of powders, 

crystals, resins, tablets, and capsules. 

The packages of these commercial 

products usually contain the warning 

‘‘not for human consumption.’’ 

Information from published scientific 

studies indicates that the most common 

routes of administration for synthetic 

cathinone substances is ingestion by 

swallowing capsules or tablets or nasal 

insufflation by snorting the powder. 

Other methods of intake include 

intravenous or intramuscular injection, 

rectal administration, and swallowing 

via ingestion by ‘‘bombing’’ (wrapping a 

dose of powder in paper). 

There is evidence that these synthetic 

cathinone substances are abused alone 

or ingested with other substances 

including other synthetic cathinones, 

pharmaceutical agents, or other 

recreational substances. Substances 

found in combination with 4-MEC, 4- 

MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, or naphyrone are: 

Other synthetic cathinones (e.g., 

methylone and MDPV), common cutting 

agents (e.g., lidocaine, caffeine, 

lignocaine, ephedrine, etc.), or other 

recreational substances (e.g., cocaine, 

methamphetamine, and amphetamine). 

Evidence from poison centers and 

published reports suggest that the 

primary users of synthetic cathinones 

are youths and young adults. Synthetic 

cathinone exposures reported to the 

Texas Poison Center Network during 

2010 and 2011 involved mostly 

adolescents (12 to 19-years-old) and 

young adults (mean age was 30-yearsold). A survey of college students 

reported that the lifetime use (used at 

least once) of synthetic cathinones 

among college students (at a large 

Southeastern United States university) 

is 25 out of 2,349 students surveyed. A 

national survey on drug use by the 

Monitoring the Future (MTF) 6 research 

program showed that 0.2% of full-time 

college students (one to four years past 

high school) used synthetic cathinone 

substances in 2012. Similarly, the use of 

synthetic cathinone substances among 

8th, 10th, and 12th grade students, and 

young adults (non-college peers aged 19 

to 28-years-old) was 0.8%, 0.6%, 1.3%, 

and 0.8%, respectively. 

Factor 5. Scope, Duration and 

Significance of Abuse 

4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP, like the 

schedule I cathinones mephedrone, 

methylone, and MDPV, are popular 

recreational drugs. Evidence that these 

synthetic cathinone substances are 

being abused is indicated by law 

enforcement encounters of these 

substances. Forensic laboratories have 

analyzed drug exhibits received from 

State, local, and Federal law 

enforcement agencies and confirmed the 

presence of 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, or a-PBP in 

these exhibits. 

STRIDE registered 1,789 drug exhibits 

pertaining to the trafficking, distribution 

and abuse of 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP 

from January 2010 to December 2013.7

Specifically, in 2010, STRIDE contains 

four reports related to 4-MEC and none 

for the other nine substances. However, 

in 2011, there were 216 reports related 

to these 10 substances, and in 2012, 

there were 1,314 reports. In 2013, there 

were 255 reports. 

NFLIS registered over 9,000 reports 

from State and local forensic 

laboratories identifying these substances 

in drug-related exhibits for the period 

from January 2010 to December 2013, 

across 42 States. Specifically, in 2010, 

NFLIS registered 13 reports from 5 

States containing many of these 

synthetic cathinone substances.8 In 

2011, there were 800 reports from 32 

States related to these substances 

registered in NFLIS, in 2012 there were 

5,519 reports from 41 States, and in 

2013 there were 2,781 reports from 42 

States. 

Additionally, large seizures of these 

substances have occurred by the United 

States Customs and Border Protection 

(CBP). At selected United States ports of 

entry, CBP encountered several 

shipments of products from April 2010 

to November 2013 containing these 

synthetic cathinone substances (4- 

MEC—78 encounters; 4-MePPP—8 

encounters; a-PVP—40 encounters; 

butylone—21 encounters; pentedrone— 

18 encounters; pentylone—10 

encounters; FMC9—13 encounters; 

naphyrone—3 encounters; a-PBP—11 

encounters), thus indicating the appeal 

of these substances. Most of the 

shipments of these synthetic cathinones 

originated overseas and were destined 

for delivery throughout the United 

States to States including Arizona, 

Arkansas, California, Colorado, Florida, 

Hawaii, Idaho, Illinois, Michigan, 

Missouri, Nebraska, Nevada, New 

Jersey, New Mexico, Oklahoma, Oregon, 

Texas, Virginia, Washington, and 

Wyoming. 

Concerns over the abuse of these 

synthetic cathinone substances have 

prompted many States to regulate them. 

As of June 24, 2013, more than half of 

the States in the United States have 

emergency scheduled or enacted 

legislation placing regulatory controls 

on some or many of the 10 synthetic 

cathinones that are the subject of this 

final order. In addition, due to the use 

of synthetic cathinones by service 

members, the United States Armed 

Forces has prohibited the use of 

synthetic cathinones for intoxication 

purposes. 

Factor 6. What, If Any, Risk There Is 

to the Public Health 

Available evidence on the overall 

public health risks associated with the 

use of synthetic cathinones indicates 

that 4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP can cause acute 

health problems leading to emergency 

department admissions, violent 

behaviors causing harm to self or others, 

or death. For example, individuals have 

presented at emergency departments 

following exposure to some of these 

synthetic cathinone substances or 

products containing them. In addition, 

products containing these synthetic 

cathinone substances often do not bear 

labeling information regarding their 

ingredients and, if they do, they may not 

list the active synthetic ingredients or 

identify the health risks and potential 

hazards associated with these products. 

Acute effects of these substances are 

those typical of sympathomimetic 

agents (e.g., cocaine, methamphetamine, 

and amphetamine) and include, among 

other effects, tachycardia, headache, 

bruxism (teeth grinding), palpitations, 

agitation, anxiety, insomnia, mydriasis, 

tremor, fever or sweating, and 

hypertension. Other effects, with public 

health risk implications, that have been 

reported from the use of synthetic 

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Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Rules and Regulations 12941 

cathinone substances include vomiting, 

palpitations, chest pain, hyperthermia, 

rhabdomyolysis, hyponatremia, 

seizures, and altered mental status 

(paranoia, hallucinations, and 

delusions). Finally, the possibility of 

death for individuals abusing 4-MEC, 4- 

MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

and a-PBP indicates that these 

substances are serious public health 

threats. Some of these synthetic 

cathinone substances have been directly 

or indirectly implicated in the death of 

individuals. For example, a 24-year-old 

female died after ingesting two capsules 

of what she believed to be ‘‘Ecstasy’’ but 

was subsequently confirmed to be a 

mixture of methylone and butylone. The 

cause of death determined by the 

medical examiner was serotonin 

syndrome secondary to methylone and 

butylone ingestion. A 21-year-old male 

who ingested butylone for suicidal 

intentions died after he developed 

seizures and suffered a cardiac and 

respiratory arrest. The cause of death 

was reported as multi-organ failure 

resulting from malignant serotonin 

syndrome. 

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 

4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP pose an 

imminent hazard to the public safety. 

The DEA is not aware of any currently 

accepted medical uses for these 

synthetic cathinones in the United 

States. A substance meeting the 

statutory requirements for temporary 

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

only be placed in schedule I. Substances 

in schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. 21 U.S.C. 812(b). Based on 

available data and information for 4- 

MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP, the Deputy 

Administrator has made the 

determination that these 10 synthetic 

cathinones 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 DEA’s 

intention to temporarily place these 10 

synthetic cathinones 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 10 

synthetic cathinones, 4-MEC, 4-MePPP, 

a-PVP, pentedrone, pentylone, 4-FMC, 

3-FMC, naphyrone, and a-PBP into 

schedule I of the CSA, and finds that 

placement of these synthetic cathinones 

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 

cathinones 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, 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP 

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, 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP, 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 March 7, 2014. Any 

person who currently handles 4-MEC, 4- 

MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP, and is not registered with the 

DEA, must submit an application for 

registration and may not continue to 

handle 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, or a-PBP as of 

March 7, 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. 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, and a-PBP 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 March 7, 2014. 

3. Labeling and Packaging. All labels 

and labeling for commercial containers 

of 4-MEC, 4-MePPP, a-PVP, butylone, 

pentedrone, pentylone, 4-FMC, 3-FMC, 

naphyrone, and a-PBP must be in 

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

and be in accordance with 21 CFR part 

1302 as of March 7, 2014. Current DEA 

registrants shall have 30 calendar days 

from March 7, 2014, to comply with all 

labeling and packaging requirements. 

4. Inventory. Every DEA registrant 

who possesses any quantity of 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP on the effective date of this 

order, must take an inventory of all 

stocks of these substances on hand as of 

March 7, 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 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

and a-PBP) on hand on a biennial basis, 

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

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12942 Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Rules and Regulations 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

5. Records. All DEA registrants must 

maintain records with respect to 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP pursuant to 21 U.S.C. 827, 958, 

and in accordance with 21 CFR parts 

1304, 1307, and 1312 as of March 7, 

2014. Current DEA registrants 

authorized to handle 4-MEC, 4-MePPP, 

a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP 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 4-MEC, 4- 

MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP must submit reports pursuant 

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

21 CFR 1304.33 as of March 7, 2014. 

7. Order Forms. All registrants who 

distribute 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, or a-PBP must 

comply with order form requirements 

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

accordance with 21 CFR part 1305 as of 

March 7, 2014. 

8. Importation and Exportation. All 

importation and exportation of 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP must be in compliance with 21 

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

accordance with 21 CFR part 1312 as of 

March 7, 2014. 

9. Quota. Only registered 

manufacturers may manufacture 4-MEC, 

4-MePPP, a-PVP, butylone, pentedrone, 

pentylone, 4-FMC, 3-FMC, naphyrone, 

or a-PBP 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 4-MEC, 4-MePPP, a-PVP, 

butylone, pentedrone, pentylone, 4- 

FMC, 3-FMC, naphyrone, or a-PBP not 

authorized by, or in violation of the 

CSA, occurring as of March 7, 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 the 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary. 

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

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of 

section 553 of the Administrative 

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

not apply to this temporary scheduling 

action. In the alternative, even assuming 

that this action might be subject to 

section 553 of the APA, the 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 the 

public safety, it would be contrary to the 

public interest to delay implementation 

of the temporary scheduling order. 

Therefore, in accordance with section 

808(2) of the CRA, this order shall take 

effect immediately upon its publication. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

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 new 

paragraphs (h)(19) through (h)(28), to 

read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(19) 4-methyl-N-ethylcathinone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

1249 (Other names: 4-MEC; 2- 

(ethylamino)-1-(4- 

methylphenyl)propan-1-one) 

(20) 4-methyl-alphapyrrolidinopropiophenone, its optical, 

positional, and geometric isomers, salts 

and salts of isomers—7498 (Other 

names: 4-MePPP; MePPP; 4-methyl-apyrrolidinopropiophenone; 1-(4- 

methylphenyl)-2-(pyrrolidin-1-yl)- 

propan-1-one) 

(21) alpha-pyrrolidinopentiophenone, 

its optical, positional, and geometric 

isomers, salts and salts of isomers— 

7545 (Other names: a-PVP; apyrrolidinovalerophenone; 1-phenyl-2- 

(pyrrolidin-1-yl)pentan-1-one) 

(22) Butylone, its optical, positional, 

and geometric isomers, salts and salts of 

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Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Rules and Regulations 12943 

isomers—7541 (Other names: bk-MBDB; 

1-(1,3-benzodioxol-5-yl)-2- 

(methylamino)butan-1-one) 

(23) Pentedrone, its optical, 

positional, and geometric isomers, salts 

and salts of isomers—1246 (Other 

names: a-methylaminovalerophenone; 

2-(methylamino)-1-phenylpentan-1-one) 

(24) Pentylone, its optical, positional, 

and geometric isomers, salts and salts of 

isomers—7542 (Other names: bk-MBDP; 

1-(1,3-benzodioxol-5-yl)-2- 

(methylamino)pentan-1-one) 

(25) 4-fluoro-N-methylcathinone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

1238 (Other names: 4-FMC; 

flephedrone; 1-(4-fluorophenyl)-2- 

(methylamino)propan-1-one) 

(26) 3-fluoro-N-methylcathinone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

1233 (Other names: 3-FMC; 1-(3- 

fluorophenyl)-2-(methylamino)propan1-one) 

(27) Naphyrone, its optical, 

positional, and geometric isomers, salts 

and salts of isomers—1258 (Other 

names: naphthylpyrovalerone; 1- 

(naphthalen-2-yl)-2-(pyrrolidin-1- 

yl)pentan-1-one) 

(28) alpha-pyrrolidinobutiophenone, 

its optical, positional, and geometric 

isomers, salts and salts of isomers— 

7546 (Other names: a-PBP; 1-phenyl-2- 

(pyrrolidin-1-yl)butan-1-one) 

Dated: February 28, 2014. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2014–04997 Filed 3–6–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Office of the Secretary 

31 CFR Part 1 

RIN 1545–AC47 

Privacy Act, Implementation 

AGENCY: Internal Revenue Service, 

Treasury. 

ACTION: Final rule. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, the Department of the 

Treasury gives notice of an amendment 

to this part to reflect revisions of 

existing Internal Revenue Service (IRS) 

systems of records and to exempt the 

resulting revised systems of records 

from certain provisions of the Privacy 

Act. Criminal Investigation has revised 

five systems of records and deleted one 

system of records. This final rule 

applies the previously approved 

exemptions to the newly revised and 

renamed systems of records. 

DATES: Effective April 7, 2014. 

ADDRESSES: Please submit comments to 

Anne Jensen, Tax Law Specialist, Office 

of Privacy, Governmental Liaison, and 

Disclosure, 1111 Constitution Avenue 

NW., Room 1621, Washington, DC 

20224. Comments will be made 

available for inspection at the IRS 

Freedom of Information Reading Room 

(Room 1621), at the above address. The 

telephone number for the Reading Room 

is (202) 317–4997 (not a toll-free call). 

FOR FURTHER INFORMATION CONTACT: 

Anne Jensen, Tax Law Specialist, Office 

of Privacy, Governmental Liaison, and 

Disclosure, 1111 Constitution Avenue 

NW., Room 1621, Washington, DC 

20024. Ms. Jensen may be reached via 

telephone at (202) 317–4997 (not a tollfree number). 

SUPPLEMENTARY INFORMATION: 5 U.S.C. 

552a(j)(2): Under 5 U.S.C. 552a(j)(2), the 

head of any agency may promulgate 

rules to exempt any system of records 

within the agency from certain 

provisions of the Privacy Act of 1974 if 

the agency or component thereof that 

maintains the system performs as its 

principal function any activities 

pertaining to the enforcement of 

criminal laws. Certain components of 

the Department of the Treasury have as 

their principal function activities 

pertaining to the enforcement of 

criminal laws. The IRS is hereby giving 

notice of a final rule to exempt 

‘‘Treasury/IRS 46.002, Management 

Information System and Case Files, 

Criminal Investigation’’; ‘‘Treasury/IRS 

46.003, Confidential Informant Records, 

Criminal Investigation’’; ‘‘Treasury/IRS 

46.005, Electronic Surveillance and 

Monitoring Records, Criminal 

Investigation’’; ‘‘Treasury/IRS 46.015, 

Relocated Witness Records, Criminal 

Investigation’’; and ‘‘Treasury/IRS 

46.050, Automated Information 

Analysis and Recordkeeping, Criminal 

Investigation,’’ from certain provisions 

of the Privacy Act of 1974, pursuant to 

5 U.S.C. 552a(j)(2) to the extent these 

records capture criminal matters; 

otherwise 5 U.S.C. 552(k)(2) applies as 

described in subsequent sections. 

The exemptions pursuant to 5 U.S.C. 

552a(j)(2) are from the provisions 5 

U.S.C. 552a(c)(3) and (4), 5 U.S.C. 

552a(d)(1), (2), (3), (4), 5 U.S.C. 

552a(e)(1), (2) and (3), 5 U.S.C. 

552a(e)(4)(G), (H), and (I), 5 U.S.C. 

552a(e)(5) and (8), 5 U.S.C. 552a(f), and 

5 U.S.C. 552a(g). As published in Part 1, 

Subpart C, of title 31 of the Code of 

Federal Regulations, section 1.36, these 

exemptions already apply to the records 

to which this final rule applies, 

therefore the reasons for the exemptions 

are not repeated here. 

SUPPLEMENTARY INFORMATION: Under 5 

U.S.C. 552a(k)(2), the head of an agency 

may promulgate rules to exempt a 

system of records from certain 

provisions of 5 U.S.C. 552a if the system 

is investigatory material compiled for 

law enforcement purposes. The IRS is 

hereby giving notice of a final rule to 

exempt ‘‘Treasury/IRS 46.050, 

Automated Information Analysis and 

Recordkeeping’’ from certain provisions 

of the Privacy Act of 1974, pursuant to 

5 U.S.C. 552a(k)(2). 

The exemptions pursuant to 5 U.S.C. 

552a(k)(2) are from the provisions (c)(3), 

(d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) 

because the system contains 

investigatory material compiled for law 

enforcement purposes. As published in 

Part 1, Subpart C, of title 31 of the Code 

of Federal Regulations, section 1.36, 

these exemptions already apply to the 

records to which this final rule applies; 

therefore the reasons for the exemptions 

are not repeated here. 

As required by Executive Order 

12866, it has been determined that this 

final rule is not a significant regulatory 

action, and therefore, does not require a 

regulatory impact analysis. 

The regulation will not have a 

substantial direct effect on the States, on 

the relationship between the Federal 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, it is 

determined that this final rule does not 

have federalism implications under 

Executive Order 13132. 

Pursuant to the requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 601– 

612, it is hereby certified that these 

regulations will not significantly affect a 

substantial number of small entities. 

The final rule imposes no duties or 

obligations on small entities. 

In accordance with the provisions of 

the Paperwork Reduction Act, the 

Department of the Treasury has 

determined that the revision of the 

systems or records notices would not 

impose new recordkeeping, application, 

reporting, or other types of information 

collection requirements. 

List of Subjects in 31 CFR Part 1 

Privacy. 

Part 1, Subpart C of title 31 of the 

Code of Federal Regulations is amended 

as follows: 

PART 1—[AMENDED] 

■ 1. The authority citation for part 1 

continues to read as follows: 

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