Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65371 

1Because the Secretary of Health and Human 

Services has delegated to the Assistant Secretary for 

Continued 

administrative law judge mails a notice 

of his or her hearing decision. 

■ 8. Amend § 416.1442 by revising 

paragraphs (d), (e) introductory text, 

(e)(1), and (f)(3) to read as follows: 

§ 416.1442 Prehearing proceedings and 

decisions by attorney advisors. 

* * * * * 

(d) Notice of a decision by an attorney 

advisor. If an attorney advisor issues a 

fully favorable decision under this 

section, we will mail a written notice of 

the decision to all parties at their last 

known addresses. We will state the 

basis for the decision and advise all 

parties that they may request that an 

administrative law judge reinstate the 

request for a hearing if they disagree 

with the decision for any reason. Any 

party who wants to make this request 

must do so in writing and send it to us 

within 60 days of the date he or she 

receives notice of the decision. The 

administrative law judge will extend the 

time limit if the requestor shows good 

cause for missing the deadline. The 

administrative law judge will use the 

standards in § 416.1411 to determine 

whether there is good cause. If the 

request is timely, an administrative law 

judge will reinstate the request for a 

hearing and offer all parties an 

opportunity for a hearing. 

(e) Effect of an attorney advisor’s 

decision. An attorney advisor’s decision 

under this section is binding unless— 

(1) You or another party to the hearing 

submits a timely request that an 

administrative law judge reinstate the 

request for a hearing under paragraph 

(d) of this section; 

* * * * * 

(f) * * * 

(3) Make the decision of an attorney 

advisor under paragraph (d) of this 

section subject to review by the Appeals 

Council if the Appeals Council decides 

to review the decision of the attorney 

advisor anytime within 60 days after the 

date of the decision under § 416.1469. 

* * * * * 

■ 9. Amend § 416.1448 by revising the 

second sentence of paragraph (a), and 

paragraph (b)(1)(ii), to read as follows: 

§ 416.1448 Deciding a case without an oral 

hearing before an administrative law judge. 

(a) Decision fully favorable. * * * 

The notice of the decision will state that 

you have the right to an oral hearing and 

to examine the evidence on which the 

administrative law judge based the 

decision. 

(b) * * * 

(1) * * * 

(ii) You live outside the United States, 

you do not inform us that you wish to 

appear, and there are no other parties 

who wish to appear. 

* * * * * 

■ 10. Revise § 416.1460 to read as 

follows: 

§ 416.1460 Vacating a dismissal of a 

request for a hearing before an 

administrative law judge. 

(a) Except as provided in paragraph 

(b) of this section, an administrative law 

judge or the Appeals Council may 

vacate a dismissal of a request for a 

hearing if you request that we vacate the 

dismissal. If you or another party wish 

to make this request, you must do so 

within 60 days of the date you receive 

notice of the dismissal, and you must 

state why our dismissal of your request 

for a hearing was erroneous. The 

administrative law judge or Appeals 

Council will inform you in writing of 

the action taken on your request. The 

Appeals Council may also vacate a 

dismissal of a request for a hearing on 

its own motion. If the Appeals Council 

decides to vacate a dismissal on its own 

motion, it will do so within 60 days of 

the date we mail the notice of dismissal 

and will inform you in writing that it 

vacated the dismissal. 

(b) If you wish to proceed with a 

hearing after you received a fully 

favorable revised determination under 

the prehearing case review process in 

§ 416.1441, you must follow the 

procedures in § 416.1441(d) to request 

that an administrative law judge vacate 

his or her order dismissing your request 

for a hearing. 

[FR Doc. 2011–27236 Filed 10–20–11; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–357] 

Schedules of Controlled Substances: 

Temporary Placement of Three 

Synthetic Cathinones Into Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final Order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration (DEA) is 

issuing this final order to temporarily 

schedule three synthetic cathinones 

under the Controlled Substances Act 

(CSA) pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). The substances are 4-methyl-Nmethylcathinone (mephedrone), 3,4- 

methylenedioxy-N-methylcathinone 

(methylone), and 3,4- 

methylenedioxypyrovalerone (MDPV). 

This action is based on a finding by the 

Administrator that the placement of 

these synthetic cathinones and their 

salts, isomers, 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 full 

effect of the CSA and its implementing 

regulations including criminal, civil and 

administrative penalties, sanctions and 

regulatory controls of Schedule I 

substances will be imposed on the 

manufacture, distribution, possession, 

importation, and exportation of these 

synthetic cathinones. 

DATES: Effective Date: This Final Order 

is effective on October 21, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone 

(202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Background 

The Comprehensive Crime Control 

Act of 1984 (Pub. L. 98–473), which was 

signed into law on October 12, 1984, 

amended section 201 of the CSA (21 

U.S.C. 811) to give the Attorney General 

the authority to temporarily place a 

substance into Schedule I of the CSA for 

one year without regard to the 

requirements of 21 U.S.C. 811(b) if he 

finds that such action is necessary to 

avoid imminent hazard to the public 

safety. 21 U.S.C. 811(h); 21 CFR 

1308.49. If proceedings to control a 

substance are initiated under 21 U.S.C. 

811(a)(1), the Attorney General may 

extend the temporary scheduling up to 

an additional six months. 21 U.S.C. 

811(h)(2). Where the necessary findings 

are made, a substance may be 

temporarily scheduled in Schedule I 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 under section 505 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355) for the substance. 21 

U.S.C. 811(h)(1). The Attorney General 

has delegated his authority under 21 

U.S.C. 811 to the Administrator of DEA. 

28 CFR 0.100. 

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

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

Administrator to notify the Secretary of 

Health and Human Services of her 

intention to temporarily place a 

substance into Schedule I of the CSA.1


emcdonald on DSK5VPTVN1PROD with RULES
65372 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 

Health of the Department of Health and Human 

Services 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.’’ 

2See ‘‘Background, Data and Analysis of 

Synthetic Cathinones: Mephedrone (4–MMC), 

Methylone (MDMC) and 3,4- 

Methylenedioxypyrovalerone (MDPV)’’ found at 

http://www.regulations.gov. 

The Administrator transmitted notice of 

her intent to place mephedrone, 

methylone and MDPV in Schedule I on 

a temporary basis to the Assistant 

Secretary in a letter dated June 15, 2011. 

The Assistant Secretary responded to 

this notice by letter dated July 25, 2011, 

and advised that based on review by the 

Food and Drug Administration (FDA) 

there are currently no investigational 

new drug applications (INDs) or 

approved new drug applications (NDAs) 

for MDPV, mephedrone, or methylone. 

The Assistant Secretary also stated that 

the Department of Health and Human 

Services has no objection to the 

temporary placement of MDPV, 

mephedrone, and methylone into 

Schedule I of the CSA. DEA has taken 

into consideration the Assistant 

Secretary’s comments. As MDPV, 

mephedrone, and methylone are not 

currently listed in any schedule under 

the CSA, as no exemptions or approvals 

are in effect for MDPV, mephedrone, 

and methylone under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355), and as this temporary 

scheduling is necessary to avoid an 

imminent hazard to the public safety, 

DEA believes that the conditions of 21 

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

A notice of intent to temporarily place 

mephedrone, methylone, and MDPV 

into Schedule I of the CSA was 

published in the Federal Register on 

September 8, 2011 (76 FR 55616). The 

data in support of the notice of intent 

and additional data continue to support 

the necessary findings to place 

mephedrone, methylone, and MDPV 

temporarily into Schedule I of the CSA 

as necessary to avoid an imminent 

hazard to the public safety.2 In making 

this finding, the 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)). These factors are 

as follows: 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(c)(4)–(6). 

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution. 21 U.S.C. 

811(h)(3). 

Mephedrone, methylone, and MDPV 

are not currently listed in any schedule 

under the CSA. The temporary 

placement of these three synthetic 

cathinones into Schedule I of the CSA 

is necessary in order to avoid an 

imminent hazard to the public safety. 

First, there has been a rapid and 

significant increase in abuse of these 

substances in the United States. As a 

result of this abuse, synthetic 

cathinones are banned in at least 37 

states in the United States and several 

countries, and all five branches of the 

U.S. military prohibit military personnel 

from possessing or using synthetic 

cathinones. Second, law enforcement 

has seized synthetic cathinones and, 

based on self-reports to law enforcement 

and health care professionals, synthetic 

cathinones are abused for their 

psychoactive properties. Third, federal, 

state and local public health 

departments and poison control centers 

have issued reports describing public 

health consequences such as emergency 

department visits and deaths from the 

use of these synthetic cathinones. Based 

on scientific data currently available, 

these three substances have the 

potential to be extremely harmful and, 

therefore, pose an imminent hazard to 

the public safety. 

Factor 4: History and Current Pattern of 

Abuse 

Synthetic cathinones are designer 

drugs of the phenethylamine class 

which are structurally and 

pharmacologically similar to 

amphetamine, 3,4- 

methylenedioxymethamphetamine 

(MDMA), cathinone and other related 

substances. The addition of a beta-keto 

(b-keto) substituent to the 

phenethylamine core structure produces 

a group of substances that now have 

cathinone as the core structure. 

Synthetic cathinones, like 

amphetamine, cathinone, 

methcathinone, and methamphetamine, 

are central nervous system (CNS) 

stimulants. 

The synthetic cathinones 

mephedrone, methylone, and MDPV 

have recently emerged on the United 

States’ illicit drug market and are being 

perceived as being ‘legal’ alternatives to 

cocaine, methamphetamine, and 

MDMA. Although synthetic cathinones 

are new to the United States’ illicit drug 

market, they have been popular drugs of 

abuse in Europe since 2007. MDPV is a 

derivative of pyrovalerone, which is a 

psychoactive drug that was used to treat 

chronic lethargy and fatigue. Research 

in anti-depressant and anti-parkinson 

agents resulted in the development and 

patenting of methylone. Methylone, 

however, has not been approved for 

these purposes. There are no currently 

accepted medical uses in treatment in 

the United States for mephedrone, 

methylone, or MDPV. 

Mephedrone, methylone, and MDPV 

are falsely marketed as ‘‘research 

chemicals,’’ ‘‘plant food,’’ or ‘‘bath 

salts.’’ They are sold at smoke shops, 

head shops, convenience stores, adult 

book stores, and gas stations. They can 

also be purchased on the Internet and 

mailed using the U.S. Postal Service or 

international mail services. The 

packages of products containing these 

synthetic cathinones usually have the 

warning ‘‘not for human consumption,’’ 

most likely in an effort to circumvent 

statutory restrictions for these 

substances. Despite disclaimers that the 

products are not intended for human 

consumption, retailers promote that 

routine urinalysis drug tests will not 

typically detect the presence of these 

synthetic cathinones. However, 

analytical methods for the detection of 

mephedrone, methylone, MDPV, and 

other synthetic cathinones have recently 

been developed for these substances. 

Evidence indicates that mephedrone, 

methylone, and MDPV are being abused 

for their psychoactive properties. Drug 

surveys found that these and other 

synthetic cathinones are being used as 

recreational drugs and are used as 

alternatives to illicit stimulants like 

MDMA and cocaine. Accordingly, 

mephedrone, methylone, and MDPV 

have been identified in human urine 

samples that were obtained for routine 

drug screenings, they have been 

detected in samples from drivers 

suspected of driving under the 

influence, and they have been detected 

by drug courts during mandatory 

periodic drug screens. They have also 

been identified in biological specimens 

from individuals (some exhibiting 

symptoms of ‘‘extreme agitation’’ or 

‘‘excited delirium’’) who have been 

arrested for possession of a controlled 

substance, child endangerment, or 

homicide. They have been detected in 

samples from decedents whose causes 

of death were reported as drug-induced 

toxicity, multiple drug toxicity, or other 

causes (e.g., blunt force trauma from a 

vehicular collision or suicide). 

Based on studies in the scientific 

literature, the marketing of products that 

contain mephedrone, methylone, and 

MDPV is geared towards teens and 

young adults. Accordingly, reports 

indicate that the main users of synthetic 

cathinones are young male adults. These 

substances are also used by mid-to-late 

adolescents and older adults. Many of 

these abusers of synthetic cathinones 

have a previous history of drug abuse. 


emcdonald on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65373 

3Analyzed on September 15, 2011. 

According to drug surveys, the 

reported average amount of synthetic 

cathinones used per dose ranged from 

approximately 25 to 250 milligrams and 

the average amount used per session 

(i.e., repeated administration and 

binging) ranged from approximately 25 

milligrams to 5 grams depending on the 

substance consumed, duration of intake, 

and route of administration. The most 

common routes of administration of 

these substances are nasal insufflation 

by snorting the powder and oral 

ingestion by swallowing capsules or 

tablets. Other reported methods of 

administration include injection, rectal 

administration, and ‘‘bombing’’ 

(wrapping a dose of powder in a paper 

wrap and swallowing). Synthetic 

cathinones have also been reported to be 

used in binges. Reasons cited for 

binging include to prolong the duration 

of effects, to satisfy a ‘‘craving,’’ or to 

satisfy a strong urge to re-dose. 

According to information found in 

drug surveys, clinical case reports, and 

law enforcement reports, users have 

reported using products containing 

mephedrone, methylone, and MDPV 

with other synthetic cathinones (e.g., 

butylone, fluoromethcathinone, 4–MEC, 

etc.), pharmaceutical agents (e.g., 

lidocaine, caffeine, benzocaine, etc.), or 

other recreational substances (e.g., 

amphetamine, MDMA, cocaine, gammabutyrolactone (GBL), kratom, N,Nbenzylpiperazine (BZP), and 1-(3- 

trifluoromethylphenyl)-piperazine 

(TFMPP)). Chemical analyses of seized 

and purchased synthetic cathinone 

products indicate that some products 

contain multiple substances. 

Furthermore, investigative toxicology 

reports of drug screens in which more 

than one substance was detected 

indicate that users have ingested 

products composed of drug 

combinations (e.g., a tablet composed of 

MDPV and BZP) or multiple drug 

products (e.g., a MDPV powder product 

and a MDMA tablet). 

Factor 5: Scope, Duration and 

Significance of Abuse 

The popularity of synthetic 

cathinones as recreational drugs has 

increased since they first appeared on 

the United States’ illicit drug market. 

According to forensic laboratory reports, 

the first appearance of these synthetic 

cathinones in the United States 

occurred in 2009. In 2009, NFLIS 

registered 15 exhibits from 8 states 

containing these three synthetic 

cathinones. In 2010, there were 574 

reports from 29 states related to these 

substances registered in NFLIS, and in 

2011 (January to August) there were 

995.3

Based on reports to DEA from law 

enforcement and public health officials, 

synthetic cathinones are becoming 

increasingly prevalent and abused 

throughout the United States. At one 

United States point of entry, the U.S. 

Customs and Border Protection (CBP) 

has encountered at least 127 shipments 

containing primarily mephedrone, 

methylone, and MDPV, as well as other 

synthetic cathinones like 4–MEC, 

butylone, fluoromethcathinone, and 

dimethylcathinone. Most of these 

shipments originated in China or India 

and were being shipped to destinations 

throughout the United States such as 

Arizona, Alaska, Hawaii, Kansas, 

Louisiana, Oklahoma, Oregon, 

Pennsylvania, Missouri, Virginia, 

Washington, and West Virginia. The 

American Association of Poison Control 

Centers (AAPCC), a non-profit, national 

organization that represents the poison 

control centers of the United States, 

reported that in 2010, poison control 

centers took 303 calls about synthetic 

cathinones. However, in just the first 

eight months of 2011, poison control 

centers have already received 4,720 

calls relating to these products. These 

calls were received in poison control 

centers representing at least 47 states 

and the District of Columbia. Individual 

state poison control centers have also 

reported an increase in the number of 

calls regarding ‘‘bath salts’’ from 2009 to 

2011. 

Concerns over the abuse of these and 

other synthetic cathinones have 

prompted many states to control these 

substances. As of September 15, 2011, at 

least 37 states have emergency 

scheduled or enacted legislation placing 

regulatory controls on some or many of 

the synthetic cathinones. These states 

include Alabama, Arkansas, 

Connecticut, Florida, Georgia, Hawaii, 

Idaho, Illinois, Indiana, Iowa, Kansas, 

Kentucky, Louisiana, Maine, Maryland, 

Michigan, Minnesota, Mississippi, 

Missouri, New Jersey, New Mexico, 

New York, North Carolina, North 

Dakota, Ohio, Oklahoma, Oregon, 

Pennsylvania, Texas, Tennessee, Utah, 

Vermont, Virginia, Washington, West 

Virginia, Wisconsin and Wyoming. 

Several countries including all members 

of the European Union have also placed 

controls on the possession and/or sale of 

one or more of these substances. 

Moreover, the use of synthetic 

cathinones by members of the U.S. 

Armed Forces is prohibited. 

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

the Public Health 

The risks to the public health 

associated with the abuse of 

mephedrone, methylone, and MDPV 

relate to acute and long term public 

health and safety problems. These 

synthetic cathinones have become a 

serious drug abuse threat as there have 

been reports of emergency room 

admissions and deaths associated with 

the abuse of these substances. 

Clinical case reports indicate that 

these synthetic cathinones produce a 

number of stimulant-like adverse effects 

such as palpitation, seizure, vomiting, 

sweating, headache, discoloration of the 

skin, hypertension, and hyper-reflexia. 

Adverse effects associated with 

consumption of these drugs as reported 

by abusers include nose-bleeds, bruxism 

(teeth grinding), paranoia, hot flashes, 

dilated pupils, blurred vision, dry 

mouth/thirst, palpitations, muscular 

tension in the jaw and limbs, headache, 

agitation, anxiety, tremor, and fever or 

sweating. Consequently, numerous 

individuals have presented at 

emergency departments in response to 

exposure incidents and several cases of 

acute toxicity have been reported due to 

the ingestion of mephedrone, 

methylone, or MDPV. In addition, case 

reports have shown that the abuse of 

synthetic cathinones can lead to 

psychological dependence like that 

reported for other stimulant drugs. 

According to clinical case reports, 

investigative toxicological reports, and 

autopsy reports, mephedrone, 

methylone, and MDPV have been 

implicated in drug induced overdose 

deaths. In at least three reported deaths, 

one of these synthetic cathinones was 

ruled as the cause of death. Other deaths 

involved individuals under the 

influence of these synthetic cathinones 

who acted violently and unpredictably 

in causing harm to themselves or others. 

There have also been reports in the 

scientific literature of deaths caused by 

individuals who were driving under the 

influence of these synthetic cathinones. 

A number of synthetic cathinones and 

their products, as identified by CBP and 

reported in the scientific literature, 

appear to originate from foreign sources. 

The manufacturers and retailers who 

make and sell these products do not 

fully disclose the product ingredients 

including the active ingredients or the 

health risks and potential hazards 

associated with these products. This 

poses significant risk to abusers who 

may not know what they are purchasing 

or the risk associated with the use of 

those products. 


emcdonald on DSK5VPTVN1PROD with RULES
65374 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 

Based on the above data, the 

continued uncontrolled manufacture, 

distribution, importation, exportation, 

and abuse of mephedrone, methylone, 

and MDPV pose an imminent hazard to 

the public safety. DEA is not aware of 

any recognized therapeutic uses of these 

synthetic cathinones in the United 

States. 

DEA has considered the three criteria 

for placing a substance into Schedule I 

of the CSA (21 U.S.C. 812), and finds 

that the data available and reviewed for 

mephedrone, methylone, and MDPV 

indicate that these synthetic cathinones 

each have a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and lack 

accepted safety for use under medical 

supervision. 

In accordance with the provisions of 

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

811(h)) and 28 CFR 0.100, the 

Administrator has considered the 

available data and the three factors 

required to support a determination to 

temporarily schedule three synthetic 

cathinones (4-methyl-Nmethylcathinone, 3,4-methylenedioxyN-methylcathinone, and 3,4- 

methylenedioxypyrovalerone) in 

Schedule I of the CSA and finds that 

placement of these synthetic cathinones 

and their salts, isomers, and salts of 

isomers into Schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety. 

Regulatory Requirements 

With the issuance of this final order, 

mephedrone, methylone, and MDPV 

become subject to the regulatory 

controls and administrative, civil and 

criminal sanctions applicable to the 

manufacture, distribution, possession, 

importation and exportation of a 

Schedule I controlled substance under 

the CSA. 

1. Registration. Any person who 

manufactures, distributes, dispenses, 

imports, exports, or possesses 

mephedrone, methylone, or MDPV or 

who engages in research or conducts 

instructional activities with respect to 

mephedrone, methylone, or MDPV, or 

who proposes to engage in such 

activities, must be registered to conduct 

such activities in accordance with 21 

U.S.C. 823 and 958. Any person who is 

currently engaged in any of the above 

activities and is not registered with DEA 

must submit an application for 

registration and may not continue their 

activities until DEA has approved that 

application. Retail sales of Schedule I 

controlled substances to the general 

public are not allowed under the 

Controlled Substances Act. 

2. Security. Mephedrone, methylone, 

and MDPV are subject to Schedule I 

security requirements. Accordingly, 

appropriately registered DEA registrants 

must manufacture, distribute and store 

these substances in accordance with 

1301.71; 1301.72(a), (c), and (d); 

1301.73; 1301.74; 1301.75(a) and (c); 

and 1301.76 of Title 21 of the Code of 

Federal Regulations as of October 21, 

2011. 

3. Labeling and packaging. All 

labeling and packaging requirements for 

controlled substances set forth in Part 

1302 of Title 21 of the Code of Federal 

Regulations shall apply to commercial 

containers of mephedrone, methylone, 

and MDPV. Current DEA registrants 

shall have thirty (30) calendar days from 

the effective date of this Final Order to 

be in compliance with all labeling and 

packaging requirements. 

4. Quotas. Quotas for mephedrone, 

methylone, and MDPV will be 

established based on registrations 

granted and quota applications received 

pursuant to Part 1303 of Title 21 of the 

Code of Federal Regulations. 

5. Inventory. Every DEA registrant 

who possesses any quantity of 

mephedrone, methylone, or MDPV is 

required to keep inventory of all stocks 

of these substances on hand pursuant to 

1304.03, 1304.04, and 1304.11 of Title 

21 of the Code of Federal Regulations. 

Every current DEA registrant who 

desires registration in Schedule I for 

mephedrone, methylone, or MDPV shall 

conduct an inventory of all stocks of 

these substances. Current DEA 

registrants shall have thirty (30) 

calendar days from the effective date of 

this Final Order to be in compliance 

with all inventory requirements. 

6. Records. All registrants who handle 

mephedrone, methylone, or MDPV are 

required to keep records pursuant to 

1304.03, 1304.04, 1304.21, 1304.22, and 

1304.23 of Title 21 of the Code of 

Federal Regulations. Current DEA 

registrants shall have thirty (30) 

calendar days from the effective date of 

this Final Order to be in compliance 

with all recordkeeping requirements. 

7. Reports. All registrants are required 

to submit reports in accordance with 

1304.33 of Title 21 of the Code of 

Federal Regulations. Registrants who 

manufacture or distribute mephedrone, 

methylone, or MDPV are required to 

comply with these reporting 

requirements and shall do so as of 

October 21, 2011. 

8. Order Forms. All registrants 

involved in the distribution of 

mephedrone, methylone, or MDPV must 

comply with order form requirements of 

Part 1305 of Title 21 of the Code of 

Federal Regulations as of October 21, 

2011. 

9. Importation and Exportation. All 

importation and exportation of 

mephedrone, methylone, or MDPV must 

be conducted by appropriately 

registered DEA registrants in 

compliance with Part 1312 of Title 21 of 

the Code of Federal Regulations on or 

after October 21, 2011. 

10. Criminal Liability. The 

manufacture, distribution, dispensation, 

or possession with the intent to conduct 

these activities: Possession, importation, 

or exportation of mephedrone, 

methylone, or MDPV not authorized by, 

or in violation of the CSA or the 

Controlled Substances Import and 

Export Act occurring as of October 21, 

2011 is unlawful. 

Pursuant to the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act) (5 

U.S.C. 801–808), DEA has submitted a 

copy of this Final Order to both Houses 

of Congress and to the Comptroller 

General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Under the authority vested in the 

Attorney General by section 201(h) of 

the CSA (21 U.S.C. 811(h)), and 

delegated to the Administrator of the 

DEA by Department of Justice 

regulations (28 CFR 0.100), the 

Administrator hereby orders that 21 

CFR Part 1308 be amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for Part 1308 

continues to read as follows: 

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

unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

adding new paragraphs (g)(6), (7) and (8) 

to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(g) * * * 

(6) 4-methyl-N-methylcathinone— 

1248 

(Other names: mephedrone) 

(7) 3,4-methylenedioxy-Nmethylcathinone—7540 

(Other names: methylone) 

(8) 3,4- 

methylenedioxypyrovalerone—7535 

(Other names: MDPV) 

* * * * * 


emcdonald on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Rules and Regulations 65375 

Dated: October 14, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–27282 Filed 10–20–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0268] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Passaic River, Harrison, NJ 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard has changed 

the drawbridge operation regulations 

that govern the operation of the 

Amtrak’s Dock Bridge across the Passaic 

River, mile 5.0, at Harrison, New Jersey. 

The owner of the bridge has requested 

relief from crewing the bridge at all 

times because the bridge has received 

few requests to open during past years. 

It is expected that an advance notice 

requirement for bridge openings will 

provide relief to the bridge owner while 

continuing to meet the reasonable needs 

of navigation. 

DATES: This rule is effective November 

21, 2011. 

ADDRESSES: Comments and related 

materials received from the public, as 

well as documents mentioned in this 

preamble as being available in the 

docket, are part of docket USCG–2011– 

0268 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2011–0268 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ This 

material is also available for inspection 

or copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. John W. McDonald, Project 

Officer, First Coast Guard District Bridge 

Branch, 617–223–8364, 

john.w.mcdonald@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On June 24, 2011, we published a 

notice of proposed rulemaking (NPRM) 

entitled Drawbridge Operation 

Regulations Passaic River in the Federal 

Register (76 FR 37039). We received no 

comments on the proposed rule. No 

public meeting was requested, and none 

was held. 

Basis and Purpose 

The Amtrak Dock Bridge, mile 5.0, 

across the Passaic River at Harrison, 

New Jersey, has a vertical clearance in 

the closed position of 24 feet at mean 

high water and 29 feet at mean low 

water. The drawbridge operation 

regulations are listed at 33 CFR 

117.739(e). 

The existing drawbridge operation 

regulations require the draw to open on 

signal; except that, from 7:20 a.m. to 

9:20 a.m. and 4:30 p.m. to 6:50 p.m., 

Monday through Friday, except Federal 

holidays, the draw need not be opened. 

At all other times, an opening may be 

delayed no more than ten minutes, 

unless the draw tender and the vessel 

operator, communicating by radiotelephone, agree to a longer delay. 

The Coast Guard received a request 

from the National Railroad Passenger 

Corporation (Amtrak), the owner of the 

bridge, for relief from crewing the bridge 

at all times, because the bridge has 

received only eight requests to open 

during the past three years. 

Amtrak requested that a twenty four 

hour advance notice be required for all 

bridge openings, except during the 

existing morning and afternoon closed 

periods. 

As a result of the fact that the bridge 

has received only eight requests to open 

during the past three years, the Coast 

Guard believes it is reasonable for the 

bridge owner to require a twenty four 

hour advance notice for bridge openings 

and that doing so would continue to 

meet the reasonable needs of navigation. 

Discussion of Comments and Changes 

The Coast Guard received no 

comments in response to the notice of 

proposed rulemaking. As a result, no 

changes have been made to this final 

rule. 

Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Executive Order 12866 and Executive 

Order 13563 

This final rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, as supplemented 

by Executive Order 13563, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

We expect the economic impact of 

this proposed rule to be minimal. 

Although this regulation may have some 

impact on the public, the potential 

impact will be minimized for the 

following reasons: 

The bridge has only received eight 

requests to open during the past three 

years. The bridge openings can still be 

obtained at any time, except the 

morning and afternoon closed periods, 

by providing at least a twenty four hour 

advance notice. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

This final rule would affect the 

following entities, some of which might 

be small entities: The owners or 

operators of vessels needing to transit 

the bridge. 

This final rule would not have a 

significant economic impact on a 

substantial number of small entities for 

the following reasons: 

The bridge only received eight 

requests to open during the past three 

years. The bridge openings can still be 

obtained at any time, except during the 

Monday through Friday closed periods, 

by providing a twenty four hour 

advance notice. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this rule would have a 

significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 


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