43978 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 

■ 2. Section 430.32 is amended by: 

■ a. Removing paragraph (f)(1)(iii); and 

■ b. Revising paragraphs (g)(4) and 

(h)(3). 

The revisions read as follows: 

§ 430.32 Energy and water conservation 

standards and their compliance dates. 

* * * * * 

(g) * * * 

(4) Clothes washers manufactured on 

or after January 1, 2018, shall have an 

Integrated Modified Energy Factor no 

less than, and an Integrated Water 

Factor no greater than: 

Product class 

Integrated 

modified 

energy factor 

(cu.ft./kWh/ 

cycle) 

Integrated 

water factor 

(gal/cycle/ 

cu.ft.) 

(i) Top-loading, Compact .........................................................................................................................................

(less than 1.6 ft3 capacity) ....................................................................................................................................... 1.15 12.0 

(ii) Top-loading, Standard ........................................................................................................................................

(1.6 ft3 or greater capacity) ..................................................................................................................................... 1.57 6.5 

(iii) Front-loading, Compact .....................................................................................................................................

(less than 1.6 ft3 capacity) ....................................................................................................................................... 1.13 8.3 

(iv) Front-loading, Standard .....................................................................................................................................

(1.6 ft3 or greater capacity) ..................................................................................................................................... 1.84 4.7 

(h) * * * (3) Clothes dryers manufactured on or 

after January 1, 2015, shall have a 

combined energy factor no less than: 

Product class 

Combined 

energy 

factor 

(lbs/kWh) 

(i) Vented Electric, Standard (4.4 ft3 or greater capacity) .................................................................................................................. 3.73 

(ii) Vented Electric, Compact (120V) (less than 4.4 ft3 capacity) ....................................................................................................... 3.61 

(iii) Vented Electric, Compact (240V) (less than 4.4 ft3 capacity) ...................................................................................................... 3.27 

(iv) Vented Gas .................................................................................................................................................................................... 3.30 

(v) Ventless Electric, Compact (240V) (less than 4.4 ft3 capacity) .................................................................................................... 2.55 

(vi) Ventless Electric, Combination Washer-Dryer .............................................................................................................................. 2.08 

* * * * * 

[FR Doc. 2021–16830 Filed 8–10–21; 8:45 am] 

BILLING CODE 6450–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–397] 

Schedules of Controlled Substances: 

Placement of Mesocarb in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing the 

substance mesocarb (chemical name: Nphenyl-N′-(3-(1-phenylpropan-2-yl)- 

1,2,3-oxadiazol-3-ium-5- 

yl)carbamimidate), including its salts, 

isomers, and salts of isomers, in 

schedule I of the Controlled Substances 

Act. This action is being taken to enable 

the United States to meet its obligations 

under the 1971 Convention on 

Psychotropic Substances. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule I controlled substances on 

persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis with, or possess), or propose to 

handle, mesocarb. 

DATES: Comments must be submitted 

electronically or postmarked, on or 

before October 12, 2021. 

Interested persons may file a request 

for hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.45 and/or 

1316.47, as applicable. Requests for 

hearing and waivers of an opportunity 

for a hearing or to participate in a 

hearing, together with a written 

statement of position on the matters of 

fact and law asserted in the hearing, 

must be received on or before 

September 10, 2021. 

ADDRESSES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

11:59 p.m. Eastern Time on the last day 

of the comment period. To ensure 

proper handling of comments, please 

reference ‘‘Docket No. DEA–397’’ on all 

electronic and written correspondence, 

including any attachments. 

• Electronic comments: Drug 

Enforcement Administration (DEA) 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal, which 

provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on http://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

submitted successfully, and there is no 

need to resubmit the same comment. 

• Paper comments: Paper comments 

that duplicate electronic submissions 

are not necessary and are discouraged. 

Should you wish to mail a paper 

comment in lieu of an electronic 

comment, send via regular or express 

mail to: Drug Enforcement 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 43979 

1As discussed in a memorandum of 

understanding entered into by 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 Secretary’s 

scheduling responsibilities under the Controlled 

Substances Act, with the concurrence of NIDA. 50 

FR 9518 (March 8, 1985). The Secretary of HHS has 

delegated to the Assistant Secretary for Health of 

HHS the authority to make domestic drug 

scheduling recommendations. 58 FR 35460 (July 1, 

1993). 

2 International Drug Scheduling; Convention on 

Psychotropic Substances; Certain Stimulant/ 

Hallucinogenic Drugs and Certain Nonbarbiturate 

Sedative Drugs, 59 FR 31639, June 20, 1994. 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation, 

together with a written statement of 

position on the matters of fact and law 

asserted in the hearing, must be sent to: 

Drug Enforcement Administration, Attn: 

Administrator, 8701 Morrissette Drive, 

Springfield, Virginia 22152. All requests 

for hearing and waivers of participation 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug & Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record. 

They will, unless reasonable cause is 

given, be made available by the Drug 

Enforcement Administration (DEA) for 

public inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. The Freedom of 

Information Act applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want to make it 

publicly available, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want to make it 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

DEA will generally make available in 

publicly redacted form comments 

containing personal identifying 

information and confidential business 

information identified as directed 

above. If a comment has so much 

confidential business information that it 

cannot be effectively redacted, DEA may 

not make available publicly all or part 

of that comment. Comments posted to 

http://www.regulations.gov may include 

any personal identifying information 

(such as name, address, and phone 

number) included in the text of your 

electronic submission that is not 

identified as directed above as 

confidential. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at http://

www.regulations.gov for easy reference. 

Request for Hearing, or Waiver of 

Participation in Hearing 

Pursuant to 21 U.S.C. 811(a), this 

action is a formal rulemaking ‘‘on the 

record after opportunity for a hearing.’’ 

Such proceedings are conducted 

pursuant to the provisions of the 

Administrative Procedure Act, 5 U.S.C. 

551–559. 21 CFR 1308.41–1308.45; 21 

CFR part 1316, subpart D. Interested 

persons may file requests for a hearing 

or notices of intent to participate in a 

hearing in conformity with the 

requirements of 21 CFR 1308.44(a) or 

(b), and they shall include a statement 

of interest in the proceeding and the 

objections or issues, if any, concerning 

which the person desires to be heard. 21 

CFR 1316.47(a). Any interested person 

may file a waiver of an opportunity for 

a hearing or to participate in a hearing 

together with a written statement 

regarding the interested person’s 

position on the matters of fact and law 

involved in any hearing as set forth in 

21 CFR 1308.44(c). 

All requests for hearing and waivers 

of participation, together with a written 

statement of position on the matters of 

fact and law involved in such hearing, 

must be sent to DEA using the address 

information provided above. 

Legal Authority 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (1971 Convention), February 

21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 

175, as amended. Procedures respecting 

changes in drug schedules under the 

1971 Convention are governed 

domestically by 21 U.S.C. 811(d)(2)–(4). 

When the United States receives 

notification of a scheduling decision 

pursuant to Article 2 of the 1971 

Convention indicating that a drug or 

other substance has been added to a 

schedule specified in the notification, 

the Secretary of the Department of 

Health and Human Services (HHS),1

after consultation with the Attorney 

General, shall first determine whether 

existing legal controls under subchapter 

I of the Controlled Substances Act (CSA) 

and the Federal Food, Drug, and 

Cosmetic Act meet the requirements of 

the schedule specified in the 

notification with respect to the specific 

drug or substance. 21 U.S.C. 811(d)(3). 

In the event that the Secretary of HHS 

(Secretary) did not so consult with the 

Attorney General, and the Attorney 

General did not issue a temporary order, 

as provided under 21 U.S.C. 811(d)(4), 

the procedures for permanent 

scheduling set forth in 21 U.S.C. 811(a) 

and (b) control. Pursuant to 21 U.S.C. 

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

rule, add to such a schedule any drug 

or other substance, if he finds that such 

drug or other substance has a potential 

for abuse, and makes with respect to 

such drug or other substance the 

findings prescribed by 21 U.S.C. 812(b) 

for the schedule in which such drug is 

to be placed. The Attorney General has 

delegated this scheduling authority to 

the Administrator of DEA. 28 CFR 

0.100. 

Background 

Mesocarb, known chemically as Nphenyl-N′-(3-(1-phenylpropan-2-yl)- 

1,2,3-oxadiazol-3-ium-5- 

yl)carbamimidate, has central nervous 

system (CNS) stimulating properties, 

and it has no approved medical use in 

the United States. Mesocarb (Sydnocarb) 

is marketed in Russia as a treatment for 

attention deficit hyperactivity disorder. 

Mesocarb’s primary mode of action is to 

stimulate the CNS via dopamine (DA) 

activation resulting in increased mental 

capacity and activity. 

Pursuant to 21 U.S.C. 811(d)(2), HHS 

published two notices in the Federal 

Register regarding mesocarb. The first 

notice requested the World Health 

Organization (WHO) consider 

information in preparing its scientific 

and medical evaluation for mesocarb.2

The second notice solicited public 

comment regarding a recommendation 

by WHO to impose international 


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3 International Drug Scheduling; Convention on 

Psychotropic Substances; World Health 

Organization Scheduling Recommendations for 

Seven Drug Substances, 60 FR 4169, January 20, 

1995. 

controls on mesocarb.3 At its 38th 

session (1995), the United Nations 

Commission on Narcotic Drugs (UN/ 

CND) listed mesocarb in Schedule IV of 

the 1971 Convention. Specifically, 

based on advice from WHO, UN/CND 

placed mesocarb in Schedule IV due to 

its low to moderate dependence 

potential and its appreciable abuse 

liability. Furthermore, mesocarb was 

found to have both little to moderate 

therapeutic usefulness and a similar 

spectrum of pharmacological effects as 

other substances in Schedule IV of the 

1971 Convention. The CSA, in 21 U.S.C. 

812(b), sets forth findings required to 

place a substance in a certain schedule 

under the CSA. As discussed below in 

the Proposed Determination to Schedule 

Mesocarb and Proposed Determination 

of Appropriate Schedule sections, DEA 

found that mesocarb must be placed in 

schedule I of the CSA. 

Article 2, paragraph 7(d), of the 1971 

Convention sets forth the minimum 

requirements that the United States 

must meet when a substance has been 

added to Schedule IV of the 1971 

Convention. Pursuant to the 1971 

Convention, the United States must 

require licenses for the manufacture, 

export and import, and distribution of 

mesocarb. The CSA’s registration 

requirement accomplishes this license 

requirement, as set forth in 21 U.S.C. 

822, 823, 957, and 958 and in 

accordance with 21 CFR parts 1301 and 

1312. In addition, the United States 

must adhere to specific export and 

import provisions set forth in the 1971 

Convention. The CSA’s export and 

import provisions accomplish this 

requirement, as established in 21 U.S.C. 

952, 953, 957, and 958 and in 

accordance with 21 CFR part 1312. 

Likewise, under Article 13, paragraphs 

1 and 2, of the 1971 Convention, a party 

to the 1971 Convention may notify 

another party, through the SecretaryGeneral of the United Nations, that it 

prohibits the importation of a substance 

in Schedule II, III, or IV of the 1971 

Convention. If such notice is presented 

to the United States, the United States 

shall take measures to ensure that the 

named substance is not exported to the 

country of the notifying party. The 

CSA’s export provisions mentioned 

above accomplish this requirement. 

Article 16, paragraph 4, of the 1971 

Convention requires the United States to 

provide annual statistical reports to the 

International Narcotics Control Board 

(INCB). Using INCB Form P, the United 

States shall provide the following 

information: (1) In regard to each 

Schedule I and II substance of the 1971 

Convention, quantities manufactured in, 

exported to, and imported from each 

country or region as well as stocks held 

by manufacturers; (2) in regard to each 

Schedule II and III substance of the 1971 

Convention, quantities used in the 

manufacture of exempt preparations; 

and (3) in regard to each Schedule II— 

IV substance of the 1971 Convention, 

quantities used for the manufacture of 

non-psychotropic substances or 

products. Lastly, under Article 2 of the 

1971 Convention, the United States 

must adopt measures in accordance 

with Article 22 to address violations of 

any statutes or regulations that are 

adopted pursuant to its obligations 

under the 1971 Convention. Persons 

acting outside the legal framework 

established by the CSA are subject to 

administrative, civil, and/or criminal 

action; therefore, the United States 

complies with this provision. 

Proposed Determination To Schedule 

Mesocarb 

Pursuant to 21 U.S.C. 811(b), DEA 

gathered the necessary data on mesocarb 

and, in 2008, submitted it to the 

Assistant Secretary for Health of HHS 

with a request for a scientific and 

medical evaluation of available 

information and a scheduling 

recommendation for mesocarb. On April 

3, 2012, HHS provided to DEA a written 

scientific and medical evaluation and 

scheduling recommendation entitled 

‘‘Basis for the Recommendation for 

Control of Mesocarb in Schedule I of the 

Controlled Substances Act (CSA).’’ 

Pursuant to 21 U.S.C. 811(b), this 

document contained HHS’ eight-factor 

analysis of the abuse potential of 

mesocarb, along with its 

recommendation that mesocarb be 

added to schedule I of the CSA. 

In response, DEA reviewed the 

scientific and medical evaluation and 

scheduling recommendation provided 

by HHS and all other relevant data and 

conducted its own eight-factor analysis 

of mesocarb’s abuse potential pursuant 

to 21 U.S.C. 811(c). Included below is a 

brief summary of each factor as 

analyzed by HHS and DEA in their 

respective eight-factor analyses, and as 

considered by DEA in its proposed 

scheduling determination. Please note 

that both DEA and HHS analyses are 

available in their entirety under 

‘‘Supporting Documents’’ of the public 

docket for this rule at http://

www.regulations.gov under docket 

number ‘‘DEA–397.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse: As reported by 

HHS, DA is known to increase 

locomotion and is also directly involved 

in the rewarding, stimulatory, and 

antidepressant effects induced by 

psychostimulants. Mesocarb, known to 

be a selective inhibitor of the DA 

transporter, is readily self-administered 

at levels equal to that of 

methamphetamine in animals, 

demonstrating the reinforcing effects of 

mesocarb. Clinical studies have also 

confirmed the reinforcing effect of 

mesocarb as compared to both 

amphetamine and methamphetamine, 

both of which are schedule II drugs. 

While reports of mesocarb abuse are 

rare, anti-doping tests have led to the 

detection of unauthorized use of the 

drug by athletes during training and 

competition. Effects following 

administration of mesocarb include 

increased locomotion, increased work 

capacity, improved cardiovascular 

function, a marked psychostimulant 

effect, excessive vitality or nervous 

energy, tachycardia, hypertension, 

weight loss, and decreased appetite. 

These data indicate that mesocarb has 

the potential for abuse similar to other 

CNS stimulants. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, If Known: 

Mesocarb modulates the uptake of DA, 

norepinephrine and 5- 

hydroxytryptomine, all of which are 

directly involved in the rewarding, 

stimulatory, and antidepressant effects 

induced by these psychostimulants. In 

comparison to amphetamine, mesocarb 

has a slower onset of action and is less 

potent; however, the stimulant effects of 

mesocarb on the CNS are longer lasting. 

Mesocarb is readily self-administered in 

both mice and monkeys and is shown to 

substitute fully for both amphetamine 

and methamphetamine when tested in a 

discriminative paradigm. Selfadministration findings have also 

predicted that mesocarb has abuse 

potential, even though it is 

approximately ten times less potent 

than methamphetamine. 

Mesocarb use in the United States is 

rare, and clinical information pertaining 

to its abuse potential is limited. 

Mesocarb is not studied scientifically 

outside of Russia or other countries that 

made up the former Union of Soviet 

Socialist Republics (USSR). In a clinical 

review by the Institute of Psychiatry of 

the Academy of Medical Sciences USSR 

and the Institute of Psychiatry of the 

Ministry of Health (Moscow), mesocarb 

was reported to produce a marked 

psychostimulant effect characterized by 

increased mental and physical activity 

along with increased locomotor and 


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4STRIDE is a database of drug exhibits sent to 

DEA laboratories for analysis. Exhibits from the 

database are from DEA, other federal agencies, and 

law enforcement agencies. On October 1, 2014, 

STARLiMS replaced STRIDE as DEA laboratory 

drug evidence data system of record. 

5NFLIS 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. 

The NFLIS participation rate, defined as the 

percentage of the national drug caseload 

represented by laboratories that have joined NFLIS, 

is over 97%. NFLIS includes drug chemistry results 

from completed analyses only. 

6Although there is no evidence suggesting that 

mesocarb has currently accepted medical uses in 

treatment in the United States, it bears noting that 

a drug cannot be found to have such medical use 

unless DEA concludes that it satisfies a five-part 

test. Specifically, with respect to a drug that has not 

been approved by FDA, to have a currently 

accepted medical use in treatment in the United 

States, all of the following must be demonstrated: 

i. The drug’s chemistry must be known and 

reproducible; ii. there must be adequate safety 

studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug 

must be accepted by qualified experts; and v. the 

scientific evidence must be widely available. 57 FR 

Continued 

speech activity. Clinical observations 

demonstrate that mesocarb, while less 

potent than both methamphetamine and 

amphetamine, has similar CNS effects as 

other stimulants, providing evidence 

that mesocarb has a similar abuse 

liability. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: Mesocarb is a white 

crystalline powder, nearly insoluble in 

water and barely soluble in alcohol. Of 

the 19 reported metabolites of mesocarb, 

the main metabolite is phydroxymesocarb (conjugated with 

sulfate), which is detected in human 

urine and plasma. Amphetamine in 

trace amounts has also been detected as 

a metabolite of mesocarb (in human 

urine and blood plasma, and in rat 

urine). In healthy human volunteers, the 

estimated detection time for mesocarb 

after administration was approximately 

10–11 days, due to the long half-lives of 

the metabolites. 

4. Its History and Current Pattern of 

Abuse: Abused by athletes worldwide 

both in training and in competition, 

mesocarb is on the list of prohibited 

substances of the World Anti-Doping 

Agency (WADA) and banned by the 

International Olympics Committee. In 

addition, mesocarb is internationally 

controlled as a Schedule IV substance 

under the 1971 Convention. Diversion 

of legitimately produced mesocarb in 

Bulgaria was mentioned as a possible 

problem in the International Narcotics 

Control Strategy Report (INCSR) of 

1993. In 2000, INCSR reported the 

primary stimulant of abuse, 

amphetamine, was being replaced by 

fenethylline (schedule I of the CSA), 

pemoline (schedule IV of the CSA), 

mesocarb, and ephedrine (in that order) 

in western Africa. Queries of DEA’s 

System to Retrieve Information from 

Drug Evidence (STRIDE)/STARLiMS 4

and the National Forensic Laboratory 

Information System (NFLIS) 5 on May 

26, 2021, did not report any occurrence 

of mesocarb, suggesting that mesocarb is 

not trafficked in the United States. 

5. The Scope, Duration, and 

Significance of Abuse: As noted above, 

mesocarb is prohibited by WADA and 

banned by the International Olympic 

Committee. It has been used by athletes 

worldwide both in training and in 

competition due to reported effects on 

learning, memory, work capacity, and 

antihypoxia. Case reports involving 

mesocarb abuse have included: (1) A 

Lithuanian athlete in the Barcelona 

1992 Olympic games; (2) a U.S. citizen 

in the Tokyo 1991 International 

Amateur Federation World 

Championships; (3) a Bulgarian athlete 

in the Helsinki 1994 European 

Championships; (4) a report by 

observers for WADA covering the 

Mediterranean Games of Tunis (Tunisia) 

in 2001; and (5) another WADA report 

in 2005 following a positive laboratory 

result that tested positive for mesocarb. 

6. What, if any, Risk There is to the 

Public Health: The presence of 

mesocarb in the United States is limited 

because of its lack of accepted medical 

use. According to HHS, mesocarb is not 

an approved drug, and there have been 

no reports of adverse effects related to 

mesocarb in the United States. Due to 

the pharmacological similarity of 

mesocarb to amphetamine and 

methamphetamine, even though the 

availability of mesocarb is limited, 

mesocarb likely presents similar risks to 

the public health as amphetamine and 

methamphetamine. 

7. Its Psychic or Physiological 

Dependence Liability: For amphetamine 

or amphetamine-like substances, related 

withdrawal symptoms can be moderate 

or limited and are characterized by 

craving, irritability, nervousness, 

psychomotor agitation, paranoia, and 

sleep disturbances. Although there are 

no direct assessments of the physiologic 

and psychic dependence of mesocarb, it 

does induce locomotor and selfadministration behaviors that are 

similar to those behaviors induced by 

amphetamine and methamphetamine. 

Mesocarb has been shown to substitute 

fully at high doses to amphetamine and 

methamphetamine in a drug 

discriminative paradigm. Therefore, 

mesocarb likely elicits a similar 

physiologic and psychic dependence 

profile as amphetamine and 

methamphetamine. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled under the CSA: Both 

HHS and DEA find that mesocarb is not 

an immediate precursor of any 

substance already controlled under the 

CSA. 

Conclusion: Based on consideration of 

the scientific and medical evaluation 

and accompanying recommendation of 

HHS, and based on DEA’s consideration 

of its own eight-factor analysis, DEA 

finds that these facts and all relevant 

data constitute substantial evidence of 

potential for abuse of mesocarb. As 

such, DEA hereby proposes to schedule 

mesocarb as a controlled substance 

under the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

outlines the findings required to place a 

drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for Health of HHS and review 

of all available data, the Administrator 

of DEA, pursuant to 21 U.S.C. 812(b)(1), 

finds that: 

(1) Mesocarb has a high potential for 

abuse. Mesocarb, similar to 

amphetamine and many other CNS 

stimulants, is a DA uptake inhibitor. In 

clinical observations, mesocarb 

produced marked pyschostimulation 

accompanied with increased mental, 

physical, locomotor, and speech activity 

similar to amphetamine, albeit with less 

potency. Pre-clinical research has also 

directly compared mesocarb to other 

CNS stimulants, including 

amphetamine and methamphetamine 

that are scheduled and controlled under 

the CSA due to their well-known high 

abuse liability. The effects of mesocarb 

on DA are qualitatively similar to these 

schedule II stimulants. Intravenous drug 

self-administration studies in animals 

have shown that mesocarb has 

reinforcing effects. Mesocarb shares 

similar discriminative stimulus effects 

with amphetamine and 

methamphetamine, though at larger 

doses. Amphetamine and 

methamphetamine have medical use 

and have high potential for abuse. 

(2) There are no approved New Drug 

Applications for mesocarb nor is there 

a known therapeutic application for 

mesocarb in the United States. 

Therefore, mesocarb has no currently 

accepted medical use in treatment in the 

United States.6


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10499 (1992), pet. for rev. denied, Alliance for 

Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 

(DC Cir. 1994). 

(3) There is a lack of accepted safety 

for use of mesocarb under medical 

supervision since mesocarb lacks any 

accepted medical use in the United 

States. Clinical findings demonstrate 

that mesocarb induces similar effects 

characteristic of other CNS stimulants 

including amphetamine and 

methamphetamine. Adverse effects 

reported for mesocarb include 

tachycardia, hypertension, weight loss, 

and decreased appetite. 

Based on these findings, the 

Administrator of DEA concludes that 

mesocarb warrants control under 

schedule I of the CSA. 21 U.S.C. 

812(b)(1). More precisely, because of its 

stimulant effects, DEA proposes placing 

mesocarb in 21 CFR 1308.11(f) (the 

stimulants category of schedule I). As 

such, the proposed control of mesocarb 

includes the substance as well as its 

salts, isomers, and salts of isomers. 

Requirements for Handling Mesocarb 

If this rule is finalized as proposed, 

mesocarb would be subject to the CSA’s 

schedule I regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

import, export, engagement in research, 

conduct of instructional activities or 

chemical analysis with, and possession 

of schedule I controlled substances, 

including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, imports, exports, 

engages in research, or conducts 

instructional activities or chemical 

analysis with, or possesses) mesocarb, 

or who desires to handle mesocarb, 

would need to be registered with 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 the effective date of a 

final scheduling action. Any person 

who currently handles mesocarb and is 

not registered with DEA would need to 

submit an application for registration 

and may not continue to handle 

mesocarb as of the effective date of a 

final scheduling action, unless DEA has 

approved that application for 

registration pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. 

2. Disposal of stocks. Any person who 

does not desire or is not able to obtain 

a schedule I registration would be 

required to surrender all quantities of 

currently held mesocarb or transfer all 

quantities of currently held mesocarb to 

a person registered with DEA before the 

effective date of a final scheduling 

action in accordance with all applicable 

federal, State, local, and tribal laws. As 

of the effective date of a final scheduling 

action, mesocarb would be required to 

be disposed of in accordance with 21 

CFR part 1317, in addition to all other 

applicable Federal, State, local, and 

tribal laws. 

3. Security. Mesocarb would be 

subject to schedule I security 

requirements and would need to be 

handled and stored pursuant to 21 

U.S.C. 821 and 823, and in accordance 

with 21 CFR 1301.71–1301.76, as of the 

effective date of a final scheduling 

action. Non-practitioners handling 

mesocarb would also need to comply 

with the employee screening 

requirements of 21 CFR 1301.90 

–1301.93. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of mesocarb would need to 

be in compliance with 21 U.S.C. 825 

and 958(e) and in accordance with 21 

CFR part 1302, as of the effective date 

of a final scheduling action. 

5. Quota. Only registered 

manufacturers would be permitted to 

manufacture mesocarb in accordance 

with a quota assigned pursuant to 21 

U.S.C. 826 and in accordance with 21 

CFR part 1303, as of the effective date 

of a final scheduling action. 

6. Inventory. Every DEA registrant 

who possesses any quantity of mesocarb 

on the effective date of a final 

scheduling action would be required to 

take an inventory of mesocarb on hand 

at that time, pursuant to 21 U.S.C. 827 

and 958 and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11(a) and 

(d). 

Any person who becomes registered 

with DEA on or after the effective date 

of the final scheduling action would be 

required to take an initial inventory of 

all stocks of controlled substances 

(including mesocarb) on hand on the 

date the registrant first engages in the 

handling of controlled substances, 

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

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant would be required to take a 

new inventory of all controlled 

substances (including mesocarb) on 

hand every two years, pursuant to 21 

U.S.C. 827 and 958 and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11. 

7. Records and Reports. Every DEA 

registrant would be required to maintain 

records and submit reports for 

mesocarb, or products containing 

mesocarb, pursuant to 21 U.S.C. 827 and 

958 and in accordance with 21 CFR 

1301.74(b) and (c) and parts 1304, 1312, 

and 1317, as of the effective date of a 

final scheduling action. Manufacturers 

and distributors would be required to 

submit reports regarding mesocarb to 

the Automation of Reports and 

Consolidated Order System pursuant to 

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

CFR parts 1304 and 1312 as of the 

effective date of a final scheduling 

action. 

8. Order Forms. Every DEA registrant 

who distributes mesocarb would be 

required to comply with order form 

requirements, pursuant to 21 U.S.C. 828 

and in accordance with 21 CFR part 

1305, as of the effective date of a final 

scheduling action. 

9. Importation and Exportation. All 

importation and exportation of 

mesocarb would need to be in 

compliance with 21 U.S.C. 952, 953, 

957, and 958 and in accordance with 21 

CFR part 1312 as of the effective date of 

a final scheduling action. 

10. Liability. Any activity involving 

mesocarb not authorized by, or in 

violation of, the CSA or its 

implementing regulations, would be 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

pursuant to Section 3(d)(1) of Executive 

Order (E.O.) 12866 and the principles 

reaffirmed in E.O. 13563. 

Executive Order 12988, Civil Justice 

Reform 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This proposed rulemaking does not 

have federalism implications warranting 


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Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules 43983 

the application of E.O. 13132. The 

proposed rule does not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521). 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–612, has reviewed this 

proposed rule, and by approving it, 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

DEA proposes placing the substance 

mesocarb, including its isomers, salts, 

and salts of isomers, in schedule I of the 

CSA. This action is being taken to 

enable the United States to meet its 

obligations under the 1971 Convention. 

If finalized, this action would impose 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances on persons who 

handle (manufacture, distribute, reverse 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis with, or 

possess), or propose to handle, 

mesocarb. 

According to HHS, mesocarb has a 

high potential for abuse, has no 

currently accepted medical use in 

treatment in the United States, and lacks 

accepted safety for use under medical 

supervision. DEA’s research confirms 

that there is no commercial market for 

mesocarb in the United States. 

Additionally, queries of DEA’s STRIDE/ 

STARLiMS and the NFLIS databases on 

May 26, 2021, did not generate any 

reports of mesocarb, suggesting that it is 

not trafficked in the United States. 

Therefore, DEA estimates that no United 

States entity currently handles mesocarb 

and does not expect any United States 

entity to handle mesocarb in the 

foreseeable future. DEA concludes that 

no United States entity would be 

affected by this rule if finalized. As 

such, the proposed rule will not have a 

significant effect on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

On the basis of information contained 

in the ‘‘Regulatory Flexibility Act’’ 

section above, DEA has determined and 

certifies pursuant to the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.) that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year * * *.’’ Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under 

provisions of the UMRA of 1995. 

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 proposed to be amended to 

read 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), 

956(b), unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

redesignating paragraphs (f)(7) through 

(10) as paragraphs (f)(8) through (11), 

and adding a new paragraph (f)(7) to 

read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(f) * * * 

(7) Mesocarb (N-phenyl-N′-(3-(1- 

phenylpropan-2-yl)-1,2,3-oxadiazol-3- 

ium-5-yl)carbamimidate). 15. 

1227XXXXXXXXXXXXXXXXXX 

* * * * * 

(f) Stimulants. Unless specifically 

excepted or unless listed in another 

schedule, any material, compound, 

mixture, or preparation which contains 

any quantity of the following substances 

having a stimulant effect on the central 

nervous system, including its salts, 

isomers, and salts of isomers: 

(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine) .................. 1585 

(2) N-Benzylpiperazine (some other names: BZP, 1-benzylpiperazine) ........................................................................................................ 7493 

(3) Cathinone .................................................................................................................................................................................................... 1235 

Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and 

norephedrone ......................................................................................................................................................................................... ..........

(4) Fenethylline ................................................................................................................................................................................................ 1503 

(5) Methcathinone (Some other names: 2-(methylamino)-propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-1- 

phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone; 

methylcathinone; AL–464; AL–422; AL–463 and UR1432), its salts, optical isomers and salts of optical isomers .............................. 1237 

(6) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) ................................................................................... 1590 

(7) N-ethylamphetamine .................................................................................................................................................................................. 1475 

(8) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine) ......... ..........

Anne Milgram, 

Administrator. 

[FR Doc. 2021–16489 Filed 8–10–21; 8:45 am] 

BILLING CODE 4410–09–P 


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