Schedules of Controlled Substances: Placement of Mesocarb in Schedule I, 43978-43983 [2021-16489]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Proposed Rules]
[Pages 43978-43983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16489]


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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.

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SUMMARY: The Drug Enforcement Administration proposes placing the 
substance mesocarb (chemical name: N-phenyl-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 https://www.regulations.gov 
and follow the on-line 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 https://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

[[Page 43979]]

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 https://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 https://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 https://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.
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    \1\ As 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).
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Background

    Mesocarb, known chemically as N-phenyl-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

[[Page 43980]]

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.
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    \2\ International Drug Scheduling; Convention on Psychotropic 
Substances; Certain Stimulant/Hallucinogenic Drugs and Certain 
Nonbarbiturate Sedative Drugs, 59 FR 31639, June 20, 1994.
    \3\ International Drug Scheduling; Convention on Psychotropic 
Substances; World Health Organization Scheduling Recommendations for 
Seven Drug Substances, 60 FR 4169, January 20, 1995.
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    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 Secretary-General 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 https://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. Self-administration 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

[[Page 43981]]

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 p-hydroxymesocarb 
(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.
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    \4\ STRIDE 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.
    \5\ NFLIS 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.
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    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 self-administration 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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    \6\ Although 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 well-
controlled studies proving efficacy; iv. the drug must be accepted 
by qualified experts; and v. the scientific evidence must be widely 
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (DC Cir. 1994).

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[[Page 43982]]

    (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

[[Page 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

0
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.

0
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:


Sec.  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-    1585
 oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)..............
(2) N-Benzylpiperazine (some other names: BZP, 1-                   7493
 benzylpiperazine)..............................................
(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)-               1237
 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........................................................
(6) ()cis-4-methylaminorex (()cis-4,5-      1590
 dihydro-4-methyl-5-phenyl-2-oxazolamine).......................
(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