Proposed Rule2021-16489
Schedules of Controlled Substances: Placement of Mesocarb in Schedule I
Primary source
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Published
August 11, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 152 (Wednesday, August 11, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. If you have received a Comment Tracking Number,
your comment has been submitted successfully, and there is no need to
resubmit the same comment.
<bullet> 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.
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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) (<plus-minus>)cis-4-methylaminorex ((<plus-minus>)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
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</html>Indexed from Federal Register on August 11, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.