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Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules
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.
812b, 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 7d, 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 CSAs 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 CSAs 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 CSAs 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 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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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. 811b, 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. 811b, 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 mesocarbs abuse potential pursuant to 21 U.S.C. 811c. 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 DEA397.

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1. The Drugs 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 Drugs Pharmacological Effects, If Known:
Mesocarb modulates the uptake of DA, norepinephrine and 5hydroxytryptomine, 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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