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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules
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for abuse, and makes with respect to such drug or other substance the findings prescribed by 21 U.S.C. 812b 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 Methiopropamine is a central nervous stimulant and is structurally related to the schedule II stimulants methamphetamine and amphetamine.
On April 21, 2017, the SecretaryGeneral of the United Nations advised the Secretary of State of the United States that during its 60th session, on March 16, 2017, the Commission on Narcotic Drugs voted to place N-methyl1-thiophen-2-ylpropan-2-amine methiopropamine in Schedule II of the 1971 Convention CND Dec/60/8.
Because the procedures in 21 U.S.C.
811d3 and 4 for consultation and issuance of a temporary order for methiopropamine, discussed in the above legal authority section, were not followed, DEA is utilizing the procedures for permanent scheduling set forth in 21 U.S.C. 811a and b to control methiopropamine. Such scheduling would satisfy the United States international obligations.
Article 2, paragraph 7b, of the 1971
Convention sets forth the minimum requirements that the United States must meet when a substance has been added to Schedule II of the 1971
Convention. Pursuant to the 1971
Convention, the United States must require licenses for the manufacture, export and import, and distribution of methiopropamine. This license requirement is accomplished by the CSAs registration requirement as set forth in 21 U.S.C. 822, 823, 957, 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. This requirement is accomplished by the CSAs export and import provisions established in 21
U.S.C. 952, 953, 957, 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 through the UN Secretary-General another party 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 notifying country. This requirement is also accomplished by the CSAs export
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provisions mentioned above. Under Article 16, paragraph 4, of the 1971
Convention, the United States is required 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 substance in Schedule I and II 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 substance in Schedule II and III of the 1971
Convention, quantities used in the manufacture of exempt preparations;
and 3 in regard to each substance in Schedule IIIV 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.
DEA notes that there are differences between the schedules of substances in the 1971 Convention and the CSA. The CSA has five schedules schedules IV
with specific criteria set forth for each schedule. Schedule I is the only possible schedule in which a drug or other substance may be placed if it has high potential for abuse and no currently accepted medical use in treatment in the United States. See 21
U.S.C. 812b. In contrast, the 1971
Convention has four schedules Schedules IIV but does not have specific criteria for each schedule. The 1971 Convention simply defines its four schedules, in Article 1, to mean the correspondingly numbered lists of psychotropic substances annexed to the Convention, and altered in accordance with Article 2.
Proposed Determination To Schedule Methiopropamine On November 20, 2018, DEA
requested HHS conduct a scientific and medical evaluation and recommend whether methiopropamine should be controlled under the CSA. On August 27, 2020 dated August 25, 2020, HHS
provided DEA a scientific and medical evaluation entitled Basis for the recommendation to control methiopropamine and its salts in schedule I of the Controlled Substance Act and a scheduling recommendation.

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Pursuant to 21 U.S.C. 811b, following consideration of the eight-factors and findings related to the substances abuse potential, legitimate medical use, safety, and dependence liability, HHS
recommended that methiopropamine be controlled in schedule I of the CSA
under 21 U.S.C. 812b. Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed the documents and all other relevant data and conducted its own eight-factor analysis in accordance with 21 U.S.C. 811c. Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its proposed scheduling action. Please note that both DEA and HHS eight-factor analyses are available in their entirety under the tab Supporting Documents of the public docket of this rulemaking action at http www.regulations.gov, under docket number DEA737.
1. The Drugs Actual or Relative Potential for Abuse: The term abuse is not defined in the CSA. However, the legislative history of the CSA suggests that DEA consider the following criteria when determining whether a particular drug or substance has a potential for abuse: 2
a There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or b There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or c Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or d The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

Both DEA and HHS eight-factor analyses found that methiopropamine has abuse potential associated with its abilities to produce psychoactive effects that are similar to those produced by schedule II stimulants such as amphetamine and methamphetamine 2 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 911444, 91st Cong., Sess. 1 1970; reprinted in 1970
U.S.C.C.A.N. 4566, 4603.

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