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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
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 DEA cannot effectively redact it, 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 confidential as directed above.
An electronic copy of this document and supplemental information to this proposed rule are available at https
www.regulations.gov for easy reference.

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Request for Hearing or Appearance;
Waiver Pursuant to 21 U.S.C. 811a, 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.
551559. 21 CFR 1308.411308.45; 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 1308.44a or b, and such requests must 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 1316.47a. 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 persons position on the matters of fact and law involved in any hearing as set forth in 21 CFR
1308.44c.
All requests for a 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 United Nations 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. 811d24.

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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 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. 811d3. In the event that the Secretary of HHS
Secretary did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811d4, the procedures for permanent scheduling set forth in 21 U.S.C. 811a and b control. Pursuant to 21 U.S.C.
811a1, the Attorney General may 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 the findings prescribed by 21 U.S.C. 812b for the schedule in which such drug or other substance is to be placed. The Attorney General has delegated this scheduling authority to the Administrator of DEA.
28 CFR 0.100.
Background Methoxetamine MXE, also known as 2-ethylamino-2-3methoxyphenylcyclohexan-1-one or 23-methoxyphenyl-2-Nethylaminocyclohexanone belongs to the arylcyclohexylamine class of drugs with dissociative anesthetic and hallucinogenic properties, similar to phencyclidine PCP and ketamine.
Methoxetamine has no approved medical use in the United States.
On December 30, 2014, DEA, in accordance with the provisions of 21
U.S.C. 811b, requested HHS provide a scientific and medical evaluation as well as a scheduling recommendation for methoxetamine. On April 14, 2017, DEA provided HHS additional scientific and updated information on methoxetamine. The April 14, 2017, 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 Secretarys 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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communication included that on May 17, 2016, the Secretary-General of the United Nations UN Secretary General advised the Secretary of State of the United States that the Commission on Narcotic Drugs CND, during its 59th Session in March 2016, voted to place methoxetamine in Schedule II of the 1971 Convention CND Dec/59/6. As a signatory to this international treaty, the United States is required, by scheduling under the CSA, to place appropriate controls on methoxetamine to meet the minimum requirements of the treaty.
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 methoxetamine. This license requirement is accomplished by the CSA with the registration 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 that are provided in the 1971 Convention. This requirement is accomplished by the CSA with the export and import provisions 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 UN Secretary-General, 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. This requirement is also accomplished by the export provisions of the CSA 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, exported to and imported from each country or region as well as stocks held by manufacturers; 2 in regard to each substance in Schedule III
and IV of the 1971 Convention, quantities manufactured, as well as quantities exported and imported; 3 in regard to each substance in Schedule II

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