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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules
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 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 1316.47a. 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 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.

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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.
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 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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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 is to be placed. The Attorney General has delegated this scheduling authority to the Administrator of DEA. 28 CFR
0.100.
Background Amineptine is a synthetic tricyclic antidepressant with central nervous system CNS stimulating properties that, according to HHS, has no approved medical use and no known therapeutic application in the United States.
Pharmacological studies indicate that amineptines primary mode of action is to increase extracellular levels of dopamine and norepinephrine as well as inhibit re-uptake of dopamine and norepinephrine within the striatum and limbic areas of the brain.
In 1978, amineptine was approved for use in France as an antidepressant and subsequently marketed in 66 countries throughout Africa, Asia, Europe, and South America. As documented by the World Health Organizations WHO
Expert Committee on Drug Dependence in its 33rd report 2003 WHO 2003
report, amineptine has been withdrawn from the market in 49 of the 66
countries. The status of current production of amineptine in other countries is not known, although a small quantity is most likely produced for research purposes.
In April 2003, the United Nations Commission on Narcotic Drugs, on the advice of the Director-General of the WHO, added amineptine to Schedule II
of the 1971 Convention, thus notifying all parties to the 1971 Convention.2
Because the procedures in 21 U.S.C.
811d3 and 4 for consultation and issuance of a temporary order for amineptine, 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 amineptine. Such scheduling would 2 https www.unodc.org/unodc/en/Resolutions/
resolution_2003-04-08_1.html.

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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 amineptine. 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 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
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