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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations
DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA509

Schedules of Controlled Substances:
Placement of paraMethoxymethamphetamine PMMA in Schedule I
Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
AGENCY:

With the issuance of this final rule, the Drug Enforcement Administration places 1-4methoxyphenyl-N-methylpropan-2amine paramethoxymethamphetamine, PMMA, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess, or propose to handle PMMA.
DATES: Effective July 26, 2021.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION:

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SUMMARY:

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 adding a drug or other substance to a specific schedule, the Secretary of the Department of Health and Human Services HHS,1 after 1 As discussed in a memorandum of understanding entered into by the Food and Drug
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consultation with the Attorney General, shall 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 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. 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, by rule, schedule or transfer between schedules 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 to schedule the drug or other substance.
The Attorney General has delegated this scheduling authority to the Administrator of the Drug Enforcement Administration DEA. 28 CFR 0.100.
Background para-Methoxymethamphetamine PMMA is a substituted phenethylamine and shares structural similarity to methamphetamine, a schedule II controlled substance, and para-methoxyamphetamine PMA, a schedule I controlled substance. PMMA
shares a similar pharmacological profile with 3,4methylenedioxymethamphetamine MDMA or ecstasy, a schedule I
controlled substance with high potential for abuse. Data obtained from preclinical studies show that, similar to MDMA, PMMAs effects are mediated by monoaminergic dopamine, norepinephrine, and serotonin transmission, mostly via activation of the serotonergic system. In animals, PMMA mimics MDMA in producing discriminative stimulus effect, which is indicative of similar subjective effects.
Law enforcement has encountered PMMA on the recreational drug market where it is sold as ecstasy, either alone or in combination with MDMA or PMA for oral consumption. For many years, PMMA has been involved in nonfatal and fatal overdoses, primarily in Europe. PMMA has no accepted medical 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 CSA, 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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use in treatment in the United States. In March 2016, the Commission on Narcotic Drugs CND voted to place PMMA in Schedule I of the 1971
Convention CND Dec/59/3 during its 59th Session due to its dependence and abuse potential.
DEA and HHS Eight Factor Analyses On December 18, 2018, in accordance with 21 U.S.C. 811b, and in response to DEAs April 7, 2017 request, HHS
provided to DEA a scientific and medical evaluation and scheduling recommendation for PMMA. DEA
reviewed HHS evaluation and recommendation for schedule I
placement, and all other relevant data, pursuant to 21 U.S.C. 811b and c, and conducted its own analysis under the eight factors stipulated in 21 U.S.C.
811c. DEA found, under 21 U.S.C.
812b1, that this substance warrants control in schedule I. Both DEA and HHS 8-Factor analyses are available in their entirety under the tab Supporting Documents of the public docket for this action at http
www.regulations.gov under Docket Number DEA509.
Notice of Proposed Rulemaking to Schedule PMMA
On May 15, 2020 85 FR 29359, DEA
published a notice of proposed rulemaking NPRM to permanently control PMMA in schedule I.
Specifically, DEA proposed to add PMMA to the hallucinogenic substances list under 21 CFR 1308.11d, and assign paragraph number 79 under paragraph d to PMMA. The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before June 15, 2020. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit comments on or before June 15, 2020. DEA did not receive any comments.
Scheduling Conclusion After consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all other relevant data constitute substantial evidence of the potential for abuse of PMMA. DEA is permanently scheduling PMMA as a controlled substance under the CSA.
Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also specifies the findings required to
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