Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Rules and Regulations DEA and HHS Eight Factor Analyses On October 12, 2018, in accordance with 21 U.S.C. 811b, and in response to DEAs March 21, 2017 request, HHS
provided to DEA a scientific and medical evaluation and a scheduling recommendation for 4,4-DMAR. DEA
subsequently reviewed HHS evaluation and recommendation for schedule I
placement and all other relevant data, 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 analyses are available in their entirety in the public docket for this rule Docket Number DEA498 at http www.regulations.gov under Supporting Documents.
Notice of Proposed Rulemaking to Schedule 4,4-DMAR
On April 7, 2020, DEA published a notice of proposed rulemaking NPRM
entitled Schedules of Controlled Substances: Placement of 4,4-DMAR in schedule I of the CSA. 85 FR 19401.
The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA
regulations on or before June 8, 2020.
No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit comments on the proposed rule on or before June 8, 2020.

lotter on DSK11XQN23PROD with RULES1

Comments Received DEA received two comments on the proposed rule to control 4,4-DMAR in schedule I of the CSA.
Support for rulemaking: One commenter recognized the dangers and public health risks, and supported the placement of 4,4-DMAR in schedule I.
DEA Response: DEA appreciates the comment in support of this rulemaking.
Dissent for rulemaking: One commenter stated that the number of 4,4-DMAR related deaths reported in Europe is small relative to its population, and evidence supporting scheduling is anecdotal. The commenter stated that schedule I control would restrict the ability to conduct research, and suggested that additional research with 4,4-DMAR should take place first before clamping down. This commenter questioned the appropriateness of control of 4,4-DMAR as a schedule I
substance and suggested schedule II
control for this substance.
DEA Response: DEA does not agree.
As discussed above, in May 2016, the Secretary-General advised the U.S.
Secretary of State that the CND voted in March 2016 to place 4,4-DMAR in
VerDate Sep<11>2014

16:14 Aug 11, 2021

Jkt 253001

Schedule II of the 1971 Convention. As the CSA recognizes, under 21 U.S.C.
8017, the United States is a party to international conventions, including the 1971 Convention, and is obligated to maintain appropriate control provisions related to the drugs that are covered by the treaty. In addition, DEA conducted an eight-factor analysis pursuant to 21
U.S.C. 811c, and based its scheduling determination on a comprehensive evaluation of all available data, not just the number of deaths and anecdotal data. As stated in the proposed rulemaking, after careful review of all data, DEA concurred with HHS
assessment that 4,4-DMAR has abuse potential comparable to other schedule I e.g. aminorex and 3,4methylenedioxymethamphetamine or II
d-amphetamine substances, and is therefore promulgating this final rule placing 4,4-DMAR in schedule I under the CSA.
With regard to the commenters statement that placement of 4,4-DMAR
in schedule I would restrict research on this substance, DEA notes that placing a substance in schedule I does not prohibit research on that substance.
Persons interested in conducting research with 4,4-DMAR can do so provided that they have a DEA schedule I researcher registration and meet all other statutory and regulatory criteria.
This registration can be obtained by submitting an application for schedule I
registration in accordance with 21 CFR
1301.11, 1301.13, 1301.18, and 1301.32.
The CSA provides the specific administrative process for the Attorney General as delegated to the Administrator, in consultation with the Secretary, to approve the registration for the bonafide research with schedule I
drug substances. 21 U.S.C. 823f; see 21
CFR 1301.18. Thus, DEA believes that adding 4,4-DMAR in the list of schedule I substances will not restrict any legitimate research.
With regard to the commenters suggestion that 4,4-DMAR be placed under schedule II, as DEA has stated in prior scheduling petitions, Congress established only one schedule, schedule I, for drugs of abuse with no currently accepted medical use in treatment in the United States and lack of accepted safety for use . . . under medical supervision. 21 U.S.C. 812b. 76 FR
40552 2011; 66 FR 20038 2001. As stated by HHS in its scientific and medical evaluation of 4,4-DMAR, there are currently no Food and Drug Administration FDA-approved drug products containing 4,4-DMAR for any clinical indication, nor are there clinical studies or petitioners that claim an accepted medical use in the United
PO 00000

Frm 00015

Fmt 4700

Sfmt 4700

44271

States. Thus, 4,4-DMAR currently has no accepted medical use in treatment in the United States.2 Therefore, placement of 4,4-DMAR in schedule I of the CSA
is appropriate.
Scheduling Conclusion After consideration of the public comments, the scientific and medical evaluations and accompanying recommendation of HHS, and conducting an independent eight-factor analysis, DEA finds substantial evidence of potential for abuse of 4,4-DMAR. As such, DEA is permanently scheduling 4,4-DMAR 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 outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary for HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 811a and 812b1, finds that:
1 4,4-DMAR has a high potential for abuse. This potential is comparable to other schedule I substances e.g., aminorex and 3,4methylenedioxymethamphetamine or schedule II substances e.g., damphetamine;
2 4,4-DMAR has no currently accepted medical use in treatment in the United States; and 3 There is a lack of accepted safety for use of 4,4-DMAR under medical supervision.
Based on these findings, the Administrator concludes that 4,4DMAR, including its salts, isomers, and salts of isomers, warrants control in schedule I of the CSA. 21 U.S.C.
812b1.
Requirements for Handling 4,4-DMAR
4,4-DMAR is subject to the CSAs schedule I regulatory controls and 2 Although there is no evidence suggesting that 4,4-DMAR has a currently accepted medical use in treatment in the United States, it bears noting that a drug cannot be found to have such medical use unless DEA concludes that it satisfies a five-part test. Specifically, with respect to a drug that has not been approved by FDA, to have a currently accepted medical use in treatment in the United States, all of the following must be demonstrated:
i. The drugs chemistry must be known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available. 57 FR
10499 1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135
D.C. Cir. 1994.

E:FRFM12AUR1.SGM

12AUR1