Drug Scheduling Actions - 2004
FR Doc 04-7219
[Federal Register: April 1, 2004 (Volume 69, Number 63)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-251E]
Schedules of Controlled Substances: Extension of Temporary Placement of Alpha-Methyltryptamine (AMT) and 5-Methoxy-N,N-Diisopropyltryptamine (5-MeO-DIPT) in Schedule I of the Controlled Substances Act
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
SUMMARY: This final rule is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to extend the temporary scheduling of alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) in Schedule I of the Controlled Substances Act (CSA). The temporary scheduling of AMT and 5-MeO-DIPT is due to expire on April 3, 2004. This document will extend the temporary scheduling of AMT and 5-MeO-DIPT to October 3, 2004 or until rulemaking proceedings are completed, whichever occurs first.
EFFECTIVE DATE: April 1, 2004.
FOR FURTHER INFORMATION CONTACT: Christine Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: On April 4, 2003, the Deputy Administrator of the DEA published a final rule in the Federal Register (68 FR 16427) amending 1308.11(g) of title 21 of the Code of Federal Regulations to temporarily place AMT and 5-MeO-DIPT into Schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). This final rule, which became effective on the date of publication, was based on findings by the Deputy Administrator that the temporary scheduling of AMT and 5-MeO-DIPT was necessary to avoid an imminent hazard to the public safety. Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) requires that the temporary
scheduling of a substance expire at the end of one year from the date of issuance of the order. However, during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, temporary scheduling of that substance may be extended for up to six months. Proceedings for the scheduling of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney General (delegated to the Administrator of the DEA pursuant to 28 CFR 0.100) on his own motion, at the request of the Secretary of Health and Human Services, or on the petition of any interested party. Such proceedings regarding AMT and 5-MeO-DIPT have been initiated by the Acting Deputy Administrator of the DEA.
The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse and the relative potential for abuse for AMT and 5-MeO-DIPT. The Acting Deputy Administrator has submitted these data to the Assistant Secretary for Health, Department of Health and Human Services. In accordance with 21 U.S.C. 811(b), the Acting Deputy Administrator has also requested a scientific and medical evaluation and a scheduling recommendation for AMT and 5-MeO-DIPT from the Assistant Secretary for Health. Therefore, the temporary scheduling of AMT and 5-MeO-DIPT which is due to expire on April 3, 2004, may be extended until October 3, 2004, or until proceedings initiated in accordance with 21 U.S.C. 811(a) are completed, whichever occurs first.
Pursuant to 21 U.S.C. 811(h)(2), the Acting Deputy Administrator hereby orders that the temporary scheduling of AMT and 5-MeO-DIPT be extended until October 3, 2004, or until the proceedings initiated in accordance with 21 U.S.C. 811(a) are completed, whichever occurs first.
The Acting Deputy Administrator of the DEA hereby certifies that extension of the temporary placement of AMT and 5-MeO-DIPT in Schedule I of the CSA will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action involves the extension of temporary control of substances with no currently accepted medical use in the United States.
The six month extension of AMT and 5-MeO-DIPT in Schedule I of the CSA is not a significant regulatory action for the purposes of Executive Order (E.O.) 12866 of September 30, 1993. Drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of E.O. 12866, section 3(d) (1). This action responds to an emergency situation posing an imminent hazard to the public safety and is essential to the criminal law enforcement function of the United States.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action has been analyzed in accordance with the principles and criteria in Executive Order 13132 and it has been determined that this final rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Dated: March 25, 2004.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 04-7219 Filed 3-31-04; 8:45 am]
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