[Federal Register Volume 69, Number 63 (Thursday, April 1, 2004)]
[Rules and Regulations]
[Pages 17034-17035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7219]


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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.

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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

[[Page 17035]]

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.

Regulatory Certifications

    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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