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58050 Federal Register/Vol. 69, No. 188/Wednesday, September 29, 2004/Rules and Regulations SUPPLEMENT NO. 4 to PART 744—ENTIT

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58050 Federal Register/Vol. 69, No. 188/Wednesday, September 29, 2004/Rules and Regulations SUPPLEMENT NO. 4 to PART 744—ENTIT 58050 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued Country/Entity License requirement License review policy Federal Register citation The following Dpeartment of Atomic Energy entities: —Bhabha Atomic Research Center (BARC); ......... For all items subject to the Case-by-case for all items 63 FR 64322, 11/19/98; 65 —Indira Gandhi Atomic Research Center (IGCAR); EAR. listed on the CCL. Pre- FR 14444, 03/17/00; 66 —Indian Rare Earths; .............................................. sumption of approval for FR 50090, 10/01/01; 69 —Nuclear reactors (including power plants) not EAR99 items. FR 56694, 09/22/04. under International Atomic Energy Agency (IAEA) safeguards, fuel reprocessing and enrich- ment facilities, heavy water production facilities and their collocated ammonia plants. The following Department of Atomic Energy entities: —Nuclear reactors (including power plants) subjet For all items subject to the Case-by-case for all items 63 FR 64322, 11/19/98; 65 to International Atomic Energy Agency (IAEA) EAR. listed on the CCL. Pre- FR 14444, 03/17/00; 66 safeguards: Tarapur (TAPS 1 & 2), Rajasthan sumption of approval for FR 50090, 10/01/01; 69 (RAPS 1 & 2). EAR99 items. Presump- FR 56694, 09/22/04. tion of approval for all items not multilaterally controlled for Nuclear Proliferation (NPI) rea- sons for use in the ‘‘bal- ance of plant’’ (non-reac- tor-related end uses) 1 activities at nuclear facili- ties subject to Inter- national Atomic Energy Agency safeguards (Rajasthan 1 & 2 and Tarapur 1 & 2). ******* 1 ‘‘Balance of Plant’’ refers to the part of a nuclear power plant used for power generation (e.g., turbines, controllers, or power distribution) to distinguish it from the nuclear reactor. Eileen M. Albanese, Department of Health and Human 811(h)(2)) requires that the temporary Director, Office of Exporter Services. Services (DHHS) and a DEA review scheduling of a substance expires at the [FR Doc. 04–21837 Filed 9–27–04; 11:43 am] indicating that AMT and 5-MeO-DIPT end of one year from the effective date BILLING CODE 3510–33–P meet the criteria for placement in of the order. However, if proceedings to Schedule I of the CSA. This final rule schedule a substance pursuant to 21 will continue to impose the regulatory U.S.C. 811(a)(1) have been initiated and controls and criminal sanctions of DEPARTMENT OF JUSTICE are pending, the temporary scheduling Schedule I substances on the of a substance may be extended for up Drug Enforcement Administration manufacture, distribution, and to six months. On March 31, 2004, the possession of AMT and 5-MeO-DIPT. Acting Deputy Administrator published 21 CFR Part 1308 EFFECTIVE DATE: September 29, 2004. a notice of proposed rulemaking in the FOR FURTHER INFORMATION CONTACT: Federal Register (69 FR 16838) to place [Docket No. DEA–252F] Christine Sannerud, PhD, Chief, Drug AMT and 5-MeO-DIPT into Schedule I and Chemical Evaluation Section, Office of the CSA on a permanent basis. The Schedules of Controlled Substances: of Diversion Control, Drug Enforcement temporary scheduling of AMT and 5- Placement of Alpha-Methyltryptamine Administration, Washington, DC 20537, MeO-DIPT, which would have expired and 5-Methoxy-N,N- Telephone (202) 307–7183. April 3, 2004, was extended to October Diisopropyltryptamine Into Schedule I SUPPLEMENTARY INFORMATION: 3, 2004 (69 FR 17034, April 1, 2004). of the Controlled Substances Act On April 4, 2003, the Deputy Administrator of the One comment was received regarding AGENCY: Drug Enforcement DEA published a final rule in the the proposed placement of these Administration (DEA), Department of Federal Register (68 FR 16427) substances into Schedule I of the CSA. Justice. amending § 1308.11(g) of Title 21 of the The DEA has gathered and reviewed ACTION: Final rule. Code of Federal Regulations to the available information regarding the temporarily place AMT and 5-MeO- pharmacology, chemistry, trafficking, SUMMARY: This final rulemaking is DIPT into Schedule I of the CSA actual abuse, pattern of abuse, and the issued by the Deputy Administrator of pursuant to the temporary scheduling relative potential for abuse for AMT and the Drug Enforcement Administration provisions of 21 U.S.C. 811(h). This 5-MeO-DIPT. The Acting Deputy (DEA) to place alpha-methyltryptamine final rule, which became effective on Administrator submitted these data to (AMT) and 5-methoxy-N,N- the date of publication, was based on the Acting Assistant Secretary for diisopropyltryptamine (5-MeO-DIPT) findings by the Deputy Administrator Health, Department of Health and into Schedule I of the Controlled that the temporary scheduling of AMT Human Services (DHHS). In accordance Substances Act (CSA). This action by and 5-MeO-DIPT was necessary to avoid with 21 U.S.C. 811(b), the Acting the DEA Deputy Administrator is based an imminent hazard to the public safety. Deputy Administrator also requested a on a scheduling recommendation by the Section 201(h)(2) of the CSA (21 U.S.C. scientific and medical evaluation and a VerDate jul<14>2003 12:35 Sep 28, 2004 Jkt 203001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58051 scheduling recommendation for AMT effects of a 20 mg dose of AMT to those problems. These raves have also become and 5-MeO-DIPT from the Acting of 50 micrograms of lysergic acid venues for the trafficking and abuse of Assistant Secretary of DHHS. On diethylamide (LSD). AMT also produces other substances in place of or in September 17, 2004, the Acting dextroamphetamine-like mood elevating addition to ‘‘Ecstasy.’’ AMT and 5-MeO- Assistant Secretary for Health effects in humans (Hollister et al., J. DIPT belong to such a group of recommended that AMT and 5-MeO- Nervous Ment. Dis., 131: 428–434, 1960; substances. DIPT be permanently controlled in Murphree et al., Clin. Pharmacol. Ther. The abuse of AMT and 5-MeO-DIPT Schedule I of the CSA. 2: 722–726, 1961). began to spread in 1999. Since that time, Alpha-methyltryptamine (AMT) and Similar to other classical these tryptamines have been 5-methoxy-N,N-diisopropyltryptamine hallucinogens, AMT binds to serotonin encountered by law enforcement (5-MeO-DIPT) are tryptamine receptors. It also inhibits 5-HT uptake, agencies in several states. These (indoleethylamine) derivatives and induces catecholamine release and substances have been commonly share several similarities with the inhibits monoamine oxidase activity. encountered in tablet, capsule or Schedule I tryptamine hallucinogens The available experimental evidence powder forms. The tablet form often such as alpha-ethyltryptamine (AET) suggests that both serotonergic and bears imprints commonly seen on and N,N-dimethyltryptamine (DMT). dopaminergic systems mediate MDMA tablets such as spider, alien Several other tryptamines also produce behavioral effects of AMT. head and ‘‘?’’ logos. These tablets also hallucinogenic/stimulant effects and are 5-MeO-DIPT produces vary in colors such as pink, purple, red, controlled as Schedule I substances pharmacological effects similar to those and orange. The powder in capsule was under the CSA (bufotenine, of several Schedule I hallucinogens. The also found to vary in colors such as diethyltryptamine, psilocybin and synthesis and preliminary human white, off-white, gray, and burnt orange. psilocyn). Although tryptamine itself psychopharmacology study on 5-MeO- Data from law enforcement officials appears to lack consistent DIPT was first published in 1981 indicate that 5-MeO-DIPT is often sold hallucinogenic/stimulant effects, (Shulgin and Carter, Comm. as ‘‘Foxy’’ or ‘‘Foxy Methoxy’’, while substitutions on the indole ring and the Psychopharmacol. 4: 363–369, 1981). AMT has been sold as ‘‘Spirals’’ at least ethylamine side-chain of this molecule According to this report, subjective in one case. Data gathered from result in pharmacologically active effects of 5-MeO-DIPT are substantially published studies indicate that these are substances (McKenna and Towers, J. similar to those of MDMA, 3,4- administered orally at doses ranging Psychoactive Drugs, 16: 347–358, 1984). methylenedioxyamphetamine (MDA) from 15–40 mg for AMT and 6–20 mg The chemical structures of AMT and 5- and 4-Bromo-2,5- for 5-MeO-DIPT. MeO-DIPT possess the critical features dimethoxyphenethylamine (2C-B). 5- According to the Florida Department necessary for hallucinogenic/stimulant MeO-DIPT is an orally active of Law Enforcement (FDLE) report activity. In drug discrimination studies, hallucinogen. Following oral issued in 2002, the abuse by teens and both AMT and 5-MeO-DIPT substitute administration of 6–10 mg, 5-MeO-DIPT young adults of AMT and 5-MeO-DIPT for 1-(2,5-dimethoxy-4-methylphenyl)- produces subjective effects with an is an emerging problem. There have aminopropane (DOM), a onset of about 20–30 minutes, a peak at been reports of abuse of AMT and 5- phenethylamine-based hallucinogen in about 1–1.5 hours and duration of about MeO-DIPT at clubs and raves in Schedule I of the CSA. The potencies of 3–6 hours. Subjects who have been Arizona, California, Florida and New DOM-like discriminative stimulus administered 5-MeO-DIPT are talkative York. Many tryptamine-based effects of these and several other similar and disinhibited. 5-MeO-DIPT dilates substances are illicitly available from tryptamine derivatives correlate well pupils. High doses of 5-MeO-DIPT United States and foreign chemical with their hallucinogenic potencies in produce nausea, jaw clenching, muscle companies and from individuals humans (Glennon et al., Eur. J. tension and overt hallucinations with through the Internet. There is also Pharmacol. 86: 453–459, 1983). both auditory and visual distortions. As evidence of attempted clandestine AMT, besides its full generalization to mentioned above, 5-MeO-DIPT fully production of AMT and 5-MeO-DIPT in DOM, also partially mimics mimics the discriminative stimulus Nevada, Virginia and Washington, DC.
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