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 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

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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 -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 , AMT binds to 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 release and substances have been commonly share several similarities with the inhibits 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 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 , and synthesis and preliminary human white, off-white, gray, and burnt orange. psilocyn). Although tryptamine itself 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 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 (-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, . 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- -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. and 3,4- effects of DOM, a Schedule I According to data from the System to methylenedioxymethamphetamine hallucinogen. According to the Retrieve Information on Drug Evidence (MDMA) in drug discrimination tests in discriminative stimulus studies (STRIDE), since 1999 Federal law experimental animals. AMT increases conducted by the Drug Evaluation enforcement authorities seized 34 drug systolic and diastolic arterial blood Committee of the College on Problems exhibits and filed 14 cases pertaining to pressures, dilates pupils and produces of Drug Dependence, 5-MeO-DIPT dose- the trafficking, distribution and abuse of strong motor stimulant effects. The dependently (0.1–3 mg/kg, IP) AMT during 1999 to 2003. The behavioral effects of orally administered generalizes to LSD with a maximal corresponding STRIDE data for 5-MeO- AMT (20 mg) in humans are slow in response of about 70% at doses (3 mg/ DIPT included 63 drug exhibits onset, occurring after 3 to 4 hours, and kg) that severely disrupted responding. pertaining to 32 cases. AMT drug gradually subsiding after 12 to 24 hours, The abuse of stimulant/ seizures included 21 capsules and but may last up to 2 days in some hallucinogenic substances in popular all 1,011.8 grams of powder, while 5-MeO- subjects. The majority of the subjects night dance parties (‘‘raves’’) and in DIPT drug seizures included 12,070 report euphoria, stimulation, muscle other venues has been a major problem tablets, 560 capsules, and 6,532.3 grams tension, muscle ache, nervous tension, in Europe since the 1990s. In the past of powder. Since 2001, the National irritability, restlessness, dizziness, several years, this activity has spread to Forensic Laboratory Information System impaired motor coordination, unsettled the United States. The Schedule I (NFLIS) registered 10 and 12 cases of feeling in stomach, inability to relax and controlled substance MDMA and its AMT and 5-MeO-DIPT, respectively. sleep, and visual effects such as blurry analogues, collectively known as AMT drug exhibits included 17 dosage vision, apparent movement of objects, Ecstasy, are the most popular drugs units and 7.53 grams of powder, while sharper outlines, brighter colors, longer abused at these raves. Their abuse has 5-MeO-DIPT drug exhibits included 24 after images, and visual hallucinations. been associated with both acute and capsules, 3 tablets and 14.42 grams of The majority of the subjects equate the long-term public health and safety powder.

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AMT and 5-MeO-DIPT share trafficking and abuse data, as of AMT and 5-MeO-DIPT which are substantial chemical and summarized herein, does exist to place distributed on or after October 29, 2004 pharmacological similarities with other AMT and 5-MeO-DIPT in Schedule I of shall comply with requirements of Schedule I tryptamine-based the CSA on a permanent basis. As these §§ 1302.03 –1302.07 of Title 21 of the hallucinogens in Schedule I of the CSA. substances have no legitimate medical Code of Federal Regulations. AMT shares pharmacological effects of use in the United States, the trafficking 4. Quotas. Quotas for AMT and 5- amphetamine, a stimulant, and DOM in, and use by individuals for the MeO-DIPT are established pursuant to and LSD, the Schedule I hallucinogens. psychoactive effects they produce, is Part 1303 of Title 21 of the Code of AMT acts as a stimulant, produces considered abuse. In addition, the Federal Regulations. euphoria and increases heart rate and control of these substances in Schedule 5. Inventory. Every registrant required blood pressure. The evidence suggests I of the CSA does not violate any legally to keep records and who possesses any that 5-MeO-DIPT mimics protected right. quantity of AMT and 5-MeO-DIPT is pharmacological effects of MDMA, Based on all the available information required to keep an inventory of all MDA, and 2C–B, the Schedule I gathered and reviewed by the DEA and stocks of the substances on hand hallucinogens. It also partially mimics in consideration of the scientific and pursuant to §§ 1304.03, 1304.04 and amphetamine effects. The risks to the medical evaluation and scheduling 1304.11 of Title 21 of the Code of public health associated with the above recommendation by the Assistant Federal Regulations. Every registrant mentioned controlled substances are Secretary of the DHHS, the Deputy who desires registration in Schedule I well known and documented. AMT and Administrator has determined that for AMT and 5-MeO-DIPT shall conduct 5-MeO-DIPT, similar to other sufficient data exist to support the an inventory of all stocks of AMT and tryptamine-or phenethylamine-based placement of AMT and 5-MeO-DIPT 5-MeO-DIPT. hallucinogens, through the alteration of into Schedule I of the CSA pursuant to 6. Records. All registrants are required sensory perception and judgment can 21 U.S.C. 811(a). The Deputy to keep records pursuant to §§ 1304.03, pose serious health risks to the user and Administrator finds: 1304.04 and §§ 1304.21–1304.23 of Title the general public. Tryptamine, the (1) AMT and 5-MeO-DIPT have a high 21 of the Code of Federal Regulations. parent molecule of AMT and 5-MeO- potential for abuse. 7. Reports. All registrants required to DIPT, is known to produce convulsions (2) AMT and 5-MeO-DIPT have no submit reports in accordance with and death in animals (Tedeschi et al., J. currently accepted medical use in § 1304.33 of Title 21 of the Code of Pharmacol. Exp. Ther. 126: 223–232, treatment in the United States. Federal Regulations shall do so 1959). Following extensive studies on (3) AMT and 5-MeO-DIPT lack regarding AMT and 5-MeO-DIPT. AMT as a possible drug accepted medical safety for use under 8. Order Forms. All registrants in 1960s, The Upjohn Company medical supervision. involved in the distribution of AMT and concluded that AMT is a highly toxic In accordance with 21 U.S.C. 5-MeO-DIPT must comply with the substance and discontinued the clinical 811(h)(5), the Deputy Administrator order form requirements of part 1305 of studies on this substance. In fact, there hereby vacates the order temporarily Title 21 of the Code of Federal were two recent published case reports placing AMT and 5-MeO-DIPT into Regulations. describing the instances of emergency Schedule I of the CSA published in the 9. Importation and Exportation. All department admissions resulting from Federal Register on April 4, 2003. importation and exportation of AMT abuse of AMT and 5-MeO-DIPT in 2003 Regulatory Requirements and 5-MeO-DIPT must be in compliance with part 1312 of Title 21 of the Code (Long et al., Vet. Human Toxicol., 45: With the issuance of this final order, of Federal Regulations. 149, 2003; Meatherall and Sharma, J. AMT and 5-MeO-DIPT continue to be 10. Criminal Liability. Any activity Anal. Toxicol., 27: 313–317, 2003). subject to regulatory controls and with AMT and 5-MeO-DIPT not There has been at least one confirmed administrative, civil and criminal authorized by, or in violation of, the death caused by the abuse of AMT in sanctions applicable to the manufacture, Controlled Substances Act or the Florida in 2003. The above data show distribution, dispensing, importing and Controlled Substances Import and that the continued, uncontrolled tablet exporting of a Schedule I controlled Export Act occurring on or after or capsule production, distribution and substance, including the following: abuse of AMT and 5-MeO-DIPT pose 1. Registration. Any person who September 29, 2004 will continue to be hazards to the public health and safety. manufactures, distributes, dispenses, unlawful. There are no recognized therapeutic imports or exports AMT and 5-MeO- Regulatory Certifications uses of these substances in the United DIPT or who engages in research or States. conducts instructional activities with Regulatory Flexibility Act The DEA received one comment from respect to AMT and 5-MeO-DIPT or who The Deputy Administrator of the DEA an organization in response to the proposes to engage in such activities hereby certifies that the placement of proposed placement of AMT and 5- must submit an application for AMT and 5-MeO-DIPT into Schedule I MeO-DIPT into Schedule I of the CSA. Schedule I registration in accordance of the CSA will not have a significant This organization did not support the with part 1301 of Title 21 of the Code economic impact upon entities whose proposed placement of these drugs into of Federal Regulations. interests must be considered under the Schedule I on the following basis: (1) 2. Security. AMT and 5-MeO-DIPT are Regulatory Flexibility Act, 5 U.S.C. 601 They believed insufficient data exists to subject to Schedule I security et seq. This action involves the control support placement into Schedule I as requirements and must be of two substances with no currently the mere use of these substances was manufactured, distributed and stored in accepted medical use in the United not abuse and (2) Prohibiting the accordance with §§ 1301.71, 1301.72(a), States. possession of these substances is a (c), and (d), 1301.73, 1301.74, 1301.75 Executive Order 12866 substantial infringement of the (a) and (c) and 1301.76 of Title 21 of the fundamental right of adults to freedom Code of Federal Regulations. This final rule is not a significant of thought. Both the DEA and the DHHS 3. Labeling and Packaging. All labels regulatory action for the purposes of have found that sufficient scientific, and labeling for commercial containers Executive Order 12866. Drug

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Scheduling matters are not subject to PART 1308—SCHEDULES OF ADDRESSES: Documents indicated in this review by the Office of Management and CONTROLLED SUBSTANCES preamble as being available in the Budget pursuant to provisions of docket are port of docket CGD13–04– Executive Order 12866, section 3(d)(1). I 1. The authority citation for Part 1308 039 and are available for inspection or continues to read as follows: copying at the U.S. Coast Guard Marine Executive Order 12988 Authority: 21 U.S.C. 811, 812, 871(b) Safety Office Puget Sound, 1519 This regulation meets the applicable unless otherwise noted. Alaskan Way South, Building 1, Seattle, standards set forth in sections 3(a) and I 2. Section 1308.11 is amended by: Washington 98134 between 8 a.m. and 3(b)(2) of Executive Order 12988 Civil I A. Redesignating existing paragraphs 4 p.m., Monday through Friday, except Justice Reform. (d)(15) through (d)(32) as paragraphs Federal holidays. Executive Order 13132 (d)(16) through (d)(33), FOR FURTHER INFORMATION CONTACT: I B. Adding a new paragraph (d)(15), Lieutenant Junior Grade Jessica Hagen at This final rule does not have I C. Further redesignating paragraphs (206) 217–6231. substantial direct effects on the States, (d)(19) through (d)(33) as paragraphs SUPPLEMENTARY INFORMATION: on the relationship between the national (d)(20) through (d)(34), government and the States, or on the I D. Adding a new paragraph (d)(19), Background and Purpose distribution of power and I E. Removing paragraphs (g)(3) and We did not publish a notice of responsibilities among the various (g)(4) to read as follows: proposed rulemaking (NPRM) for this levels of government. Therefore, in § 1308.11 Schedule I. regulation. Under 5 U.S.C. 553(b)(B), the accordance with Executive Order 13132, Coast Guard finds that good cause exists * * * * * it is determined that this rule will not for not publishing an NPRM. The (d) * * * have sufficient federalism implications hydroplane race poses several dangers (15) Alpha-methyltryptamine (other to warrant the preparation of a to the public including excessive noise, name: AMT)—7432. federalism assessment. objects falling from any accidents, and * * * * * Unfunded Mandates Reform Act of 1995 hydroplanes racing at high speeds in (19) 5-methoxy-N,N- proximity to other vessels. Accordingly, This rule will not result in the diisopropyltryptamine (other name: 5- prompt regulatory action is needed in expenditure by State, local and tribal MeO-DIPT) —7439. order to provide for the safety of governments, in the aggregate, or by the * * * * * spectators and participants during the private sector, of $114,000,000 or more Dated: September 23, 2004. event. If normal notice and comment in any one year, and it will not procedures were followed, this rule significantly or uniquely affect small Michele M. Leonhart, Deputy Administrator. would not become effective until after governments. Therefore, no actions were the date of the event. The Coast Guard [FR Doc. 04–21755 Filed 9–28–04; 8:45 am] deemed necessary under provisions of finds that good cause exists for not the Unfunded Mandates Reform Act of BILLING CODE 4410–09–P publishing an NPRM, because doing so 1995. would be contrary to the interests of Small Business Regulatory Enforcement public safety because immediate action DEPARTMENT OF HOMELAND Fairness Act of 1996 is necessary to protect the public. SECURITY Under 5 U.S.C.(d)(3), for the same This rule is not a major rule as Coast Guard reasons cited above, the Coast Guard defined by Section 804 of the Small finds that good cause exists for making Business Regulatory Enforcement 33 CFR Part 100 this rule effective in less than 30 days Fairness Act of 1996. This rule will not after publication in the Federal result in an annual effect on the [CGD13–04–039] Register. economy of $100,000,000 or more; a major increase in costs or prices; or RIN 1625–AA08 Discussion of Rule significant adverse effects on Special Local Regulations for Marine This rule will create two regulated competition, employment, investment, Events, Strait Thunder Hydroplane areas, a race area and a viewing area. productivity, innovation, or on the Races, Port Angeles, WA These regulated areas restrict the ability of United States-based movement of spectator, non-participant, companies to compete with foreign- AGENCY: Coast Guard, DHS. vessels during hydroplane races. These based companies in domestic and ACTION: Temporary final rule. regulated areas assist in minimizing the export markets. inherent dangers associated with SUMMARY: List of Subjects in 21 CFR Part 1308 The Coast Guard is hydroplane races. These dangers establishing temporary special local include, but are not limited to, excessive Administrative practice and regulations for the Strait Thunder noise, race craft traveling at high speed procedure, Drug traffic control, Hydroplane Races held on the waters of in close proximity to one another and to Reporting and recordkeeping Port Angeles Harbor, Port Angeles, spectator craft, and the risk of airborne requirements. Washington. These special local objects from any accidents associated I Under the authority vested in the regulations limit the movement of non- with hydroplanes. In the event that Attorney General by Section 201(a) of the participating vessels in the regulated hydroplanes require emergency CSA (21 U.S.C. 811(a)), and delegated to race area and provide for a viewing area assistance, rescuers must have the Administrator of the DEA by the for spectator craft. This rule is needed immediate and unencumbered access to Department of Justice regulations (28 to provide for the safety of life on the craft. The Coast Guard, through this CFR 0.100) and re-delegated to the navigable waters during the event. action, intends to promote the safety of Deputy Administrator pursuant to 28 DATES: This rule is effective from 9 a.m. personnel, vessels, and facilities in the CFR 0.104, the Deputy Administrator on October 1, 2004 through 5 p.m. on area. Due to these concerns, public amends 21 CFR Part 1308 as follows: October 3, 2004 Pacific Daylight Time. safety requires these regulations to

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