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Home , Diethyltryptamine, Tryptamine

Federal Register / Vol. 68, No. 18 / Tuesday, January 28, 2003 / Proposed Rules 4127

FERRIS. The full text of this document § 157.205 Notice procedure. Table I, under paragraph (d) of this is available via FERRIS in Portable (a) Applicability. No activity section, or if the project is required to Document Format (PDF) and described in §§ 157.208(b), restore service to prevent loss of life, WordPerfect format for viewing, 157.211(a)(2), 157.214 or 157.216(b), impairment of health, or damage to printing, and/or downloading. To access except for activity required to restore property in an emergency due to a this document in FERRIS, type the service to prevent loss of life, sudden unanticipated loss of natural gas docket number excluding the last three impairment of health, or damage to supply or capacity, the certificate holder digits of this document in the docket property in an emergency due to a is authorized to make miscellaneous number field. sudden unanticipated loss of natural gas rearrangements of any facility, or 51. User assistance is available for supply or capacity, is authorized by a acquire, construct, replace, or operate FERRIS and FERC’s Web site during blanket certificate granted under this any eligible facility. For projects normal business hours. For assistance, subpart, unless, prior to undertaking undertaken pursuant to this section to contact FERC Online Support at such activity: restore service to prevent loss of life, [email protected] or toll- * * * * * impairment of health, or damage to free at (866) 208–3676, or for TTY 4. In § 157.207, the introductory text property due to a sudden unanticipated contact (202) 502–8659. is revised and a new paragraph (i) is loss of natural gas supply or capacity, added to read as follows: the Director of the Office of Energy List of Subjects in 18 CFR part 157 Projects shall designate a staff member Administrative practice and § 157.207 General reporting requirements. to advise and consult with the procedure, Natural gas, Reporting and In the case of an emergency due to a certificate holder, and the certificate record keeping requirements. sudden unanticipated loss of natural gas holder shall consult with the designated supply or capacity, the certificate holder By direction of the Commission. staff member during the period that the must file, in the manner prescribed in construction is in progress. A staff Magalie R. Salas, §§ 157.6(a) and 385.2011 of this chapter, Secretary. member designated by the Director of a report describing activity to be the Office of Energy Projects shall be In consideration of the foregoing, the undertaken to restore service in advance Commission proposes to amend part present on the construction site as of such activity in accordance with necessary or appropriate based on the 157, Chapter I, Title 18, Code of Federal paragraph (i) of this section. In addition, Regulations, as follows. nature of the project and shall have on or before May 1 of each year, the delegated authority to take whatever certificate holder must file, in the PART 157—APPLICATIONS FOR steps are necessary to insure the manner prescribed in §§ 157.6(a) and CERTIFICATES OF PUBLIC protection of all environmental 385.2011 of this chapter, an annual CONVENIENCE AND NECESSITY AND resources during activities associated report of all blanket certificate activities, FOR ORDERS PERMITTING AND with construction of the project. This including all activities undertaken to APPROVING ABANDONMENT UNDER authority shall allow the design and restore service following a sudden SECTION 7 OF THE NATURAL GAS implementation of any additional unanticipated loss of natural gas supply ACT measures deemed necessary (including or capacity. The annual report must be stop work authority) to assure continued 1. The authority citation for part 157 signed under oath by a senior official of compliance with the intent of the continues to read as follows: the company and list for the previous environmental conditions as well as the Authority: 15 U.S.C. 717–717W, 3301– calendar year: avoidance or mitigation of adverse 3432; 42 U.S.C. 7101–7352. * * * * * environmental impact resulting from (i) Reports describing emergency 2. In § 157.202, the last sentence in project construction. activities to be undertaken to restore * * * * * paragraph (b)(2)(i) and paragraph service following a sudden (b)(2)(ii)(C) are revised to read as unanticipated loss of natural gas supply [FR Doc. 03–1698 Filed 1–27–03; 8:45 am] follows: or capacity shall to the extent BILLING CODE 6717–01–P § 157.202 Definitions. practicable contain the information for * * * * * the facilities as required by the pertinent (b) Subpart F definitions. *** regulatory provisions specified in DEPARTMENT OF JUSTICE (2)(i) * * * Replacements for the paragraphs (a) through (h) of this Drug Enforcement Administration primary purpose of creating additional section. The report shall include the main line capacity are not eligible estimated costs of each activity and an 1 21 CFR Part 1308 facilities; however, replacements for the updated USGS 7 ⁄2 minute series (scale primary purpose of restoring service to 1:24000) topographic map (or map of [DEA–238N] prevent loss of life, impairment of equivalent or greater detail, as health, or damage to property due to appropriate) showing the location of Schedules of Controlled Substances: sudden unanticipated damage to main existing and proposed facilities, and Temporary Placement of Alpha- line facilities are eligible facilities. indicating the location of any sensitive methyltryptamine and 5-methoxy-N,N- (ii) Exclusions: *** environmental areas crossed by either Into Schedule I (C) A facility, including compression the existing or proposed facilities. 5. In § 157.208, paragraph (a) is AGENCY: Drug Enforcement and looping, that alters the capacity of Administration (DEA), Justice. a main line, except replacement revised to read as follows: ACTION: Notice of intent. facilities covered under § 157.208 Construction, acquisition, § 157.202(b)(2)(i); operation, replacement, and miscellaneous SUMMARY: The Deputy Administrator of * * * * * rearrangement of facilities. the Drug Enforcement Administration 3. In § 157.205, paragraph (a), (a) Automatic authorization. If the (DEA) is issuing this notice of intent to introductory text, is revised to read as project cost does not exceed the cost temporarily place - follows: limitations set forth in column 1 of methyltryptamine (AMT) and 5-

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methoxy-N,N-diisopropyltryptamine (5- imminent hazard to the public safety, Nervous Ment. Dis., 131: 428–434, 1960; MeO-DIPT) into Schedule I of the the Deputy Administrator is required to Murphree et al., Clin. Pharmacol. Ther., Controlled Substances Act (CSA) consider three of the eight factors set 2: 722–726, 1961). AMT also produces pursuant to the temporary scheduling forth in section 201(c) of the CSA (21 hallucinations and - provisions of the CSA. This intended U.S.C. 811(c)). These factors are as like mood elevating effects. action is based on a finding by the DEA follows: (4) History and current pattern 5-MeO-DIPT also produces Deputy Administrator that the of abuse; (5) The scope, duration and pharmacological effects similar to those placement of AMT and 5-MeO-DIPT significance of abuse; and (6) What, if of other Schedule I such into Schedule I of the CSA is necessary any, risk there is to the public health. as DMT. The synthesis and preliminary to avoid an imminent hazard to the human study on Alpha-methyltryptamine and 5- 5-MeO-DIPT was first published in 1981 public safety. Finalization of this action methoxy-N,N-diisopropyltryptamine will impose the criminal sanctions and (Shulgin and Carter, Comm. regulatory controls of a Schedule I Alpha-methyltryptamine (AMT) and Psychopharmacol. 4: 363–369, 1981). 5- substance on the manufacture, 5-methoxy-N,N-diisopropyltryptamine MeO-DIPT is an orally active distribution, and possession of AMT (5-MeO-DIPT) are . Following oral and 5-MeO-DIPT. (indoleethylamine) derivatives and administration of 6–10 mg, 5-MeO-DIPT share several similarities with the produces subjective effects with an FOR FURTHER INFORMATION CONTACT: Schedule I tryptamine hallucinogens, Frank Sapienza, Chief, Drug and onset at about 20–30 minutes, a peak at alpha-ethyltryptamine (AET) and N,N- Chemical Evaluation Section, Office of about 1–1.5 hours and a duration of dimethyltryptamine (DMT), Diversion Control, Drug Enforcement about 3–6 hours. Subjects who have respectively. Several other been administered 5-MeO-DIPT are Administration, Washington, DC 20537, also produce hallucinogenic/stimulant talkative and disinhibited. 5-MeO-DIPT Telephone (202) 307–7183. effects and are controlled as Schedule I causes mydriasis. High doses of 5-MeO- SUPPLEMENTARY INFORMATION: substances under the CSA (bufotenine, DIPT produce nausea, jaw clenching, Background , and muscle tension and overt hallucinations ). Although tryptamine itself with both auditory and visual The Comprehensive Crime Control appears to lack consistent distortions. Act of 1984 (Pub. L. 98–473) amended hallucinogenic/stimulant effects, section 201 of the CSA (21 U.S.C. 811) substitutions on the ring and the History and Current Pattern of Abuse to give the Attorney General the ethylamine side-chain of this molecule The popularity and use of authority to temporarily place a result in pharmacologically active hallucinogenic/stimulant substances at substance into Schedule I of the CSA for substances (McKenna and Towers, J. raves (all-night dance parties) and other one year without regard to the Psychoactive Drugs, 16: 347–358, 1984). social venues have been a major requirements of 21 U.S.C. 811(b) if he The chemical structures of AMT and problem in Europe since the 1990s. In finds that such action is necessary to 5-MeO-DIPT possess the critical features the past several years, this activity has avoid an imminent hazard to the public necessary for hallucinogenic/stimulant spread to the United States. The safety. The Attorney General may activity. Thus, both AMT and 5-MeO- Schedule I controlled substance 3,4- extend the temporary scheduling up to DIPT are likely to have a methylenedioxymethamphetamine 6 months. A substance may be pharmacological profile substantially (MDMA or Ecstasy) and its analogues temporarily scheduled under the similar to other Schedule I tryptamine are the most frequently abused drugs at emergency provision of the CSA if that derivatives such as DMT and AET. In these raves. Their abuse has been substance is not listed in any other drug discrimination studies, both AMT associated with both acute and long- schedule under section 202 of the CSA and 5-MeO-DIPT substitute for 1-(2,5- term public health and safety problems. (21 U.S.C. 812) or if there is no dimethoxy-4-methylphenyl)- Raves have also become venues for the exemption or approval in effect under aminopropane (DOM), a trafficking and abuse of new, non- 21 U.S.C. 355 for the substance. The -based hallucinogen in controlled substances distributed as Attorney General has delegated his Schedule I of the CSA. The potencies of legal substitutes for, or in addition to, authority under 21 U.S.C. 811 to the DOM-like discriminative stimulus MDMA. 5-MeO-DIPT and AMT belong Deputy Administrator of DEA (28 CFR effects of these and several other similar to such a group of substances. 0.100). tryptamine derivatives correlate well Data gathered from published studies, Section 201(h)(4) of the CSA (21 with their hallucinogenic potencies in supplemented by reports on Internet U.S.C. 811(h)(4)) requires the Deputy humans (Glennon et al., Eur. J. websites indicate that these are often Administrator to notify the Assistant Pharmacol. 86:453–459, 1983). administered orally at doses ranging Secretary for Health, delegate of the AMT shares other pharmacological from 15–40 mg for AMT and 6–20 mg Secretary of Health and Human properties with Schedule I for 5-MeO-DIPT. Other routes of Services, of his intention to temporarily hallucinogens such as AET. AMT administration include smoking and place a substance into Schedule I of the increases systolic and diastolic arterial snorting. Data from law-enforcement CSA. Comments submitted by the blood pressures. The behavioral effects officials indicate that 5-MeO-DIPT is Assistant Secretary for Health in of orally administered AMT (20 mg) in often sold as ‘‘Foxy’’ or ‘‘Foxy response to this notification, including humans are slow in onset, occurring Methoxy’’, while AMT has been sold as whether there is an exemption or after 3 to 4 hours and gradually subside ‘‘Spirals’’ at least in one case. Both approval in effect for the substance in after 12 to 24 hours, but may last up to substances have been commonly question under the Federal Food, Drug 2 days in some subjects. The majority of encountered in tablet and capsule and Cosmetic Act, shall be taken into the subjects report nervous tension, forms. consideration before a final order is irritability, restlessness, inability to published. sleep, blurry vision, mydriasis and Scope, Duration and Significance of In making a finding that places a equate the effects of a 20 mg dose to Abuse substance temporarily into Schedule I of those of 50 micrograms of lysergic acid According to forensic laboratory data, the CSA is necessary to avoid an diethylamide (LSD) (Hollister et al., J. the first encounter of AMT and 5–MeO–

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DIPT occurred in 1999. Since then, law substances each have a high potential Regulatory Certifications enforcement officials in Arizona, for abuse, no currently accepted medical Regulatory Flexibility Act California, Colorado, Delaware, Florida, use in treatment in the United States Idaho, Illinois, Iowa, New Jersey, and are not safe for use under medical The Deputy Administrator hereby Oregon, Texas, Virginia, Washington, supervision. certifies that this rulemaking has been Wisconsin and the District or Columbia drafted in accordance with the Role of the Assistant Secretary for have encountered these substances. Regulatory Flexibility Act (5 U.S.C. Health in Temporary Scheduling According to the Florida Department of 605(b)), has reviewed this regulation, Law Enforcement (FDLE), the abuse by Section 201(h)(4) of the CSA (21 and by approving it certifies that this teens and young adults of AMT and 5– regulation will not have a significant MeO–DIPT is an emerging problem. U.S.C. 811(h)(4)) requires the Deputy Administrator to notify the Assistant economic impact on a substantial There have been reports of abuse of number of small entities. This action AMT and 5–MeO–DIPT at clubs and Secretary for Health, delegate of the Secretary of Health and Human provides a notice of intent to raves in Arizona, California, Florida and temporarily place AMT and 5-MeO- Services, of his intention to temporarily New York. Many tryptamine-based DIPT into Schedule I of the CSA. DEA place substances into Schedule I of the substances are illicitly available from is not aware of any legitimate uses of CSA. Comments submitted by the United States and foreign chemical AMT and 5-MeO-DIPT in the United companies and from individuals Assistant Secretary for Health in States. through the Internet. A gram of AMT or response to the notification regarding 5–MeO–DIPT as bulk powder costs less AMT and 5–MeO–DIPT, including Executive Order 12988 than $150 from illicit sources on the whether there is an exemption or This regulation meets the applicable Internet. DEA is not aware of any approval in effect for the substances in standards set forth in Sections 3(a) and legitimate medical or scientific use of question under the Federal Food, Drug AMT and 5–MeO–DIPT. There is recent 3(b)(2) of Executive Order 12988 Civil and Cosmetic Act, shall be taken into Justice Reform. evidence suggesting the attempted consideration before a final order is clandestine production of AMT and 5– published. Executive Order 13132 Federalism MeO–DIPT in Nevada, Virginia and Washington, DC. Based on the above data, the This rule will not have substantial continued uncontrolled distribution and direct effects on the States, on the Public Health Risks abuse of AMT and 5–MeO–DIPT pose relationship between the national AMT and 5–MeO–DIPT share an imminent risk to the public safety. government and the States, or on the substantial chemical and DEA is not aware of any recognized distribution of power and pharmacological similarities with other therapeutic uses of these substances in responsibilities among the various Schedule I tryptamine-based the United States. levels of government. Therefore, in hallucinogens in Schedule I of the CSA In accordance with the provisions of accordance with Executive Order 13132, (AET and DMT). This makes it likely section 201(h) of the CSA (21 U.S.C. it is determined that this rule will not that these drugs cause similar health has sufficient federalism implications to hazards. Tryptamine, the parent 811(h)) and 28 CFR 0.100, the Deputy Administrator has considered the warrant the preparation of a Federalism molecule of AMT and 5–MeO–DIPT, is Assessment. known to produce convulsions and available data and the three factors death in animals (Tedeschi et al., J. required for a determination to Unfunded Mandates Reform Act Pharmacol. Exp. Ther. 126:223–232, temporarily schedule AMT and 5–MeO– This rule will not result in the 1959). AMT and 5–MeO–DIPT, similar DIPT in Schedule I of the CSA and finds to other tryptaine- or phenethylamine- that placement of AMT and 5–MeO– expenditure by State, local and tribal based hallucinogens, through the DIPT into Schedule I of the CSA is governments, in the aggregate, or by the alteration of sensory perception and necessary to avoid an imminent hazard private sector, of $100,000,000 or more judgment can pose serious health risks to the public safety. in any one year, and it will not significantly or uniquely affect small to the user and the general public. Because the Deputy Administrator Further, there have been several self- governments. Therefore, no actions were finds that it is necessary to temporarily deemed necessary under provisions of reports on Internet websites describing place AMT and 5–MeO–DIPT into the reported abuse of these substances the Unfunded Mandates Reform Act of Schedule I to avoid an imminent hazard 1995. in combination with other controlled to the public safety, the final order, if drugs, namely MDMA, marijuana, issued, will be effective on the date of Small Business Regulatory Enforcement gamma hydroxybutyric acid (GHB) and publication of the Federal Register. Fairness Act of 1996 2,5-dimethoxy-4-(n)- AMT and 5–MeO–DIPT will be subject propylthiophenethylamine (–T–7). This rule is not a major rule as This practice of drug abuse involving to the regulatory controls and defined by section 804 of the Small combinations poses additional health administrative, civil and criminal Business Regulatory Enforcement risks to the users and the general public. sanctions applicable to the manufacture, Fairness Act of 1996. This rule will not Available information indicates that distribution, possession, importing and result in an annual effect on the AMT and 5–MeO–DIPT lack any exporting of a Schedule I controlled economy of $100,000,000 or more; a approved therapeutic use in the United substance under the CSA. Further, it is major increase in costs or prices; or States. The safety of these substances for the intention of the Deputy significant adverse effects on use in humans has not been studied. Administrator to issue such a final order competition, employment, investment, DEA has considered the three criteria as soon as possible after the expiration productivity, innovation, or on the for placing a substance into Schedule I of thirty days from the date of ability of United States-based of the CSA (21 U.S.C. 812). The data publication of this notice and the date companies to compete with foreign- available and reviewed for AMT and 5– that notification was transmitted to the based companies in domestic and MeO–DIPT indicate that these Assistant Secretary for Health. export markets.

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List of Subjects in 21 CFR Part 1308 DATES: Comments and related material anchorage area in the Galveston Bay Administrative practice and must reach the Coast Guard on or before area. HOGANSAC, a Congressionally- procedure, Drug traffic control, March 31, 2003. chartered Federal advisory committee, Narcotics, Prescription drugs, Reporting ADDRESSES: You may mail comments is responsible for advising, consulting and record keeping requirements. and related material to Commander, with and making recommendations to Eighth Coast Guard District (m), Hale the Secretary of Transportation on Under the authority vested in the Boggs Federal Bldg., 501 Magazine matters relating to the transit of vessels Attorney General by Section 201(h) of Street, New Orleans, LA 70130, or to and from the ports of Galveston, the CSA (21 U.S.C. 811(h), and deliver comments and related material Houston and Texas City and the safety delegated to the Deputy Administrator to Room 1341 at the same address of maritime navigation in the Galveston of the DEA by Department of Justice between 8 a.m. and 3:30 p.m., Monday regulations (28 CFR 0.100), the Deputy Bay area. Participants at the February through Friday, except Federal holidays. Administrator hereby intends to order 2002 HOGANSAC meeting noted that a Commander, Eighth Coast Guard that 21 CFR part 1308 be amended as third anchorage in the Bolivar Roads District (m) maintains the public docket follows: area was necessary to address port for this rulemaking. Comments and security and navigation safety concerns. PART 1308—SCHEDULES OF material received from the public, as After extensive discussion, including CONTROLLED SUBSTANCES well as documents indicated in this the observations of and comments from preamble as being available in the members of the public in attendance, 1. The authority citation for 21 CFR docket, will become part of this docket HOGANSAC recommended that the part 1308 continues to read as follows: and will be available for inspection or Coast Guard establish a third anchorage Authority: 21 U.S.C. 811, 812, 871b, unless copying at Commander, Eighth Coast area in Bolivar Roads. otherwise noted. Guard District (m) between 8 a.m. and 3:30 p.m., Monday through Friday, Based on the recommendation of 2. Section 1308.11 is to be amended except Federal holidays. HOGANSAC the Coast Guard proposes by adding paragraph (g)(6) and (7) to a third anchorage area, anchorage area read as follows: FOR FURTHER INFORMATION CONTACT: Lieutenant (LT) Karrie Trebbe, Project (C), in Bolivar Roads. The proposed § 1308.11 Schedule I. Manager for Eighth Coast Guard District anchorage area, located inside the * * * * * Commander, telephone (504) 589–6271. Galveston Bay Entrance Jetties, would provide a sheltered location for vessels (g) * * * SUPPLEMENTARY INFORMATION: (6) Alpha-methyltryptamine (AMT), to anchor during heavy weather or its isomers, salts and salts of isomers: Request for Comments reduced visibility conditions. The 7432. We encourage you to participate in existing anchorages, anchorage area (A) (7) 5-methoxy-N,N- this rulemaking by submitting and anchorage area (B), are generally diisopropyltryptamine (5-MeO-DIPT), comments and related material. If you full during these same periods and there its isomers, salts and salts of isomers: do so, please include your name and is no alternative sheltered anchorage in 7439. address, identify the docket number for Bolivar Roads. The proposed location of * * * * * this rulemaking (CCGD8–02–018), anchorage area (C), abuts the western edge of anchorage area (B), is in a Dated: January 10, 2003. indicate the specific section of this document to which each comment naturally deep portion of Bolivar Roads, John B. Brown, III, applies, and give the reason for each and is outside any heavily traveled Deputy Administrator. comment. Please submit all comments section of the waterway. [FR Doc. 03–1800 Filed 1–27–03; 8:45 am] and related material in an unbound This third anchorage area is also BILLING CODE 4410–09–M 1 format, no larger than 8 ⁄2 by 11 inches, necessary because port security-related suitable for copying. If you would like initiatives adopted by various terminals to know they reached us, please enclose and facilities in the Galveston Bay area DEPARTMENT OF TRANSPORTATION a stamped, self-addressed postcard or have restricted pier side operations envelope. We will consider all Coast Guard critical to the efficient flow of maritime comments and material received during commerce. For example, bunkering, the comment period. We may change 33 CFR Part 110 provisions deliveries, and personnel this proposed rule in view of them. transfer operations are restricted or [CGD08–02–018] Public Meeting prohibited by numerous facilities in the RIN 2115–AA98 We do not now plan to hold a public ports of Galveston, Houston and Texas meeting. But you may submit a request City. The nature of those activities Anchorage Regulation; Bolivar Roads, requires that they be accomplished in Galveston, TX for a meeting by writing to Commander, Eighth Coast Guard District (m) at the calm water conditions and relatively AGENCY: Coast Guard, DOT. address under ADDRESSES explaining close to shore. As a result, vessel operators and ship owners rely upon the ACTION: Notice of proposed rulemaking. why one would be beneficial. If we determine that a public meeting would existing anchorage areas (anchorage SUMMARY: The Coast Guard proposes to aid this rulemaking, we will hold one at areas (A) and (B)) in Galveston Bay to create a new anchorage area in Bolivar a time and place announced by a later conduct these operations. Increasingly, Roads near Galveston, Texas. The notice in the Federal Register. anchorage space in those areas is in high establishment of this new anchorage demand. A third designated anchorage area would enhance navigational safety, Background and Purpose area would relieve congestion and support regional maritime security At its February 2002 meeting the provide anchorage space to needs, and contribute to the free flow of Houston/Galveston Navigation Safety accommodate the ever-increasing commerce in the Houston/Galveston Advisory Committee (HOGANSAC) volumes of traffic in the Galveston Bay area. recommended establishment of a third area.

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