[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Proposed Rules]
[Pages 42217-42220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20204]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-331]


Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-
Dimethyltryptamine Into Schedule I of the Controlled Substances Act

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Deputy Administrator of the Drug Enforcement 
Administration (DEA) is issuing this notice of proposed rulemaking to 
place the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) and 
its salts into schedule I of the Controlled Substances Act (CSA). This 
proposed action is based on a recommendation from the Acting Assistant 
Secretary for Health of the Department of Health and Human Services 
(DHHS) and on an evaluation of the relevant data by DEA. If finalized 
as proposed, this action would impose the criminal sanctions and 
regulatory controls of schedule I substances under the CSA on the 
manufacture, distribution, dispensing, importation, exportation, and 
possession of 5-MeO-DMT.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before September 21, 2009. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after midnight Eastern time on the last day of the 
comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-331'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to the Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
[email protected]. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site. DEA will 
accept electronic comments containing Microsoft Word, WordPerfect, 
Adobe PDF, or Excel files only. DEA will not accept any file format 
other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, 
Virginia 22152, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

Comments and Requests for Hearing

    In accordance with the provisions of the CSA (21 U.S.C. 811(a)), 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557). 
All persons are invited to submit their comments or objections with 
regard to this proposal. Requests for a hearing may be submitted by 
interested persons and must conform to the requirements of 21 CFR 
1308.44 and 1316.47. The request should state, with particularity, the 
issues concerning which the person desires to be heard and the 
requestor's interest in the proceeding. Only interested persons, 
defined in the regulations as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811),'' may request a hearing.

21 CFR 1308.42. Please note that DEA may grant a hearing only ``for the 
purpose of receiving factual evidence and expert opinion regarding the 
issues involved in the issuance, amendment or repeal of a rule 
issuable'' pursuant to 21 U.S.C. 811(a). All correspondence regarding 
this matter should be submitted to the DEA using the address 
information provided above.

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the Drug

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Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

Explanation of 5-methoxy-N,N-dimethyltryptamine

    5-MeO-DMT is related to the schedule I hallucinogen, N,N-
dimethyltryptamine (DMT), in its chemical structure and pharmacological 
properties. 5-MeO-DMT also shares pharmacological similarities with 
several other schedule I hallucinogens such as 2,5-dimethoxy-4-
methylamphetamine (DOM), lysergic acid diethylamide (LSD) and 
mescaline. In animal drug discrimination studies, DOM, LSD, mescaline, 
DMT, and alpha-methyltryptamine (AMT) fully substitute for the 
discriminative stimulus cue of 5-MeO-DMT. In in vitro receptor binding 
studies, 5-MeO-DMT, similar to DMT and other schedule I hallucinogens, 
binds to central serotonin 2 (5-HT2) receptors.
    Studies show that the potencies of hallucinogens in humans 
correlate with their drug affinities for the 5-HT2 receptor 
and discriminative stimulus potencies. Accordingly, 5-MeO-DMT produces 
psychoactive effects in humans following inhalation (~6-20 mg), 
intravenous injection (~0.7-3.1 mg), sublingual (~10 mg), intranasal 
insufflation (~10 mg) and oral (~30 mg) (if encapsulated or taken with 
a monoamine oxidase inhibitor) routes of administration. Anecdotal 
reports from humans who have used 5-MeO-DMT describe hallucinogenic 
effects similar to those produced by DMT. 5-MeO-DMT, however, is 
reported to be 4 to 5-fold more potent than DMT when administered by 
inhalation, sublingual or oral (if encapsulated) routes of 
administration.

Control of 5-methoxy-N,N-dimethyltryptamine

    Evidence of the abuse of 5-MeO-DMT was first reported in 1999 by 
federal law enforcement personnel. According to the System to Retrieve 
Information on Drug Evidence (STRIDE), a federal database for seized 
drug exhibits analyzed by DEA laboratories, from January 1999 to 
December 2008, law enforcement seized 33 drug exhibits and filed 23 
cases pertaining to the trafficking, distribution and abuse of 5-MeO-
DMT. The seized drug exhibits comprised 89 grams of powder and 10 
milliliters of liquid containing 5-MeO-DMT. Since 2004, National 
Forensic Laboratory Information System (NFLIS), a database for drug 
cases analyzed by federal, state and local forensic laboratories, 
registered 23 state and local cases involving 27 analyzed items 
containing 5-MeO-DMT.
    There is evidence of clandestine laboratory operations to 
synthesize 5-MeO-DMT. 5-MeO-DMT has been encountered in powder, 
capsule, and liquid forms. 5-MeO-DMT is typically abused either by 
smoking or insufflating the powder. Investigations by federal law 
enforcement indicate that individuals, especially youths and young 
adults, are purchasing 5-MeO-DMT from Internet-based chemical 
suppliers. In addition, there are several instances where 5-MeO-DMT was 
sold as a counterfeit of MDMA.
    The risks to the public health associated with the abuse of 5-MeO-
DMT are similar to the risks associated with those of schedule I 
hallucinogens. 5-MeO-DMT can pose serious health risks to the user and 
general public through its ability to induce hallucinogenic effects and 
other sensory distortions and impaired judgment. Self-reports that are 
posted on Internet Web sites describe the abuse of this substance in 
combination with other controlled drugs such as DMT, N,N-
diethyltryptamine (DET), LSD, marijuana, ecstasy, or mushrooms 
(contains psilocybin and psilocin). This practice of drug abuse 
involving combinations can pose additional health risks to the users 
and the general public. These data show that the continued trafficking 
and abuse of 5-MeO-DMT pose hazards to the public health and safety. 
Indeed, there have been reports of emergency room admissions and death 
associated with the abuse of 5-MeO-DMT.
    There are no FDA-approved drug products. 5-MeO-DMT has never been 
approved by the FDA for marketing as a human drug product in the United 
States and there are no recognized therapeutic uses of 5-MeO-DMT in the 
United States.
    References to the above studies and data may be found in the Health 
and Human Services scheduling recommendation and DEA's independent 
analysis, both of which are available on the electronic docket 
associated with this rulemaking.

Placement of 5-MeO-DMT Into Schedule I

    In accordance with 21 U.S.C. 811(b) of the CSA, DEA has gathered 
and reviewed the available information regarding the pharmacology, 
chemistry, trafficking, actual abuse, pattern of abuse, and the 
relative potential for abuse of 5-MeO-DMT. On February 21, 2007, the 
Deputy Administrator of the DEA submitted these data to the Acting 
Assistant Secretary for Health, Department of Health and Human 
Services. In accordance with 21 U.S.C. 811(b), the Deputy Administrator 
also requested a scientific and medical evaluation and a scheduling 
recommendation for 5-MeO-DMT from the Acting Assistant Secretary for 
Health. On December 18, 2008, the Principal Deputy Assistant Secretary 
for Health, Department of Health and Human Services (DHHS), sent the 
Deputy Administrator of the DEA a scientific and medical evaluation and 
a letter recommending that 5-MeO-DMT and its salts be placed into 
schedule I of the CSA. Enclosed with the letter was a document prepared 
by FDA entitled, ``Basis for the Recommendation to Control 5-Methoxy-
Dimethyltryptamine (5-MeO-DMT) in Schedule I of the Controlled 
Substances Act.'' The document contained a review of the factors which 
the CSA requires the

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Secretary to consider (21 U.S.C. 811(b)). The factors considered by the 
Assistant Secretary of Health and DEA with respect to 5-MeO-DMT were:
    (1) Actual or relative potential for abuse;
    (2) Scientific evidence of its pharmacological effects, if known;
    (3) The state of current scientific knowledge regarding the drug;
    (4) History and current pattern of abuse;
    (5) The scope, duration, and significance of abuse;
    (6) What, if any, risk there is to the public health;
    (7) Psychic or physiological dependence liability; and
    (8) Whether the substance is an immediate precursor of a substance 
already controlled under the CSA.
    Based on the recommendation of the Assistant Secretary for Health, 
received in accordance with section 201(b) of the Act (21 U.S.C. 
811(b)), and the independent review of the available data by DEA, the 
Deputy Administrator finds that sufficient data exist to support the 
placement of 5-MeO-DMT into schedule I of the CSA pursuant to 21 U.S.C. 
811(a). The specific findings required pursuant to 21 U.S.C. 811 and 
812 for 5-MeO-DMT to be placed into schedule I are as follows:
    (1) 5-MeO-DMT has a high potential for abuse.
    (2)5-MeO-DMT has no currently accepted medical use in treatment in 
the United States.
    (3) There is a lack of accepted safety for use of 5-MeO-DMT under 
medical supervision.

Regulatory Requirements

    If this rule is finalized as proposed, 5-methoxy-N,N-
dimethyltryptamine would be subject to regulatory controls and 
administrative, civil and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importation and exportation of a 
schedule I controlled substance, including the following:
    Registration. Any person who manufactures, distributes, dispenses, 
imports or exports 5-methoxy-N,N-dimethyltryptamine or who engages in 
research or conducts instructional activities with respect to 5-
methoxy-N,N-dimethyltryptamine, or who proposes to engage in such 
activities, would be required to submit an application for schedule I 
registration in accordance with part 1301 of Title 21 of the Code of 
Federal Regulations.
    Security. 5-methoxy-N,N-dimethyltryptamine would be subject to 
schedule I security requirements and must be manufactured, distributed 
and stored in accordance with Sec. Sec.  1301.71; 1301.72(a), (c), and 
(d); 1301.73; 1301.74; 1301.75(a) and (c); and 1301.76 of Title 21 of 
the Code of Federal Regulations.
    Labeling and Packaging. All labels and labeling for commercial 
containers of 5-methoxy-N,N-dimethyltryptamine which are distributed on 
or after the effective date of a Final Rule finalizing this regulation 
would be required to comply with requirements of Sec. Sec.  1302.03 
through 1302.07 of Title 21 of the Code of Federal Regulations.
    Quotas. Quotas for 5-methoxy-N,N-dimethyltryptamine would be 
established pursuant to the requirements of part 1303 of Title 21 of 
the Code of Federal Regulations.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of 5-methoxy-N,N-dimethyltryptamine upon the 
effective date of any Final Rule finalizing these regulations would be 
required to keep an inventory of all stocks of the substance on hand 
pursuant to Sec. Sec.  1304.03, 1304.04 and 1304.11 of Title 21 of the 
Code of Federal Regulations. Every registrant who desires registration 
in schedule I to handle 5-methoxy-N,N-dimethyltryptamine would be 
required to conduct an inventory of all stocks of the substance.
    Records. All registrants who handle 5-methoxy-N,N-
dimethyltryptamine would be required to keep records pursuant to 
Sec. Sec.  1304.03, 1304.04 1304.21, 1304.22, and 1304.23 of Title 21 
of the Code of Federal Regulations.
    Reports. All registrants required to submit reports in accordance 
with Sec.  1304.33 of Title 21 of the Code of Federal Regulations would 
be required to do so regarding 5-methoxy-N,N-dimethyltryptamine.
    Order Forms. All registrants involved in the distribution of 5-
methoxy-N,N-dimethyltryptamine would be required to comply with the 
order form requirements of part 1305 of Title 21 of the Code of Federal 
Regulations.
    Importation and Exportation. All importation and exportation of 5-
methoxy-N,N-dimethyltryptamine would be required to be in compliance 
with part 1312 of Title 21 of the Code of Federal Regulations.
    Criminal Liability. Any activity with 5-methoxy-N,N-
dimethyltryptamine not authorized by, or in violation of, the 
Controlled Substances Act or the Controlled Substances Import and 
Export Act occurring on or after the effective date of any Final Rule 
finalizing these regulations would be unlawful.

Regulatory Certifications

Executive Order 12866

    In accordance with the provisions of the CSA (21 U.S.C. 811(a)), 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review 
by the Office of Management and Budget pursuant to Executive Order 
12866, section 3(d)(1).

Regulatory Flexibility Act

    The Deputy Administrator, in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612), has reviewed this proposed rule and 
by approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. This proposed rule, 
if finalized, would place 5-methoxy-N,N-dimethyltryptamine into 
schedule I of the Controlled Substances Act.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of State 
law; nor does it impose enforcement responsibilities on any State; nor 
does it diminish the power of any State to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under provisions of the Unfunded Mandates 
Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Congressional 
Review Act). 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

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based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

    Under the authority vested in the Attorney General by section 
201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the 
Administrator of DEA by Department of Justice regulations (28 CFR 
0.100), and redelegated to the Deputy Administrator pursuant to 28 CFR 
0.104, the Deputy Administrator hereby proposes that 21 CFR part 1308 
be amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

    2. Section 1308.11 is amended by:
    A. Redesignating existing paragraphs (d)(15) through (d)(34) as 
paragraphs (d)(16) through (d)(35).
    B. Adding a new paragraph (d)(15).


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (15) 5-methoxy-N,N-dimethyltryptamine, its isomers, salts and salts 
of isomers--7431.
    Some trade or other names: 5-methoxy-3-[2-
(dimethylamino)ethyl]indole; 5-MeO-DMT.
* * * * *

    Dated: August 12, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-20204 Filed 8-20-09; 8:45 am]
BILLING CODE 4410-09-P