The rest of the announcement>
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
[[Page 42218]]
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
[[Page 42219]]
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
[[Page 42220]]
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
