[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Proposed Rules]
[Pages 55502-55504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25939]
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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; reopening of comment period.
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SUMMARY: On August 21, 2009, the Drug Enforcement Administration (DEA)
published a notice of proposed rulemaking in the Federal Register, 74
FR 42217, to place the substance 5-methoxy-N,N-dimethyltryptamine (5-
MeO-DMT) and its salts into schedule I of the Controlled Substances Act
(CSA). The original 30-day comment period expired on September 21,
2009. DEA is reopening the comment period for an additional 30-day
period.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before November 27, 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
[[Page 55503]]
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 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.
Reopening of Comment Period
On August 21, 2009, the Drug Enforcement Administration (DEA)
published a notice of proposed rulemaking in the Federal Register, 74
FR 42217, to place the substance 5-methoxy-N,N-dimethyltryptamine (5-
MeO-DMT) and its salts into schedule I of the Controlled Substances Act
(CSA). 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. 5-MeO-DMT is related to the
schedule I hallucinogen, N,N-dimethyltryptamine (DMT), in its chemical
structure and pharmacological properties. Further, 5-MeO-DMT shares
pharmacological similarities with several other schedule I
hallucinogens such as 2,5-dimethoxy-4-methylamphetamine (DOM), lysergic
acid diethylamide (LSD) and mescaline. 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. 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 Food and Drug Administration has never approved 5-MeO-DMT 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. 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.
Consequently, 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.
In accordance with 21 U.S.C. 811(b) of the CSA, DEA 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.
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 found 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).
DEA's proposed rule made reference to the documents discussed above
and stated that these documents were available for viewing on the
electronic
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docket associated with the rulemaking. Specifically, the documents
cited in the rulemaking are as follows:
1. Letter from the Principal Deputy Assistant Secretary for Health,
Department of Health and Human Services, recommending that 5-MeO-DMT
and its salts be placed into schedule I of the CSA with a scientific
and medical evaluation titled ``Basis for the Recommendation to Control
5-Methoxy-Dimethyltryptamine (5-MeO-DMT) in Schedule I of the
Controlled Substances Act,'' December 18, 2008.
2. DEA's final scheduling document titled ``5-Methoxy-N,N-
Dimethyltryptamine Scheduling Review Document: Eight Factor Analysis,''
July 17, 2009.
After the comment period closed on September 21, 2009, DEA
discovered that the supporting documents referenced in the proposed
rule were not posted to the electronic docket, thus not available for
public viewing. Such documentation has since been posted to the
electronic docket and is available for review. DEA wishes to ensure all
interested members of the public have an opportunity to review these
materials and comment. Accordingly, DEA is reopening the public comment
period and will accept comments for an additional 30 days. Comments
already submitted in response to the August 21, 2009, notice will be
considered and need not be resubmitted.
Dated: October 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E9-25939 Filed 10-27-09; 8:45 am]
BILLING CODE 4410-09-P