[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