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

Federal Register: October 28, 2009 (Volume 74, Number 207)

Proposed Rules

Page 55502-55504

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr28oc09-25

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.

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 dea.diversion.policy@usdoj.gov. 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

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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

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