Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-Dimethyltryptamine Into Schedule I of the Controlled Substances Act, 55502-55504 [E9-25939]

Download as PDF 55502 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Proposed Rules 6. As locum tenens practitioners, do you administer, dispense and prescribe controlled substances? Does your authority to do so vary in the States in which you practice? 7. Can you have more than one locum tenens job at a time? Those That Employ and Place Locum Tenens Practitioners 8. What role do you have in the locum tenens process? 9. Do you assist with State and Federal licensure/registration? If so, how? 10. What types of practitioners do you employ or place (e.g., physicians, dentists, nurse practitioners)? 11. How do you verify the locum tenens practitioner’s credentials? 12. Are criminal background checks performed on locum tenens practitioners? 13. What is the geographical coverage for locum tenens (e.g., local, statewide, multi-state, national)? 14. How much time is there between assignments for one practitioner? Institutions That Retain the Services of Locum Tenens Practitioners mstockstill on DSKH9S0YB1PROD with PROPOSALS 15. How many locum tenens placement agencies do you contract with? 16. How frequently do you secure locum tenens services? 17. What credentialing checks do you perform on the locum tenens practitioners working for you? Do you perform fewer checks for practitioners supplied by agencies than you do for practitioners you contract with individually? 18. For how long do you secure locum tenens services (i.e., duration)? 19. For what specialties do you use locum tenens practitioners? 20. What authority do you grant locum tenens practitioners? (For example, can they administer, dispense, or prescribe controlled substances? Under whose DEA registration would such an activity occur?) 21. Do you grant locum tenens practitioners the same controlled substance authority that other practitioners using the institution’s DEA registration to dispense controlled substances have? If not, why not? State Regulatory Authorities 22. What are the State requirements for locum tenens practice for practitioners (e.g., physicians, dentists)? 23. Does the State waive State medical licensure (or automatically grant temporary courtesy licensure) for locum tenens practitioners if they are properly licensed in another State? If so, what VerDate Nov<24>2008 16:11 Oct 27, 2009 Jkt 220001 checks are performed to confirm State licensure in the other State? 24. If granted, for how long is the waiver or courtesy licensure? 25. What are the State requirements for locum tenens practice for mid-level practitioners (e.g., physician assistants, nurse practitioners)? 26. Does the State waive State licensure (or automatically grant temporary courtesy licensure) for locum tenens practitioners who are mid-level practitioners if they are properly licensed in another State? If so, what checks are performed to confirm State licensure in the other State? 27. If granted, for how long is the waiver or courtesy licensure? 28. If the State requires State licensure with the medical or other professional board, how long is it good for? 29. Does the State grant locum tenens practitioners the same controlled substance authority that it grants to practitioners that are fully licensed by the State professional board? If not, why not? 30. To dispense controlled substances, must a locum tenens practitioner obtain a State controlled substance registration? 31. Does the State medical or other professional board report board actions against locum tenens practitioners to the National Practitioner database and to States in which the locum tenens practitioner holds a license? Regulatory Certifications This action is an Advance Notice of Proposed Rulemaking (ANPRM). Accordingly, the requirement of Executive Order 12866 to assess the costs and benefits of this action does not apply. Rather, among the purposes DEA has in publishing this ANPRM is to seek information from the public regarding locum tenens practitioners. Similarly, the requirements of section 603 of the Regulatory Flexibility Act do not apply to this action since, at this stage, it is an ANPRM and not a ‘‘rule’’ as defined in section 601 of the Regulatory Flexibility Act. Following review of the comments received to this ANPRM, if DEA promulgates a Notice or Notices of Proposed Rulemaking regarding this issue, DEA will conduct all analyses required by the Regulatory Flexibility Act, Executive Order 12866, and any other statutes or Executive Orders relevant to those rules and in effect at the time of promulgation. Dated: October 21, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. E9–25937 Filed 10–27–09; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–331] Schedules of Controlled Substances: Placement of 5-Methoxy-N,NDimethyltryptamine 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 5methoxy-N,N-dimethyltryptamine (5MeO-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 https:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the https://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 E:\FR\FM\28OCP1.SGM 28OCP1 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Proposed Rules https://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. mstockstill on DSKH9S0YB1PROD with PROPOSALS 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 https:// 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 VerDate Nov<24>2008 16:11 Oct 27, 2009 Jkt 220001 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 5methoxy-N,N-dimethyltryptamine (5MeO-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-4methylamphetamine (DOM), lysergic acid diethylamide (LSD) and mescaline. According to the System to Retrieve Information on Drug Evidence PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 55503 (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 Internetbased chemical suppliers. In addition, there are several instances where 5MeO-DMT was sold as a counterfeit of MDMA. The Food and Drug Administration has never approved 5MeO-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-MeODMT. 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-MeODMT 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-MeODMT 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 E:\FR\FM\28OCP1.SGM 28OCP1 55504 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Proposed Rules 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-MeODMT 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-MeODMT) in Schedule I of the Controlled Substances Act,’’ December 18, 2008. 2. DEA’s final scheduling document titled ‘‘5-Methoxy-N,NDimethyltryptamine 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 POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2010–3; Order No. 321] Periodic Reporting Rules Postal Regulatory Commission. Proposed rulemaking; availability of rulemaking petition. AGENCY: mstockstill on DSKH9S0YB1PROD with PROPOSALS ACTION: SUMMARY: This document announces a proposed rulemaking in response to a recent Postal Service petition involving periodic reporting rules. The petition, which is the twenty-first in a recent series, addresses the Postal Service’s request to prepare annual compliance reports using only the pro forma adjustment financial results. DATES: Comments are due November 2, 2009. VerDate Nov<24>2008 16:11 Oct 27, 2009 Jkt 220001 Submit comments electronically via the Commission’s Filing Online system at https:// www.prc.gov. Commenters who cannot submit their views electronically should contact the person identified in FOR FURTHER INFORMATION CONTACT by telephone for advice on alternatives to electronic filing. FOR FURTHER INFORMATION CONTACT: Stephen L. Sharfman, General Counsel, 202–789–6820 or stephen.sharfman@prc.gov. SUPPLEMENTARY INFORMATION: Prior to September 30, 2009, section 103 of the Postal Accountability and Enhancement Act (PAEA) required the Postal Service to pay $5.4 billion each year into the Postal Service Retiree Health Benefit Fund. Public Law 109–435, 120 Stat. 3251 (2006). On September 30, 2009, Congress adopted the 2010 Continuing Appropriations Resolution, which, among other things, reduced the payment due on September 30, 2009 from $5.4 billion to $1.4 billion. Legislative Branch Appropriations Act, 2010, Public Law 111–068. It made the revision retroactive by directing that it take effect as if it had been part of the enactment of section 803(a)(1)(B) of the PAEA in 2006. The President did not sign the 2010 Continuing Appropriations Resolution until the following day, October 1, 2009. According to Generally Accepted Accounting Principles (GAAP), books of account are closed on the last day of the fiscal year. Therefore, under GAAP, the relief contained in the continuing resolution cannot be reflected in the Postal Service’s financial accounts for FY 2009. In an effort to both comply with GAAP, and with the intent of Congress to relieve the Postal Service from $4 billion in health care funding obligations covering the 2009 fiscal year, the Postal Service anticipates filing audited financial statements for both FY 2009 and FY 2010 that present results according to GAAP, but add a column showing a pro forma adjustment of those results which would show the $4 billion reduction in health care obligation taking effect in FY 2009, rather than FY 2010. The Postal Service provided suggested language in its filing which can be accessed via the Commission’s Web site: https:// www.prc.gov/Docs/65/65273/ Pet.Prop.21.PSRHBF.Accntng.pdf. On October 20, 2009, the Postal Service filed a Petition with the Commission asking it to amend its periodic reporting rules to allow the Postal Service to prepare the annual compliance reports that it provides to ADDRESSES: PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 the Commission each year using only the pro forma results.1 It argues that the pro forma results would better serve the regulatory goals of the Commission because they would more accurately reflect its actual financial condition, and would make its financial reporting to the Commission consistent with the treatment that it anticipates the Office of Personnel Management and the Office of Management and Budget will apply to the Postal Service’s finances in preparing the Federal budget. Id. at 5. The Postal Service asks the Commission to process its proposed change in analytic principles expeditiously. It notes that it is required to submit all of its FY 2009 financial results to the Government Financial Reporting System by November 16, 2009. It states that it will require significant lead time to prepare those materials. It expresses the hope that meeting this timeline will be made feasible by what it believes to be the narrowness of the issue that its proposal presents. Id. at 6. Because of the need for expedition described above, the Commission will require that public comments be submitted by November 2, 2009. The Commission anticipates that it may set an effective date for any proposed change to its periodic reporting rules resulting from this proceeding that is less than the 30-day period normally required for substantive rules considered under 5 U.S.C. 553.2 It is ordered: 1. The Commission establishes Docket No. RM2010–3 to consider the matters raised by the Petition of the United States Postal Service Requesting Authorization to Utilize Pro Forma Accounting Data in Periodic Reporting (Proposal Twenty-One). 2. Interested persons may submit initial comments on or before November 2, 2009. 3. The Commission will determine the need for reply comments after review of the initial comments. 4. R. Kevin Harle is designated to serve as the Public Representative representing the interests of the general public in this proceeding. 5. The Secretary shall arrange for publication of this notice in the Federal Register. Authority: 39 U.S.C. 3652. 1 Petition of the United States Postal Service Requesting Authorization to Utilize Pro Forma Accounting Data in Periodic Reporting (Proposal Twenty-One), October 20, 2009 (Petition). 2 5 U.S.C. 553(d)(3) allows substantive rules considered under 5 U.S.C. 553 to take effect in less than 30 days from the date that the rule is approved for ‘‘good cause found and published with the rule.’’ E:\FR\FM\28OCP1.SGM 28OCP1

Agencies

[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Proposed Rules]
[Pages 55502-55504]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the https://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]]

https://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 https://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

[[Page 55504]]

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

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