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Proposed Rule

Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV; Announcement of Hearing

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice of hearing on proposed rulemaking.

SUMMARY:

This is notice that the Drug Enforcement Administration (DEA) will hold a hearing with respect to the proposed placement of carisoprodol in schedule IV of the Controlled Substances Act (21 U.S.C. 801, et seq.). The control of carisoprodol was initially proposed in a Notice of Proposed Rulemaking published in the Federal Start Printed Page 14539Register on November 17, 2009 [74 FR 59108].

DATES:

Interested persons desiring to participate in this hearing must provide written notice of desired participation as set out below, on or before April 26, 2010.

The hearing will commence on May 4, 2010 at 10 a.m. at 600 Army Navy Drive, Arlington, VA 22202.

ADDRESSES:

To ensure proper handling of notification, please reference “Docket No. DEA-333” on all correspondence. Written notification sent via regular or express mail should be sent to Hearing Clerk, Office of the Administrative Law Judge, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152.

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FOR FURTHER INFORMATION CONTACT:

Hearing Clerk, Office of the Administrative Law Judge, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone (202) 307-8188.

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SUPPLEMENTARY INFORMATION:

Background

On November 17, 2009, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (74 FR 59108) to place the substance carisoprodol into schedule IV of the Controlled Substances Act (CSA) (21 U.S.C. 801, et seq.). The NPRM stated that, if this scheduling action were finalized, carisoprodol would be subject to the regulatory controls and criminal sanctions of schedule IV, as are applicable to the manufacture, distribution, dispensing, importation, and exportation of carisoprodol and products containing carisoprodol.

The NPRM invited interested parties to submit comments, objections, and requests for hearing on or before December 17, 2009. The DEA received 18 comments in response to the NPRM. Seventeen commenters strongly supported the control of carisoprodol. These commenters included health care providers, an organization representing pharmaceutical manufacturers and distributors, State regulatory agencies and State Departments of Health officials, law enforcement entities and one pain management association.

According to these commenters, carisoprodol products are being diverted, abused, misused, and sold on the street and from Internet sites without legitimate prescriptions. Commenters indicated carisoprodol is being abused with other controlled drugs such as opioids. There are incidences of pain patients addicted to carisoprodol.

While 17 comments were supportive of control, one commenter requested a hearing on the issue. This commenter stated that it believes “that the NPRM and the associated documentation do not provide substantial evidence to support the proposed scheduling of carisoprodol.” Additionally, the petitioner stated that “the proposal gives inadequate weight to the negative impact on patient care of scheduling carisoprodol.” In requesting a hearing, the commenter stated its intention to present factual information concerning the relative potential for abuse of carisoprodol, and expert opinion concerning the significance and reliability of data cited in the NPRM and associated materials.

All comments received in response to the NPRM are part of the administrative record and will be considered by DEA in determining whether to finalize the rule placing carisoprodol into schedule IV.

Hearing Notification

In response to this request, DEA is convening a hearing on the NPRM. Accordingly, notice is hereby given that a hearing in connection with this proposed scheduling action will commence on May 4, 2010, at 10 a.m. at the Drug Enforcement Administration, 600 Army Navy Drive, Arlington, VA 22202 and will continue until all interested persons, as that term is defined in 21 CFR 1300.01(b)(19), desiring to participate, who have given notice of such desire as prescribed below, have been heard. The hearing will be conducted pursuant to the provisions of 5 U.S.C. 556 and 557, and 21 CFR 1308.41-1308.45, and 1316.41-1316.68.

Every interested person desiring to participate in the hearing shall file a written notice of intention to participate, in duplicate, with the Hearing Clerk, Office of the Administrative Law Judge, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, on or before April 26, 2010. Each notice of intention to participate must be in the form prescribed in 21 CFR 1316.48. The commenter who requested the hearing is hereby directed to file with the Administrative Law Judge a notice of its continued intention to participate in the hearing and to state with particularity its interest in the proceeding.

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Dated: March 21, 2010.

Michele M. Leonhart,

Deputy Administrator.

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[FR Doc. 2010-6763 Filed 3-25-10; 8:45 am]

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