[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Proposed Rules]
[Pages 14538-14539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6763]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-333]


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

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of hearing on proposed rulemaking.

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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

[[Page 14539]]

Register 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.

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.

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.

    Dated: March 21, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-6763 Filed 3-25-10; 8:45 am]
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