[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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