[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Notices]               
[Page 43526]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au06-90]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Importer of Controlled Substances; Notice of Application

    Prior to issuing a registration under 21 U.S.C. 952(a)(2)(B), and 
in accordance with 21 CFR 1301.34(a), this is notice that on April 13, 
2005, Kenco VPI, Division of Kenco Group Inc., 350 Corporate Place, 
Chattanooga, TN 37419, has made application to the Drug Enforcement 
Administration (DEA) by letter to be registered as an importer of 
Nabilone (7379), a basic class of controlled substance listed in 
Schedule II.
    The company plans to import the listed controlled substance for 
distribution to its customers.
    Kenco VPI has been an importer of Schedule III-V controlled 
substances since June 14, 2004. On April 14, 2005, the DEA added 
Schedule II to the firm's importer registration. The DEA also added the 
drug code for Nabilone, a Schedule II controlled substance, to the 
firm's registration on April 28, 2005. Both amendments to the 
registration were made without benefit of the required legal process 
for modifying the DEA registration. Kenco VPI is currently complying 
with the legal requirements to register as a Schedule III importer. In 
addition the firm was given authorization to import the Nabilone 
product into the United States on May 12, 2005. The Nabilone product 
was approved by the Food & Drug Administration on May 15, 2006. DEA has 
agreed to allow Kenco VPI to continue to import the Nabilone product 
into the United States, while the firm is completing the required legal 
process.
    Any manufacturer who on April 13, 2005, was registered, or applying 
to be registered with DEA to manufacture such basic class of controlled 
substance may file comments or objections to the issuance of the 
proposed registration and may, at the same time, file a written request 
for a hearing on such application pursuant to 21 CFR 1301.43 and in 
such form as prescribed by 21 CFR 1316.47. For purposes of this Notice, 
DEA has chosen recognized applicable manufacturers registered on April 
13, 2005, the date on which Kenco submitted its initial request to have 
Nabilone added to its DEA importer registration. By employing this 
date, DEA seeks to equitably address its initial failure to publish 
Kenco's request to import Nabilone, while at the same time allowing 
those entities that would have been in a position to request a hearing 
on April 13, 2005, had DEA filed a timely notice, the right to request 
a hearing.
    Any such written comments or objections being sent via regular mail 
may be addressed, in quintuplicate, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/ODL; or any being sent via express mail should be sent 
to DEA Headquarters, Attention: DEA Federal Register Representative/
ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must 
be filed no later than August 31, 2006.
    This procedure is to be conducted simultaneously with and 
independent of the procedures described in 21 CFR 1301.34(b), (c), (d), 
(e), and (f). As noted in a previous notice published in the Federal 
Register on September 23, 1975, (40 FR 43745-46), all applicants for 
registration to import a basic class of any controlled substance listed 
in Schedule I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

    Dated: July 26, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E6-12256 Filed 7-31-06; 8:45 am]

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