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.Start Signature
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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