Justia Regulation Tracker

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[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]               
[Page 55583]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-97]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Importer of Controlled Substances Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of 
such a substance, provide manufacturers holding registrations for the 
bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with Title 21 Code of Federal Regulations 
(CFR), 1301.34(a), this is notice that on August 27, 2009, Formulation 
Technologies LLC., 11400 Burnet Road, Suite 4010, Austin, Texas 78758, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Fentanyl (9801), a basic class 
of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
analytical characterization, secondary packaging, and for distribution 
to clinical trial sites.
    Any bulk manufacturer who is presently, or is 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.
    Any such comments or objections being sent via regular mail should 
be addressed, in quintuplicate, to the Drug Enforcement Administration, 
Office of Diversion Control, Federal Register Representative (ODL), 
8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed 
no later than November 27, 2009.
    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 
substances 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: October 20, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-25862 Filed 10-27-09; 8:45 am]

BILLING CODE 4410-09-P