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Federal Register
Notices > Importers >
Aptuit
FR Doc E6-9511 [Federal Register: June 19, 2006 (Volume 71, Number 117)]
[Notices] [Page 35310] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn06-86]
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)(B) 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 21
CFR 1301.34(a), this is notice that on January 20, 2006, Aptuit, 10245
Hickman Mills Drive, Kansas City, Missouri 64137, made application by letter to
the Drug Enforcement Administration (DEA) for registration as an importer of a
Cocaine derivative under the drug code for Cocaine (9041), a basic class of
controlled substance in Schedule II.
The company plans to import bulk capsules in dosage form specifically for
packaging for a clinical trial study.
Any manufacturer who is presently, or is applying to be, registered with DEA
to manufacture such basic classes of controlled substances 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 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, Liaison and Policy Section (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 July 19,
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 301.34(b), (c), (d), (e) and (f) are satisfied.
Dated: June 12, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E6-9511 Filed 6-16-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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