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Aptuit
FR Doc E6-12171 [Federal Register: July 31, 2006 (Volume 71, Number 146)]
[Notices] [Page 43210-43211] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy06-89]
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) 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 May 25, 2006, Aptuit, 10245 Hickman
Mills Drive, Kansas City, Missouri 64137, made application by letter to the Drug
[[Page 43211]]
Enforcement Administration (DEA) for registration as an importer of Marihuana
(7360), a basic class of controlled substance in Schedule I.
The company plans to import a finished pharmaceutical product containing
cannabis extracts in dosage form 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 should 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 30, 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: July 25, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E6-12171 Filed 7-28-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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