Federal
Register Notices > Importers
>
CIMA Labs, Inc.
FR Doc E7-17766 [Federal Register: September 10, 2007 (Volume 72, Number
174)] [Notices] [Page 51664] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se07-77]
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 July 19, 2007, CIMA Labs, Inc., 7325 Aspen
Lane, Brooklyn Park, Minnesota 55428, made application by letter to the Drug
Enforcement Administration (DEA) 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 basic class of controlled substance for
clinical trials and research.
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), Washington, DC
20537, or any being sent via express mail should be sent to Drug Enforcement
Administration, Office of Diversion Control, Federal Register Representative (ODL),
2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no
later than October 10, 2007.
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: August 28, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E7-17766 Filed 9-7-07; 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).
|