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Federal Register
Notices > Importers Notice of Application 2009
> Aptuit (Allendale) Inc.
FR Doc E9-14724[Federal Register: June 23, 2009 (Volume 74, Number 119)]
[Notices] [Page 29719] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn09-81]
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 substances, 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 28, 2009, Aptuit (Allendale) Inc., 75 Commerce Drive, Allendale, New Jersey
07401, made application by renewal to the Drug Enforcement Administration (DEA)
for registration as an importer of the basic classes of controlled substances
listed in schedule II.
| Drug |
Schedule |
| Lisdexamfetamine (1205) |
II |
| Noroxymorphone (9668) |
II |
The company plans to import the basic classes of controlled substances for
clinical trials and research.
Any bulk 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 comments or objections 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 July 23, 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 the basic classes 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: June 15, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration.
[FR Doc. E9-14724 Filed 6-22-09; 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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