Notice of Application - 2010
[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]
[Page 65658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc10-102]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on July 12, 2010, Noramco, Inc., Division of Ortho-
McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801, 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 |
| Raw Opium (9600) |
II |
| Concentrate of Poppy Straw (9670) |
II |
| Tapentadol (9780) |
II |
The company plans to import the Raw Opium (9600) and Concentrate of
Poppy Straw (9670) to manufacture other controlled substances. The
company plans to import Tapentadol (9780) in intermediate form for the
bulk manufacture of Tapentadol (9780) which it will distribute to its
customers.
No comments, objections, or requests for any hearings will be
accepted on any application for registration or re-registration to
import crude opium, poppy straw, concentrate of poppy straw, and coca
leaves. As explained in the Correction to Notice of Application
pertaining to Rhodes Technologies, 72 FR 3417 (2007), comments and
requests for hearings on applications to import narcotic raw material
are not appropriate.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedule I or II, which fall under the authority
of section 1002(a)(2)(B) of the Act [21 U.S.C. 952(a)(2)(B)] may, in
the circumstances set forth in 21 U.S.C. 958(i), 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 November 26, 2010.
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 21U.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 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator,Office of Diversion Control,Drug
Enforcement Administration.
[FR Doc. 2010-27025 Filed 10-25-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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