Notice of Application - 2011
[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25989]
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 21 CFR 1301.34(a), this is notice
that on August 11, 2011, Fisher Clinical Services, Inc., 7554 Schantz
Road, Allentown, Pennsylvania 18106, made application by renewal to the
Drug Enforcement Administration (DEA) to be registered as an importer
of the following basic classes of controlled substances:
|Tapentadol (9780)|| II|
The company plans to import the listed substances for analytical
research and clinical trials.
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 written 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 7, 2011.
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 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: September 27, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
[FR Doc. 2011-25989 Filed 10-6-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).