Notice of Application - 2012
Federal Register, Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Page 24984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10047]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application;
Clinical Supplies Management, Inc.
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 November 13, 2011, Clinical Supplies Management, Inc., 342 42nd
Street South, Fargo, North Dakota 58103, made application by renewal to
the Drug Enforcement Administration (DEA) to be registered as an
importer of Sufentanil (9740), a basic class of controlled substance
listed in schedule II.
The company plans to import the listed controlled substance with
the sole purpose of packaging, labeling, and distributing to customers
which are qualified clinical sites conducting clinical trials under the
auspices of an FDA-approved clinical study.
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 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 May 29, 2012.
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: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-10047 Filed 4-25-12; 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). |
