[Federal Register: August 10, 2004 (Volume 69, Number 153)]
[Notices]
[Page 48522]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au04-119]
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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
registration under 21 U.S.C. 952(a)(2)(B) 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 May 8, 2004, Hospira, Inc., 1776 North Centennial Drive,
McPherson, Kansas 67460-1247, made application to the Drug Enforcement
Administration (DEA) for registration as an importer of Remifentanil
(9739), a basic class of controlled substance listed in Schedule II.
The company plans to import the basic class of controlled substance
for use in dosage unit manufacturing.
Any 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 objection or requests for hearing may be
addressed, in quintuplicate, to the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, United
States Department of Justice, Washington, DC 20537, Attention: DEA
Federal Register Representative (CCD) and must be filed no later than
September 9, 2004.
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 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: July 28, 2004.
Joseph T. Rannazzisi,
Deputy Director, Office of Diversion Control, Drug Enforcement
Administration.
[FR Doc. 04-18176 Filed 8-9-04; 8:45 am]
BILLING CODE 4410-09-M