[Federal Register Volume 64, Number 23 (Thursday, February 4, 1999)]
[Notices]
[Page 5677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2681]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importation of Controlled Substances; Notice of Application
Pursuant to Section 1008 of the Controlled Substances Import and
Export Act (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 Section 1002(a) 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 Section 1301.34 of Title 21, Code of
Federal Regulations (CFR), notice is hereby given that on December 2,
1998, Akorn Manufacturing Inc., DBA Taylor Pharmaceuticals, 150 Wyckles
Road, Decatur, Illinois 62522, made application by letter to the Drug
Enforcement Administration to be registered as an importer of
sufentanil (9740), a basic class of controlled substance listed in
Schedule II.
The firm plans to import the sufentanil for development of
analytical methods and initial formulation.
Any manufacturer holding, or applying for, registration as a bulk
manufacturer of this basic class of controlled substance may file
written comments on or objections to the application described above
and may, at the same time, file a written request for a hearing on such
application in accordance with 21 CFR 1301.43 in such form as
prescribed by 21 CFR 1316.47.
Any such comments, objections or requests for a hearing may be
addressed, in quintuplicate, to the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, United
States Department of Justice, Washington, D.C. 20537, Attention: DEA
Federal Register Representative (CCR), and must be filed no later than
March 8, 1999.
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 at 40 FR 43745-46
(September 23, 1995), 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(a), (b), (c),
(d), (e), and (f) are satisfied.
Dated: January 27, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 99-2681 Filed 2-3-99; 8:45 am]
BILLING CODE 4410-09-M
