[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24162]
[[Page Unknown]]
[Federal Register: September 30, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Importation of Controlled Substances; 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 1311.42 of Title 21, Code of
Federal Regulations (CFR), notice is hereby given that on August 26,
1994, Sanofi Winthrop Inc., formerly Sanofi Winthrop L.P., DBA Sanofi
Winthrop Pharmaceutical, 200 East Oakton Street, Des Plaines, Illinois
60018, made application to the Drug Enforcement Administration to be
registered as an importer of the basic classes of controlled substances
listed below:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Codeine (9050)............................................ II
Hydromorphone (9150)...................................... II
Meperidine (9230)......................................... II
Morphine (9300)........................................... II
------------------------------------------------------------------------
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 1301.54 in such form as
prescribed by 21 CFR 1316.47.
Any such comments, objections, or requests for a hearing may be
addressed 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 (CCR), and must be filed no later than October 31, 1994.
This procedure is to be conducted simultaneously with and
independent of the procedures described in 21 CFR 1311.42 (b), (c),
(d), (e), and (f). As noted in a previous notice at 40 FR 43745-46
(September 23, 1975), 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 1311.42 (a), (b), (c),
(d), (e), and (f) are satisfied.
Dated: September 22, 1994.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 94-24162 Filed 9-29-94; 8:45 am]
BILLING CODE 4410-09-M
