[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]


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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