[Federal Register Volume 62, Number 91 (Monday, May 12, 1997)]
[Notices]
[Page 25970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12292]
=======================================================================
-----------------------------------------------------------------------
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 1311.42 of Title 21, Code of
Federal Regulations (CFR) notice is hereby given that by application
dated August 16, 1996, and relevant written statements of fact dated
January 17, 1997, Astra USA, Inc., Attn: Charles E. Yoa, Legal
Department, 50 Otis Street, P.O. Box 4500, Westborough, Massachusetts
01581-4500, made application to the Drug Enforcement Administration to
be registered as an importer of cocaine (9041) a basic class of
controlled substance listed in Schedule II.
The firms plans to manufacture finished dosage pharmaceutical
products.
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 Acting 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 July 11,
1997.
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 basic
classes of any controlled substances in Schedule I or II are and will
continue to be required to demonstrate to the Acting Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration that the requirements for such 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: April 10, 1997.
Terrance W. Woodworth,
Acting Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration.
[FR Doc. 97-12292 Filed 5-9-97; 8:45 am]
BILLING CODE 4410-09-M
