[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)]
[Notices]
[Page 13169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6921]


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DEPARTMENT OF JUSTICE

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 on May 6, 1996, 
Glaxo Wellcome Inc., Attn: Jeffrey A. Weiss, 1011 North Arendell 
Avenue, P.O. Box 1217, Zebulon, North Carolina 27597-2309, made 
application to the Drug Enforcement Administration to be registered as 
an importer of remifentanil (9739), which did not become a basic class 
of controlled substance in Schedule II until November of 1996. 
Therefore, this application was not processed until remifentanil was 
controlled and relevant statements of fact dated February 12, 1997, 
were received.
    The remifentanil is being imported for the production of Ultiva 
dosage forms and for research and new product development.
    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 in 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 April 
18, 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 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: March 12, 1997.
Terrance W. Woodworth,
Acting Deputy Assistant Administrator, Office of Diversion Control, 
Drug Enforcement Administration.
[FR Doc. 97-6921 Filed 3-18-97; 8:45 am]
BILLING CODE 4410-09-M