Importer of Controlled Substances; Notice of Application, 77253 [2011-31766]

Download as PDF 77253 Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Notices The assessment of annual needs may be adjusted at a later date pursuant to 21 CFR 1315.13. Dated: December 1, 2011. Michele M. Leonhart, Administrator. Dated: December 5, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–31776 Filed 12–9–11; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2011–31777 Filed 12–9–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Importer of Controlled Substances; Notice of Registration Pursuant to 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 21 U.S.C. 952(a)(2) 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 21 CFR 1301.34(a), this is notice that on October 17, 2011, Hospira Inc., 1776 North Centennial Drive, McPherson, Kansas 67460–1247, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil for use in dosage form manufacturing. Any bulk manufacturers who are presently, or are applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 11, 2012. 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 published in the Federal Register on September 23, 1975, 40 FR 43745, 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 By Notice dated September 27, 2011, and published in the Federal Register on October 7, 2011, 76 FR 62446, Fisher Clinical Services, Inc., 7554 Schantz Road Allentown, Pennsylvania 18106, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Schedule jlentini on DSK4TPTVN1PROD with NOTICES Noroxymorphone (9668) .............. Sufentanil (9740) .......................... Tapentadol (9780) ........................ II II II The company plans to import the listed substances for analytical research and clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Fisher Clinical Services, Inc. to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. VerDate Mar<15>2010 15:55 Dec 09, 2011 Jkt 226001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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(b), (c), (d), (e), and (f) are satisfied. Dated: December 5, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–31766 Filed 12–9–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on September 12, 2011, Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances listed in schedule II: Drug Coca Leaves (9040) ..................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Schedule II II II II II The company plans to import the listed controlled substances as raw materials, to be used in the manufacture of bulk controlled substances, for distribution to its customers. No comments, objections, or requests for any hearings will be accepted on any application for registration or reregistration to import crude opium, poppy straw, concentrate of poppy straw, and coca leaves. Comments and requests for hearings on applications to import narcotic raw material are not appropriate, in accordance with 72 FR 3417 (2007). In regards to the non-narcotic raw material, the company plans to import gram amounts to be used as reference standards for sale to its customers. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Page 77253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31766]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 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 21 U.S.C. 952(a)(2) 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 21 CFR 1301.34(a), this is notice 
that on October 17, 2011, Hospira Inc., 1776 North Centennial Drive, 
McPherson, Kansas 67460-1247, made application by renewal to the Drug 
Enforcement Administration (DEA) to be registered as an importer of 
Remifentanil (9739), a basic class of controlled substance listed in 
schedule II.
    The company plans to import Remifentanil for use in dosage form 
manufacturing.
    Any bulk manufacturers who are presently, or are applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance may file comments or objections to the issuance of the 
proposed registration and may, at the same time, file a written request 
for a hearing on such application pursuant to 21 CFR 1301.43 and in 
such form as prescribed by 21 CFR 1316.47.
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than January 11, 2012.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR Sec.  1301.34(b), 
(c), (d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745, 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(b), (c), (d), (e), and (f) are satisfied.

    Dated: December 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-31766 Filed 12-9-11; 8:45 am]
BILLING CODE 4410-09-P
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