Manufacturer of Controlled Substances; Notice of Application, 61909 [E8-24768]

Download as PDF Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. DEPARTMENT OF JUSTICE Drug Enforcement Administration sroberts on PROD1PC70 with NOTICES 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 registration 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 Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on September 4, 2008, Formulation Technologies LLC., 11400 Burnet Road, Suite 4010, Austin, Texas 78758, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for analytical characterization, secondary packaging, and/or for distribution to clinical trial sites. Any bulk manufacturer who is presently, or is 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 comments or objections being sent via regular mail 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 November 17, 2008. 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 substances 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 VerDate Aug<31>2005 19:18 Oct 16, 2008 Jkt 217001 Dated: October 9, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8–24783 Filed 10–16–08; 8:45 am] BILLING CODE 4410–09–P 61909 Dated: October 9, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8–24767 Filed 10–16–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on August 5, 2008, Noramco Inc., Division of Ortho McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Methylphenidate (1724) ................ Methylphenidate HCL (1726) ....... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Thebaine (9333) ........................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... I I I II II II II II II II II II II II II II II II The company plans to bulk manufacture the above listed controlled substances for sale and distribution to manufacturers for product development and formulation. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). 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 December 16, 2008. PO 00000 Frm 00133 Fmt 4703 Sfmt 4703 Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 10, 2008, Penick Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070, made application by letter to the Drug Enforcement Administration (DEA) as a bulk manufacturer of Oripavine (9330), a basic class of controlled substance listed in schedule II. The company will use the above listed controlled substance in the manufacture of other controlled substance intermediates for sale to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). 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 December 16, 2008. Dated: October 9, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8–24768 Filed 10–16–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 15, 2008, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Page 61909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24768]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on July 10, 2008, Penick 
Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070, 
made application by letter to the Drug Enforcement Administration (DEA) 
as a bulk manufacturer of Oripavine (9330), a basic class of controlled 
substance listed in schedule II.
    The company will use the above listed controlled substance in the 
manufacture of other controlled substance intermediates for sale to its 
customers.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, may file comments 
or objections to the issuance of the proposed registration pursuant to 
21 CFR 1301.33(a).
    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 December 16, 2008.

    Dated: October 9, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E8-24768 Filed 10-16-08; 8:45 am]
BILLING CODE 4410-09-P
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