Importer of Controlled Substances; Notice of Application, 75494 [2010-30336]

Download as PDF 75494 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices Onondaga County Shepard Settlement Cemetery, Stump & Foster Rds, Shepard Settlement, 10000938 Orange County Beakes, John G., House, 134 W Main St, Middletown, 10000939 Grace Episcopal Church, 58 N St, Middletown, 10000945 Mapes, Mortimer L., House & Seward Homestead, 35 N Main St, Florida, 10000942 TEXAS Drug Harris County Near Northside Historic District, Roughly bounded by Little White Oak Bayou on the N; Hogan on the S; I–45 On the W and the block between N Main and Keene Houston, 10000960 Hays County Lane, James C., House, (Rural Properties of Hays County, Texas MPS) 306 Wimberley Square, Wimberley, 10000961 St. Lawrence County Fort la Presentation Site, Address Restricted, Ogdensburg, 10000944 Hunt County Washington Hotel, 2612 Washington St, Greenville, 10000962 Steuben County Gold Seal Winery, West Lake Rd, Hammondsport, 10000946 Uvalde County Nicolas Street School, 332 Nicolas St, Uvalde, 10000963 Sullivan County Greenfield Preparative Meeting House, NY 55 at Denman Mt Rd, Grahamsville, 10000956 Related Action: Request for REMOVAL has been made for the following resources: Washington County McNish, Alexander, House, 194 CR 30, New York, 10000959 Simonds, L.C., Adirondack Cabin, 130 Cat Den Rd, Clemons, 10000941 Larimer County Big Thompson River Bridge I, US 34 at milepost 65.53 Larimer, 02001144 Big Thompson River Bridge II, US 34 at milepost 66.22 Larimer, 02001141 SOUTH DAKOTA Brookings County Hall, John L., House, 121 Samara Ave, Volga, 10000955 Lockhart House, 1001 6th Ave, Brookings, 10000954 Davison County Henline, Ellis and Roberta Farmstead, 39987 252nd St, Mount Vernon, 10000950 Faulk County Edgerton, Dr. William, House, 308 Tenth Ave S, Faulkton, 10000951 Tripp County Wewela Hall, Lots 3 and 4, Block 34, Government Townsite of Wewela, Wewela, 10000952 Walworth County Molstad Lake Park, (Federal Relief Construction in South Dakota MPS) 1 3⁄4 mi N of HWY 12 on 293rd Ave, Glenham, 10000953 TENNESSEE Anderson County Daugherty Furniture Building, 307 N Main St, Clinton, 10000936 mstockstill on DSKH9S0YB1PROD with NOTICES Davidson County Municipal Public Works Garage Industrial District, 33 Peabody St, Nashville, 10000949 Henderson County Doe Creek School, Doe Creek Rd, approx 1⁄2 mi N of Dyer Rd, Sardis, 10000935 Knox County Lebanon in the Forks Cemetery, (Knoxville and Knox County MPS) Asbury Rd N of Norfolk Southern Railroad, Knoxville, 10000934 VerDate Mar<15>2010 16:09 Dec 02, 2010 Jkt 223001 COLORADO KENTUCKY Jefferson County Bloedner, August, Monument, Cave Hill Cemetery, jct. of Payne St. & Lexington Rd., Louisville, 97000688 [FR Doc. 2010–30312 Filed 12–2–10; 8:45 am] BILLING CODE 4312–51–P 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 6, 2010, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule Methylphenidate (1724) ................ PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 II Fentanyl (9801) ............................ Schedule II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. 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 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 3, 2011. 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 43745–46), 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: November 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–30336 Filed 12–2–10; 8:45 am] BILLING CODE 4410–09–P 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 E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Page 75494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30336]


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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 6, 2010, Mylan Technologies, Inc., 110 Lake Street, 
Saint Albans, Vermont 05478, made application by renewal to the Drug 
Enforcement Administration (DEA) to be registered as an importer of the 
basic classes of controlled substances listed in schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.
    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 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 3, 2011.
    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 43745-46), 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: November 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-30336 Filed 12-2-10; 8:45 am]
BILLING CODE 4410-09-P
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