Importer of Controlled Substances; Notice of Application, 63155-63156 [E9-28824]

Download as PDF 63155 Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, and (3) projected completion dates for each task. II. Electronic Access Persons with access to the Internet may obtain the draft program standards at https://www.fda.gov/downloads/ RegulatoryInformation/Guidances/ UCM125448.pdf. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Annual Frequency per Response No. of Respondents 44 1There Total Annual Responses 1 Hours per Response 44 Total Hours 40 1,760 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED FIRST-YEAR BASELINE SELF-ASSESSMENT BURDEN1 Five-Year Frequency per Response No. of Respondents 17 1There 1 Hours per Response 17 Total Hours 200 3,400 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 23, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–28834 Filed 12–1–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLCAC069000 L17110000 AL0000] Notice of Public Meeting of the Carrizo Plain National Monument Advisory Council AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Public Meeting. mstockstill on DSKH9S0YB1PROD with NOTICES Total First-Year Responses SUMMARY: In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Carrizo Plain National Monument Advisory Council (MAC) will meet as indicated below. DATES: The meeting will be held on Saturday, January 23, 2010, at the Carissa Plain Elementary School, located approximately 2 miles northwest of Soda Lake Road on Highway 58. The meeting will begin at 10 a.m. and finish at 3 p.m. The meeting will focus on the Resource Management Plan/Environmental Impact Statement (RMP/EIS) being developed for the Carrizo Plain National Monument. There will be a public comment period from 2 p.m. to 3 p.m. FOR FURTHER INFORMATION CONTACT: The BLM, attention: Johna Hurl, Monument Manager, 3801 Pegasus Drive, VerDate Nov<24>2008 18:28 Dec 01, 2009 Jkt 220001 Bakersfield, CA 93308. Phone (661) 391–6093 or e-mail: jhurl@blm.gov. SUPPLEMENTARY INFORMATION: The ninemember MAC advises the Secretary of the Interior, through the BLM, on a variety of public land issues associated with the public land management of the Carrizo Plain National Monument in Central California. At this meeting, monument staff will present updated information on the progress of the RMP/ EIS. Draft alternatives being developed by the Carrizo managing partners—the BLM, the California Department of Fish and Game and The Nature Conservancy—will be the focus of this meeting. This meeting is open to the public. Depending on the number of persons wishing to comment, and the time available, the time allotted for individual oral comments may be limited. Individuals who plan to attend and need special assistance such as sign language interpretation or other reasonable accommodations should contact the BLM as indicated below. Dated: November 25, 2009. Janet Bedrosian, Deputy State Director, External Affairs, California State Office. [FR Doc. E9–28808 Filed 12–1–09; 8:45 am] BILLING CODE 4310–40–P JUDICIAL CONFERENCE OF THE UNITED STATES Meeting of the Judicial Conference Advisory Committee on Rules of Civil Procedure Judicial Conference of the United States Advisory Committee on Rules of Civil Procedure. AGENCY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 ACTION: Notice of open meeting. SUMMARY: The Advisory Committee on Rules of Civil Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation. March 18–19, 2010. Time: 8:30 a.m. to 5 p.m. ADDRESSES: Emory Law School, 1301 Clifton Road, Atlanta, GA 30322. FOR FURTHER INFORMATION CONTACT: John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502–1820. DATES: Dated: November 23, 2009. John K. Rabiej, Chief, Rules Committee Support Office. [FR Doc. E9–28531 Filed 12–1–09; 8:45 am] BILLING CODE 2210–55–M DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application This is notice that on July 1, 2009, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the basic classes of controlled substances listed in schedule II: Drug Opium, raw (9600) ........................ Poppy Straw Concentrate (9670) E:\FR\FM\02DEN1.SGM 02DEN1 Schedule II II 63156 Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices The company plans to import the basic classes of controlled substances for manufacture of active pharmaceutical ingredients for sale to its customers. As explained in the Correction to Notice of Application pertaining to Rhodes Technologies, 72 FR 3417 (2007), comments and requests for hearings on applications to import narcotic raw material are not appropriate. 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 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 23, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–28824 Filed 12–1–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration mstockstill on DSKH9S0YB1PROD 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 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 8, 2009, Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Oxycodone (9143) ........................ Hydromorphone (9150) ................ VerDate Nov<24>2008 18:28 Dec 01, 2009 The company plans to import the listed controlled substances as finished dosage forms (FDF) for analytical testing and distribution for clinical trials. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances 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 4, 2010. 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 23, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–28827 Filed 12–1–09; 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 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 Schedule such a substance, provide manufacturers holding registrations for II the bulk manufacture of the substance II an opportunity for a hearing. Jkt 220001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on September 22, 2009, ISP Freetown Fine Chemicals, 238 South Main Street, Assonet, Massachusetts 02702, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II. The company plans to import the controlled substance to manufacture amphetamine. 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 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 4, 2010. 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 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 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 23, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–28825 Filed 12–1–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated August 21, 2009, and published in the Federal Register on E:\FR\FM\02DEN1.SGM 02DEN1

Agencies

[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Pages 63155-63156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28824]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    This is notice that on July 1, 2009, Cambrex Charles City, Inc., 
1205 11th Street, Charles City, Iowa 50616, made application by renewal 
to the Drug Enforcement Administration (DEA) for registration as an 
importer of the basic classes of controlled substances listed in 
schedule II:

------------------------------------------------------------------------
                             Drug                               Schedule
------------------------------------------------------------------------
Opium, raw (9600)............................................         II
Poppy Straw Concentrate (9670)...............................         II
------------------------------------------------------------------------


[[Page 63156]]

    The company plans to import the basic classes of controlled 
substances for manufacture of active pharmaceutical ingredients for 
sale to its customers.
    As explained in the Correction to Notice of Application pertaining 
to Rhodes Technologies, 72 FR 3417 (2007), comments and requests for 
hearings on applications to import narcotic raw material are not 
appropriate.
    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 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 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-28824 Filed 12-1-09; 8:45 am]
BILLING CODE 4410-09-P
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