Importer of Controlled Substances; Notice of Application; Alkermes Gainesville, LLC, 6132 [2013-01837]

Download as PDF 6132 Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices Dated: January 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 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 following basic classes of controlled substances: Drug BILLING CODE 4410–09–P Schedule Methylphenidate (1724) ................ Fentanyl (9801) ............................ srobinson on DSK4SPTVN1PROD with [FR Doc. 2013–01835 Filed 1–28–13; 8:45 am] II II Drug Enforcement Administration 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 classes of controlled substances listed in schedule II, which falls 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. 958(i), 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 February 28, 2013. 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 schedules 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. VerDate Mar<15>2010 16:47 Jan 28, 2013 Jkt 229001 DEPARTMENT OF JUSTICE Importer of Controlled Substances; Notice of Application; Alkermes Gainesville, LLC Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on October 11, 2012, Alkermes Gainesville, LLC., 1300 Gould Drive, Gainesville, Georgia 30504, made application to the Drug Enforcement Administration (DEA) for registration as an importer of noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the listed substance for analytical research and testing. The import of the above listed basic class of controlled substance will be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedules 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. 958(i), 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 February 28, 2013. 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 schedules I PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 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: January 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–01837 Filed 1–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended ACTION: Notice. The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ‘‘Petition Requirements and Investigative Data Collection: Trade Act of 1974, as Amended,’’ to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before February 28, 2013. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site, http://www.reginfo.gov/ public/do/PRAMain, on the day following publication of this notice or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: OIRA_submission@omb.eop.gov. SUMMARY: E:\FR\FM\29JAN1.SGM 29JAN1

Agencies

[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Page 6132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01837]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; 
Alkermes Gainesville, LLC

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on October 11, 2012, Alkermes Gainesville, LLC., 1300 
Gould Drive, Gainesville, Georgia 30504, made application to the Drug 
Enforcement Administration (DEA) for registration as an importer of 
noroxymorphone (9668), a basic class of controlled substance listed in 
schedule II.
    The company plans to import the listed substance for analytical 
research and testing.
    The import of the above listed basic class of controlled substance 
will be granted only for analytical testing and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial distribution in the United 
States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedules 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. 958(i), 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 February 28, 2013.
    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 
schedules 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: January 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-01837 Filed 1-28-13; 8:45 am]
BILLING CODE 4410-09-P