Importer of Controlled Substances, Notice of Application; Watson Pharma, Inc., 33440 [2013-13177]

Download as PDF 33440 Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices Paul Madison Eckles, Skadden, Arps, Slate, Meagher & Flom, Four Times Square, 42nd Floor, New York, NY 10036, (212) 735–2578, pmeckles@skadden.com. For Simon & Schuster: Yehudah Lev Buchweitz, Weil, Gotshal & Manges LLP (NYC), 767 Fifth Avenue, 25th Fl., New York, NY 10153, (212) 310–8000 x8256, yehudah.buchweitz@weil.com. Additionally, courtesy copies of this Response to Comments have been provided to the following: For the State of Connecticut: W. Joseph Nielsen, Assistant Attorney General, Antitrust Division, Office of the Attorney General, 55 Elm Street, Hartford, CT 06106, (860) 808–5040, Joseph.Nielsen@ct.gov. For the State of Texas: Gabriel R. Gervey, Assistant Attorney General, Antitrust Division, Office of the Attorney General of Texas, 300 W. 15th Street, Austin, Texas 78701, (512) 463– 1262, gabriel.gervey@oag.state.tx.us. For the Private Plaintiffs: Jeff D. Friedman, Hagens Berman, 715 Hearst Ave., Suite 202, Berkeley, CA 94710, (510) 725–3000, jefff@hbsslaw.com. s/Stephen T. Fairchild Stephen T. Fairchild Attorney for the United States, United States Department of Justice, Antitrust Division, 450 Fifth Street NW., Suite 4000, Washington, DC 20530, (202) 532–4925, stephen.fairchild@usdoj.gov. [FR Doc. 2013–13133 Filed 6–3–13; 8:45 am] BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE Drug Enforcement Administration tkelley on DSK3SPTVN1PROD with NOTICES Importer of Controlled Substances, Notice of Application; Watson Pharma, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on May 3, 2013, Watson Pharma, Inc., 2455 Wardlow Road, Corona, California 92880–2882, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug Schedule Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ VerDate Mar<15>2010 18:33 Jun 03, 2013 The company plans to import the listed controlled substances for analytical testing and clinical trials. The import of the above listed basic classes of controlled substances 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 July 5, 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: May 24, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–13177 Filed 6–3–13; 8:45 am] BILLING CODE 4410–09–P II II II II Jkt 229001 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration; Rhodes Technologies By a Notice dated April 10, 2013, and published in the Federal Register on April 19, 2013, 78 FR 23594, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816, 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 Opium Raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II The company plans to import the listed controlled substances in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured API’s in bulk to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Rhodes Technologies 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 Rhodes Technologies 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. Dated: May 24, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–13178 Filed 6–3–13; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00116 Fmt 4703 Sfmt 9990 E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13177]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances, Notice of Application; Watson 
Pharma, Inc.

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on May 3, 2013, Watson Pharma, Inc., 2455 Wardlow Road, 
Corona, California 92880-2882, made application by renewal to the Drug 
Enforcement Administration (DEA) for registration as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical testing and clinical trials.
    The import of the above listed basic classes of controlled 
substances 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 July 5, 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: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-13177 Filed 6-3-13; 8:45 am]
BILLING CODE 4410-09-P
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