Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 16436 [2015-06967]

Download as PDF 16436 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices United States District Judge XII. No Reacquisition For a period of five years from the date of entry of this Final Judgment, Defendants may not apply for or obtain any bus stop authorizations for hop-on, hop-off bus tours at the locations of the divested CitySights Bus Stop Authorizations, except that, after May 1, 2016, if the NYCDOT revokes a bus stop authorization currently granted to an affiliate of Twin America other than City Sights, Defendants may apply for or obtain a bus stop authorization at the location of a divested CitySights Bus Stop Authorization that is at or in close proximity to the location of the bus stop authorization NYCDOT has revoked. Nothing in this Final Judgment shall be construed to prohibit Defendants from applying for or obtaining from the NYCDOT bus stop authorizations at locations other than the locations of the CitySights Bus Stop Authorizations, nor to limit the NYCDOT’s ability to alter or amend Defendants’ bus stop authorizations. XIII. Retention of Jurisdiction This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions. XIV. Expiration of Final Judgment Unless this Court grants an extension, this Final Judgment shall expire ten years from the date of its entry, except that Sections XI and XII shall expire five years from the date of this Final Judgment’s entry. mstockstill on DSK4VPTVN1PROD with NOTICES XV. Public Interest Determination Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and the United States’ responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest. Dated: lllllllllllllllllllll lllllllllllllllllllll Judge Andrew L. Carter, Jr. VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 Controlled substance Schedule [FR Doc. 2015–07055 Filed 3–26–15; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before April 27, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 27, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152 SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on October 13, 2014, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505, applied to be registered as an importer of the following basic classes of controlled substances: DATES: Controlled substance Amphetamine (1100) .................. PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 Schedule II Lisdexamfetamine (1205) ........... Methylphenidate (1724) .............. Pentobarbital (2270) ................... Oxycodone (9143) ...................... Hydromorphone (9150) .............. Hydrocodone (9193) ................... Levorphanol (9220) .................... Morphine (9300) ......................... Oxymorphone (9652) .................. Remifentanil (9739) .................... Fentanyl (9801) .......................... II II II II II II II II II II 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. Dated: March 20, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–06967 Filed 3–26–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1140–0031] Agency Information Collection Activities: Proposed eCollection eComments Requested; Records of Acquisition and Disposition, Registered Importers of Arms, Ammunition, and Implements of War on the U.S. Munitions Imports List Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 30-day notice. AGENCY: The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register Volume 80, Number 14, page 3252 on January 22, 2015, allowing for a 60 day comment period. DATES: The purpose of this notice is to allow for an additional 30 days for public comment until April 27, 2015. FOR FURTHER INFORMATION CONTACT: If you have comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions SUMMARY: E:\FR\FM\27MRN1.SGM 27MRN1

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[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Page 16436]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06967]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before April 27, 2015. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 27, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
October 13, 2014, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, 
Morgantown, West Virginia 26505, applied to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Levorphanol (9220).........................  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Remifentanil (9739)........................  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.

    Dated: March 20, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-06967 Filed 3-26-15; 8:45 am]
 BILLING CODE 4410-09-P
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