Bulk Manufacturer of Controlled Substances Registration, 63219-63220 [2016-22082]

Download as PDF 63219 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices to which the United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law. D. If at the time information or documents are furnished by Defendants to the United States, Defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure, and Defendants mark each pertinent page of such material, ‘‘Subject to claim of protection under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure,’’ then the United States shall give Defendants ten (10) calendar days notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding). asabaliauskas on DSK3SPTVN1PROD with NOTICES XI. No Reacquisition and Other Prohibited Activities Defendants may not (1) reacquire any part of the Divestiture Assets, (2) acquire any option to reacquire any part of the Divestiture Assets or to assign the Divestiture Assets to any other person, (3) enter into any local marketing agreement, joint sales agreement, other cooperative selling arrangement, or shared services agreement, or conduct other business negotiations jointly with the Acquirers with respect to the Divestiture Assets, or (4) provide financing or guarantees of financing with respect to the Divestiture Assets, during the term of this Final Judgment. The shared services prohibition does not preclude Defendants from continuing or entering into agreements in a form customarily used in the industry to (1) share news helicopters or (2) pool generic video footage that does not include recording a reporter or other on-air talent, and does not preclude Defendants from entering into any nonsales-related shared services agreement or transition services agreement that is approved in advance by the United States in its sole discretion. XII. 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. Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to XIII. Expiration of Final Judgment exercise all necessary functions with Unless this Court grants an extension, respect to the promulgation and this Final Judgment shall expire ten implementation of 21 CFR part 1301, years from the date of its entry. incident to the registration of manufacturers, distributors, dispensers, XIV. Public Interest Determination importers, and exporters of controlled Entry of this Final Judgment is in the substances (other than final orders in public interest. The parties have connection with suspension, denial, or complied with the requirements of the revocation of registration) has been Antitrust Procedures and Penalties Act, redelegated to the Deputy Assistant 15 U.S.C § 16, including making copies Administrator of the DEA Office of available to the public of this Final Diversion Control (‘‘Deputy Assistant Judgment, the Competitive Impact Administrator’’) pursuant to section 7 of Statement, and any comments thereon, 28 CFR part 0, appendix to subpart R. and the United States’ responses to In accordance with 21 CFR comments. Based upon the record 1301.33(a), this is notice that on before the Court, which includes the November 18, 2015, Alcami Wisconsin Competitive Impact Statement and any Corporation, W130 N10497 Washington comments and response to comments Drive, Germantown, Wisconsin 53022 filed with the Court, entry of this Final applied to be registered as a bulk Judgment is in the public interest. manufacturer of alfentanil (9737), a Date: llllllllllllllllll basic class of controlled substance listed in schedule II. Court approval subject to procedures of Antitrust Procedures and Penalties Act, 15 The company plans to manufacture U.S.C. § 16 reference standards for distribution to lllllllllllllllllllll their research and forensic customers. United States District Judge. Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–22086 Filed 9–13–16; 8:45 am] BILLING CODE P [FR Doc. 2016–22100 Filed 9–13–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation ACTION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration 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 1301.33(a) on or before November 14, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled DATES: ACTION: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUMMARY: Company FR Docket Johnson Matthey, Inc .............................................................................................................. Mallinckrodt, LLC ..................................................................................................................... American Radiolabeled Chemicals .......................................................................................... Rhodes Technologies .............................................................................................................. VerDate Sep<11>2014 20:55 Sep 13, 2016 Jkt 238001 PO 00000 Notice of registration. Frm 00054 Fmt 4703 Sfmt 4703 81 81 81 81 FR FR FR FR 3475 ............................ 31959 .......................... 31960 .......................... 34371 .......................... E:\FR\FM\14SEN1.SGM 14SEN1 Published January 21, 2016. May 20, 2016. May 20, 2016. May 31, 2016. 63220 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices Company FR Docket Sigma Aldrich Research Biochemicals, Inc ............................................................................. 81 FR 38217 .......................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted registration as a bulk manufacturer to the above listed persons. Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. 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 1301.33(a), this is notice that on July 27, 2016, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance [FR Doc. 2016–22082 Filed 9–13–16; 8:45 am] BILLING CODE 4410–09–P Dihydromorphine (9145) ............... Hydromorphone (9150) ................ DEPARTMENT OF JUSTICE I II The company plans to manufacture Hydromorphone (9150) for distribution to its customers. Dihydromorphine (9145) is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc. ACTION: Schedule Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. Notice of application. [FR Doc. 2016–22074 Filed 9–13–16; 8:45 am] 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 1301.33(a) on or before November 14, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: The Attorney General has delegated her SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: United States Pharmacopeial Convention ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: Published June 13, 2016. 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 October 14, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 14, 2016. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated her 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 February 26, 2016, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Cathinone (1235) ......................................................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. Lysergic acid diethylamide (7315) ............................................................................................................................................................... Marihuana (7360) ........................................................................................................................................................................................ VerDate Sep<11>2014 20:55 Sep 13, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1 I I I I

Agencies

[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Pages 63219-63220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22082]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: Registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as bulk 
manufacturers of various classes of controlled substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as manufacturers of various basic classes of controlled 
substances. Information on previously published notices is listed in 
the table below. No comments or objections were submitted for these 
notices.

------------------------------------------------------------------------
            Company                FR Docket            Published
------------------------------------------------------------------------
Johnson Matthey, Inc..........  81 FR 3475.....  January 21, 2016.
Mallinckrodt, LLC.............  81 FR 31959....  May 20, 2016.
American Radiolabeled           81 FR 31960....  May 20, 2016.
 Chemicals.
Rhodes Technologies...........  81 FR 34371....  May 31, 2016.

[[Page 63220]]

 
Sigma Aldrich Research          81 FR 38217....  June 13, 2016.
 Biochemicals, Inc.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of these registrants to manufacture 
the applicable 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. The DEA investigated each of the company's maintenance of 
effective controls against diversion by inspecting and testing each 
company's physical security systems, verifying each company's 
compliance with state and local laws, and reviewing each company's 
background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted registration as a bulk manufacturer to 
the above listed persons.

    Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22082 Filed 9-13-16; 8:45 am]
BILLING CODE 4410-09-P
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