Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, Inc., 61469-61470 [2015-25882]

Download as PDF Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices XIII. NO REACQUISITION Defendants may not reacquire any part of the Divestiture Assets during the term of this Final Judgment. XIV. 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. XV. EXPIRATION OF FINAL JUDGMENT Unless this Court grants an extension, this Final Judgment shall expire ten (10) years from the date of its entry. mstockstill on DSK4VPTVN1PROD with NOTICES XVI. 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 this l day oflll, 2015. Court approval subject to procedures of Antitrust Procedures and Penalties Act, 15 U.S.C. 16 llllllllllllllllll l United States District Judge SCHEDULE A List of products and functionality included in ‘‘Divested Product,’’ as defined in Section II.L of this Final Judgment: Dealertrack eCarList®; Dealertrack AAX®; Inventory+; InventoryPro; PriceDriver; TrueTarget® (including TrueTarget® Appraisal and TrueTarget® Pricing Reports); TrueTarget® Mobile; Inventory+Mobile (including Inventory+ for iPhone® and Android); Inventory Management Stocking and Sourcing; TrueScore; Inventory+ Appraisal Workflow; Inventory+ Merchandising; AutoInk and eBay Listing and Merchandising Tools (including VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 integrated AutoInk description writer and direct distribution to leading Web sites such as backpage.com, Craigslist, eBay Motors); Dealer Web sites (eCarList only); Dealertrack AutoReel® with TruVoiceTM; Inventory+ integrated, ‘‘multi-site’’ lead Management system (including Email Lead Management); Dealertrack Interactive Automated Incentives; OutClickTM; Inventory Health Report; Lot Services; PROShots; Inventory+ New Car Pricing; Dealertrack Inventory+ integration; Inventory+ Multiplatform Listing; Appraisal Central; GroupTrade; Software code for Inventory+ Exchange (including Social Trade and OpenTrade) and its predecessor Dealertrack Marketplace; Ability to enable Dealertrack SmartChat® reporting within Inventory+ for customers who have both Inventory+ and SmartChat®; and Fully integrated access and interoperability with Broker Connection. [FR Doc. 2015–26042 Filed 10–9–15; 8:45 am] BILLING CODE P 61469 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 the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 methylphenidate (1724), a basic class of controlled substance listed in schedule II. The company plans to import the listed substance as a raw material for updated testing purposes for EU customer requirements. 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: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2015–25881 Filed 10–9–15; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P [Docket No. DEA–392] Importer of Controlled Substances Registration: Unither Manufacturing, LLC ACTION: Unither Manufacturing, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Unither Manufacturing, LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22552, Unither Manufacturing, LLC, 331 Clay Road, Rochester, New York 14623 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Unither Manufacturing, LLC to import the basic class of controlled substance is PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 Drug Enforcement Administration [Docket No. DEA–392] Notice of registration. SUMMARY: DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, 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 1301.33(a) on or before December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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. DATES: E:\FR\FM\13OCN1.SGM 13OCN1 61470 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 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 1301.33(a), this is notice that on August 10, 2015, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. Louis, Missouri 63146 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................ Ibogaine (7260) ............................ Lysergic Acid diethylamide (7315) Tetrahydrocannabinols (7370) ...... Dimethyltryptamine (7435) ........... 1-[1-(2Thienyl)cyclohexyl]piperidine (7470) ........................................ Dihydromorphine (9145) ............... Heroin (9200) ................................ Normorphine (9313) ..................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Metazocine (9240) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273) ............... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) .................... Phenazocine (9715) ..................... Carfentanil (9743) ......................... Fentanyl (9801) ............................ I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–25882 Filed 10–9–15; 8:45 am] [FR Doc. 2015–25879 Filed 10–9–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab ACTION: Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals ACTION: Notice of application. 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 December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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 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 1301.33(a), this is notice that on August 6, 2015, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Registered bulk manufacturers of the affected basic class, 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 December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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 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 1301.33(a), this is notice that on August 7, 2015, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810 applied to be registered as a bulk manufacturer of morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards. DATES: PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 Controlled Substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Remifentanil (9739) ...................... E:\FR\FM\13OCN1.SGM 13OCN1 Schedule I I II

Agencies

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61469-61470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25882]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: American 
Radiolabeled Chemicals, 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 
1301.33(a) on or before December 14, 2015.

ADDRESSES:  Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
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.

[[Page 61470]]


SUPPLEMENTARY INFORMATION: 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 1301.33(a), this is notice that on August 
10, 2015, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. 
Louis, Missouri 63146 applied to be registered as a bulk manufacturer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                     Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010).............................          I
Ibogaine (7260)..............................................          I
Lysergic Acid diethylamide (7315)............................          I
Tetrahydrocannabinols (7370).................................          I
Dimethyltryptamine (7435)....................................          I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470).................          I
Dihydromorphine (9145).......................................          I
Heroin (9200)................................................          I
Normorphine (9313)...........................................          I
Amphetamine (1100)...........................................         II
Methamphetamine (1105).......................................         II
Amobarbital (2125)...........................................         II
Phencyclidine (7471).........................................         II
Phenylacetone (8501).........................................         II
Cocaine (9041)...............................................         II
Codeine (9050)...............................................         II
Dihydrocodeine (9120)........................................         II
Oxycodone (9143).............................................         II
Hydromorphone (9150).........................................         II
Ecgonine (9180)..............................................         II
Hydrocodone (9193)...........................................         II
Meperidine (9230)............................................         II
Metazocine (9240)............................................         II
Methadone (9250).............................................         II
Dextropropoxyphene, bulk (non-dosage forms) (9273)...........         II
Morphine (9300)..............................................         II
Oripavine (9330).............................................         II
Thebaine (9333)..............................................         II
Oxymorphone (9652)...........................................         II
Phenazocine (9715)...........................................         II
Carfentanil (9743)...........................................         II
Fentanyl (9801)..............................................         II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances as radiolabeled compounds for biochemical 
research.

    Dated: October 2, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
 [FR Doc. 2015-25882 Filed 10-9-15; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.