80_FR_61666 80 FR 61469 - Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, Inc.

80 FR 61469 - Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 197 (October 13, 2015)

Page Range61469-61470
FR Document2015-25882

Federal Register, Volume 80 Issue 197 (Tuesday, October 13, 2015) 
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61469-61470]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25882]


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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

Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61469 XIII. NO REACQUISITION integrated AutoInk description writer consistent with the public interest and Defendants may not reacquire any and direct distribution to leading Web with United States obligations under part of the Divestiture Assets during the sites such as backpage.com, Craigslist, international treaties, conventions, or term of this Final Judgment. eBay Motors); protocols in effect on May 1, 1971. The Dealer Web sites (eCarList only); DEA investigated the company’s XIV. RETENTION OF JURISDICTION Dealertrack AutoReel® with maintenance of effective controls This Court retains jurisdiction to TruVoiceTM; against diversion by inspecting and enable any party to this Final Judgment Inventory+ integrated, ‘‘multi-site’’ lead testing the company’s physical security to apply to this Court at any time for Management system (including Email systems, verifying the company’s further orders and directions as may be Lead Management); compliance with state and local laws, necessary or appropriate to carry out or Dealertrack Interactive Automated and reviewing the company’s construe this Final Judgment, to modify Incentives; background and history. any of its provisions, to enforce OutClickTM; Therefore, pursuant to 21 U.S.C. compliance, and to punish violations of Inventory Health Report; 952(a) and 958(a), and in accordance its provisions. Lot Services; with 21 CFR 1301.34, the above-named PROShots; company is granted registration as an XV. EXPIRATION OF FINAL Inventory+ New Car Pricing; importer of methylphenidate (1724), a JUDGMENT Dealertrack Inventory+ integration; basic class of controlled substance listed Unless this Court grants an extension, Inventory+ Multiplatform Listing; in schedule II. this Final Judgment shall expire ten (10) Appraisal Central; The company plans to import the years from the date of its entry. GroupTrade; listed substance as a raw material for Software code for Inventory+ Exchange updated testing purposes for EU XVI. PUBLIC INTEREST (including Social Trade and customer requirements. DETERMINATION OpenTrade) and its predecessor The company plans to import the Entry of this Final Judgment is in the Dealertrack Marketplace; listed controlled substances in finished public interest. The parties have Ability to enable Dealertrack dosage form (FDF) from foreign sources complied with the requirements of the SmartChat® reporting within for analytical testing and clinical trials Antitrust Procedures and Penalties Act, Inventory+ for customers who have in which the foreign FDF will be 15 U.S.C. 16, including making copies both Inventory+ and SmartChat®; and compared to the company’s own available to the public of this Final Fully integrated access and domestically-manufactured FDF. This Judgment, the Competitive Impact interoperability with Broker analysis is required to allow the Statement, and any comments thereon Connection. company to export domestically- and the United States’ responses to [FR Doc. 2015–26042 Filed 10–9–15; 8:45 am] manufactured FDF to foreign markets. comments. Based upon the record BILLING CODE P Dated: October 2, 2015. before the Court, which includes the Louis J. Milione, Competitive Impact Statement and any comments and response to comments DEPARTMENT OF JUSTICE Deputy Assistant Administrator. filed with the Court, entry of this Final [FR Doc. 2015–25881 Filed 10–9–15; 8:45 am] Judgment is in the public interest. Drug Enforcement Administration BILLING CODE 4410–09–P Dated this l day oflll, 2015. [Docket No. DEA–392] Court approval subject to procedures of DEPARTMENT OF JUSTICE Antitrust Procedures and Penalties Act, Importer of Controlled Substances 15 U.S.C. 16 Registration: Unither Manufacturing, LLC Drug Enforcement Administration lllllllllllllllllll [Docket No. DEA–392] United States District Judge ACTION: Notice of registration. SCHEDULE A Bulk Manufacturer of Controlled SUMMARY: Unither Manufacturing, LLC Substances Application: American List of products and functionality applied to be registered as an importer Radiolabeled Chemicals, Inc. included in ‘‘Divested Product,’’ as of a certain basic class of controlled defined in Section II.L of this Final substance. The Drug Enforcement ACTION: Notice of application. Judgment: Administration (DEA) grants Unither Dealertrack eCarList®; Manufacturing, LLC registration as an DATES: Registered bulk manufacturers of Dealertrack AAX®; importer of this controlled substance. the affected basic classes, and Inventory+; SUPPLEMENTARY INFORMATION: By notice applicants therefore, may file written InventoryPro; dated April 14, 2015, and published in comments on or objections to the PriceDriver; the Federal Register on April 22, 2015, issuance of the proposed registration in TrueTarget® (including TrueTarget® accordance with 21 CFR 1301.33(a) on 80 FR 22552, Unither Manufacturing, Appraisal and TrueTarget® Pricing or before December 14, 2015. LLC, 331 Clay Road, Rochester, New Reports); ADDRESSES: Written comments should York 14623 applied to be registered as TrueTarget® Mobile; Inventory+Mobile (including Inventory+ an importer of a certain basic class of be sent to: Drug Enforcement mstockstill on DSK4VPTVN1PROD with NOTICES for iPhone® and Android); controlled substance. No comments or Administration, Attention: DEA Federal Inventory Management Stocking and objections were submitted for this Register Representative/ODXL, 8701 Sourcing; notice. Morrissette Drive, Springfield, Virginia TrueScore; The DEA has considered the factors in 22152. Request for hearings should be Inventory+ Appraisal Workflow; 21 U.S.C. 823, 952(a) and 958(a) and sent to: Drug Enforcement Inventory+ Merchandising; determined that the registration of Administration, Attention: Hearing AutoInk and eBay Listing and Unither Manufacturing, LLC to import Clerk/LJ, 8701 Morrissette Drive, Merchandising Tools (including the basic class of controlled substance is Springfield, Virginia 22152. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

61470 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices SUPPLEMENTARY INFORMATION: The Dated: October 2, 2015. Dated: October 2, 2015. Attorney General has delegated her Louis J. Milione, Louis J. Milione, authority under the Controlled Deputy Assistant Administrator. Deputy Assistant Administrator. Substances Act to the Administrator of [FR Doc. 2015–25882 Filed 10–9–15; 8:45 am] [FR Doc. 2015–25879 Filed 10–9–15; 8:45 am] the Drug Enforcement Administration BILLING CODE 4410–09–P BILLING CODE 4410–09–P (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE implementation of 21 CFR part 1301, incident to the registration of Drug Enforcement Administration Drug Enforcement Administration manufacturers, distributors, dispensers, [Docket No. DEA–392] importers, and exporters of controlled [Docket No. DEA–392] substances (other than final orders in Bulk Manufacturer of Controlled connection with suspension, denial, or Bulk Manufacturer of Controlled Substances Application: Apertus revocation of registration) has been Substances Application: Cambridge Pharmaceuticals redelegated to the Deputy Assistant Isotope Lab Administrator of the DEA Office of ACTION: Notice of application. Diversion Control (‘‘Deputy Assistant ACTION: Notice of application. Administrator’’) pursuant to section 7 of DATES: Registered bulk manufacturers of 28 CFR part 0, appendix to subpart R. DATES: Registered bulk manufacturers of the affected basic classes, and In accordance with 21 CFR the affected basic class, and applicants applicants therefore, may file written 1301.33(a), this is notice that on August therefore, may file written comments on comments on or objections to the 10, 2015, American Radiolabeled or objections to the issuance of the issuance of the proposed registration in Chemicals, Inc., 101 Arc Drive, St. proposed registration in accordance accordance with 21 CFR 1301.33(a) on Louis, Missouri 63146 applied to be with 21 CFR 1301.33(a) on or before or before December 14, 2015. registered as a bulk manufacturer of the December 14, 2015. ADDRESSES: Written comments should following basic classes of controlled ADDRESSES: Written comments should be sent to: Drug Enforcement substances: be sent to: Drug Enforcement Administration, Attention: DEA Federal Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Controlled substance Schedule Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be Gamma Hydroxybutyric Acid 22152. Request for hearings should be sent to: Drug Enforcement (2010) ........................................ I sent to: Drug Enforcement Ibogaine (7260) ............................ I Administration, Attention: Hearing Lysergic Acid diethylamide (7315) I Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Tetrahydrocannabinols (7370) ...... I Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Dimethyltryptamine (7435) ........... I Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The 1-[1-(2- SUPPLEMENTARY INFORMATION: Attorney General has delegated her Thienyl)cyclohexyl]piperidine The Attorney General has delegated authority under the Controlled (7470) ........................................ I her authority under the Controlled Substances Act to the Administrator of Dihydromorphine (9145) ............... I Substances Act to the Administrator of the Drug Enforcement Administration Heroin (9200) ................................ I Normorphine (9313) ..................... I the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to Amphetamine (1100) .................... II (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with Methamphetamine (1105) ............ II exercise all necessary functions with respect to the promulgation and Amobarbital (2125) ....................... II respect to the promulgation and implementation of 21 CFR part 1301, Phencyclidine (7471) .................... II implementation of 21 CFR part 1301, incident to the registration of Phenylacetone (8501) .................. II incident to the registration of manufacturers, distributors, dispensers, Cocaine (9041) ............................. II manufacturers, distributors, dispensers, importers, and exporters of controlled Codeine (9050) ............................. II importers, and exporters of controlled substances (other than final orders in Dihydrocodeine (9120) ................. II substances (other than final orders in connection with suspension, denial, or Oxycodone (9143) ........................ II Hydromorphone (9150) ................ II connection with suspension, denial, or revocation of registration) has been Ecgonine (9180) ........................... II revocation of registration) has been redelegated to the Deputy Assistant Hydrocodone (9193) ..................... II redelegated to the Deputy Assistant Administrator of the DEA Office of Meperidine (9230) ........................ II Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Metazocine (9240) ........................ II Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of Methadone (9250) ........................ II Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. Dextropropoxyphene, bulk (non- 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR dosage forms) (9273) ............... II In accordance with 21 CFR 1301.33(a), this is notice that on August Morphine (9300) ........................... II 1301.33(a), this is notice that on August 6, 2015, Apertus Pharmaceuticals, 331 Oripavine (9330) ........................... II Thebaine (9333) ........................... II 7, 2015, Cambridge Isotope Lab, 50 Consort Drive, St. Louis, Missouri 63011 Oxymorphone (9652) .................... II Frontage Road, Andover, Massachusetts applied to be registered as a bulk mstockstill on DSK4VPTVN1PROD with NOTICES Phenazocine (9715) ..................... II 01810 applied to be registered as a bulk manufacturer of the following basic Carfentanil (9743) ......................... II manufacturer of morphine (9300), a classes of controlled substances: Fentanyl (9801) ............................ II basic class of controlled substance listed in schedule II. Controlled Substance Schedule The company plans to manufacture The company plans to utilize small small quantities of the listed controlled quantities of the listed controlled Marihuana (7360) ......................... I Tetrahydrocannabinols (7370) ..... I substances as radiolabeled compounds substance in the preparation of Remifentanil (9739) ...................... II for biochemical research. analytical standards. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1


Document Created: 2018-02-27 08:48:13
Document Modified: 2018-02-27 08:48:13
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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.
FR Citation80 FR 61469 
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