Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals, LLC, 49578-49579 [2018-21348]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 49578 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices Mira Labs, Inc., Los Angeles, CA; ClearObject, Inc., Fishers, IN; Aegis Industrial Software Corporation, Horsham, PA; CH Hanson LLC, Naperville, IL; Marshall, Gerstein & Borun LLP, Chicago, IL; ARC Precision, Isanti, MN; Authenticiti, Inc., San Francisco, CA; DiMonte Group, Warrenville, IL; Applied Automation Technologies, Inc., Rochester Hills, MI; Janiero Digital, Chicago, IL; Simio, Pittsburgh, PA; Aunalytics, South Bend, IN; American Gear Manufacturers Association, Alexandria, VA; ML Design Technologies, Palo Alto, CA; Bain & Company, Boston, MA; Eural USA, Chicago, IL; Sigmaxim, Inc., Norwood, MA; Electric Imp., Los Altos, CA; Entringa, Chicago, IL; Fraight Inc., Chicago, IL; Xcelgo, Atlanta, GA; Duracell, Chicago, IL; ProMANAGE, Chicago, IL; DP Technology Corp., Camarillo, CA; ClearBlade, Austin, TX; CyberPoint International, Baltimore, MD; Proto Labs, Maple Plain, MN; SWARM Engineering, San Juan, Capistrano, CA; Catalytic, Naperville, IL; CyPhy Works, Danvers, MA; VANTIQ, Walnut Creek, CA; Alta Via Consulting, Palos Heights, IL; Beacon Interactive, Waltham, MA; Cimetrix Inc., Midvale, UT; Factory Physics, Bryan, TX; Ekta Flow LLC, Chicago, IL; Machine Metrics, Inc., Northampton, MA; RetoLogic, Santa Clara, CA; University of New Hampshire, Durham, NH; Consolidated Nuclear Security, Oak Ridge, TN; Design Interactive, Inc., Orlando, FL; EMNS, Inc., Downers Grove, IL; Supply Dynamics, Loveland, OH; Vision Three, Bloomington, IN; University of Central Florida, Orlando, FL; DMR International, Woodstock, IL; iBASEt, Foothill Ranch, CA; Shape Fidelity, Huntsville, AL; AE Machines, Champaign, IL; Montronix, Ann Arbor, MI; Transco Products, Chicago, IL; Hardinge, Inc., Elmira, NY; The Northridge Group, Rosemont, IL; BEET, Plymouth, MI; and Hallsten Innovations, Barberton, OH, have been added as parties to this venture. Also, Warwick Analytics, Chicago, IL; Wittenstein North America, Bartlett, IL; Hallsten Innovations Ltd., Chicago, IL; Metrosage LLC, Volcano, CA; CUBRC, Buffalo, NY; Building Blocks, Inc., Chicago, IL; Manufacturing Renaissance, Chicago, IL; 3 Degrees LLC, Chicago, IL; Concurrent Technologies Corporation, Johnstown, PA; Alliance for Industry & Manufacturing, Chicago, IL; Strong Oak, Chicago, IL; Koneksys LLC, San Francisco, CA; Isola USA Corp., Chandler, AZ; Sera Laser Precision, Libertyville, IL; EDM Department, Inc., Bartlett, IL; Sensorhound, West Lafayette, IN; Actvcontent, Sunnyvale, VerDate Sep<11>2014 17:16 Oct 01, 2018 Jkt 247001 CA; 4D Technology, Tucson, AZ; Huntington Ingalls, Inc., Pascagoula, MS; Grant Thornton, Chicago, IL; Agility Network Services, Chicago, IL; Isomorph Development, Inc., Cleveland, OH; Golden Corridor Advanced Manufacturing Partnership, Schaumburg, IL; Sandalwood Engineering & Ergonomics, Livonia, MI; Renaissance Service, Inc., Fairborn, OH; WW Grainger Inc., Lake Forest, IL; Tech Mahindra Americas Inc., Plano, TX; Boston Consulting Group, Boston, MA; CapGemini US LLC, Atlanta, GA; SaltFlats Labs, Santa Clara, CA; Verena Solutions LLC, Chicago, IL; Siewert Solutions, Wylie, TX; Rocky Mountain Technology Alliance, Inc., Colorado Springs, CO; Prairiefire Consulting Inc., Urbana, IL; Wiegel Tool Works, Wood Dale, IL; and Source3, New York, NY, have withdrawn as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and DMDII intends to file additional written notifications disclosing all changes in membership. On January 5, 2016, DMDII filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on March 9, 2016 (81 FR 12525). The last notification was filed with the Department on June 26, 2017. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on August 15, 2017 (82 FR 38709). Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division. [FR Doc. 2018–21432 Filed 10–1–18; 8:45 am] BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies ACTION: Notice; correction. The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 15, 2018, concerning a notice of application that inadvertently did not include the controlled substance Fentanyl (9801). SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Correction In the Federal Register on August 15, 2018, in FR Doc No: 2018–17605 (83 FR 158) on pages 40567 and 40568, correct the table to include the following basic class of controlled substance: Controlled substance Fentanyl .................... Drug code 9801 Schedule II Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–21352 Filed 10–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals, LLC 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 on or before December 3, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 March 14, 2018, AMPAC Fine Chemicals, LLC, Highway 50 and Hazel Avenue, Building 05001, Rancho Cordova, California 95670 applied to be registered DATES: E:\FR\FM\02OCN1.SGM 02OCN1 49579 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Methylphenidate ....... Levomethorphan ...... Levorphanol .............. Thebaine .................. Remifentanil ............. Tapentadol ............... Drug code Schedule II II II II II II [FR Doc. 2018–21348 Filed 10–1–18; 8:45 am] The companies listed below applied to be registered as bulk 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. SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUMMARY: BILLING CODE 4410–09–P 1724 9210 9220 9333 9739 9780 The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Notice of registration. Company FR docket Published American Radiolabeled Chem ................................................................................................................................. Cerilliant Corporation ............................................................................................................................................... 83 FR 28664 83 FR 28664 June 20, 2018. June 20, 2018. 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 a registration as a bulk manufacturer to the above listed companies. Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–21353 Filed 10–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] amozie on DSK3GDR082PROD with NOTICES1 Dated: September 20, 2018. John J. Martin, Assistant Administrator. Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City ACTION: Controlled substance Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the DATES: VerDate Sep<11>2014 18:39 Oct 01, 2018 Jkt 247001 issuance of the proposed registration on or before December 3, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 June 8, 2018, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of the basic classes of controlled substances: Gamma Hydroxybutyric Acid. Amphetamine ................. Lisdexamfetamine .......... Methylphenidate ............. 4-Anilino-N-phenethyl-4piperidine (ANPP). Phenylacetone ................ Cocaine .......................... PO 00000 Frm 00050 Fmt 4703 Drug code Drug code Codeine .......................... Oxycodone ..................... Hydromorphone .............. Hydrocodone .................. Morphine ........................ Oripavine ........................ Thebaine ........................ Opium extracts ............... Opium fluid extract ......... Opium tincture ................ Opium, powdered ........... Oxymorphone ................. Noroxymorphone ............ Fentanyl .......................... 9050 9143 9150 9193 9300 9330 9333 9610 9620 9630 9639 9652 9668 9801 Schedule II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–21351 Filed 10–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration Schedule 2010 I 1100 1205 1724 8333 II II II II 8501 9041 II II Sfmt 4703 Controlled substance ACTION: Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances. SUMMARY: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Pages 49578-49579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21348]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: AMPAC 
Fine Chemicals, LLC


ACTION: Notice of application.

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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 on or before December 3, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 March 
14, 2018, AMPAC Fine Chemicals, LLC, Highway 50 and Hazel Avenue, 
Building 05001, Rancho Cordova, California 95670 applied to be 
registered

[[Page 49579]]

as a bulk manufacturer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
       Controlled substance             Drug code           Schedule
------------------------------------------------------------------------
Methylphenidate...................  1724.............  II
Levomethorphan....................  9210.............  II
Levorphanol.......................  9220.............  II
Thebaine..........................  9333.............  II
Remifentanil......................  9739.............  II
Tapentadol........................  9780.............  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution to its customers.

    Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-21348 Filed 10-1-18; 8:45 am]
 BILLING CODE 4410-09-P