Bulk Manufacturer of Controlled Substances Registration, 55205 [2018-24005]

Download as PDF 55205 Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices Cambridge, UK; Clear Scientific, LLC, Cambridge, MA; Cornerstone Government Affairs, Inc., Washington, DC; DePuy Synthes Products, Inc., Raynham, MA; Dignitas Technologies, Orlando, FL; ECM Therapeutics, Inc., Warrendale, PA; ElMindA Ltd., Herzliya, Israel; Family Health International DBA FHI 360, Durham, NC; Hypatia Project, Reston, VA; Institutes for Behavior Resources, Inc. (IBR), Baltimore, MD; Integrated MicroSciences, LLC, Frederick, MD; J. Craig Venter Institute (JCVI), Rockville, MD; KaloCyte, Inc., St. Louis, MO; Lieber Institute, Inc., Baltimore, MD; NanoDirect, LLC, Baltimore, MD; OXYVITA, Inc., Middletown, NY; Parsons Government Services, Inc., Pasadena, CA; Protocentral, Inc., Woburn, MA; Q2Pharma, Haifa, Israel; RAIN Scientific, Inc., Asheville, NC; Rehat, LLC, Pittsburgh, PA; Research Foundation for Mental Hygiene, Inc. (NYSPI), New York, NY; Responde2 Corporation, Mountain View, CA; Saint Barnabas Medical Center (SBMC), Livingston, NJ; San Diego Blood Bank, San Diego, CA; SmartMD Systems, Inc., Manchester Center, VT; Sonica LLC, Evanston, IL; Spire, San Francisco, CA; Syracuse University, Syracuse, NY; The Charles Stark Draper Laboratory, Inc. (Draper), Cambridge, MA; The University of Arizona, Defense and Security Research Institute (DSRI), Tucson, AZ; Trauma Insight, LLC, San Antonio, TX; Trustees of Boston University, Boston, MA; University of Central Florida Research Foundation, Inc., Orlando, FL; University of Houston—Cullen College of Engineering, Houston, TX; Vivonics, Inc., Bedford, MA; and Washington State University, Pullman, WA; have been added 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 MTEC intends to file additional written notifications disclosing all changes in membership. On May 9, 2014, MTEC 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 June 9, 2014 (79 FR 32999). The last notification was filed with the Department on May 3, 2018. A notice was published in the Federal VerDate Sep<11>2014 17:57 Nov 01, 2018 Jkt 247001 Register pursuant to Section 6(b) of the Act on June 19, 2018 (83 FR 28448). Suzanne Morris, Chief, Premerger and Division Statistics Unit Antitrust Division. Dated: October 24, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–24005 Filed 11–1–18; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2018–23989 Filed 11–1–18; 8:45 am] BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: The 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: 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: FR citation Chemtos, 83 FR 37520 LLC. Johnson 83 FR 34880 Matthey Inc. AMRI 83 FR 38179 Rensselaer, Inc. Published August 1, 2018. July 23, 2018. August 3, 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. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 January 2, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: Notice of registration. Company Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc. 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 September 13, 2018, Janssen Pharmaceuticals, Inc., Buildings 1–5 & 7–14, 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Schedule Methylphenidate ............... Hydromorphone ................ Hydrocodone .................... Oripavine .......................... Thebaine ........................... Tapentadol ........................ 1724 9150 9193 9330 9333 9780 II II II II II II E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Page 55205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24005]


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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: The 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.

SUPPLEMENTARY INFORMATION: 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.

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             Company                  FR citation          Published
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Chemtos, LLC....................  83 FR 37520.......  August 1, 2018.
Johnson Matthey Inc.............  83 FR 34880.......  July 23, 2018.
AMRI Rensselaer, Inc............  83 FR 38179.......  August 3, 2018.
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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 a registration as a bulk manufacturer 
to the above listed companies.

    Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24005 Filed 11-1-18; 8:45 am]
 BILLING CODE 4410-09-P