Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc., 55205-55206 [2018-24006]

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 55206 Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: October 24, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–24006 Filed 11–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Amended Consent Decree Under the Clean Air Act On October 25, 2018, the Department of Justice lodged a proposed Amended Consent Decree with the United States District Court of the Virgin Islands in the lawsuit entitled United States of America v. Virgin Islands Water and Power Authority, Civil Action No. 3:14– cv–00086. The original Consent Decree resolved the Clean Air Act violations as alleged in the Complaint filed by the United States on October 30, 2014. The violations alleged in the Complaint with respect to VIWAPA’s St. Thomas facility include VIWAPA’s failure to properly operate and/or maintain its water injection systems on its gas turbine units, failure to operate in compliance with NOX, sulfuric acid mist, particulate matter and VOC emission limits, failure to operate in compliance with opacity limits, failure to perform required audits and maintain required quality data availability, failure to properly operate and calibrate the continuous emission monitoring systems (CEMS) for NOX and CO, failure to conduct stack testing every 30 months, and failure to properly report non-compliance. The violations alleged in the Complaint with respect to VIWAPA’s St. John facility concern VIWAPA’s failure to comply with the RICE NESHAP regulations, failure to timely submit a Title V renewal application and operation without a Title V permit, and failure to conduct stack testing every 30 months. The Consent Decree, entered by the Court on September 30, 2016, requires VIWAPA to generate a high percentage of its KWh from liquid propane gas or liquid natural gas and renewables, to implement a spare parts inventory program, to control NOX emissions through improved operation of its water injection system, to maintain and operate continuous emissions monitoring systems on specified units, to operate a video camera system for visible emissions, to perform stack testing, and to conduct targeted selfaudits and third party audits given its long term compliance problems. The VerDate Sep<11>2014 17:57 Nov 01, 2018 Jkt 247001 Consent Decree also required a $1,300,000 penalty, which VIWAPA has paid. The proposed Amended Consent Decree makes certain changes to the Consent Decree, including: Updating references to current operating units; adding new units called reciprocating internal combustion engines to the requirements of Paragraph 13 and any requirements associated with the requirements of Paragraph 13; updating aspects of the Consent Decree that have become outdated and are no longer relevant to its enforcement; addressing the current status of the St. John Unit; edits to Paragraph 21 regarding the Atomizer on Unit 14; and adding a date certain for the performance of a stack test. The Department of Justice will receive, for a period of thirty (30) days from the date of this publication, comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General for the Environmental and Natural Resources Division, and should refer to United States v. Virgin Islands Water and Power Authority, DOJ Ref. # 90–5–2–1– 10424. All comments must be submitted no later than thirty days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By e-mail ...... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: http:// www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ— ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $22.75 (25 cents per page reproduction cost) payable to the United States Treasury. Robert Maher, Assistant Section Chief, Environmental Enforcement Section, Environment & Natural Resources Division. [FR Doc. 2018–23985 Filed 11–1–18; 8:45 am] BILLING CODE 4410–15–P PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE U.S. Marshals Service [OMB Number 1105–0096] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With No Changes, of a Previously Approved Collection; Sequestered Juror Information Form U.S. Marshals Service, Department of Justice. ACTION: 30-Day notice. AGENCY: The Department of Justice (DOJ), U.S. Marshals Service (USMS), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register on August 29, 2018, allowing for a 60-day comment period. DATES: Comments are encouraged and will be accepted for an additional 30 days until December 3, 2018. FOR FURTHER INFORMATION CONTACT: If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Nicole Timmons either by mail at CG–3, 10th Floor, Washington, DC 20530–0001, by email at Nicole.Timmons@usdoj.gov, or by telephone at 202–236–2646. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to OIRA_ submissions@omb.eop.gov. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; SUMMARY: E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55205-55206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24006]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceuticals, 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 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.

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 
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:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate.........................   1724  II
Hydromorphone...........................   9150  II
Hydrocodone.............................   9193  II
Oripavine...............................   9330  II
Thebaine................................   9333  II
Tapentadol..............................   9780  II
------------------------------------------------------------------------


[[Page 55206]]

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

    Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24006 Filed 11-1-18; 8:45 am]
 BILLING CODE 4410-09-P