Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc., 5812 [2018-02642]

Download as PDF 5812 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). 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 1301.34(a), this is notice that on November 10, 2017, Mylan Technologies Inc., 110 Lake St., Saint Albans, VT 05478 applied to be registered as an importer of the following basic classes of controlled substances: DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration [OMB Number 1103–0098] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc. SUPPLEMENTARY INFORMATION: Controlled substance sradovich on DSK3GMQ082PROD with NOTICES Methylphenidate ........... Fentanyl ........................ Drug code Schedule 1724 9801 II II 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 domestically manufactured FDF to foreign markets. Authorization will not extend to the import of Food and Drug Administration approved or nonapproved finish dosage forms for commercial sale. Dated: February 1, 2018. Susan A Gibson, Deputy Assistant Administrator. [FR Doc. 2018–02641 Filed 2–8–18; 8:45 am] BILLING CODE 4410–09–P 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 April 10, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 December 13, 2017, Siemens Healthcare Diagnostics Inc., 100 GBC Drive, Mailstop 514, Newark, DE 19702 applied to be registered as a bulk manufacturer of the following basic class of controlled substance: SUPPLEMENTARY INFORMATION: Controlled substance Ecgonine ....................... Drug code 9180 16:57 Feb 08, 2018 II The company plans to bulk manufacture a material used in the manufacture of reagents for a Cocaine in vitro diagnostic test system. Dated: February 1, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–02642 Filed 2–8–18; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 Schedule Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Proposed eCollection eComments Requested; COPS Application Package Community Oriented Policing Services, Department of Justice. ACTION: 30-Day notice. AGENCY: The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting 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 December 1, 2017, to obtain comments from the public and affected agencies. DATES: The purpose of this notice is to allow for an additional 30 days for public comment March 12, 2018. FOR FURTHER INFORMATION CONTACT: If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Lashon M. Hilliard, Department of Justice Office of Community Oriented Policing Services, 145 N Street NE, Washington, DC 20530 or at (202) 514– 6563. 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 20530 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; —Enhance the quality, utility, and clarity of the information to be collected; and SUMMARY: E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02642]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Siemens 
Healthcare Diagnostics Inc.

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 April 10, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 
December 13, 2017, Siemens Healthcare Diagnostics Inc., 100 GBC Drive, 
Mailstop 514, Newark, DE 19702 applied to be registered as a bulk 
manufacturer of the following basic class of controlled substance:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Ecgonine...............................     9180  II
------------------------------------------------------------------------

    The company plans to bulk manufacture a material used in the 
manufacture of reagents for a Cocaine in vitro diagnostic test system.

    Dated: February 1, 2018.
 Susan A. Gibson,
 Deputy Assistant Administrator.
[FR Doc. 2018-02642 Filed 2-8-18; 8:45 am]
 BILLING CODE 4410-09-P
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