Importer of Controlled Substances Application: Xcelience, 22519 [2018-10300]

Download as PDF 22519 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices Company FR Docket Patheon Pharmaceuticals, Inc ................................................................ Chattem Chemicals, Inc .......................................................................... INSYS Manufacturing LLC ...................................................................... Siemens Healthcare Diagnostics Inc ...................................................... Cerilliant Corporation ............................................................................... Noramco, Inc ........................................................................................... Johnson Matthey, Inc .............................................................................. 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: May 7, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–10304 Filed 5–14–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Xcelience ACTION: Notice of application. Registered bulk importers 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 June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing daltland on DSKBBV9HB2PROD with NOTICES DATES: VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 83 83 83 83 83 83 83 FR FR FR FR FR FR FR 5274 5274 5810 5812 5809 5808 7221 .................................... .................................... .................................... .................................... .................................... .................................... .................................... should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (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 April 11, 2018, Xcelience, 4901 West Grace Street, Tampa, FL 33607 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Amphetamine ... 1100 Schedule II The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes. The import of this class of controlled substance will be granted only for analytical testing, research and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Published February February February February February February February 6, 2018. 6, 2018. 9, 2018. 9, 2018. 9, 2018. 9, 2018. 20, 2018. Dated: April 25, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–10300 Filed 5–14–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1110–0064] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension, Without Change, of a Currently Approved Collection; FBI Expungement Form (FD–1114) Criminal Justice Information Services Division, Federal Bureau of Investigation, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, 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 is published to obtain comments from the public and affected agencies. DATES: Comments are encouraged and will be accepted for 60 days until July 16, 2018. FOR FURTHER INFORMATION CONTACT: If you have additional 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 Gerry Lynn Brovey, Supervisory Information Liaison Specialist, FBI, CJIS, Resources Management Section, Administrative Unit, Module C–2, 1000 Custer Hollow Road, Clarksburg, West Virginia, 26306 (facsimile: 304–625– 5093) or email glbrovey@ic.fbi.gov. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. SUMMARY: E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Page 22519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10300]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Xcelience

ACTION: Notice of application.

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DATES: Registered bulk importers 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 June 14, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before June 14, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (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)

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 1301.34(a), this is notice that on April 
11, 2018, Xcelience, 4901 West Grace Street, Tampa, FL 33607 applied to 
be registered as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Amphetamine........................            1100  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.
    The import of this class of controlled substance will be granted 
only for analytical testing, research and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial sale.

    Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10300 Filed 5-14-18; 8:45 am]
 BILLING CODE 4410-09-P
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