Importer of Controlled Substances Registration: Fisher Clinical Services, Inc., 20418 [2016-07945]

Download as PDF 20418 Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 February 12, 2016, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607 applied to be registered as an importer of coca leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in bulk for the manufacture of controlled substance for distribution to its customers. SUPPLEMENTARY INFORMATION: Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–07944 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Fisher Clinical Services, Inc. ACTION: Notice of registration. Fisher Clinical Services, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Fisher Clinical Services, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 9, 2015, and published in the Federal Register on December 17, 2015, 80 FR 78766, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:35 Apr 06, 2016 Jkt 238001 The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Fisher Clinical Services, Inc. to import the 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 the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances: Controlled substance Methylphenidate (1724) ............. Levorphanol (9220) ................... Noroxymorphone (9668) ............ Tapentadol (9780) ..................... Schedule II II II II The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Placement of these (this) drug code (s) onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–07945 Filed 4–6–16; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Navinta, 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 in accordance with 21 CFR 1301.33(a) on or before June 6, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 10, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Pentobarbital (2270) ............... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Remifentanil (9739) ................. Fentanyl (9801) ....................... Schedule II II II II The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually upon FDA approval to produce commercial size batches for distribution to dosage form manufacturers. E:\FR\FM\07APN1.SGM 07APN1

Agencies

[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)]
[Notices]
[Page 20418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07945]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Fisher Clinical 
Services, Inc.

ACTION: Notice of registration.

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SUMMARY: Fisher Clinical Services, Inc. applied to be registered as an 
importer of certain basic classes of controlled substances. The Drug 
Enforcement Administration (DEA) grants Fisher Clinical Services, Inc. 
registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated December 9, 2015, and 
published in the Federal Register on December 17, 2015, 80 FR 78766, 
Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, 
Pennsylvania 18106 applied to be registered as an importer of certain 
basic classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Fisher Clinical 
Services, Inc. to import the 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 the company's maintenance of 
effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
           Controlled substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724)....................  II
Levorphanol (9220)........................  II
Noroxymorphone (9668).....................  II
Tapentadol (9780).........................  II
------------------------------------------------------------------------

    The company plans to import the listed substances for analytical 
research, testing, and clinical trials. This authorization does not 
extend to the import of a finished FDA approved or non-approved dosage 
form for commercial distribution in the United States.
    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. Placement of these (this) drug code (s) onto the company's 
registration does not translate into automatic approval of subsequent 
permit applications to import controlled substances. Approval of permit 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under to 21 U.S.C. 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-07945 Filed 4-6-16; 8:45 am]
BILLING CODE 4410-09-P