Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 13521 [2018-06325]

Download as PDF 13521 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp Clinical Services, INC. 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 April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 DATES: 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 February 2, 2018, Sharp Clinical Services INC., 300 Kimberton Rd., Phoenixville, PA 19460 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Marihuana ........................................................................................................................................................................ 3,4-Methylenedioxymethamphetamine ............................................................................................................................ Psilocybin ......................................................................................................................................................................... The company plans to import the listed controlled substances for analytical research, testing, and clinical trials. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 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 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–06319 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] sradovich on DSK3GMQ082PROD with NOTICES Bulk Manufacturer of Controlled Substances Application: Navinta LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 29, 2018. DATES: VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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, 2017, Navinta LLC, 1499 Lower Ferry Rd. Ewing, NJ 08618 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Controlled substance 2010 7360 7405 7437 Drug code Pentobarbital .... 4-Anilino-Nphenethyl-4piperidine (ANPP). Levorphanol ...... Remifentanil ...... Fentanyl ............ Schedule I I I I Schedule 2270 8333 II II 9220 9739 9801 II II II The company plans to initially manufacture API quantities of the listed controlled substances for validation purposes and FDA approval. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–06325 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Siegfried USA, 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 DATES: E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06325]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before May 29, 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 
September 13, 2017, Navinta LLC, 1499 Lower Ferry Rd. Ewing, NJ 08618 
applied to be registered as a bulk manufacturer for the basic classes 
of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Pentobarbital......................            2270  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Levorphanol........................            9220  II
Remifentanil.......................            9739  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to initially manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval.

    Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06325 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P
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