Importer of Controlled Substances Application: Novitium Pharma, LLC, 13520 [2018-06318]

Download as PDF 13520 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 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 June 5, 2017, Fisher Clinical Services, Inc., 700 A–C Nestle Way, Breinigsville, Pennsylvania 18031–1522 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Methylphenidate ..... Levorphanol ............ Noroxymorphone .... Tapentadol .............. Drug code 1724 9220 9668 9780 Schedule II II II II The company plans to import the listed controlled substances in finished dosage form for testing, and clinical trials purposes only. This authorization does not extend to the import of a finished Food and Drug Administration (FDA) approved or non-approved dosage form for commercial distribution in the United States. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–06321 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. Importer of Controlled Substances Application: Lannett Company, Inc. ACTION: 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests 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. 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 24, 2014, Lannett Company, Inc., 9001 Torresdale Avenue, Philadelphia, Pennsylvania 19136 applied to be registered as an importer of tetrahydrocannabinols (7370), a basic class of controlled substance listed in schedule I. The company plans to import the finished dosage forms to support their abbreviated new drug application (ANDA) submission to the U.S. Food and Drug Administration (FDA). No other activity for this drug code is authorized for this registration. [FR Doc. 2018–06313 Filed 3–28–18; 8:45 am] Notice of application. BILLING CODE 4410–09–P 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 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 Morrissette Drive, Springfield, Virginia sradovich on DSK3GMQ082PROD with NOTICES DATES: VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Novitium Pharma, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 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. 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. ADDRESSES: 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 January 8, 2018, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, NJ 08520 applied to be registered as an importer of the Schedule II controlled substance Levorphanol (9220). The company plans to import the controlled substance to develop the manufacturing process for a drug product that will in turn be used to produce a tablet equivalent to the current brand product. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–06318 Filed 3–28–18; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06318]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Novitium Pharma, 
LLC

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 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 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.

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 
January 8, 2018, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, NJ 
08520 applied to be registered as an importer of the Schedule II 
controlled substance Levorphanol (9220).
    The company plans to import the controlled substance to develop the 
manufacturing process for a drug product that will in turn be used to 
produce a tablet equivalent to the current brand product.

    Dated: March 15, 2018.
Susan A. Gibson,
 Deputy Assistant Administrator.
[FR Doc. 2018-06318 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P
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