Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC, 57389 [2015-24123]

Download as PDF Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices 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. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–24121 Filed 9–22–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chemtos, 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 November 23, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: 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. mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 In accordance with 21 CFR 1301.33(a), this is notice that on May 28, 2015, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, Texas 78737–9331 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Marihuana (7360) ......................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Etorphine HCI (9059) ................... Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Isomethadone (9226) ................... Meperidine (9230) ........................ Meperidine intermediate-A (9232) Meperidine intermediate-B (9233) Meperidine intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Dihydroetorphine (9334) ............... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Racemethorphan (9732) .............. Racemorphan (9733) ................... Schedule I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers for use as reference standards. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. 57389 also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 23, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: 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 June 16, 2015, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for product development and preparation of stability batches. [FR Doc. 2015–24123 Filed 9–22–15; 8:45 am] Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P [FR Doc. 2015–24118 Filed 9–22–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Importer of Controlled Substances Application: Fresenius Kabi USA, LLC [Docket No. DEA–392] ACTION: Importer of Controlled Substances Registration: Rhodes Technologies 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 in accordance with 21 CFR 1301.34(a) on or before October 23, 2015. Such persons may DATES: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 ACTION: Notice of registration. Rhodes Technologies applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Rhodes Technologies SUMMARY: E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24123]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Chemtos, 
LLC

ACTION: Notice of application.

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

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 in accordance with 21 CFR 
1301.33(a) on or before November 23, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 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 May 
28, 2015, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, 
Texas 78737-9331 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Etorphine HCI (9059).......................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Ecgonine (9180)............................  II
Ethylmorphine (9190).......................  II
Hydrocodone (9193).........................  II
Levomethorphan (9210)......................  II
Levorphanol (9220).........................  II
Isomethadone (9226)........................  II
Meperidine (9230)..........................  II
Meperidine intermediate-A (9232)...........  II
Meperidine intermediate-B (9233)...........  II
Meperidine intermediate-C (9234)...........  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Dihydroetorphine (9334)....................  II
Levo-alphacetylmethadol (9648).............  II
Oxymorphone (9652).........................  II
Racemethorphan (9732)......................  II
Racemorphan (9733).........................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances in bulk for distribution to its customers for use 
as reference standards.

    Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24123 Filed 9-22-15; 8:45 am]
 BILLING CODE 4410-09-P
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