Importer of Controlled Substances Registration: Rhodes Technologies, 57389-57390 [2015-24119]

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 57390 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22556, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island, 02816 applied to be registered as an importer of a certain basic classes of controlled substances. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Rhodes Technologies 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 Opium, raw (9600) ...................... Poppy Straw Concentrate (9670) II II The company plans to import the listed controlled substances in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–24119 Filed 9–22–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE mstockstill on DSK4VPTVN1PROD with NOTICES Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. ACTION: Notice of application. VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 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. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. 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. DEPARTMENT OF JUSTICE 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 June 16, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUMMARY: DATES: ADDRESSES: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Remifentanil (9739) ...................... Fentanyl (9801) ............................ Schedule I I II II II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code (7360) marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture synthetic tetrahydrocannabinols (7370). No other activity for this drug code is authorized for this registration. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 [FR Doc. 2015–24127 Filed 9–22–15; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Wildlife Laboratories, Inc. ACTION: Notice of registration. Wildlife Laboratories, Inc., applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Wildlife Laboratories, Inc. registration as an importer of those controlled substances. By notice dated June 12, 2015, and published in the Federal Register on June 23, 2015, 80 FR 35975, Wildlife Laboratories, Inc., 1230 W. Ash Street, Suite D, Windsor, Colorado 80550 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 Wildlife Laboratories, 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 basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Etorphine (except HCl) (9056) ..... Etorphine HCl (9059) ................... Schedule I II The company plans to import the listed controlled substances for sale to its customer. E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Pages 57389-57390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24119]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Rhodes 
Technologies

ACTION: Notice of registration.

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

SUMMARY: Rhodes Technologies applied to be registered as an importer of 
certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Rhodes Technologies

[[Page 57390]]

registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015, 80 FR 22556, 
Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island, 
02816 applied to be registered as an importer of a certain basic 
classes of controlled substances. Comments and request for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007).
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Rhodes Technologies 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
------------------------------------------------------------------------
Opium, raw (9600).........................  II
Poppy Straw Concentrate (9670)............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
order to bulk manufacture controlled substances in Active 
Pharmaceutical Ingredient (API) form. The company distributes the 
manufactured APIs in bulk to its customers.

    Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24119 Filed 9-22-15; 8:45 am]
 BILLING CODE 4410-09-P

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