Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 22555-22556 [2015-09325]

Download as PDF 22555 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices Controlled substance Schedule Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Fentanyl (9801) ............................ II II II II II II February 10, 2015, Stepan Company, Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 07607 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule The company plans to import the listed controlled substances for clinical trials, research and analytical purposes. Cocaine (9041) ............................. Ecgonine (9180) ........................... Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. The company plans to manufacture the listed controlled substances in bulk for distribution to its customer. [FR Doc. 2015–09339 Filed 4–21–15; 8:45 am] Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. BILLING CODE 4410–09–P II II [FR Doc. 2015–09327 Filed 4–21–15; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Stepan Company Drug Enforcement Administration ACTION: Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. 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 22, 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 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 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 DATES: asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. DEA–392] Notice of application. VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 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 22, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 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 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. DATES: PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 In accordance with 21 CFR 1301.33(a), this is notice that on January 29, 2015, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Codeine-N-oxide (9053) ............... Dihydromorphine (9145) ............... Morphine-N-oxide (9307) ............. Amphetamine (1100) .................... Methylphenidate (1724) ................ Phenylacetone (8501) .................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ Schedule I I I II II II II II II II II II II II II II II II II II II II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–09331 Filed 4–21–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City 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 22, 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. DATES: E:\FR\FM\22APN1.SGM 22APN1 22556 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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 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 15, 2014, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule asabaliauskas on DSK5VPTVN1PROD with NOTICES Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ 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 [FR Doc. 2015–09325 Filed 4–21–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Rhodes Technologies 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 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. DATES: 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. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 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 March 10, 2015, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: The company plans to manufacture the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE Controlled Substance Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Schedule 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: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–09338 Filed 4–21–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Almac Clinical Services Inc. (ACSI) 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 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 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 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 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 March DATES: E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22555-22556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09325]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

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 June 22, 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.

[[Page 22556]]


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 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 
15, 2014, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616 applied to be registered as a bulk manufacturer the following 
basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium, raw (9600)..........................  II
Opium extracts (9610)......................  II
Opium fluid extract (9620).................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Opium, granulated (9640)...................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Poppy Straw Concentrate (9670).............  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.

    Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09325 Filed 4-21-15; 8:45 am]
 BILLING CODE 4410-09-P
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