80_FR_22632 80 FR 22555 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

80 FR 22555 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

Page Range22555-22555
FR Document2015-09331

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015)
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22555]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09331]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Noramco, 
Inc.

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/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.
    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                       Schedule
------------------------------------------------------------------------
Codeine-N-oxide (9053).....................  I
Dihydromorphine (9145).....................  I
Morphine-N-oxide (9307)....................  I
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Phenylacetone (8501).......................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  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
Tapentadol (9780)..........................  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



                                                                                     Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices                                                                   22555

                                                            Controlled substance                   Schedule    February 10, 2015, Stepan Company,                            In accordance with 21 CFR
                                                                                                               Natural Products Department, 100 W.                         1301.33(a), this is notice that on January
                                                    Amphetamine (1100) ....................        II          Hunter Avenue, Maywood, New Jersey                          29, 2015, Noramco, Inc., 500 Swedes
                                                    Methylphenidate (1724) ................        II          07607 applied to be registered as a bulk                    Landing Road, Wilmington, Delaware
                                                    Oxycodone (9143) ........................      II          manufacturer of the following basic                         19801–4417 applied to be registered as
                                                    Hydromorphone (9150) ................          II
                                                                                                               classes of controlled substances:                           a bulk manufacturer of the following
                                                    Hydrocodone (9193) .....................       II
                                                    Fentanyl (9801) ............................   II                                                                      basic classes of controlled substances:
                                                                                                                       Controlled substance                     Schedule
                                                       The company plans to import the                                                                                              Controlled substance                   Schedule
                                                                                                               Cocaine (9041) .............................    II
                                                    listed controlled substances for clinical                  Ecgonine (9180) ...........................     II           Codeine-N-oxide (9053) ...............         I
                                                    trials, research and analytical purposes.                                                                               Dihydromorphine (9145) ...............         I
                                                      Dated: April 14, 2015.                                     The company plans to manufacture                           Morphine-N-oxide (9307) .............          I
                                                    Joseph T. Rannazzisi,                                      the listed controlled substances in bulk                     Amphetamine (1100) ....................        II
                                                                                                               for distribution to its customer.                            Methylphenidate (1724) ................        II
                                                    Deputy Assistant Administrator.                                                                                         Phenylacetone (8501) ..................        II
                                                    [FR Doc. 2015–09339 Filed 4–21–15; 8:45 am]                  Dated: April 14, 2015.                                     Codeine (9050) .............................   II
                                                    BILLING CODE 4410–09–P                                     Joseph T. Rannazzisi,                                        Dihydrocodeine (9120) .................        II
                                                                                                               Deputy Assistant Administrator.                              Oxycodone (9143) ........................      II
                                                                                                               [FR Doc. 2015–09327 Filed 4–21–15; 8:45 am]                  Hydromorphone (9150) ................          II
                                                    DEPARTMENT OF JUSTICE                                                                                                   Hydrocodone (9193) .....................       II
                                                                                                               BILLING CODE 4410–09–P
                                                                                                                                                                            Morphine (9300) ...........................    II
                                                    Drug Enforcement Administration                                                                                         Oripavine (9330) ...........................   II
                                                                                                                                                                            Thebaine (9333) ...........................    II
                                                    [Docket No. DEA–392]                                       DEPARTMENT OF JUSTICE                                        Opium extracts (9610) ..................       II
                                                                                                                                                                            Opium fluid extract (9620) ............        II
                                                    Bulk Manufacturer of Controlled                            Drug Enforcement Administration                              Opium tincture (9630) ..................       II
                                                    Substances Application: Stepan                             [Docket No. DEA–392]                                         Opium, powdered (9639) .............           II
                                                    Company                                                                                                                 Opium, granulated (9640) ............          II
                                                                                                               Bulk Manufacturer of Controlled                              Oxymorphone (9652) ...................         II
                                                    ACTION:    Notice of application.                          Substances Application: Noramco, Inc.
                                                                                                                                                                            Noroxymorphone (9668) ..............           II
                                                                                                                                                                            Tapentadol (9780) ........................     II
                                                    DATES:  Registered bulk manufacturers of                   ACTION:    Notice of application.
                                                    the affected basic classes, and                                                                                          The company plans to manufacture
                                                    applicants therefore, may file written                     DATES:  Registered bulk manufacturers of                    the above-listed controlled substances
                                                    comments on or objections to the                           the affected basic classes, and                             in bulk for distribution to its customers.
                                                    issuance of the proposed registration in                   applicants therefore, may file written                        Dated: April 14, 2015.
                                                    accordance with 21 CFR 1301.33(a) on                       comments on or objections to the                            Joseph T. Rannazzisi,
                                                    or before June 22, 2015.                                   issuance of the proposed registration in                    Deputy Assistant Administrator.
                                                    ADDRESSES: Written comments should                         accordance with 21 CFR 1301.33(a) on                        [FR Doc. 2015–09331 Filed 4–21–15; 8:45 am]
                                                    be sent to: Drug Enforcement                               or before June 22, 2015.
                                                                                                                                                                           BILLING CODE 4410–09–P
                                                    Administration, Attention: DEA Federal                     ADDRESSES: Written comments should
                                                    Register Representative/ODXL, 8701                         be sent to: Drug Enforcement
                                                    Morrissette Drive, Springfield, Virginia                   Administration, Attention: DEA Federal                      DEPARTMENT OF JUSTICE
                                                    22152. Request for hearings should be                      Register Representative/ODW, 8701
                                                    sent to: Drug Enforcement                                  Morrissette Drive, Springfield, Virginia                    Drug Enforcement Administration
                                                    Administration, Attention: Hearing                         22152. Request for hearings should be                       [Docket No. DEA–392]
                                                    Clerk/LJ, 8701 Morrissette Drive,                          sent to: Drug Enforcement
                                                    Springfield, Virginia 22152.                               Administration, Attention: Hearing                          Bulk Manufacturer of Controlled
                                                    SUPPLEMENTARY INFORMATION: The                             Clerk/LJ, 8701 Morrissette Drive,                           Substances Application: Cambrex
                                                    Attorney General has delegated his                         Springfield, Virginia 22152.                                Charles City
                                                    authority under the Controlled                             SUPPLEMENTARY INFORMATION: The
                                                    Substances Act to the Administrator of                     Attorney General has delegated his                          ACTION:     Notice of application.
                                                    the Drug Enforcement Administration                        authority under the Controlled
                                                    (DEA), 28 CFR 0.100(b). Authority to                       Substances Act to the Administrator of                      DATES:  Registered bulk manufacturers of
                                                    exercise all necessary functions with                      the Drug Enforcement Administration                         the affected basic classes, and
                                                    respect to the promulgation and                            (DEA), 28 CFR 0.100(b). Authority to                        applicants therefore, may file written
                                                    implementation of 21 CFR part 1301,                        exercise all necessary functions with                       comments on or objections to the
                                                    incident to the registration of                            respect to the promulgation and                             issuance of the proposed registration in
                                                    manufacturers, distributors, dispensers,                   implementation of 21 CFR part 1301,                         accordance with 21 CFR 1301.33(a) on
                                                    importers, and exporters of controlled                     incident to the registration of                             or before June 22, 2015.
                                                    substances (other than final orders in                     manufacturers, distributors, dispensers,                    ADDRESSES: Written comments should
                                                    connection with suspension, denial, or                     importers, and exporters of controlled                      be sent to: Drug Enforcement
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                                                    revocation of registration) has been                       substances (other than final orders in                      Administration, Attention: DEA Federal
                                                    redelegated to the Deputy Assistant                        connection with suspension, denial, or                      Register Representative/ODXL, 8701
                                                    Administrator of the DEA Office of                         revocation of registration) has been                        Morrissette Drive, Springfield, Virginia
                                                    Diversion Control (‘‘Deputy Assistant                      redelegated to the Deputy Assistant                         22152. Request for hearings should be
                                                    Administrator’’) pursuant to section 7 of                  Administrator of the DEA Office of                          sent to: Drug Enforcement
                                                    28 CFR part 0, appendix to subpart R.                      Diversion Control (‘‘Deputy Assistant                       Administration, Attention: Hearing
                                                       In accordance with 21 CFR                               Administrator’’) pursuant to section 7 of                   Clerk/LJ, 8701 Morrissette Drive,
                                                    1301.33(a), this is notice that on                         28 CFR part 0, appendix to subpart R.                       Springfield, Virginia 22152.


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Document Created: 2015-12-16 08:27:40
Document Modified: 2015-12-16 08:27:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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.
FR Citation80 FR 22555 

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