80_FR_22637 80 FR 22560 - Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.

80 FR 22560 - Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range22560-22561
FR Document2015-09326

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015)
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22560-22561]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09326]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cody 
Laboratories, 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/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 July 
3, 2014, Cody Laboratories, Inc., Steve Hartman--Vice President of 
Compliance, 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be 
registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Dihydromorphine (9145).....................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Phenylacetone (8501).......................  II

[[Page 22561]]

 
Cocaine (9041).............................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Oxymorphone (9652).........................  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.

    Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09326 Filed 4-21-15; 8:45 am]
BILLING CODE 4410-09-P



                                                    22560                             Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices

                                                    manufacturers, distributors, dispensers,                    Morrissette Drive, Springfield, Virginia                    DEPARTMENT OF JUSTICE
                                                    importers, and exporters of controlled                      22152. Request for hearings should be
                                                    substances (other than final orders in                      sent to: Drug Enforcement                                   Drug Enforcement Administration
                                                    connection with suspension, denial, or                      Administration, Attention: Hearing                          [Docket No. DEA–392]
                                                    revocation of registration) has been                        Clerk/LJ, 8701 Morrissette Drive,
                                                    redelegated to the Deputy Assistant                         Springfield, Virginia 22152.                                Bulk Manufacturer of Controlled
                                                    Administrator of the DEA Office of                                                                                      Substances Application: Cody
                                                    Diversion Control (‘‘Deputy Assistant                       SUPPLEMENTARY INFORMATION:      The
                                                                                                                                                                            Laboratories, Inc.
                                                    Administrator’’) pursuant to section 7 of                   Attorney General has delegated his
                                                    28 CFR part 0, appendix to subpart R.                       authority under the Controlled                              ACTION:     Notice of application.
                                                      In accordance with 21 CFR                                 Substances Act to the Administrator of
                                                    1301.33(a), this is notice that on                          the Drug Enforcement Administration                         DATES:  Registered bulk manufacturers of
                                                    December 23, 2014, Johnson Matthey                          (DEA), 28 CFR 0.100(b). Authority to                        the affected basic classes, and
                                                    Pharmaceutical Materials, Inc.,                             exercise all necessary functions with                       applicants therefore, may file written
                                                    Pharmaceutical Service, 25 Patton Road,                     respect to the promulgation and                             comments on or objections to the
                                                    Devens, Massachusetts 01434 applied to                      implementation of 21 CFR part 1301,                         issuance of the proposed registration in
                                                    be registered as a bulk manufacturer of                     incident to the registration of                             accordance with 21 CFR 1301.33(a) on
                                                    the following basic classes of controlled                   manufacturers, distributors, dispensers,                    or before June 22, 2015.
                                                    substances:                                                 importers, and exporters of controlled                      ADDRESSES: Written comments should
                                                                                                                substances (other than final orders in                      be sent to: Drug Enforcement
                                                            Controlled substance                    Schedule                                                                Administration, Attention: DEA Federal
                                                                                                                connection with suspension, denial, or
                                                    Amphetamine (1100) ....................         II          revocation of registration) has been                        Register Representative/ODXL, 8701
                                                    Methylphenidate (1724) ................         II          redelegated to the Deputy Assistant                         Morrissette Drive, Springfield, Virginia
                                                    Nabilone (7379) ............................    II          Administrator of the DEA Office of                          22152. Request for hearings should be
                                                    Hydrocodone (9193) .....................        II          Diversion Control (‘‘Deputy Assistant                       sent to: Drug Enforcement
                                                    Alfentanil (9737) ...........................   II          Administrator’’) pursuant to section 7 of                   Administration, Attention: Hearing
                                                    Remifentanil (9739) ......................      II
                                                                                                                28 CFR part 0, appendix of subpart R.                       Clerk/LJ, 8701 Morrissette Drive,
                                                    Sufentanil (9740) ..........................    II                                                                      Springfield, Virginia 22152.
                                                                                                                  In accordance with 21 CFR
                                                                                                                                                                            SUPPLEMENTARY INFORMATION: The
                                                      The company plans to utilize this                         1301.33(a), this is notice that on June
                                                                                                                                                                            Attorney General has delegated his
                                                    facility to manufacture small quantities                    10, 2013, AMRI Rensselaer, Inc., 33
                                                                                                                                                                            authority under the Controlled
                                                    of the listed controlled substances in                      Riverside Avenue, Rensselaer, New                           Substances Act to the Administrator of
                                                    bulk and to conduct analytical testing in                   York 12144 applied to be registered as                      the Drug Enforcement Administration
                                                    support of the company’s primary                            a bulk manufacturer of the following                        (DEA), 28 CFR 0.100(b). Authority to
                                                    manufacturing facility in West Deptford,                    basic classes controlled substances:                        exercise all necessary functions with
                                                    New Jersey. The controlled substances
                                                                                                                                                                            respect to the promulgation and
                                                    manufactured in bulk at this facility will                          Controlled substance                     Schedule   implementation of 21 CFR part 1301,
                                                    be distributed to its company’s
                                                                                                                                                                            incident to the registration of
                                                    customers.                                                  Marihuana (7360) .........................      I
                                                                                                                                                                            manufacturers, distributors, dispensers,
                                                      Dated: April 14, 2015.                                    Tetrahydrocannabinols (7370) .....              I
                                                                                                                Amphetamine (1100) ....................         II
                                                                                                                                                                            importers, and exporters of controlled
                                                    Joseph T. Rannazzisi,                                                                                                   substances (other than final orders in
                                                                                                                Lisdexamfetamine (1205) .............           II
                                                    Deputy Assistant Administrator.                             Methylphenidate (1724) ................         II
                                                                                                                                                                            connection with suspension, denial, or
                                                    [FR Doc. 2015–09330 Filed 4–21–15; 8:45 am]                 Pentobarbital (2270) .....................      II          revocation of registration) has been
                                                    BILLING CODE P                                              4-Anilino-N-phenethyl-4-piperidine              II          redelegated to the Deputy Assistant
                                                                                                                  (8333).                                                   Administrator of the DEA Office of
                                                                                                                Meperidine (9230) ........................      II          Diversion Control (‘‘Deputy Assistant
                                                    DEPARTMENT OF JUSTICE                                       Fentanyl (9801) ............................    II          Administrator’’) pursuant to section 7 of
                                                                                                                                                                            28 CFR part 0, appendix to subpart R.
                                                    Drug Enforcement Administration                                                                                            In accordance with 21 CFR
                                                                                                                  The company plans to manufacture
                                                    [Docket No. DEA–392]                                                                                                    1301.33(a), this is notice that on July 3,
                                                                                                                bulk controlled substances for use in
                                                                                                                                                                            2014, Cody Laboratories, Inc., Steve
                                                                                                                product development and for                                 Hartman—Vice President of
                                                    Bulk Manufacturer of Controlled
                                                    Substances Application: AMRI                                distribution to its customers.                              Compliance, 601 Yellowstone Avenue,
                                                    Rensselaer, Inc.                                              In reference to drug code 7360                            Cody, Wyoming 82414 applied to be
                                                                                                                (marihuana), and 7370 (THC), the                            registered as a bulk manufacturer of the
                                                    ACTION:    Notice of application.                           company plans to bulk manufacture                           following basic classes of controlled
                                                                                                                these drugs as synthetic. No other                          substances:
                                                    DATES:  Registered bulk manufacturers of                    activity for this drug code is authorized
                                                    the affected basic classes, and                                                                                                  Controlled substance                 Schedule
                                                                                                                for this registration.
                                                    applicants therefore, may file written
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    comments on or objections to the                              Dated: April 14, 2015.                                     Dihydromorphine (9145) ...............       I
                                                    issuance of the proposed registration in                    Joseph T. Rannazzisi,                                        Amphetamine (1100) ....................      II
                                                    accordance with 21 CFR 1301.33(a) on                                                                                     Methamphetamine (1105) ............          II
                                                                                                                Deputy Assistant Administrator.
                                                    or before June 22, 2015.                                                                                                 Amobarbital (2125) .......................   II
                                                                                                                [FR Doc. 2015–09324 Filed 4–21–15; 8:45 am]                  Pentobarbital (2270) .....................   II
                                                    ADDRESSES: Written comments should                          BILLING CODE 4410–09–P                                       Secobarbital (2315) ......................   II
                                                    be sent to: Drug Enforcement                                                                                             4-Anilino-N-phenethyl-4-piperidine           II
                                                    Administration, Attention: DEA Federal                                                                                     (ANPP) (8333).
                                                    Register Representative/ODXL, 8701                                                                                       Phenylacetone (8501) ..................      II



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                                                                                      Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices                                                          22561

                                                            Controlled substance                    Schedule    (DEA), 28 CFR 0.100(b). Authority to                  material are not appropriate. 72 FR 3417
                                                                                                                exercise all necessary functions with                 (January 25, 2007).
                                                    Cocaine (9041) .............................    II          respect to the promulgation and                       SUPPLEMENTARY INFORMATION: The
                                                    Codeine (9050) .............................    II          implementation of 21 CFR part 1301,                   Attorney General has delegated his
                                                    Dihydrocodeine (9120) .................         II          incident to the registration of                       authority under the Controlled
                                                    Oxycodone (9143) ........................       II          manufacturers, distributors, dispensers,
                                                    Hydromorphone (9150) ................           II
                                                                                                                                                                      Substances Act to the Administrator of
                                                    Diphenoxylate (9170) ...................        II
                                                                                                                importers, and exporters of controlled                the Drug Enforcement Administration
                                                    Ecgonine (9180) ...........................     II          substances (other than final orders in                (DEA), 28 CFR 0.100(b). Authority to
                                                    Hydrocodone (9193) .....................        II          connection with suspension, denial, or                exercise all necessary functions with
                                                    Meperidine (9230) ........................      II          revocation of registration) has been                  respect to the promulgation and
                                                    Methadone (9250) ........................       II          redelegated to the Deputy Assistant                   implementation of 21 CFR part 1301,
                                                    Morphine (9300) ...........................     II          Administrator of the DEA Office of                    incident to the registration of
                                                    Thebaine (9333) ...........................     II          Diversion Control (‘‘Deputy Assistant                 manufacturers, distributors, dispensers,
                                                    Oxymorphone (9652) ...................          II          Administrator’’) pursuant to section 7 of             importers, and exporters of controlled
                                                    Alfentanil (9737) ...........................   II          28 CFR part 0, appendix to subpart R.                 substances (other than final orders in
                                                    Remifentanil (9739) ......................      II              In accordance with 21 CFR
                                                    Sufentanil (9740) ..........................    II
                                                                                                                                                                      connection with suspension, denial, or
                                                    Fentanyl (9801) ............................    II
                                                                                                                1301.34(a), this is notice that on                    revocation of registration) has been
                                                                                                                February 9, 2015, Stepan Company,                     redelegated to the Deputy Assistant
                                                      The company plans to manufacture                          Natural Products Dept., 100 W. Hunter                 Administrator of the DEA Office of
                                                    the listed controlled substances in bulk                    Avenue, Maywood, New Jersey 07607                     Diversion Control (‘‘Deputy Assistant
                                                    for sale to its customers.                                  applied to be registered as an importer               Administrator’’) pursuant to section 7 of
                                                                                                                of coca leaves (9040), a basic class of               28 CFR part 0, appendix to subpart R.
                                                      Dated: April 14, 2015.                                    controlled substance listed in schedule                  In accordance with 21 CFR
                                                    Joseph T. Rannazzisi,                                       II.                                                   1301.34(a), this is notice that on
                                                    Deputy Assistant Administrator.                                 The company plans to import the                   November 17, 2014, Siegfried USA,
                                                    [FR Doc. 2015–09326 Filed 4–21–15; 8:45 am]                 listed controlled substance to                        LLC, 33 Industrial Park Road,
                                                    BILLING CODE 4410–09–P                                      manufacture bulk controlled substances                Pennsville, New Jersey 08070 applied to
                                                                                                                for distribution to its customers.                    be registered as an importer of the
                                                                                                                  Dated: April 14, 2015.                              following basic classes of controlled
                                                    DEPARTMENT OF JUSTICE                                       Joseph T. Rannazzisi,                                 substances:
                                                    Drug Enforcement Administration                             Deputy Assistant Administrator.
                                                                                                                                                                               Controlled substance                Schedule
                                                                                                                [FR Doc. 2015–09342 Filed 4–21–15; 8:45 am]
                                                    [Docket No. DEA–392]
                                                                                                                BILLING CODE 4410–09–P                                 Opium, raw (9600) .......................   II
                                                                                                                                                                       Poppy Straw Concentrate (9670)              II
                                                    Importer of Controlled Substances
                                                    Application: Stepan Company                                                                                          The company plans to import the
                                                                                                                DEPARTMENT OF JUSTICE
                                                    ACTION:    Notice of application.                                                                                 listed controlled substances to bulk
                                                                                                                Drug Enforcement Administration                       manufacture API’s for distribution to its
                                                    DATES:  Registered bulk manufacturers of                    [Docket No. DEA–392]                                  customer.
                                                    the affected basic class, and applicants                                                                            Dated: April 14, 2015.
                                                    therefore, may file written comments on                     Importer of Controlled Substances                     Joseph T. Rannazzisi,
                                                    or objections to the issuance of the                        Application: Siegfried USA, LLC                       Deputy Assistant Administrator.
                                                    proposed registration in accordance                                                                               [FR Doc. 2015–09336 Filed 4–21–15; 8:45 am]
                                                                                                                ACTION:   Notice of application.
                                                    with 21 CFR 1301.34(a) on or before                                                                               BILLING CODE 4410–09–P
                                                    May 22, 2015. Such persons may also                         DATES:  Registered bulk manufacturers of
                                                    file a written request for a hearing on                     the affected basic classes, and
                                                    the application pursuant to 21 CFR                          applicants therefore, may file written                DEPARTMENT OF JUSTICE
                                                    1301.43 on or before May 22, 2015.                          comments on or objections to the
                                                    ADDRESSES: Written comments should                          issuance of the proposed registration in              Drug Enforcement Administration
                                                    be sent to: Drug Enforcement                                accordance with 21 CFR 1301.34(a) on                  [Docket No. DEA–392]
                                                    Administration, Attention: DEA Federal                      or before May 22, 2015. Such persons
                                                    Register Representative/ODXL, 8701                          may also file a written request for a                 Importer of Controlled Substances
                                                    Morrissette Drive, Springfield, Virginia                    hearing on the application pursuant to                Registration: Actavis Pharma, Inc.
                                                    22152. Request for hearings should be                       21 CFR 1301.43 on or before May 22,
                                                    sent to: Drug Enforcement                                                                                         ACTION:    Notice of registration.
                                                                                                                2015.
                                                    Administration, Attention: Hearing                          ADDRESSES: Written comments should                    SUMMARY:   Actavis Pharma, Inc. applied
                                                    Clerk/LJ, 8701 Morrissette Drive,                           be sent to: Drug Enforcement                          to be registered as an importer of certain
                                                    Springfield, Virginia 22152. Comments                       Administration, Attention: DEA Federal                basic classes of controlled substances.
                                                    and request for hearings on applications                    Register Representative/ODXL, 8701                    The Drug Enforcement Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    to import narcotic raw material are not                     Morrissette Drive, Springfield, Virginia              (DEA) grants Actavis Pharma, Inc.,
                                                    appropriate. 72 FR 3417 (January 25,                        22152. Request for hearings should be                 registration as an importer of those
                                                    2007).                                                      sent to: Drug Enforcement                             controlled substances.
                                                    SUPPLEMENTARY INFORMATION:   The                            Administration, Attention: Hearing                    SUPPLEMENTARY INFORMATION: By notice
                                                    Attorney General has delegated his                          Clerk/LJ, 8701 Morrissette Drive,                     dated May 28, 2014, and published in
                                                    authority under the Controlled                              Springfield, Virginia 22152. Comments                 the Federal Register on June 4, 2014, FR
                                                    Substances Act to the Administrator of                      and requests for hearings on                          79 32315, Actavis Pharma, Inc., 2455
                                                    of the Drug Enforcement Administration                      applications to import narcotic raw                   Wardlow Road, Corona, California


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Document Created: 2015-12-16 08:27:46
Document Modified: 2015-12-16 08:27:46
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 22560 

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