83_FR_5836 83 FR 5808 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

83 FR 5808 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5808-5808
FR Document2018-02645

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018)
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5808]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02645]


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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 on or before April 10, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
6, 2017, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 
applied to be registered as a bulk manufacturer for the basic classes 
of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Cathinone..............................     1235  I
Gamma Hydroxybutyric Acid..............     2010  I
Marihuana Extract......................     7350  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Codeine-N-oxide........................     9053  I
Dihydromorphine........................     9145  I
Hydromorphinol.........................     9301  I
Morphine-N-oxide.......................     9307  I
Amphetamine............................     1100  II
Lisdexamfetamine.......................     1205  II
Methylphenidate........................     1724  II
Nabilone...............................     7379  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 tincture.........................     9630  II
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Alfentanil.............................     9737  II
Sufentanil.............................     9740  II
Carfentanil............................     9743  II
Tapentadol.............................     9780  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture bulk active pharmaceutical 
ingredients (APIs) and reference standards for distribution to their 
customers.
    In reference to drug codes 7360 (marihuana) and 7370 
(tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

    Dated: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02645 Filed 2-8-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                5808                           Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices

                                                inspection at the Office of the Secretary                                                       Drug                  Administration, Attention: DEA Federal
                                                                                                          Controlled substance                            Schedule
                                                and on EDIS.3                                                                                   code                  Register Representative/DRW, 8701
                                                  This action is taken under the                                                                                      Morrissette Drive, Springfield, Virginia
                                                authority of section 337 of the Tariff Act              Cathinone .....................          1235     I
                                                                                                                                                                      22152.
                                                of 1930, as amended (19 U.S.C. 1337),                   Gamma Hydroxybutyric                     2010     I
                                                and of §§ 201.10 and 210.8(c) of the                      Acid.                                                       SUPPLEMENTARY INFORMATION:      The
                                                                                                        Marihuana Extract ........               7350     I
                                                Commission’s Rules of Practice and                                                                                    Attorney General has delegated his
                                                                                                        Marihuana .....................          7360     I
                                                Procedure (19 CFR 201.10, 210.8(c)).                    Tetrahydrocannabinols                    7370     I           authority under the Controlled
                                                  By order of the Commission.                           Codeine-N-oxide ...........              9053     I           Substances Act to the Administrator of
                                                  Issued: February 6, 2018.                             Dihydromorphine ..........               9145     I           the Drug Enforcement Administration
                                                Lisa R. Barton,                                         Hydromorphinol ............              9301     I           (DEA), 28 CFR 0.100(b). Authority to
                                                                                                        Morphine-N-oxide .........               9307     I           exercise all necessary functions with
                                                Secretary to the Commission.                            Amphetamine ...............              1100     II
                                                [FR Doc. 2018–02616 Filed 2–8–18; 8:45 am]
                                                                                                                                                                      respect to the promulgation and
                                                                                                        Lisdexamfetamine ........                1205     II
                                                BILLING CODE 7020–02–P                                  Methylphenidate ...........              1724     II          implementation of 21 CFR part 1301,
                                                                                                        Nabilone .......................         7379     II          incident to the registration of
                                                                                                        Codeine ........................         9050     II          manufacturers, distributors, dispensers,
                                                DEPARTMENT OF JUSTICE                                   Dihydrocodeine .............             9120     II          importers, and exporters of controlled
                                                                                                        Oxycodone ...................            9143     II          substances (other than final orders in
                                                Drug Enforcement Administration                         Hydromorphone ............               9150     II          connection with suspension, denial, or
                                                                                                        Hydrocodone ................             9193     II
                                                                                                                                                                      revocation of registration) has been
                                                [Docket No. DEA–392]                                    Morphine .......................         9300     II
                                                                                                        Oripavine ......................         9330     II          redelegated to the Assistant
                                                Bulk Manufacturer of Controlled                         Thebaine .......................         9333     II          Administrator of the DEA Diversion
                                                Substances Application: Noramco, Inc.                   Opium tincture ..............            9630     II          Control Division (‘‘Assistant
                                                                                                        Oxymorphone ...............              9652     II          Administrator’’) pursuant to section 7 of
                                                ACTION:   Notice of application.                        Noroxymorphone ..........                9668     II          28 CFR part 0, appendix to subpart R.
                                                                                                        Alfentanil .......................       9737     II
                                                DATES:  Registered bulk manufacturers of                Sufentanil ......................        9740     II            In accordance with 21 CFR
                                                the affected basic classes, and                         Carfentanil ....................         9743     II          1301.33(a), this is notice that on
                                                applicants therefore, may file written                  Tapentadol ....................          9780     II          December 6, 2017, AMRI Rensselaer,
                                                comments on or objections to the                        Fentanyl ........................        9801     II          Inc., 33 Riverside Avenue, Rensselaer,
                                                issuance of the proposed registration on                                                                              New York 12144 applied to be
                                                or before April 10, 2018.                                  The company plans to manufacture                           registered as a bulk manufacturer of the
                                                                                                        bulk active pharmaceutical ingredients                        following basic classes of controlled
                                                ADDRESSES: Written comments should
                                                                                                        (APIs) and reference standards for                            substances:
                                                be sent to: Drug Enforcement
                                                                                                        distribution to their customers.
                                                Administration, Attention: DEA Federal
                                                                                                           In reference to drug codes 7360                                                               Drug
                                                Register Representative/DRW, 8701                                                                                       Controlled substance                     Schedule
                                                                                                        (marihuana) and 7370                                                                             code
                                                Morrissette Drive, Springfield, Virginia
                                                                                                        (tetrahydrocannabinols), the company
                                                22152.                                                                                                                Marihuana .....................     7360   I
                                                                                                        plans to bulk manufacture these drugs
                                                SUPPLEMENTARY INFORMATION: The                          as synthetic. No other activities for these                   Tetrahydrocannabinols               7370   I
                                                Attorney General has delegated his                      drug codes are authorized for this                            Amphetamine ...............         1100   II
                                                authority under the Controlled                          registration.                                                 Lisdexamfetamine ........           1205   II
                                                Substances Act to the Administrator of                                                                                Pentobarbital ................      2270   II
                                                                                                          Dated: January 31, 2018.
                                                the Drug Enforcement Administration                                                                                   4-Anilino-N-phenethyl-4-            8333   II
                                                                                                        Susan A. Gibson,                                                piperidine (ANPP).
                                                (DEA), 28 CFR 0.100(b). Authority to
                                                exercise all necessary functions with                   Deputy Assistant Administrator.                               Codeine ........................    9050   II
                                                respect to the promulgation and                         [FR Doc. 2018–02645 Filed 2–8–18; 8:45 am]                    Oxycodone ...................       9143   II
                                                implementation of 21 CFR part 1301,                     BILLING CODE 4410–09–P                                        Hydromorphone ............          9150   II
                                                incident to the registration of                                                                                       Hydrocodone ................        9193   II
                                                manufacturers, distributors, dispensers,                                                                              Meperidine ....................     9230   II
                                                importers, and exporters of controlled                  DEPARTMENT OF JUSTICE                                         Morphine .......................    9300   II
                                                substances (other than final orders in
                                                                                                        Drug Enforcement Administration
                                                connection with suspension, denial, or                                                                                  The company plans to manufacture
                                                revocation of registration) has been                    [Docket No. DEA–392]                                          bulk controlled substances for use in
                                                redelegated to the Assistant                                                                                          product development and for
                                                Administrator of the DEA Diversion                      Bulk Manufacturer of Controlled                               distribution to its customers.
                                                Control Division (‘‘Assistant                           Substances Application: AMRI
                                                                                                        Rensselaer, Inc.                                                In reference to drug codes 7360
                                                Administrator’’) pursuant to section 7 of
                                                                                                                                                                      (marihuana) and 7370 (THC), the
                                                28 CFR part 0, appendix to subpart R.
                                                   In accordance with 21 CFR                            ACTION:     Notice of application.                            company plans to bulk manufacture
                                                1301.33(a), this is notice that on July 6,                                                                            these drugs as synthetics. No other
                                                                                                        DATES:  Registered bulk manufacturers of                      activities for these drug codes are
sradovich on DSK3GMQ082PROD with NOTICES




                                                2017, Noramco, Inc., 1440 Olympic
                                                                                                        the affected basic classes, and                               authorized for this registration.
                                                Drive, Athens, Georgia 30601 applied to
                                                                                                        applicants therefore, may file written
                                                be registered as a bulk manufacturer for                                                                                Dated: January 31, 2018.
                                                                                                        comments on or objections to the
                                                the basic classes of controlled                                                                                       Susan A. Gibson,
                                                                                                        issuance of the proposed registration on
                                                substances:                                                                                                           Deputy Assistant Administrator.
                                                                                                        or before April 10, 2018.
                                                  3 Electronic Document Information System              ADDRESSES: Written comments should                            [FR Doc. 2018–02644 Filed 2–8–18; 8:45 am]
                                                (EDIS): https://edis.usitc.gov.                         be sent to: Drug Enforcement                                  BILLING CODE 4410–09–P




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Document Created: 2018-02-09 00:12:03
Document Modified: 2018-02-09 00:12:03
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 on or before April 10, 2018.
FR Citation83 FR 5808 

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