82_FR_19161 82 FR 19083 - Importer of Controlled Substances Application: Cambridge Isotope Laboratories

82 FR 19083 - Importer of Controlled Substances Application: Cambridge Isotope Laboratories

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range19083-19084
FR Document2017-08346

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017)
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19083-19084]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08346]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Cambridge Isotope 
Laboratories

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 
1301.34(a) on or before May 25, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before May 25, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement

[[Page 19084]]

Administration, Attn: Administrator, 8701 Morrissette Drive, 
Springfield, Virginia 22152. All requests for hearing should also be 
sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 
8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: 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 1301.34(a), this is notice that on August 
25, 2016, Cambridge Isotope Laboratories, 50 Frontage Road, Andover, 
Massachusetts 01810 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance             Drug code         Schedule
------------------------------------------------------------------------
Mephedrone (4-Methyl-N-                         1248  I
 methylcathinone).
Gamma Hydroxybutyric Acid...........            2010  I
Methaqualone........................            2565  I
Lysergic acid diethylamide..........            7315  I
Marihuana...........................            7360  I
Tetrahydrocannabinols...............            7370  I
3,4-Methylenedioxyamphetamine.......            7400  I
3,4-Methylenedioxy-N-                           7404  I
 ethylamphetamine.
3,4-Methylenedioxymethamphetamine...            7405  I
Methylone (3,4-Methylenedioxy-N-                7540  I
 methylcathinone).
Butylone............................            7541  I
Heroin..............................            9200  I
Pentobarbital.......................            2270  II
Secobarbital........................            2315  II
Phencyclidine.......................            7471  II
Cocaine.............................            9041  II
Dihydrocodeine......................            9120  II
Ecgonine............................            9180  II
Meperidine..........................            9230  II
Dextropropoxyphene, bulk (non-dosage            9273  II
 forms).
Fentanyl............................            9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical research, testing and clinical trials.

    Dated: April 18, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-08346 Filed 4-24-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                   Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices                                                         19083

                                                      This action is taken under the                        redelegated to the Assistant                            In accordance with 21 CFR
                                                    authority of section 337 of the Tariff Act              Administrator of the DEA Diversion                    1301.33(a), this is notice that on June 1,
                                                    of 1930, as amended (19 U.S.C. 1337),                   Control Division (‘‘Assistant                         2016, Cedarburg Pharmaceuticals Inc., A
                                                    and of §§ 201.10 and 210.8(c) of the                    Administrator’’) pursuant to section 7 of             Division of Albany Molecular Research
                                                    Commission’s Rules of Practice and                      28 CFR part 0, appendix to subpart R.                 Inc. (AMRI), 870 Badger Circle, Grafton,
                                                    Procedure (19 CFR 201.10, 210.8(c)).                      In accordance with 21 CFR                           Wisconsin 53024 applied to be
                                                      By order of the Commission.
                                                                                                            1301.34(a), this is notice that on                    registered as a bulk manufacturer of the
                                                                                                            December 16, 2016, Janssen Ortho LLC,                 following basic classes of controlled
                                                      Dated: April 18, 2017.
                                                                                                            State Road 933 DM 0.1 Mamey Ward,                     substances:
                                                    Lisa R. Barton,                                         Gurabo, Puerto Rico 00778 applied to be
                                                    Secretary to the Commission.                            registered as an importer of tapentadol                                                  Drug
                                                                                                                                                                    Controlled Substance                     Schedule
                                                    [FR Doc. 2017–08232 Filed 4–24–17; 8:45 am]             (9780), a basic class of controlled                                                      Code
                                                    BILLING CODE 7020–02–P                                  substance listed in schedule II.
                                                                                                              The company plans to import an                       Marihuana ...................      7360   I
                                                                                                                                                                   Tetrahydrocannabinols              7370   I
                                                                                                            intermediate form of tapentadol (9780)                 Lisdexamfetamine ......            1205   II
                                                    DEPARTMENT OF JUSTICE                                   to bulk manufacture tapentadol for                     4-Anilino-N-phenethyl-             8333   II
                                                                                                            distribution to its customers.                           4-piperidine (ANPP).
                                                    Drug Enforcement Administration                           Dated: April 18, 2017.                               Remifentanil ................      9739   II
                                                                                                            Louis J. Milione,                                      Fentanyl ......................    9801   II
                                                    [Docket No. DEA–392]
                                                                                                            Assistant Administrator.
                                                    Importer of Controlled Substances                                                                                The company plans to manufacture
                                                                                                            [FR Doc. 2017–08345 Filed 4–24–17; 8:45 am]
                                                    Application: Janssen Ortho LLC                                                                                the above-listed controlled substances
                                                                                                            BILLING CODE 4410–09–P                                in bulk for distribution to its customers.
                                                    ACTION:   Notice of application.                                                                              In reference to drug codes 7360
                                                                                                                                                                  marihuana, the company plans to bulk
                                                                                                            DEPARTMENT OF JUSTICE
                                                    DATES:  Registered bulk manufacturers of                                                                      manufacture cannabidiol as a synthetic
                                                    the affected basic class, and applicants                Drug Enforcement Administration                       intermediate. This controlled substance
                                                    therefore, may file written comments on                                                                       will be further synthesized to bulk
                                                    or objections to the issuance of the                    [Docket No. DEA–392]                                  manufacture a synthetic
                                                    proposed registration in accordance                                                                           tetrahydrocannabinols 7370. No other
                                                                                                            Bulk Manufacturer of Controlled
                                                    with 21 CFR 1301.34(a) on or before                                                                           activity for this drug code is authorized
                                                                                                            Substances Application: Cedarburg
                                                    May 25, 2017. Such persons may also                                                                           for this registration.
                                                                                                            Pharmaceuticals
                                                    file a written request for a hearing on                                                                         Dated: April 18, 2017.
                                                    the application pursuant to 21 CFR                      ACTION:   Notice of application.                      Louis J. Milione,
                                                    1301.43 on or before May 25, 2017.                                                                            Assistant Administrator.
                                                    ADDRESSES: Written comments should                      DATES:  Registered bulk manufacturers of
                                                                                                                                                                  [FR Doc. 2017–08343 Filed 4–24–17; 8:45 am]
                                                    be sent to: Drug Enforcement                            the affected basic classes, and
                                                                                                                                                                  BILLING CODE 4410–09–P
                                                    Administration, Attention: DEA Federal                  applicants therefore, may file written
                                                    Register Representative/DRW, 8701                       comments on or objections to the
                                                    Morrissette Drive, Springfield, Virginia                issuance of the proposed registration in
                                                                                                                                                                  DEPARTMENT OF JUSTICE
                                                    22152. All requests for hearing must be                 accordance with 21 CFR 1301.33(a) on
                                                    sent to: Drug Enforcement                               or before June 26, 2017.                              Drug Enforcement Administration
                                                    Administration, Attn: Administrator,                    ADDRESSES: Written comments should
                                                                                                                                                                  [Docket No. DEA–392]
                                                    8701 Morrissette Drive, Springfield,                    be sent to: Drug Enforcement
                                                    Virginia 22152. All requests for hearing                Administration, Attention: DEA Federal                Importer of Controlled Substances
                                                    should also be sent to: (1) Drug                        Register Representative/DRW, 8701                     Application: Cambridge Isotope
                                                    Enforcement Administration, Attn:                       Morrissette Drive, Springfield, Virginia              Laboratories
                                                    Hearing Clerk/LJ, 8701 Morrissette                      22152.
                                                    Drive, Springfield, Virginia 22152; and                 SUPPLEMENTARY INFORMATION: The                        ACTION:      Notice of application.
                                                    (2) Drug Enforcement Administration,                    Attorney General has delegated his
                                                    Attn: DEA Federal Register                              authority under the Controlled                        DATES:  Registered bulk manufacturers of
                                                    Representative/DRW, 8701 Morrissette                    Substances Act to the Administrator of                the affected basic classes, and
                                                    Drive, Springfield, Virginia 22152.                     the Drug Enforcement Administration                   applicants therefore, may file written
                                                    SUPPLEMENTARY INFORMATION: The                          (DEA), 28 CFR 0.100(b). Authority to                  comments on or objections to the
                                                    Attorney General has delegated his                      exercise all necessary functions with                 issuance of the proposed registration in
                                                    authority under the Controlled                          respect to the promulgation and                       accordance with 21 CFR 1301.34(a) on
                                                    Substances Act to the Administrator of                  implementation of 21 CFR part 1301,                   or before May 25, 2017. Such persons
                                                    the Drug Enforcement Administration                     incident to the registration of                       may also file a written request for a
                                                    (DEA), 28 CFR 0.100(b). Authority to                    manufacturers, distributors, dispensers,              hearing on the application pursuant to
                                                    exercise all necessary functions with                   importers, and exporters of controlled                21 CFR 1301.43 on or before May 25,
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    respect to the promulgation and                         substances (other than final orders in                2017.
                                                    implementation of 21 CFR part 1301,                     connection with suspension, denial, or                ADDRESSES: Written comments should
                                                    incident to the registration of                         revocation of registration) has been                  be sent to: Drug Enforcement
                                                    manufacturers, distributors, dispensers,                redelegated to the Assistant                          Administration, Attention: DEA Federal
                                                    importers, and exporters of controlled                  Administrator of the DEA Diversion                    Register Representative/DRW, 8701
                                                    substances (other than final orders in                  Control Division (‘‘Assistant                         Morrissette Drive, Springfield, Virginia
                                                    connection with suspension, denial, or                  Administrator’’) pursuant to section 7 of             22152. All requests for hearing must be
                                                    revocation of registration) has been                    28 CFR part 0, appendix to subpart R.                 sent to: Drug Enforcement


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                                                    19084                                      Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices

                                                    Administration, Attn: Administrator,                                         authority under the Controlled                                               redelegated to the Assistant
                                                    8701 Morrissette Drive, Springfield,                                         Substances Act to the Administrator of                                       Administrator of the DEA Diversion
                                                    Virginia 22152. All requests for hearing                                     the Drug Enforcement Administration                                          Control Division (‘‘Assistant
                                                    should also be sent to: (1) Drug                                             (DEA), 28 CFR 0.100(b). Authority to                                         Administrator’’) pursuant to section 7 of
                                                    Enforcement Administration, Attn:                                            exercise all necessary functions with                                        28 CFR part 0, appendix to subpart R.
                                                    Hearing Clerk/LJ, 8701 Morrissette                                           respect to the promulgation and                                                In accordance with 21 CFR
                                                    Drive, Springfield, Virginia 22152; and                                      implementation of 21 CFR part 1301,                                          1301.34(a), this is notice that on August
                                                    (2) Drug Enforcement Administration,                                         incident to the registration of                                              25, 2016, Cambridge Isotope
                                                    Attn: DEA Federal Register                                                   manufacturers, distributors, dispensers                                      Laboratories, 50 Frontage Road,
                                                    Representative/DRW, 8701 Morrissette                                         importers, and exporters of, controlled                                      Andover, Massachusetts 01810 applied
                                                    Drive, Springfield, Virginia 22152.                                          substances (other than final orders in                                       to be registered as an importer of the
                                                    SUPPLEMENTARY INFORMATION: The                                               connection with suspension, denial, or                                       following basic classes of controlled
                                                    Attorney General has delegated his                                           revocation of registration) has been                                         substances:

                                                                                                                            Controlled substance                                                                                          Drug code     Schedule

                                                    Mephedrone (4-Methyl-N-methylcathinone) ..................................................................................................................                                  1248   I
                                                    Gamma Hydroxybutyric Acid .........................................................................................................................................                         2010   I
                                                    Methaqualone ................................................................................................................................................................               2565   I
                                                    Lysergic acid diethylamide ............................................................................................................................................                     7315   I
                                                    Marihuana ......................................................................................................................................................................            7360   I
                                                    Tetrahydrocannabinols ..................................................................................................................................................                    7370   I
                                                    3,4-Methylenedioxyamphetamine ..................................................................................................................................                            7400   I
                                                    3,4-Methylenedioxy-N-ethylamphetamine .....................................................................................................................                                 7404   I
                                                    3,4-Methylenedioxymethamphetamine ..........................................................................................................................                                7405   I
                                                    Methylone (3,4-Methylenedioxy-N-methylcathinone) ....................................................................................................                                       7540   I
                                                    Butylone .........................................................................................................................................................................          7541   I
                                                    Heroin ............................................................................................................................................................................         9200   I
                                                    Pentobarbital ..................................................................................................................................................................            2270   II
                                                    Secobarbital ...................................................................................................................................................................            2315   II
                                                    Phencyclidine .................................................................................................................................................................             7471   II
                                                    Cocaine ..........................................................................................................................................................................          9041   II
                                                    Dihydrocodeine ..............................................................................................................................................................               9120   II
                                                    Ecgonine ........................................................................................................................................................................           9180   II
                                                    Meperidine .....................................................................................................................................................................            9230   II
                                                    Dextropropoxyphene, bulk (non-dosage forms) ............................................................................................................                                    9273   II
                                                    Fentanyl .........................................................................................................................................................................          9801   II



                                                       The company plans to import the                                           DATES:  Registered bulk manufacturers of                                     implementation of 21 CFR part 1301,
                                                    listed controlled substances for                                             the affected basic classes, and                                              incident to the registration of
                                                    analytical research, testing and clinical                                    applicants therefore, may file written                                       manufacturers, distributors, dispensers,
                                                    trials.                                                                      comments on or objections to the                                             importers, and exporters of controlled
                                                      Dated: April 18, 2017.                                                     issuance of the proposed registration in                                     substances (other than final orders in
                                                    Louis J. Milione,                                                            accordance with 21 CFR 1301.33(a) on                                         connection with suspension, denial, or
                                                    Assistant Administrator.
                                                                                                                                 or before June 26, 2017.                                                     revocation of registration) has been
                                                    [FR Doc. 2017–08346 Filed 4–24–17; 8:45 am]                                  ADDRESSES: Written comments should                                           redelegated to the Assistant
                                                    BILLING CODE 4410–09–P
                                                                                                                                 be sent to: Drug Enforcement                                                 Administrator of the DEA Diversion
                                                                                                                                 Administration, Attention: DEA Federal                                       Control Division (‘‘Assistant
                                                                                                                                 Register Representative/DRW, 8701                                            Administrator’’) pursuant to section 7 of
                                                    DEPARTMENT OF JUSTICE                                                        Morrissette Drive, Springfield, Virginia                                     28 CFR part 0, appendix to subpart R.
                                                                                                                                 22152.
                                                    Drug Enforcement Administration                                                                                                                             In accordance with 21 CFR
                                                                                                                                 SUPPLEMENTARY INFORMATION:    The                                            1301.33(a), this is notice that on
                                                    [Docket No. DEA–392]                                                         Attorney General has delegated his                                           November 22, 2016, Siegfried USA,
                                                                                                                                 authority under the Controlled                                               LLC, 33 Industrial Park Road,
                                                    Bulk Manufacturer of Controlled                                              Substances Act to the Administrator of                                       Pennsville, New Jersey 08070 applied to
                                                    Substances Application: Siegfried                                            the Drug Enforcement Administration                                          be registered as a bulk manufacturer of
                                                    USA, LLC                                                                     (DEA), 28 CFR 0.100(b). Authority to                                         the following basic classes of controlled
                                                                                                                                 exercise all necessary functions with                                        substances:
                                                    ACTION:       Notice of application.
                                                                                                                                 respect to the promulgation and
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                            Controlled substance                                                                                          Drug code     Schedule

                                                    Gamma Hydroxybutyric Acid .........................................................................................................................................                         2010   I
                                                    Dihydromorphine ............................................................................................................................................................                9145   I
                                                    Hydromorphinol ..............................................................................................................................................................               9301   I
                                                    Methylphenidate .............................................................................................................................................................               1724   II
                                                    Amobarbital ....................................................................................................................................................................            2125   II
                                                    Pentobarbital ..................................................................................................................................................................            2270   II
                                                    Secobarbital ...................................................................................................................................................................            2315   II



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Document Created: 2017-04-25 02:18:33
Document Modified: 2017-04-25 02:18:33
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 1301.34(a) on or before May 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 25, 2017.
FR Citation82 FR 19083 

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