81_FR_54761 81 FR 54603 - Importer of Controlled Substances Application: Bellwyck Clinical Services

81 FR 54603 - Importer of Controlled Substances Application: Bellwyck Clinical Services

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range54603-54603
FR Document2016-19437

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 September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016)
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Page 54603]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19437]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Bellwyck Clinical 
Services

ACTION: Notice of application.

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

SUMMARY: 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 September 15, 2016. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 15, 2016.

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

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on April 
18, 2016, Bellwyck Clinical Services, 8946 Global Way, West Chester, 
Ohio 45069 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
                  Controlled substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724)..................................              II
Oxycodone (9143)........................................              II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets. Authorization will not extend to the import of FDA approved or 
non-approved finished dosage forms for commercial sale.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19437 Filed 8-15-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                   Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices                                                54603

                                                    issuance of the proposed registration in                  clinical trials, research and analytical               In accordance with 21 CFR
                                                    accordance with 21 CFR 1301.34(a) on                      purposes.                                            1301.34(a), this is notice that on April
                                                    or before September 15, 2016. Such                                                                             18, 2016, Bellwyck Clinical Services,
                                                                                                              Louis J. Milione,
                                                    persons may also file a written request                                                                        8946 Global Way, West Chester, Ohio
                                                                                                              Deputy Assistant Administrator.                      45069 applied to be registered as an
                                                    for a hearing on the application
                                                                                                              [FR Doc. 2016–19438 Filed 8–15–16; 8:45 am]          importer of the following basic classes
                                                    pursuant to 21 CFR 1301.43 on or before
                                                    September 15, 2016.                                       BILLING CODE 4410–09–P                               of controlled substances:

                                                    ADDRESSES:   Written comments should                                                                               Controlled substance            Schedule
                                                    be sent to: Drug Enforcement                              DEPARTMENT OF JUSTICE
                                                    Administration, Attention: DEA Federal                                                                         Methylphenidate (1724) ........                II
                                                                                                              Drug Enforcement Administration                      Oxycodone (9143) ................              II
                                                    Register Representative/ODW, 8701
                                                    Morrissette Drive, Springfield, Virginia                                                                          The company plans to import the
                                                                                                              [Docket No. DEA–392]
                                                    22152. All requests for hearing must be                                                                        listed controlled substances in finished
                                                    sent to: Drug Enforcement                                 Importer of Controlled Substances                    dosage form (FDF) from foreign sources
                                                    Administration, Attn: Administrator,                      Application: Bellwyck Clinical Services              for analytical testing and clinical trials
                                                    8701 Morrissette Drive, Springfield,                                                                           in which the foreign FDF will be
                                                    Virginia 22152. All requests for hearing                  ACTION:   Notice of application.                     compared to the company’s own
                                                    should also be sent to: (1) Drug                                                                               domestically-manufactured FDF. This
                                                    Enforcement Administration, Attn:                         SUMMARY:   Registered bulk                           analysis is required to allow the
                                                    Hearing Clerk/LJ, 8701 Morrissette                        manufacturers of the affected basic                  company to export domestically-
                                                                                                              classes, and applicants therefore, may               manufactured FDF to foreign markets.
                                                    Drive, Springfield, Virginia 22152; and
                                                                                                              file written comments on or objections               Authorization will not extend to the
                                                    (2) Drug Enforcement Administration,
                                                                                                              to the issuance of the proposed                      import of FDA approved or non-
                                                    Attn: DEA Federal Register                                registration in accordance with 21 CFR
                                                    Representative/ODW, 8701 Morrissette                                                                           approved finished dosage forms for
                                                                                                              1301.34(a) on or before September 15,                commercial sale.
                                                    Drive, Springfield, Virginia 22152.                       2016. Such persons may also file a
                                                    SUPPLEMENTARY INFORMATION:      The                       written request for a hearing on the                 Louis J. Milione,
                                                    Attorney General has delegated her                        application pursuant to 21 CFR 1301.43               Deputy Assistant Administrator.
                                                    authority under the Controlled                            on or before September 15, 2016.                     [FR Doc. 2016–19437 Filed 8–15–16; 8:45 am]
                                                    Substances Act to the Administrator of                    ADDRESSES: Written comments should                   BILLING CODE 4410–09–P

                                                    the Drug Enforcement Administration                       be sent to: Drug Enforcement
                                                    (DEA), 28 CFR 0.100(b). Authority to                      Administration, Attention: DEA Federal
                                                                                                              Register Representative/ODW, 8701                    DEPARTMENT OF JUSTICE
                                                    exercise all necessary functions with
                                                    respect to the promulgation and                           Morrissette Drive, Springfield, Virginia
                                                                                                                                                                   Drug Enforcement Administration
                                                    implementation of 21 CFR part 1301,                       22152. All requests for hearing must be
                                                    incident to the registration of                           sent to: Drug Enforcement                            [Docket No. DEA–392]
                                                    manufacturers, distributors, dispensers,                  Administration, Attn: Administrator,
                                                                                                              8701 Morrissette Drive, Springfield,                 Importer of Controlled Substances
                                                    importers, and exporters of controlled                                                                         Application: AMRI Rensselaer, Inc.
                                                    substances (other than final orders in                    Virginia 22152. All requests for hearing
                                                                                                              should also be sent to: (1) Drug                     ACTION:   Notice of application.
                                                    connection with suspension, denial, or
                                                                                                              Enforcement Administration, Attn:
                                                    revocation of registration) has been
                                                                                                              Hearing Clerk/LJ, 8701 Morrissette                   SUMMARY:   Registered bulk
                                                    redelegated to the Deputy Assistant                       Drive, Springfield, Virginia 22152; and              manufacturers of the affected basic
                                                    Administrator of the DEA Office of                        (2) Drug Enforcement Administration,                 classes, and applicants therefore, may
                                                    Diversion Control (‘‘Deputy Assistant                     Attn: DEA Federal Register                           file written comments on or objections
                                                    Administrator’’) pursuant to section 7 of                 Representative/ODW, 8701 Morrissette                 to the issuance of the proposed
                                                    28 CFR part 0, appendix to subpart R.                     Drive, Springfield, Virginia 22152.                  registration in accordance with 21 CFR
                                                      In accordance with 21 CFR                               SUPPLEMENTARY INFORMATION: The                       1301.34(a) on or before September 15,
                                                    1301.34(a), this is notice that on June 2,                Attorney General has delegated her                   2016. Such persons may also file a
                                                    2016, Actavis Laboratories FL., Inc.,                     authority under the Controlled                       written request for a hearing on the
                                                    4955 Orange Drive, Davie, Florida 33314                   Substances Act to the Administrator of               application pursuant to 21 CFR 1301.43
                                                    applied to be registered as an importer                   the Drug Enforcement Administration                  on or before September 15, 2016.
                                                    of the following basic classes of                         (DEA), 28 CFR 0.100(b). Authority to                 ADDRESSES: Written comments should
                                                    controlled substances:                                    exercise all necessary functions with                be sent to: Drug Enforcement
                                                                                                              respect to the promulgation and                      Administration, Attention: DEA Federal
                                                         Controlled substance               Schedule          implementation of 21 CFR part 1301,                  Register Representative/ODW, 8701
                                                                                                              incident to the registration of                      Morrissette Drive, Springfield, Virginia
                                                    Amphetamine (1100) ............                      II   manufacturers, distributors, dispensers              22152. All requests for hearing must be
                                                    Methylphenidate (1724) ........                      II   importers, and exporters of controlled               sent to: Drug Enforcement
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                                                    Oxycodone (9143) ................                    II   substances (other than final orders in               Administration, Attn: Administrator,
                                                    Hydromorphone (9150) ........                        II   connection with suspension, denial, or               8701 Morrissette Drive, Springfield,
                                                    Hydrocodone (9193) .............                     II   revocation of registration) has been                 Virginia 22152. All requests for hearing
                                                    Fentanyl (9801) ....................                 II   redelegated to the Deputy Assistant                  should also be sent to: (1) Drug
                                                                                                              Administrator of the DEA Office of                   Enforcement Administration, Attn:
                                                      The company plans to import the                         Diversion Control (‘‘Deputy Assistant                Hearing Clerk/LJ, 8701 Morrissette
                                                    above-listed controlled substances for                    Administrator’’) pursuant to section 7 of            Drive, Springfield, Virginia 22152; and
                                                                                                              28 CFR part 0, appendix to subpart R.                (2) Drug Enforcement Administration,


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Document Created: 2016-08-16 03:20:10
Document Modified: 2016-08-16 03:20:10
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.
FR Citation81 FR 54603 

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