83_FR_37673 83 FR 37525 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.

83 FR 37525 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 148 (August 1, 2018)

Page Range37525-37525
FR Document2018-16466

Federal Register, Volume 83 Issue 148 (Wednesday, August 1, 2018)
[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Notices]
[Page 37525]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16466]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research 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 August 31, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before August 31, 2018.

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 Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request 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 delegated 
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 July 
3, 2018, Galephar Pharmaceutical Research Inc., #100 Carr 198 
Industrial Park, Juncos, Puerto Rico 00777 applied to be registered as 
an importer of the following basic class of controlled substance:

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Hydromorphone..........................    9150  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.

    Dated: July 23, 2018.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2018-16466 Filed 7-31-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices                                                        37525

                                                                                    Drug                   respect to the promulgation and                        Hearing Clerk/LJ, 8701 Morrissette
                                                   Controlled substance                      Schedule
                                                                                    code                   implementation of 21 CFR part 1301,                    Drive, Springfield, Virginia 22152; and
                                                                                                           incident to the registration of                        (2) Drug Enforcement Administration,
                                                Phenylacetone ................      8501    II             manufacturers, distributors, dispensers,               Attn: DEA Federal Register
                                                Poppy Straw Con-                    9670    II             importers, and exporters of controlled                 Representative/DRW, 8701 Morrissette
                                                  centrate.
                                                                                                           substances (other than final orders in                 Drive, Springfield, Virginia 22152.
                                                Tapentadol ......................   9780    II
                                                                                                           connection with suspension, denial, or                 SUPPLEMENTARY INFORMATION: The
                                                                                                           revocation of registration) has been                   Attorney General has delegated his
                                                   The company plans to import narcotic
                                                                                                           delegated to the Assistant Administrator               authority under the Controlled
                                                raw materials to manufacture bulk
                                                                                                           of the DEA Diversion Control Division                  Substances Act to the Administrator of
                                                controlled substances for distribution to
                                                                                                           (‘‘Assistant Administrator’’) pursuant to              the Drug Enforcement Administration
                                                its customers. The company plans to
                                                                                                           section 7 of 28 CFR part 0, appendix to                (DEA), 28 CFR 0.100(b). Authority to
                                                import an intermediate form of
                                                                                                           subpart R.                                             exercise all necessary functions with
                                                tapentadol (9780), to bulk manufacture                        In accordance with 21 CFR
                                                tapentadol for distribution to its                                                                                respect to the promulgation and
                                                                                                           1301.34(a), this is notice that on July 3,             implementation of 21 CFR part 1301,
                                                customers.                                                 2018, Galephar Pharmaceutical                          incident to the registration of
                                                  Dated: July 23, 2018.                                    Research Inc., #100 Carr 198 Industrial                manufacturers, distributors, dispensers,
                                                John J. Martin,                                            Park, Juncos, Puerto Rico 00777 applied                importers, and exporters of controlled
                                                Assistant Administrator.                                   to be registered as an importer of the                 substances (other than final orders in
                                                [FR Doc. 2018–16467 Filed 7–31–18; 8:45 am]                following basic class of controlled                    connection with suspension, denial, or
                                                BILLING CODE 4410–09–P                                     substance:                                             revocation of registration) has been
                                                                                                                                                                  redelegated to the Assistant
                                                                                                                                            Drug
                                                                                                                Controlled substance        code      Schedule    Administrator of the DEA Diversion
                                                DEPARTMENT OF JUSTICE                                                                                             Control Division (‘‘Assistant
                                                                                                           Hydromorphone ..............      9150     II          Administrator’’) pursuant to section 7 of
                                                Drug Enforcement Administration                                                                                   28 CFR part 0, appendix to subpart R.
                                                [Docket No. DEA–392]                                          The company plans to import the                        In accordance with 21 CFR
                                                                                                           listed controlled substance in finished                1301.34(a), this is notice that on April
                                                Importer of Controlled Substances                          dosage form for clinical trials, research              4, 2018, Ultra Scientific Inc., 250 Smith
                                                Application: Galephar Pharmaceutical                       and analytical purposes.                               Street, North Kingstown, Rhode Island
                                                Research Inc.                                                Dated: July 23, 2018.                                02852 applied to be registered as an
                                                                                                           John J. Martin,                                        importer of the following basic classes
                                                ACTION:    Notice of application.                                                                                 of controlled substances:
                                                                                                           Assistant Administrator.
                                                DATES:  Registered bulk manufacturers of                   [FR Doc. 2018–16466 Filed 7–31–18; 8:45 am]                                                Drug
                                                                                                                                                                    Controlled substance                     Schedule
                                                the affected basic classes, and                            BILLING CODE 4410–09–P                                                                     code
                                                applicants therefore, may file written
                                                comments on or objections to the                                                                                  Marihuana .......................   7360   I
                                                                                                           DEPARTMENT OF JUSTICE                                  Tetrahydrocannabinols ...           7370   I
                                                issuance of the proposed registration on
                                                or before August 31, 2018. Such persons                                                                             The company plans to import
                                                                                                           Drug Enforcement Administration
                                                may also file a written request for a                                                                             derivatives of the listed controlled
                                                hearing on the application on or before                    [Docket No. DEA–392]
                                                                                                                                                                  substances for use as chemical
                                                August 31, 2018.                                                                                                  standards for testing and calibration
                                                                                                           Importer of Controlled Substances
                                                ADDRESSES: Written comments should                                                                                only of analytical equipment. The above
                                                                                                           Application: Ultra Scientific Inc.
                                                be sent to: Drug Enforcement                                                                                      controlled substances will not be
                                                Administration, Attention: DEA Federal                     ACTION:    Notice of application.                      imported for human or animal
                                                Register Representative/DRW, 8701                                                                                 consumption.
                                                Morrissette Drive, Springfield, Virginia                   DATES:  Registered bulk manufacturers of                 Dated: July 23, 2018.
                                                22152. All requests for hearing must be                    the affected basic classes, and
                                                                                                                                                                  John J. Martin,
                                                sent to: Drug Enforcement                                  applicants therefore, may file written
                                                Administration, Attn: Administrator,                                                                              Assistant Administrator.
                                                                                                           comments on or objections to the
                                                8701 Morrissette Drive, Springfield,                       issuance of the proposed registration on               [FR Doc. 2018–16465 Filed 7–31–18; 8:45 am]
                                                Virginia 22152. All request for hearing                    or before August 31, 2018. Such persons                BILLING CODE 4410–09–P
                                                should also be sent to: (1) Drug                           may also file a written request for a
                                                Enforcement Administration, Attn:                          hearing on the application on or before
                                                Hearing Clerk/LJ, 8701 Morrissette                         August 31, 2018.                                       DEPARTMENT OF JUSTICE
                                                Drive, Springfield, Virginia 22152; and                    ADDRESSES: Written comments should                     Drug Enforcement Administration
                                                (2) Drug Enforcement Administration,                       be sent to: Drug Enforcement
                                                Attn: DEA Federal Register                                 Administration, Attention: DEA Federal                 [Docket No. DEA–392]
                                                Representative/DRW, 8701 Morrissette                       Register Representative/DRW, 8701
                                                Drive, Springfield, Virginia 22152.                                                                               Importer of Controlled Substances
                                                                                                           Morrissette Drive, Springfield, Virginia
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                                                                  Application: Anderson Brecon, Inc.
                                                SUPPLEMENTARY INFORMATION: The                             22152. All requests for hearing must be
                                                Attorney General has delegated his                         sent to: Drug Enforcement                              ACTION:    Notice of application.
                                                authority under the Controlled                             Administration, Attn: Administrator,
                                                Substances Act to the Administrator of                     8701 Morrissette Drive, Springfield,                   DATES:  Registered bulk manufacturers of
                                                the Drug Enforcement Administration                        Virginia 22152. All request for hearing                the affected basic classes, and
                                                (DEA), 28 CFR 0.100(b). Authority to                       should also be sent to: (1) Drug                       applicants therefore, may file written
                                                exercise all necessary functions with                      Enforcement Administration, Attn:                      comments on or objections to the


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Document Created: 2018-08-01 01:22:36
Document Modified: 2018-08-01 01:22:36
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 August 31, 2018. Such persons may also file a written request for a hearing on the application on or before August 31, 2018.
FR Citation83 FR 37525 

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