Importer of Controlled Substances Application: Shertech Laboratories, LLC, 26446-26447 [2019-11876]
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26446
Federal Register / Vol. 84, No. 109 / Thursday, June 6, 2019 / Notices
therefore has determined to exercise its
authority to extend the review period by
up to 90 days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: This review is being
conducted under authority of title VII of
the Tariff Act of 1930; this notice is
published pursuant to section 207.62 of
the Commission’s rules.
By order of the Commission.
Issued: May 31, 2019.
Lisa Barton,
Secretary to the Commission.
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: American
Radiolabeled Chem
ACTION:
Notice of application.
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 5, 2019.
DATES:
[FR Doc. 2019–11819 Filed 6–5–19; 8:45 am]
BILLING CODE 7020–02–P
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
DEPARTMENT OF JUSTICE
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 7, 2019,
American Radiolabeled Chem, 101 Arc
Drive, Saint Louis, Missouri 63146
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Ibogaine ...........................................................................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine ...............................................................................................................................
Dihydromorphine .............................................................................................................................................................
Heroin ..............................................................................................................................................................................
Normorphine ....................................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
Phenylacetone .................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Metazocine ......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Phenazocine ....................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to manufacture
small quantities of the above-listed
controlled substances as radiolabeled
compounds for biochemical research.
Dated: May 24, 2019.
John J. Martin,
Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Shertech Laboratories,
LLC
khammond on DSKBBV9HB2PROD with NOTICES
[FR Doc. 2019–11878 Filed 6–5–19; 8:45 am]
ACTION:
BILLING CODE 4410–09–P
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 July 8, 2019. Such persons
may also file a written request for a
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hearing on the application on or before
July 8, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
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,
SUPPLEMENTARY INFORMATION:
Notice of application.
DATES:
2010
7260
7315
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7470
9145
9200
9313
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7471
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9041
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9652
9715
9743
9801
Schedule
E:\FR\FM\06JNN1.SGM
06JNN1
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Federal Register / Vol. 84, No. 109 / Thursday, June 6, 2019 / Notices
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
February 25, 2019, Shertech
Laboratories, LLC, 1185 Woods Chapel
Road, Duncan, South Carolina 29334
applied to be registered as an importer
of the following basic class of controlled
substance:
controlled substance in bulk form to
conduct clinical trials.
Approval of permit applications will
occur only when the registrant’s activity
is consistent with what is authorized
under to 21 U.S.C.952 (a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: May 17, 2019.
John J. Martin,
Assistant Administrator.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[FR Doc. 2019–11876 Filed 6–5–19; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Cocaine ........................
Drug
code
9041
Schedule
[Docket No. DEA–392]
II
Bulk Manufacturer of Controlled
Substances Application: SpecGx LLC
The company plans to import
synthetic derivatives of the listed
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 5, 2019.
DATES:
ACTION:
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 1, 2019,
SpecGx LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147 applied to
be registered as a bulk manufacturer of
the following basic class of controlled
substances:
Notice of application.
khammond on DSKBBV9HB2PROD with NOTICES
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Difenoxin ..........................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Butyryl Fentanyl ...............................................................................................................................................................
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) .....................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
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7370
9053
9145
9168
9307
9313
9634
9821
9822
9850
1100
1105
1205
1724
7379
8333
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9273
9300
9330
9333
9630
9639
9652
9668
9737
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9801
Schedule
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]]>Agencies
[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Notices]
[Pages 26446-26447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11876]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Shertech
Laboratories, LLC
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 July 8, 2019. Such
persons may also file a written request for a hearing on the
application on or before July 8, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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,
[[Page 26447]]
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
February 25, 2019, Shertech Laboratories, LLC, 1185 Woods Chapel Road,
Duncan, South Carolina 29334 applied to be registered as an importer of
the following basic class of controlled substance:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Cocaine................................ 9041 II
------------------------------------------------------------------------
The company plans to import synthetic derivatives of the listed
controlled substance in bulk form to conduct clinical trials.
Approval of permit applications will occur only when the
registrant's activity is consistent with what is authorized under to 21
U.S.C.952 (a)(2).
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.
Dated: May 17, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-11876 Filed 6-5-19; 8:45 am]
BILLING CODE 4410-09-P
