Importer of Controlled Substances Application: Almac Clinical Services Inc. (ACSI), 22556-22557 [2015-09333]
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
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 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
1301.33(a), this is notice that on May 15,
2014, Cambrex Charles City, 1205 11th
Street, Charles City, Iowa 50616 applied
to be registered as a bulk manufacturer
the following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
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[FR Doc. 2015–09325 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Rhodes Technologies
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 in
accordance with 21 CFR 1301.34(a) on
or before May 22, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before May 22,
2015.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments
and request for hearings on applications
to import narcotic raw material are not
appropriate. 72 FR 3417 (January 25,
2007).
ADDRESSES:
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 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 March
10, 2015, Rhodes Technologies, 498
Washington Street, Coventry, Rhode
Island 02816 applied to be registered as
an importer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers, for dosage form
development, for clinical trials, and for
use in stability qualification studies.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Controlled Substance
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
Schedule
II
II
The company plans to import the
listed controlled substances in order to
bulk manufacture controlled substances
in Active Pharmaceutical Ingredient
(API) form. The company distributes the
manufactured APIs in bulk to its
customers.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09338 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Almac Clinical Services
Inc. (ACSI)
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 in
accordance with 21 CFR 1301.34(a) on
or before May 22, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before May 22,
2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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 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 March
DATES:
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
22557
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
1301.33(a), this is notice that on January
2, 2015, Sigma Aldrich Research
Biochemicals, Inc., 1–3 Strathmore
Road, Natick, Massachusetts 01760–
2447 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Schedule
5, 2015, Almac Clinical Services Inc.,
(ACSI), 25 Fretz Road, Souderton,
Pennsylvania 18964 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled substance
Schedule
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
Controlled substance
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09333 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Sigma Aldrich
Research Biochemicals, Inc.
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 in
accordance with 21 CFR 1301.33(a) on
or before June 22, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
Cathinone (1235) ..........................
Methcathinone (1237) ..................
Mephedrone
(4-Methyl-Nmethylcathinone) (1248).
Aminorex (1585) ...........................
Alpha-ethyltryptamine (7249) .......
Lysergic acid diethylamide (7315)
Tetrahydrocannabinols (7370) .....
4-Bromo-2,5dimethoxyamphetamine (7391).
4-Bromo-2,5dimethoxyphenethylamine
(7392).
4-Methyl-2,5dimethoxyamphetamine (7395).
2,5-Dimethoxyamphetamine
(7396).
3,4-Methylenedioxyamphetamine
(7400).
N-Hydroxy-3,4methylenedioxyamphetamine
(7402).
3,4-Methylenedioxy-Nethylamphetamine (7404).
3,4Methylenedioxymethamphetamine (7405).
Dimethyltryptamine (7435) ...........
Psilocybin (7437) ..........................
5-Methoxy-N,Ndiisopropyltryptamine (7439).
1-[1-(2Thienyl)cyclohexyl]piperidine
(7470).
N-Benzylpiperazine (7493) ...........
MDPV
(3,4Methylenedioxypyrovalerone)
(7535).
Methylone (3,4-Methylenedioxy-Nmethylcathinone).
(7540) ...........................................
Heroin (9200) ...............................
Normorphine (9313) .....................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Nabilone (7379) ............................
1-Phenylcyclohexylamine (7460)
Phencyclidine (7471) ....................
Cocaine (9041) .............................
Codeine (9050) .............................
Ecgonine (9180) ...........................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Meperidine (9230) ........................
Metazocine (9240) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Schedule
Controlled substance
Levo-alphacetylmethadol (9648) ..
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Carfentanil (9743) .........................
Fentanyl (9801) ............................
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The company plans to manufacture
reference standards.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09328 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Cayman
Chemicals Company
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 in
accordance with 21 CFR 1301.33(a) on
or before June 22, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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 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
1301.33(a), this is notice that on July 24,
2014, Cayman Chemical Company, 1180
DATES:
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]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22556-22557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09333]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Almac Clinical
Services Inc. (ACSI)
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 22, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before May 22, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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 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 March
[[Page 22557]]
5, 2015, Almac Clinical Services Inc., (ACSI), 25 Fretz Road,
Souderton, Pennsylvania 18964 applied to be registered as an importer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Tapentadol (9780).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09333 Filed 4-21-15; 8:45 am]
BILLING CODE 4410-09-P
