80 FR 52510 - Importer of Controlled Substances Application: Cambrex Charles City

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 168 (August 31, 2015)

Page Range		52510-52511
FR Document		2015-21557

Federal Register, Volume 80 Issue 168 (Monday, August 31, 2015)

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Pages 52510-52511]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21557]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Cambrex Charles 
City

ACTION: Notice of application.

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[[Page 52511]]


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 September 30, 2015. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 30, 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. 
Comments and request for hearings on applications to import narcotic 
raw material are not appropriate. 72 FR 3417 (January 25, 2007).

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 June 
3, 2015, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616-3466 applied to be registered as an importer of the following 
basic classes of controlled substances:

 
------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
internal use, and to manufacture bulk intermediates for sale to its 
customers.

    Dated: August 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-21557 Filed 8-28-15; 8:45 am]
BILLING CODE 4410-09-P

52510 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices

Administrator’’) pursuant to section 7 of implementation of 21 CFR part 1301, Clerk/LJ, 8701 Morrissette Drive,
28 CFR part 0, appendix to subpart R. incident to the registration of Springfield, Virginia 22152. Comments
In accordance with 21 CFR manufacturers, distributors, dispensers, and requests for hearings on
1301.34(a), this is notice that on April importers, and exporters of controlled applications to import narcotic raw
24, 2015, Alltech Associates, Inc., 2051 substances (other than final orders in material are not appropriate. 72 FR 3417
Waukegan Road, Deerfield, Illinois connection with suspension, denial, or (January 25, 2007).
60015 applied to be registered as an revocation of registration) has been SUPPLEMENTARY INFORMATION: The
importer of the following basic classes redelegated to the Deputy Assistant Attorney General has delegated her
of controlled substances: Administrator of the DEA Office of authority under the Controlled
Diversion Control (‘‘Deputy Assistant Substances Act to the Administrator of
Controlled substance Schedule Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
28 CFR part 0, appendix to subpart R. (DEA), 28 CFR 0.100(b). Authority to
Gamma Hydroxybutyric Acid I In accordance with 21 CFR
(2010). exercise all necessary functions with
1301.34(a), this is notice that on July 27, respect to the promulgation and
Lysergic acid diethylamide (7315) I
Heroin (9200) ............................... I 2015, Catalent Pharma Solutions, LLC, implementation of 21 CFR part 1301,
Meperidine (9230) ........................ II 10381 Decatur Road, Philadelphia, incident to the registration of
Pennsylvania 19114 applied to be manufacturers, distributors, dispensers
The company plans to import these registered as an importer of importers, and exporters of, controlled
controlled substances for the hydromorphone (9150), a basic class of substances (other than final orders in
manufacture of reference standards. controlled substance listed in schedule connection with suspension, denial, or
II. revocation of registration) has been
Dated: August 21, 2015. The company plans to import the
Joseph T. Rannazzisi,
redelegated to the Deputy Assistant
above listed controlled substance for a Administrator of the DEA Office of
Deputy Assistant Administrator. clinical trial study. Approval of permit Diversion Control (‘‘Deputy Assistant
[FR Doc. 2015–21470 Filed 8–28–15; 8:45 am] applications will occur only when the Administrator’’) pursuant to section 7 of
BILLING CODE 4410–09–P registrant’s business activity is 28 CFR part 0, appendix to subpart R.
consistent with what is authorized In accordance with 21 CFR
under to 21 U.S.C. 952(a)(2). 1301.34(a), this is notice that on July 16,
DEPARTMENT OF JUSTICE Authorization will not extend to the 2014, Noramco, Inc., 1440 Olympic
import of FDA approved or non- Drive, Athens, Georgia 30601, applied to
Drug Enforcement Administration approved finished dosage forms for be registered as an importer of the
[Docket No. DEA–392] commercial sale. following basic classes of controlled
Dated: August 21, 2015. substances:
Importer of Controlled Substances Joseph T. Rannazzisi,
Application: Catalent Pharma Controlled substance Schedule
Deputy Assistant Administrator.
Solutions, LLC
[FR Doc. 2015–21520 Filed 8–28–15; 8:45 am] Phenylacetone (8501) .................. II
ACTION: Notice of application. BILLING CODE 4410–09–P Thebaine (9333) ........................... II
Poppy Straw Concentrate (9670) II
DATES: Registered bulk manufacturers of Tapentadol (9780) ........................ II
the affected basic class, and applicants DEPARTMENT OF JUSTICE
therefore, may file written comments on The company plans to import
or objections to the issuance of the Drug Enforcement Administration thebaine (9333) analytical reference
proposed registration in accordance [Docket No. DEA–392] standards for distribution to its
with 21 CFR 1301.34(a) on or before customers. The company plans to
September 30, 2015. Such persons may Importer of Controlled Substances import an intermediate form of
also file a written request for a hearing Application: Noramco, Inc. tapentadol (9780) to bulk manufacture
on the application pursuant to 21 CFR tapentadol for distribution to its
1301.43 on or before September 30, ACTION: Notice of application. customers. The company plans to
2015. import phenylacetone (8501) and poppy
DATES: Registered bulk manufacturers of straw concentrate (9670) to manufacture
ADDRESSES: Written comments should the affected basic classes, and other controlled substances.
be sent to: Drug Enforcement applicants therefore, may file written
Administration, Attention: DEA Federal Dated: August 21, 2015.
comments on or objections to the
Register Representative/ODXL, 8701 issuance of the proposed registration in Joseph T. Rannazzisi,
Morrissette Drive, Springfield, Virginia accordance with 21 CFR 1301.34(a) on Deputy Assistant Administrator.
22152. Request for hearings should be or before September 30, 2015. Such [FR Doc. 2015–21545 Filed 8–28–15; 8:45 am]
sent to: Drug Enforcement persons may also file a written request BILLING CODE 4410–09–P
Administration, Attention: Hearing for a hearing on the application
Clerk/LJ, 8701 Morrissette Drive, pursuant to 21 CFR 1301.43 on or before
Springfield, Virginia 22152. September 30, 2015. DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: The ADDRESSES: Written comments should
Drug Enforcement Administration
tkelley on DSK3SPTVN1PROD with NOTICES

Attorney General has delegated her be sent to: Drug Enforcement
authority under the Controlled Administration, Attention: DEA Federal [Docket No. DEA–392]
Substances Act to the Administrator of Register Representative/ODXL, 8701
the Drug Enforcement Administration Morrissette Drive, Springfield, Virginia Importer of Controlled Substances
(DEA), 28 CFR 0.100(b). Authority to 22152. Request for hearings should be Application: Cambrex Charles City
exercise all necessary functions with sent to: Drug Enforcement ACTION: Notice of application.
respect to the promulgation and Administration, Attention: Hearing

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Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices 52511

DATES: Registered bulk manufacturers of Dated: August 21, 2015. Controlled substance Schedule
the affected basic classes, and Joseph T. Rannazzisi,
applicants therefore, may file written Deputy Assistant Administrator. Remifentanil (9739) ...................... II
comments on or objections to the [FR Doc. 2015–21557 Filed 8–28–15; 8:45 am]
Sufentanil (9740) .......................... II
issuance of the proposed registration in BILLING CODE 4410–09–P
accordance with 21 CFR 1301.34(a) on The company plans to utilize this
or before September 30, 2015. Such facility to manufacture small quantities
persons may also file a written request DEPARTMENT OF JUSTICE of the listed controlled substances in
for a hearing on the application bulk and to conduct analytical testing in
pursuant to 21 CFR 1301.43 on or before Drug Enforcement Administration support of the company’s primary
September 30, 2015. manufacturing facility in West Deptford,
[Docket No. DEA–392] New Jersey. The controlled substances
ADDRESSES: Written comments should manufactured in bulk at this facility will
be sent to: Drug Enforcement Manufacturer of Controlled
be distributed to its company’s
Administration, Attention: DEA Federal Substances Registration: Johnson
customers.
Register Representative/ODXL, 8701 Matthey Pharmaceutical Materials, Inc.
Dated: August 21, 2015.
Morrissette Drive, Springfield, Virginia ACTION: Notice of registration. Joseph T. Rannazzisi,
22152. Request for hearings should be
Deputy Assistant Administrator.
sent to: Drug Enforcement SUMMARY: Johnson Matthey
[FR Doc. 2015–21521 Filed 8–28–15; 8:45 am]
Administration, Attention: Hearing Pharmaceutical Materials, Inc. applied
Clerk/LJ, 8701 Morrissette Drive, BILLING CODE 4410–09–P
to be registered as a manufacturer of
Springfield, Virginia 22152. Comments certain basic classes of controlled
and request for hearings on applications substances. The Drug Enforcement
DEPARTMENT OF JUSTICE
to import narcotic raw material are not Administration (DEA) grants Johnson
appropriate. 72 FR 3417 (January 25, Matthey Pharmaceutical Materials, Inc. Drug Enforcement Administration
2007). registration as a manufacturer of those
controlled substances. [Docket No. DEA–392]
SUPPLEMENTARY INFORMATION: The
SUPPLEMENTARY INFORMATION: By notice Bulk Manufacturer of Controlled
Attorney General has delegated her
dated April 14, 2015, and published in Substances Application: Rhodes
authority under the Controlled
the Federal Register on April 22, 2015, Technologies
Substances Act to the Administrator of 80 FR 22559, Johnson Matthey
the Drug Enforcement Administration Pharmaceutical Materials, Inc., 25 ACTION: Notice of application.
(DEA), 28 CFR 0.100(b). Authority to Patton Road, Devens, Massachusetts
exercise all necessary functions with 01434 applied to be registered as a DATES: Registered bulk manufacturers of
respect to the promulgation and manufacturer of certain basic classes of the affected basic classes, and
implementation of 21 CFR part 1301, controlled substances. No comments or applicants therefore, may file written
incident to the registration of objections were submitted for this comments on or objections to the
manufacturers, distributors, dispensers, notice. issuance of the proposed registration in
importers, and exporters of controlled The DEA has considered the factors in accordance with 21 CFR 1301.33(a) on
substances (other than final orders in 21 U.S.C. 823(a) and determined that or before October 30, 2015.
connection with suspension, denial, or the registration of Johnson Matthey ADDRESSES: Written comments should
revocation of registration) has been Pharmaceutical Materials, Inc. to be sent to: Drug Enforcement
redelegated to the Deputy Assistant manufacture the basic classes of Administration, Attention: DEA Federal
Administrator of the DEA Office of controlled substances is consistent with Register Representative/ODXL, 8701
Diversion Control (‘‘Deputy Assistant the public interest and with United Morrissette Drive, Springfield, Virginia
Administrator’’) pursuant to section 7 of States obligations under international 22152. Request for hearings should be
28 CFR part 0, appendix to subpart R. treaties, conventions, or protocols in sent to: Drug Enforcement
In accordance with 21 CFR effect on May 1, 1971. The DEA Administration, Attention: Hearing
1301.34(a), this is notice that on June 3, investigated the company’s maintenance Clerk/LJ, 8701 Morrissette Drive,
2015, Cambrex Charles City, 1205 11th of effective controls against diversion by Springfield, Virginia 22152.
Street, Charles City, Iowa 50616–3466 inspecting and testing the company’s SUPPLEMENTARY INFORMATION: The
applied to be registered as an importer physical security systems, verifying the Attorney General has delegated her
of the following basic classes of company’s compliance with state and authority under the Controlled
controlled substances: local laws, and reviewing the company’s Substances Act to the Administrator of
background and history. the Drug Enforcement Administration
Therefore, pursuant to 21 U.S.C. (DEA), 28 CFR 0.100(b). Authority to
Controlled substance Schedule 823(a), and in accordance with 21 CFR exercise all necessary functions with
1301.33, the above-named company is respect to the promulgation and
4-Anilino-N-phenethyl-4-piperidine II granted registration as a bulk implementation of 21 CFR part 1301,
(8333). manufacturer of the basic classes of incident to the registration of
Phenylacetone (8501) .................. II controlled substances: manufacturers, distributors, dispensers,
Opium, raw (9600) ....................... II
tkelley on DSK3SPTVN1PROD with NOTICES

importers, and exporters of controlled
Poppy Straw Concentrate (9670) II Controlled substance Schedule substances (other than final orders in
Amphetamine (1100) .................... II
connection with suspension, denial, or
The company plans to import the Methylphenidate (1724) ................ II revocation of registration) has been
listed controlled substances for internal Nabilone (7379) ............................ II redelegated to the Deputy Assistant
use, and to manufacture bulk Hydrocodone (9193) ..................... II Administrator of the DEA Office of
intermediates for sale to its customers. Alfentanil (9737) ........................... II Diversion Control (‘‘Deputy Assistant

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Document Created: 2018-02-23 11:04:09
Document Modified: 2018-02-23 11:04:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015.
FR Citation		80 FR 52510

80 FR 52510 - Importer of Controlled Substances Application: Cambrex Charles City

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 168 (August 31, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration