80 FR 76311 - Importer of Controlled Substances Registration: Cody Laboratories, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 235 (December 8, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 235 (December 8, 2015)
| Page Range | 76311-76312 | |
| FR Document | 2015-30814 |
[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)] [Notices] [Pages 76311-76312] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30814] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Cody Laboratories, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: [[Page 76312]] By notice dated August 10, 2015, and published in the Federal Register on August 18, 2015, 80 FR 50032, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414-9321 applied to be registered as an importer of certain basic classes of controlled substances. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Cody Laboratories, Inc. to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Phenylacetone (8501)....................... II Poppy Straw Concentrate (9670)............. II Tapentadol (9780).......................... II ------------------------------------------------------------------------ The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with the DEA as a manufacturer of several controlled substances that are manufactured from poppy straw concentrate. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacturer tapentadol for distribution to its customers. Dated: November 30, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-30814 Filed 12-7-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices 76311
and BOEM. However, BSEE works importers, and exporters of controlled classes of controlled substances.
closely with BOEM to review the substances (other than final orders in Comments and requests for hearings on
regulatory reporting requirements and to connection with suspension, denial, or applications to import narcotic raw
ensure there is no duplicative reporting. revocation of registration) has been material are not appropriate. 72 FR 3417
For more information on BSEE and redelegated to the Deputy Assistant (January 25, 2007). No comments or
BOEM individual reporting Administrator of the DEA Office of objections were submitted for this
requirements refer to 30 CFR 250 and Diversion Control (‘‘Deputy Assistant notice.
550 respectively. Administrator’’) pursuant to section 7 of The DEA has considered the factors in
Public Availability of Comments: 28 CFR part 0, appendix to subpart R. 21 U.S.C. 823, 952(a) and 958(a) and
Before including your address, phone In accordance with 21 CFR determined that the registration of
number, email address, or other 1301.33(a), this is notice that on October Cambrex Charles City to import the
personal identifying information in your 26, 2015, Johnson Matthey basic classes of controlled substances is
comment, you should be aware that Pharmaceutical Materials, Inc., consistent with the public interest and
your entire comment—including your Pharmaceutical Service, 25 Patton Road, with United States obligations under
personal identifying information—may Devens, Massachusetts 01434 applied to international treaties, conventions, or
be made publicly available at any time. be registered as a bulk manufacturer of protocols in effect on May 1, 1971. The
While you can ask us in your comment the following basic classes controlled DEA investigated the company’s
to withhold your personal identifying substances: maintenance of effective controls
information from public review, we against diversion by inspecting and
cannot guarantee that we will be able to Controlled substance Schedule testing the company’s physical security
do so. systems, verifying the company’s
Amphetamine (1100) .................... II
Dated: November 19, 2015. compliance with state and local laws,
Methylphenidate (1724) ................ II
Robert W. Middleton, Nabilone (7379) ............................ II and reviewing the company’s
Deputy Chief, Office of Offshore Regulatory Hydrocodone (9193) ..................... II background and history.
Programs. Alfentanil (9737) ........................... II Therefore, pursuant to 21 U.S.C.
[FR Doc. 2015–30883 Filed 12–7–15; 8:45 am] Remifentanil (9739) ...................... II 952(a) and 958(a), and in accordance
BILLING CODE 4310–VH–P
Sufentanil (9740) .......................... II with 21 CFR 1301.34, the above-named
company is granted registration as an
The company plans to utilize this importer of the following basic classes
facility to manufacture small quantities of controlled substances:
DEPARTMENT OF JUSTICE
of the listed controlled substances in
Drug Enforcement Administration bulk and to conduct analytical testing in Controlled substance Schedule
support of the company’s primary
[Docket No. DEA–392] manufacturing facility in West Deptford, 4-Anilino-N-phenethyl-4-piperidine II
New Jersey. The controlled substances (ANPP) (8333).
Bulk Manufacturer of Controlled Phenylacetone (8501) .................. II
manufactured in bulk at this facility will Opium, raw (9600) ....................... II
Substances Application: Johnson
be distributed to its customers. Poppy Straw Concentrate (9670) II
Matthey Pharmaceutical Materials, Inc.
Dated: November 30, 2015.
ACTION: Notice of application. Louis J. Milione, The company plans to import the
Deputy Assistant Administrator. listed controlled substances for internal
DATES: Registered bulk manufacturers of use, and to manufacture bulk
[FR Doc. 2015–30811 Filed 12–7–15; 8:45 am]
the affected basic classes, and intermediates for sale to its customers.
BILLING CODE 4410–09–P
applicants therefore, may file written
Dated: November 30, 2015.
comments on or objections to the
issuance of the proposed registration in Louis J. Milione,
DEPARTMENT OF JUSTICE Deputy Assistant Administrator.
accordance with 21 CFR 1301.33(a) on
or before February 8, 2016. [FR Doc. 2015–30813 Filed 12–7–15; 8:45 am]
Drug Enforcement Administration
ADDRESSES: Written comments should BILLING CODE 4410–09–P
be sent to: Drug Enforcement [Docket No. DEA–392]
Administration, Attention: DEA Federal Importer of Controlled Substances
Register Representative/OD/D, 8701 DEPARTMENT OF JUSTICE
Registration: Cambrex Charles City
Morrissette Drive, Springfield, Virginia Drug Enforcement Administration
22152. Request for hearing should be ACTION: Notice of registration.
sent to: Drug Enforcement
SUMMARY: Cambrex Charles City applied [Docket No. DEA–392]
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive, to be registered as an importer of certain
Importer of Controlled Substances
Springfield, Virginia 22152. basic classes of controlled substances.
Registration: Cody Laboratories, Inc.
SUPPLEMENTARY INFORMATION: The The Drug Enforcement Administration
Attorney General has delegated her (DEA) grants Cambrex Charles City ACTION: Notice of registration.
authority under the Controlled registration as an importer of those
Substances Act to the Administrator of controlled substances. SUMMARY: Cody Laboratories, Inc.
applied to be registered as an importer
Lhorne on DSK9F6TC42PROD with NOTICES
the Drug Enforcement Administration SUPPLEMENTARY INFORMATION: By notice
(DEA), 28 CFR 0.100(b). Authority to dated August 21, 2015, and published in of certain basic classes of controlled
exercise all necessary functions with the Federal Register on August 31, substances. The Drug Enforcement
respect to the promulgation and 2015, 80 FR 52510, Cambrex Charles Administration (DEA) grants Cody
implementation of 21 CFR part 1301, City, 1205 11th Street, Charles City, Laboratories, Inc. registration as an
incident to the registration of Iowa 50616–3466 applied to be importer of those controlled substances.
manufacturers, distributors, dispensers, registered as an importer of certain basic SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 14:17 Dec 07, 2015 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/80_FR_76546/page/1.svg)
![76312 Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices
By notice dated August 10, 2015, and DEPARTMENT OF JUSTICE The company plans to manufacture
published in the Federal Register on bulk controlled substances for use in
August 18, 2015, 80 FR 50032, Cody Drug Enforcement Administration product development and for
Laboratories, Inc., 601 Yellowstone distribution to its customers.
Avenue, Cody, Wyoming 82414–9321 [Docket No. DEA–392] In reference to drug code 7360
applied to be registered as an importer (marihuana), and 7370 (THC), the
Bulk Manufacturer of Controlled company plans to bulk manufacture
of certain basic classes of controlled
Substances Application: AMRI these drugs as synthetic. No other
substances. Comments and requests for
Rensselaer, Inc. activities for these drug codes are
hearings on applications to import
narcotic raw material are not authorized for this registration.
ACTION: Notice of application.
appropriate. 72 FR 3417 (January 25, Dated: November 30, 2015.
2007). No comments or objections were DATES: Registered bulk manufacturers of Louis J. Milione,
submitted for this notice. the affected basic classes, and Deputy Assistant Administrator.
The DEA has considered the factors in applicants therefore, may file written [FR Doc. 2015–30812 Filed 12–7–15; 8:45 am]
21 U.S.C. 823, 952(a) and 958(a) and comments on or objections to the BILLING CODE 4410–09–P
determined that the registration of Cody issuance of the proposed registration in
Laboratories, Inc. to import the basic accordance with 21 CFR 1301.33(a) on
or before February 8, 2016. DEPARTMENT OF JUSTICE
classes of controlled substances is
consistent with the public interest and ADDRESSES: Written comments should
be sent to: Drug Enforcement Notice of Lodging of Proposed
with United States obligations under Consent Decree Under CERCLA
international treaties, conventions, or Administration, Attention: DEA Federal
protocols in effect on May 1, 1971. The Register Representative/OD/D, 8701 On November 20, 2015, the
Morrissette Drive, Springfield, Virginia Department of Justice lodged a proposed
DEA investigated the company’s
22152. Request for hearing should be Consent Decree with the United States
maintenance of effective controls
sent to: Drug Enforcement District Court for the Northern District
against diversion by inspecting and Administration, Attention: Hearing
testing the company’s physical security of Oklahoma, in the lawsuit entitled
Clerk/LJ, 8701 Morrissette Drive, United States v. The Doe Run Resources
systems, verifying the company’s Springfield, Virginia 22152.
compliance with state and local laws, Childress Royalty Corporation and NL
SUPPLEMENTARY INFORMATION: Industries Inc., Case No. 4:15–cv–
and reviewing the company’s
The Attorney General has delegated 00663–CVE–TLW.
background and history. her authority under the Controlled Defendants leased property where
Therefore, pursuant to 21 U.S.C. Substances Act to the Administrator of mining operations took place at the Tar
952(a) and 958(a), and in accordance the Drug Enforcement Administration Creek Site. The proposed settlement
with 21 CFR 1301.34, the above-named (DEA), 28 CFR 0.100(b). Authority to resolves the United States’ claims and
company is granted registration as an exercise all necessary functions with the claims of the State of Oklahoma on
importer of the following basic classes respect to the promulgation and behalf of the Oklahoma Department of
of controlled substances: implementation of 21 CFR part 1301, Environmental Quality against The Doe
incident to the registration of Run Resources Corporation (‘‘Doe Run’’)
manufacturers, distributors, dispensers, and NL Industries Inc. (‘‘NL’’) under
importers, and exporters of controlled Section 107 of CERCLA for recovery of
Controlled substance Schedule substances (other than final orders in response costs incurred and to be
connection with suspension, denial, or incurred at the Site. Under the proposed
Phenylacetone (8501) .................. II revocation of registration) has been Consent Decree, Doe Run will pay
Poppy Straw Concentrate (9670) II redelegated to the Deputy Assistant $3,433,137 and NL will pay $6,603,590
Tapentadol (9780) ........................ II Administrator of the DEA Office of to resolve the United States’ claims. Doe
Diversion Control (‘‘Deputy Assistant Run and NL will pay $62,000 and
The company plans to import narcotic Administrator’’) pursuant to section 7 of $225,000 respectively to resolve the
raw materials for manufacturing and 28 CFR part 0, appendix to subpart R. claims of the State. In addition, the
further distribution to its customers. In accordance with 21 CFR Settling Federal Agency (the
The company is registered with the DEA 1301.33(a), this is notice that on October Department of the Interior) is resolving
as a manufacturer of several controlled 2, 2015, AMRI Rensselaer, Inc., 33 its CERCLA liability at the Site by
substances that are manufactured from Riverside Avenue, Rensselaer, New paying $5.0 million.
poppy straw concentrate. York 12144 applied to be registered as The publication of this notice opens
a bulk manufacturer of the following a period for public comment on the
The company plans to import an basic classes controlled substances: Consent Decree. Comments should be
intermediate form of tapentadol (9780),
addressed to the Assistant Attorney
to bulk manufacturer tapentadol for Controlled substance Schedule
General, Environment and Natural
distribution to its customers.
Marihuana (7360) ......................... I Resources Division, and should refer to
Dated: November 30, 2015. Tetrahydrocannabinols (7370) ..... I United States of America v. The Doe
Louis J. Milione, Amphetamine (1100) .................... II Run Resources Childress Royalty
Lhorne on DSK9F6TC42PROD with NOTICES
Deputy Assistant Administrator. Lisdexamfetamine (1205) ............. II Corporation and NL Industries Inc.,
Methylphenidate (1724) ................ II Case No. 4:15–cv–00663–CVE–TLW, D.J.
[FR Doc. 2015–30814 Filed 12–7–15; 8:45 am]
Pentobarbital (2270) ..................... II Ref. No. 90–11–2–330/10. All comments
BILLING CODE 4410–09–P 4-Anilino-N-phenethyl-4-piperidine II must be submitted no later than thirty
(ANPP) (8333). (30) days after the publication date of
Meperidine (9230) ........................ II
Fentanyl (9801) ............................ II
this notice. Comments may be
submitted either by email or by mail:
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Document Created: 2015-12-14 13:27:02
Document Modified: 2015-12-14 13:27:02
| 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 registration. | |
| FR Citation | 80 FR 76311 |
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