80 FR 58790 - Manufacturer of Controlled Substances Registration: Noramco, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 189 (September 30, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 189 (September 30, 2015)
| Page Range | 58790-58790 | |
| FR Document | 2015-24747 |
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)] [Notices] [Page 58790] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24747] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Noramco, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22555, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Noramco, Inc. to manufacture 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Codeine-N-oxide (9053)..................... I Dihydromorphine (9145)..................... I Morphine-N-oxide (9307).................... I Amphetamine (1100)......................... II Methylphenidate (1724)..................... II Phenylacetone (8501)....................... II Codeine (9050)............................. II Dihydrocodeine (9120)...................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Hydrocodone (9193)......................... II Morphine (9300)............................ II Oripavine (9330)........................... II Thebaine (9333)............................ II Opium extracts (9610)...................... II Opium fluid extract (9620)................. II Opium tincture (9630)...................... II Opium, powdered (9639)..................... II Opium, granulated (9640)................... II Oxymorphone (9652)......................... II Noroxymorphone (9668)...................... II Tapentadol (9780).......................... II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: September 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-24747 Filed 9-29-15; 8:45 am] BILLING CODE 4410-09-P
![58790 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices
Controlled substance Schedule inspecting and testing the company’s sulfuric acid mist, particulate matter
physical security systems, verifying the and VOC emission limits, failure to
Methadone (9250) ........................ II company’s compliance with state and operate in compliance with opacity
Methadone intermediate (9254) ... II local laws, and reviewing the company’s limits, failure to perform required audits
Dextropropoxyphene, bulk (non- II background and history. and maintain required quality data
dosage forms) (9273). Therefore, pursuant to 21 U.S.C. availability, failure to properly operate
Morphine (9300) ........................... II
Thebaine (9333) ........................... II
823(a), and in accordance with 21 CFR and calibrate the continuous emission
Levo-alphacetylmethadol (9648) .. II 1301.33, the above-named company is monitoring systems (CEMS) for NOX
Oxymorphone (9652) ................... II granted registration as a bulk and CO, failure to conduct stack testing
Noroxymorphone (9668) .............. II manufacturer of the basic classes of every 30 months, and failure to properly
Racemethorphan (9732) .............. II controlled substances: report non-compliance. The violations
Alfentanil (9737) ........................... II alleged in the Complaint with respect to
Remifentanil (9739) ...................... II Controlled substance Schedule VIWAPA’s St. John facility concern
Sufentanil (9740) .......................... II VIWAPA’s failure to comply with the
Carfentanil (9743) ......................... II Codeine-N-oxide (9053) ............... I
Tapentadol (9780) ........................ II
RICE NESHAP regulations, failure to
Dihydromorphine (9145) ............... I
Fentanyl (9801) ............................ II timely submit a Title V renewal
Morphine-N-oxide (9307) ............. I
Amphetamine (1100) .................... II
application and operation without a
The company plans to manufacture Methylphenidate (1724) ................ II Title V permit, and failure to conduct
small quantities of the listed controlled Phenylacetone (8501) .................. II stack testing every 30 months.
substances to make reference standards Codeine (9050) ............................. II The Consent Decree requires VIWAPA
which will be distributed to their Dihydrocodeine (9120) ................. II to generate a high percentage of its KWh
customers. Oxycodone (9143) ........................ II from liquid propane gas or liquid
Hydromorphone (9150) ................ II natural gas and renewables, to
Dated: September 21, 2015. Hydrocodone (9193) ..................... II implement a spare parts inventory
Joseph T. Rannazzisi, Morphine (9300) ........................... II program, to control NOX emissions
Deputy Assistant Administrator. Oripavine (9330) ........................... II through improved operation of its water
Thebaine (9333) ........................... II
[FR Doc. 2015–24748 Filed 9–29–15; 8:45 am] injection system, to maintain and
Opium extracts (9610) .................. II
BILLING CODE 4410–09–P
Opium fluid extract (9620) ............ II operate continuous emissions
Opium tincture (9630) .................. II monitoring systems on specified units,
Opium, powdered (9639) ............. II to operate a video camera system for
DEPARTMENT OF JUSTICE Opium, granulated (9640) ............ II visible emissions, to perform stack
Oxymorphone (9652) ................... II testing, and to conduct targeted self-
Drug Enforcement Administration Noroxymorphone (9668) .............. II audits and third party audits given its
[Docket No. DEA–392] Tapentadol (9780) ........................ II long term compliance problems. The
Consent Decree also requires a
Manufacturer of Controlled The company plans to manufacture $1,300,000 penalty to be paid within
Substances Registration: Noramco, the above-listed controlled substances two years of the Effective Date of the
Inc. in bulk for distribution to its customers. Consent Decree. The penalty amount
Dated: September 21, 2015. was based upon VIWAPA’s limited
ACTION: Notice of registration. financial ability to pay a penalty.
Joseph T. Rannazzisi,
The Department of Justice will
SUMMARY: Noramco, Inc. applied to be Deputy Assistant Administrator.
receive, for a period of thirty (30) days
registered as a manufacturer of certain [FR Doc. 2015–24747 Filed 9–29–15; 8:45 am]
from the date of this publication,
basic classes of controlled substances. BILLING CODE 4410–09–P
comments relating to the Consent
The Drug Enforcement Administration
Decree. Comments should be addressed
(DEA) grants Noramco, Inc. registration
to the Assistant Attorney General for the
as a manufacturer of those controlled DEPARTMENT OF JUSTICE
Environmental and Natural Resources
substances.
Notice of Lodging of Proposed Division, and should refer to United
SUPPLEMENTARY INFORMATION: By notice States v. Virgin Islands Water and
Consent Decree Under the Clean Air
dated April 14, 2015, and published in Act Power Authority, DOJ Ref. # 90–5–2–1–
the Federal Register on April 22, 2015, 10424. All comments must be submitted
80 FR 22555, Noramco, Inc., 500 On September 24, 2015, the no later than thirty days after the
Swedes Landing Road, Wilmington, Department of Justice lodged a proposed publication date of this notice.
Delaware 19801–4417 applied to be Consent Decree with the United States Comments may be submitted either by
registered as a manufacturer of certain District Court of the Virgin Islands in email or by mail:
basic classes of controlled substances. the lawsuit entitled United States of
No comments or objections were America v. Virgin Islands Water and To submit Send them to:
submitted for this notice. Power Authority, Civil Action No. 3:14– comments:
The DEA has considered the factors in cv–00086.
21 U.S.C. 823(a) and determined that The Consent Decree resolves Clean By email ....... pubcomment-ees.enrd@
usdoj.gov.
the registration of Noramco, Inc. to Air Act violations alleged in the By mail ......... Assistant Attorney General,
mstockstill on DSK4VPTVN1PROD with NOTICES
manufacture the basic classes of Complaint filed by the United States on U.S. DOJ—ENRD, P.O.
controlled substances is consistent with October 30, 2014. The violations alleged Box 7611, Washington, DC
the public interest and with United in the Complaint with respect to 20044–7611.
States obligations under international VIWAPA’s St. Thomas facility include
treaties, conventions, or protocols in VIWAPA’s failure to properly operate During the public comment period,
effect on May 1, 1971. The DEA and/or maintain its water injection the Consent Decree may be examined
investigated the company’s maintenance systems on its gas turbine units, failure and downloaded at this Justice
of effective controls against diversion by to operate in compliance with NOX, Department Web site: http://
VerDate Sep<11>2014 21:47 Sep 29, 2015 Jkt 235001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\30SEN1.SGM 30SEN1](https://thefederalregister.org/doc/80_FR_58979/page/1.svg)
Document Created: 2015-12-15 09:31:40
Document Modified: 2015-12-15 09:31:40
| 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 58790 |
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