Manufacturer of Controlled Substances; Notice of Application, 63203 [2010-25849]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices CPC and requires CPC to inform EPA of its choice of compliance option within 30 days from the effective date of the decree. Under Option 1, CPC will construct a new Kiln 6 as authorized by an Arizona Department of Environmental Quality permit within a 42-month time period and permanently shut down kilns 1–4 within six months of commencing operation of Kiln 6. Under Option 2, CPC will continue to operate Kilns 1 through 4 but will install Particulate Matter controls (enclosures, spraybars and upgrades to existing baghouses) and accept more stringent limits than those already in the permit on equipment previously modified. Option 2 requires stricter opacity standards for some limestone storage piles, mill feed hoppers, and mill rejects bins. Option 2 also imposes lower emission limits on various baghouses and dust collectors and requires the installation of a bag leak detection system. Option 2 also requires CPC to install software to optimize the operation of the existing kilns, which EPA expects will lead to reduced fuel use and reduced combustion emissions. The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to pubcomment-ees.enrd@usdoj.gov or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611, and should refer to United States v. CalPortland Company, No. 4:10–CV–00573–DCB and DOJ No. 90– 5–2–1–08306. The Consent Decree may be examined at the Office of the United States Attorney for the District of Arizona, 405 W. Congress Street, Suite 4800, Tucson, AZ 85701–5040. During the public comment period, the Consent Decree may also be examined on the following Department of Justice Web site: https:// www.usdoj.gov/enrd/ Consent_Decrees.html. A copy of the Consent Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611, or by faxing or e-mailing a request to Tonia Fleetwood, tonia.fleetwood@usdoj.gov, Fax No. (202) 514–0097, phone confirmation number (202) 514–1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $11.25 (25 cents per VerDate Mar<15>2010 16:30 Oct 13, 2010 Jkt 223001 page reproduction cost) payable to the U.S. Treasury. Maureen Katz, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2010–25876 Filed 10–13–10; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on January 28, 2010, PCAS–Nanosyn, LLC, 3331–B Industrial Drive, Santa Rosa, California 95403, made application to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Amphetamine (1100) .................... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Phencyclidine (7471) .................... Codeine (9050) ............................. Diprenorphine (9058) ................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Morphine (9300) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II The company is a contract manufacturer. At the request of the company’s customers, it manufactures derivatives of controlled substances in bulk form only. The primary service provided by the company to its customers is the development of the process of manufacturing the derivative. As part of its service to its customers, the company distributes the derivatives of the controlled substances it manufactures to those customers. The company’s customers use the newlycreated processes and the manufactured derivatives in furtherance of formulation processes and dosage form manufacturing; pre-clinical studies, including toxicological studies; clinical studies supporting investigational Drug Applications; and use in stability studies. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR § 1301.33(a). PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 63203 Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 13, 2010. Dated: October 6, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–25849 Filed 10–13–10; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA–2010–0044] Advisory Committee on Construction Safety and Health (ACCSH); Notice of Reestablishment of Charter Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice of reestablishment of the ACCSH Charter. AGENCY: The Secretary of Labor has reestablished the Charter of the Advisory Committee on Construction Safety and Health (ACCSH) for two years. FOR FURTHER INFORMATION CONTACT: Mr. Francis Dougherty, Office of Construction Services, Directorate of Construction, Occupational Safety and Health Administration, Room N–3468, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693–2020 (TTY (877) 889–5627). SUPPLEMENTARY INFORMATION: In accordance with the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App. 2), and its implementing regulations (41 CFR 102–3 et seq.), the Secretary of Labor (Secretary) is reestablishing the ACCSH Charter for two years. The Charter will be dated, signed, and filed on October 29, 2010 and will expire two years from the date filed. ACCSH is a continuing advisory committee established under Section 107 of the Contract Work Hours and Safety Standards Act (Construction Safety Act (CSA))(40 U.S.C. 3704(d)(4)), to advise the Secretary and the Assistant Secretary of Labor for Occupational Safety and Health in the formulation of construction safety and health standards as well as on policy matters arising under the CSA and the Occupational SUMMARY: E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 75, Number 198 (Thursday, October 14, 2010)]
[Notices]
[Page 63203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25849]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on January 28, 2010, PCAS-
Nanosyn, LLC, 3331-B Industrial Drive, Santa Rosa, California 95403, 
made application to the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of the basic classes of controlled substances listed in 
schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Methylphenidate (1724).....................  II
Phencyclidine (7471).......................  II
Codeine (9050).............................  II
Diprenorphine (9058).......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company is a contract manufacturer. At the request of the 
company's customers, it manufactures derivatives of controlled 
substances in bulk form only. The primary service provided by the 
company to its customers is the development of the process of 
manufacturing the derivative. As part of its service to its customers, 
the company distributes the derivatives of the controlled substances it 
manufactures to those customers. The company's customers use the newly-
created processes and the manufactured derivatives in furtherance of 
formulation processes and dosage form manufacturing; pre-clinical 
studies, including toxicological studies; clinical studies supporting 
investigational Drug Applications; and use in stability studies.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, may file comments 
or objections to the issuance of the proposed registration pursuant to 
21 CFR Sec.  1301.33(a).
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than December 13, 2010.

    Dated: October 6, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-25849 Filed 10-13-10; 8:45 am]
BILLING CODE 4410-09-P
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